Hubert H. Humphrey Building
Washington, D.C.
The National Committee on Vital and Health Statistics was convened on February 21-22 at the Hubert Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Mr. Scanlon noted the presence of a new President and new HHS Secretary since the last NCVHS meeting. He described the Department’s preliminary work on a study by the National Academy of Sciences on race and ethnicity data in the health area. The NAS committee will be apprised of the National Committee’s work in this area. After noting that Dr. Sondik would be reporting on the Data Council’s work in the international area on WHO projects, Mr. Scanlon reported on the Data Council’s new working group to develop an overall strategy for the Department’s surveys on youth and substance abuse. The Data Strategy Work Group has been working on the 2002 budget, and work between that group and the HHS budget office has been close over the last year. Agency heads were asked to give special consideration to a set of priorities for improving data. The planning process worked well within HHS with respect to common data needs. Finally, Mr. Scanlon reviewed the status of recent NCVHS recommendations to the Department.
Dr. Braithwaite then reported that the HHS privacy rules were released on December 28, 2000. He said the Department hopes to release three more standards in 2001, and it is ready to act quickly on any needed revisions to published standards, consistent with HIPAA procedures.
Dr. Robinsue Frohboese, Deputy Director and Acting Head of the Office of HHS Civil Rights (OCR), discussed the final privacy rule and the role of OCR, which is responsible for enforcement. She said that due to a “glitch” in the submission of the rule, it will not go into effect until April 15, 2001, with the compliance date for all but small plans being two years after that. During this period, the Department will focus on public education, outreach, and technical assistance, and she described activities in each of these areas. OCR also is interested in suggestions on anything that may need fine-tuning. In response to a question, Dr. Frohboese said NCVHS would have an important role to play in any rule modification activities.
Linda Sanches of ASPE then gave a broad overview of the privacy rule: who is covered, new rights and requirements for covered entities, new requirements for business associates, and the HHS enforcement capacity. She noted that this is the first comprehensive set of health privacy protections that affects almost every provider and all health plans. It does not preempt more stringent or protective state laws. In response to a question, she expressed the view that its most important impact is to enable people to get information they had not had access to, and to give insight into how their information is used.
Edward Sondik, Ph.D., Director, NCHS, CDC
Dr. Sondik was part of a delegation to a meeting of the Executive Board of the World Health Organization on January 15-20, 2001. The Executive Board considered issues related to the WHO’s World Health Report, concerning both the document itself and the framework for continued evaluation of health status and health systems. Dr. Sondik gave an overview of the analytical framework for the Report, which was used to rank countries’ health care systems in terms of efficiency and performance, and he discussed some of the issues raised about the framework, the methodology and data validity, and the way the report was released.
At the meeting, the U.S. delegation recommended working on the validity and reliability of the analysis, to link the Report to health system improvement. It raised questions about what the summary measures really mean in terms of health system performance. The delegation also called for scientific peer review. The Executive Board included most of these points in its final recommendations. The framework that provides the core domains of health and that will be used for the continued evaluation of health status and health systems is the ICIDH-2. The Executive Board gave it a “ringing endorsement” as a classification system on functioning.
One purpose of the Report was to stimulate the development of more and better data resources, and Dr. Sondik said this is happening. Many countries were not happy with the data used to evaluate them, and they are now sending in better data. Both Dr. Sondik and Mr. Scanlon reported that the Report also has stimulated heightened efforts at cooperation among countries, to develop more valid and comparable assessments of the performance of their health care systems. The next step for the Report will be a regional review of the framework.
During the discussion period, the difference between the definitions of equity used in the U.S. and in the WHO Report were noted. Members commented on the need for a research agenda on these topics. Dr. Sondik stressed that the Department is very interested in getting the Committee’s thoughts on the directions it should take in this area.
The Committee discussed two draft reports that will be revised based on members comments. The reports are the Fourth Annual Report to Congress on HIPAA Implementation and the NCVHS Update to the Department. Minor edits were suggested to the first report, and for the second, it was suggested that the descriptions of Subcommittee activities be amplified. The final decisions on these documents are noted under Actions.
Dr. Hardy reported that an NCHS group is evaluating the feasibility of releasing more often than annual estimates for a small set of key health indicators from the National Health Interview Survey (NHIS), and doing so shortly after data collection. This is made possible by the cleaner and more rapid data produced by CAPI. The group convened an advisory body composed of federal representatives and outside health policy experts to suggest indicators, and a preliminary list has been developed. The NCHS team has concluded it can produce reliable quarterly or semi-annual estimates for most of the indicators. The information will be posted on the NCHS Website, probably starting with a release of some 2001 data in the summer of this year. NCHS will invite feedback as to the usefulness of the information.
During the discussion period, NCVHS members praised the idea of releasing data more rapidly, but expressed concern about a number of factors, including the potential impact on the use of the Healthy People 2010 leading health indicators, the adult focus of the current list, and the appropriateness of terminology used. It was suggested that both “sentinel” and “indicator” be avoided, possibly in favor of an emphasis on quick data turnaround. Questions also were raised about what the notion of sentinel health indicators is meant to convey, and about how the project is related to Healthy People 2010. The developers were encouraged to reconcile their list as much as possible with the 2010 indicators, and to provide explanations for the differences. It was also suggested that the focus of this NHIS project be on areas where little information is available, such as rural health, and that efforts be made to address future trends and to “think about where we want to go.” Other suggestions were creation of an advisory group to help establish a set of criteria, consultation with the Data Council about the direction and content of the project, and careful attention to the dissemination strategy. Finally, it was suggested that the Data Council develop a strategy encompassing all of the Department’s “indicator”-type projects.
Donna Pickett, M.P.H., R.H.I.A., NCHS
Ms. Pickett gave some background on the International Classification of Diseases and Health Related Problems and its latest revision, ICD-10, which was implemented for mortality in the U.S. in 1999. A study conducted under contract to HHS determined that with a clinical modification (and only with it), ICD-10 would be a significant improvement over ICD-9-CM for morbidity and worth the costs of implementation. After explaining why a clinical modification is needed, Ms. Pickett summarized the key features of ICD-10-CM. It is now being finalized based on recommendations from various sources, and an alphabetic index and crosswalks are being developed, along with revised guidelines. All will be tested under contract to HCFA. Training materials and a database version are under development.
In the discussion period, Dr. Starfield noted a number of concerns, particularly related to incentives to upcode. Dr. Cohn encouraged Ms. Pickett and her colleagues to document the benefits of ICD-10-CM over current practices, and also to involve others in the health care industry, including insurers and managed care representatives, in testing efforts.
A motion was unanimously passed approving the report on the Committee’s 50 years of history.
The Committee passed a motion approving a process for finalizing the NCVHS Update to the Department, as described under Actions.
The Committee approved a process for revising the Fourth Annual Report to Congress on HIPAA implementation (see Actions). It also approved a letter drafted by this Subcommittee concerning NDC codes (see Actions). Dr. Cohn reported that the letter on NDC codes will require a revised final rule, which is allowed under HIPAA.
The Subcommittee plans to hold hearings on recommendations and next steps on the PMRI on March 19-20. In May 1-2, and possibly again at the end of May, it will hold another hearing to take recommendations from the Designated Standards Maintenance Organizations (DSMOs) on any needed changes or recommendations related to the standards.
Mr. Rothstein reported that the Subcommittee plans to organize a hearing on the implementation of HIPAA privacy regulations, probably to be held prior to the June NCVHS meeting and in Chicago. The hearing will not be held until/unless the privacy rules are released. The Subcommittee also recommended an agenda item for the June meeting.
Dr. Friedman reported that the tentative deadline for draft one of the final report on a vision for 21st century health statistics is July 2001 (to be reviewed by the Data Council, the Committee, and NCHS), with a second draft by early September (to be circulated for external review) and a final report ready for review in February 2002. At Dr. Lumpkin’s suggestion, he said he would distribute the draft outline to the full Committee immediately.
Dr. Lumpkin reported that the Workgroup is now working on its final report, with the unifying theme being getting the right information to the right people at the right time for shared decision-making. Over the next few months, the Workgroup will be working on a series of recommendations for federal, state, and local government, for providers, and for other groups.
Dr. Friedman reported that the Subcommittee is working on its criteria and priorities for future projects.
Dr. Newacheck said the Subcommittee is continuing its project on functional status, and would present a draft report to the Committee for action in June (having circulated it in advance). The report will discuss the potential benefits of including functional status in administrative records and computerized patient records and propose that the International Classification of Functioning, Disability and Health (AKA ICIDH-2) be studied and tested as a possible classification for this purpose. Dr. Cohn offered some comments related to standards issues.
Dr. Mays reported on activities related to the OMB Guidance on race and ethnicity data, and the Committee approved a process for the Committee to provide comments to OMB concerning that document (see Actions).
DAY ONE
The first day of the meeting was chaired, in Dr. Lumpkin’s absence, by Dr. Simon Cohn, who asked all present to introduce themselves and reviewed the agenda before welcoming the first speaker.
Mr. Scanlon noted that since the last NCVHS meeting, a new Secretary of HHS has taken office, along with a new President. The Secretary has stated that his high priorities include Medicare, the Patient’s Bill of Rights, and affordable health insurance. As soon as possible, the Secretary will be briefed about the Committee and its recent recommendations.
Mr. Scanlon then reported on HHS activities in the data policy area. HHS has been directed to fund a study by the National Academy of Sciences on race and ethnicity data in the health area, with a report due to Congress in about a year on the effects of SES, race, and ethnicity on access to health care; disparities in health and other social outcomes; and the data needed to enforce equal access to care. The report also will examine the effectiveness of HHS and private sector data systems in this regard, and develop recommendations. HHS is currently talking with NAS about how to set up the study. HHS will bring the past work of NCVHS in this area to the attention of the Academy panel that does the study (probably through the National Research Council), and will have the panel brief the National Committee. The recommendations of the Data Council’s own race and ethnicity working group will also be provided to the NAS panel. Mr. Scanlon speculated that in areas where HHS has no control over providers’ data collection, it may be advisable to work with industry on developing consensus on what data to collect.
He turned to the Data Council’s work in the international arena, particularly on World Health Organization projects. He noted that later in this meeting, Dr. Sondik would discuss the World Health Report, which has prompted concerns among some countries. The HHS International and Refugee Health Office asked the Data Council to set up an expert group representing HHS and other agencies, to advise on this and other subjects. The Committee will be provided with its position paper on the World Health Report. Dr. Sondik will also report on the other activity in this area, ICIDH-2 and efforts to harmonize summary measures of health status.
In another area, the Data Council was asked to set up a working group to look at the three major surveys on youth and substance abuse, to analyze and show how the studies fit together and look for opportunities for coordination and integration to provide a more comprehensive picture.
The Data Strategy Work Group has been working on the 2002 budget, and work between that group and the HHS budget office has been close over the last year. The Data Council developed a framework for planning investments to improve data and information for decision-making. The framework was provided to agencies, who proposed enhancements. The strategy group then put together a cross-cutting analysis with a small subset of priorities that were communicated to the budget office¾ e.g., stabilizing the NCHS core data systems and increasing capacity for state and local data. Agency heads were asked to give that subset special consideration. Mr. Scanlon stressed that the outcome of the budget process is unpredictable, but the planning process worked well within HHS with respect to common data needs.
Finally he reviewed the status of NCVHS recommendations to the Department, including those on ICIDH-2, HIPAA implementation issues, and patient medical record information standards. Agencies were asked to comment on ways in which HHS could advance the Committee’s recommendations, and most have come forward with suggestions as well as expressions of concern in some areas. Both have been communicated to the Subcommittee on Standards and Security. In another area, Mr. Scanlon said there is growing interest in the NHII and how to help move it forward.
The privacy rule was published on December 28, giving HIPAA a “kick-start…in the real world.” The DSMOs have set up their web site, and WEDI recently held hearings on people’s experience implementing the HIPAA standards. For example, there is some concern about the time allowed for implementation, given the complexity of the standards; and there are calls for a security rule to go with the privacy rule. The Secretary is working with others on a more rapid means of issuing a maintenance and modifications to the standards.
Three proposed rules are planned for “estimated” release in 2001: for the plan identifier, claims attachment standard transaction, and general enforcement of the non-privacy HIPAA standards.
In response to a question, Dr. Braithwaite said the Department could act quickly to adopt changes to the standards if they are recommended promptly by the DSMOs. HIPAA allows amendments to the rules during the first year.
Dr. Robinsue Frohboese, Deputy Director and Acting Head of the Office of HHS Civil Rights (OCR), discussed the final privacy rule and the role of OCR. She noted that the Secretary has received many letters, some praising the rule and some expressing concerns about areas of it. Although it was scheduled to go into effect on February 26, a glitch in the way it was submitted has resulted in a delay, so it will go into effect on April 15, 2001 and then most providers have two years before it will be enforced (three years for small providers).
During this period, the Department is focusing on public education, outreach, and technical assistance. Authority for enforcement has been delegated to the OCR. The body of experts who put the rule together has been kept intact to advise on the interim activities, and OCR is working closely with the Data Council. It will be discussing implementation with representatives of the Social Security Administration, the Department of Veterans Affairs, and the DoD. GAO recently provided important testimony on the privacy rule at a Senate Health Committee hearing.
OCR has a toll-free number (1-866-627-7748) to field questions about the rule, and has received some 800 calls. It also has a website (www.hhs.gov/ocr/hipaa) that has generated about 250 e-mails, which are being analyzed to identify FAQs. A speaker’s bureau has made some 40 presentations, and more are scheduled. In addition to educating people and answering questions, the Office is interested in suggestions on anything that may need fine-tuning. It has a Policy Subcommittee and a Strategic Planning Committee which develops resource materials and is working on an enforcement plan.
In response to a question, Dr. Frohboese said NCVHS would have an important role to play in any rule modification activities. She said she would discuss this with the Privacy Subcommittee. Dr. Cohn said the Standards Subcommittee would also be available.
Linda Sanches of ASPE then gave a broad overview of the privacy rule: who is covered, new rights and requirements for covered entities, new requirements for business associates, and the HHS enforcement capacity. She noted that the rule (a result of HIPAA, subtitle F) was finalized after a review of 52,000 comments.
The rule covers health care providers who transmit health information in electronic transactions, health plans, and health care clearinghouses, as well as their business associates who hold protected information. Protected health information is individually identifiable health information that is transmitted or maintained in any form or medium.
Ms. Sanches identified key points on which there has been misunderstanding. First, required disclosures are limited to 1) disclosures to the individual who is the subject of the information and 2) disclosures to OCR to determine compliance. All other uses and disclosures in the rule are permissive, not required.
This is the first comprehensive set of health privacy protections that affects almost every provider and all health plans. It sets a “national floor” and does not preempt more stringent or protective state laws. It establishes a set of rights for individuals who are the subject of heath information¾ e.g., the right to an accounting of disclosures (one of six listed).
All uses and disclosures that a covered entity may make must be limited to what is permitted in the rule. It specifies requirements for uses and disclosures in four categories, including those related to health care operations (including payment) and those for specific public purposes. In all these areas except treatment by health care providers, covered entities must apply a “minimum necessary” analysis. Covered entities must set up general policies and procedures that they will follow in this regard, for both routine and non-routine disclosures. Minimum necessary also applies to requests for information. It does not apply to disclosures required by law.
Ms. Sanches identified the conditions under which written consents are required, noting that the consents are one-time-only forms. They are different from individual authorization, which is more detailed than consent. Treatment may not be conditioned on authorization for disclosure of information for other purposes. She explained nuances in this area involving oral assent, such as directory listings when a person is a hospital inpatient, and disaster relief situations.
The rule has detailed definitions and conditions for disclosures for a set of public purposes for which uses and disclosures can be made without individual consent or authorization. For example, Ms. Sanches discussed the requirements related to legally mandated disclosures and those for health oversight and public health. She also commented on applications of the rule for work that is outsourced or done by business associates. The covered entity must obtain “satisfactory assurance” (contractual) that the business associate will safeguard the information. She discussed the administrative requirements for covered entities, which include designating a privacy official, developing policies and procedures, and providing privacy training to the workforce.
Regarding enforcement, she said the statute establishes monetary and criminal penalties for violation. She noted that covered entities need to read the rule, and that many entities that are not covered will be affected by it so they need to think about their relationships with covered entities. She gave some examples, and then invited questions.
Dr. Cohn hailed the idea of having FAQs, in view of the complexity of the rules. Asked by Dr. Starfield what she viewed as the biggest single change the rules bring about, Ms. Sanches said they enable people to get information they had not had access to, and give insight into how their information is used. She confirmed that the new compliance date is April 15, 2003.
She and Dr. Fitzmaurice then explained about the new requirements for creation of privacy boards to review all research using protected health information. The board will be structured similar to an IRB. Other questions concerned the circumstances under which treatment is conditioned on consent, the thinking about the “partner” in organized health care, the “minimum necessary” requirement, and the process whereby consumers can inspect and amend their medical records.
Dr. Sondik was part of a delegation to a meeting of the Executive Board of the World Health Organization on January 15-20, 2001. The U.S. delegation included Tom Novotny (OIRH), May Lou Valdez (OIRH), Greg Meyer (AHRQ) and Dr. Sondik. The Executive Board considered two major issues related to its publication, the World Health Report: the document itself, and a framework for continued evaluation of health status and health systems.
The purpose of the health system performance analysis was to evaluate the efficiency of systems, based on the relationships between structures, expenditures, and outcomes. The overall goal was to improve health systems and to empower the public with information that is relevant to their well being. Dr. Sondik outlined its analytic framework, which was used to rank countries’ health care systems in terms of their efficiency and performance. The framework has gotten the most attention, he said. Issues concern the analytic framework itself, the validity of the data used, and the process surrounding release of the report. For example, data for the 191 member states were extrapolated from the available data on 30 countries. Member countries did not see the report prior to its release.
The framework has two dimensions: the average level of health in a country, and the distribution of health (getting at the issue of equity). Both health and responsiveness were measured in each of these dimensions, along with a fifth element, the distribution of financial contribution within the population. Together, these five elements were used to determine the system’s efficiency. (Responsiveness is the term used for what WHO calls the “non-health-improving” dimensions of interactions with the health system, including respect for persons and access to social support.)
The measure of fairness or equity is based on the difference between individual financial contributions to health expenses and the national average contribution. Dr. Sondik explained how the five elements (health level, health distribution, responsiveness, responsiveness distribution, and fairness of finance) were combined to determine the health care performance (efficiency) of a country. The determination involves the ratio between each country’s “maximum attainable” (based on expenditures and educational level) and “minimum possible” (what the health would be with no investments) levels. He noted that when all are plotted on a graph, there is a “frontier” that indicates a maximum level that is attainable for a given expenditure.
The framework that provides the core domains of health and that will be used for the continued evaluation of health status and health systems is the ICIDH-2 (also called the International Classification of Functioning, Disability, and Health). The classification has a list of core domains related to function; they do not include internal health information (e.g., particular diagnosis) or risk factors (e.g., drug use). Together they form a definition of health that will be combined into a summary health measure, using DALEs.
One purpose of the Report was to stimulate the development of more and better data resources, and Dr. Sondik said this is happening. Many countries were not happy with the data used to evaluate them, and they are sending in better data.
At its aforementioned meeting, the WHO Executive Board looked at several issues. Many countries felt it was not possible to rank 191 countries. The responsiveness index was an issue, along with the framework for efficiency and what it is really measuring. Peer review was strongly recommended. The use of the rankings was questioned; in general, Dr. Sondik said, “the rankings rankled.” The U.S. delegation recommended working on the validity and reliability of the analysis, to link the Report to health system improvement. It raised questions about what the summary measures really mean in terms of health system performance. The delegation also called for scientific peer review, an evaluation of the Report’s impact on system change, and efforts to harmonize with other countries in order to better compare health status. Dr. Sondik said the Report has had positive results in stimulating countries to work together toward better comparisons.
The WHO Director General endorsed a technical consultation process across all WHO regions and establishment of a small advisory group, and production of the Report every other year rather than annually. The WHO Executive Board requested (among other things) initiation of a scientific peer review and a multi-year plan for research and development, along with a plan to improve data quality. The Board issued a “strong, ringing endorsement” of ICIDH-2, independent of its appropriateness for country surveys and summary health measures. The next step for the Report will be a regional review of the framework. Cooperative activity on survey development has begun between the U.S., Canada, and some European countries.
Dr. Sondik concluded that the professional delegation from the U.S. “did a wonderful service” for the Department in stimulating a focus on these topics, which he expects will continue. He also praised the caliber of the WHO Executive Board and their skill in addressing these complicated issues.
Dr. Starfield was the first of several members to express appreciation for Dr. Sondik’s explanation of the World Health Report. She observed that the operative definition of equity used in the Report differs from that used in the U.S.; the latter is based on systematic disparities between population subgroups. Dr. Sondik said more research and development is needed in this area.
Dr. Friedman praised the goal of the Report but said he found its methodology “absolutely opaque.” In particular, he noted that the responsiveness measure was based only on “talking to a few folks in each country” and on obtaining a subjective opinion from them. Dr. Sondik agreed, adding that the Report erred in not identifying its shortcomings or issues to be dealt with, both in the introduction and in the conclusion. Other issues are that it extrapolated from data on only 30 countries, and that its approach to distribution of health was not valid.
Mr. Scanlon commented that despite the flaws in the methodology and analytical framework, the Report was having a “good positive outcome” in getting countries to think about the overall performance of their health systems. This points to a research agenda.
In conclusion, Dr. Sondik stressed that the Department is very interested in getting the Committee’s thoughts on the directions it should take in this area.
Dr. Cohn led the group in a review of a draft of a Congressionally mandated annual report to Congress and the Secretary on HIPAA implementation. Questions were raised about the discussion of local codes, NCVHS activity on the unique individual identifier, and whether or not to call for a privacy law now that the rule has been released. Plans to revise the report will be presented for action in day two of this meeting.
This report is intended to highlight NCVHS reports issued in 2000. Dr. Cohn noted that it provides a nice short summary of the full breadth of Committee activities. He suggested augmenting the sections on the work of each of the subcommittees.
Dr. Hardy said that with CDC support, a group at NCHS is evaluating the feasibility of releasing more often than annual estimates for a small set of key health indicators from the National Health Interview Survey (NHIS), and doing so shortly after data collection. The project is not assured, but it is looking “very promising.” The NHIS has been in the field for more than forty years with two main purposes: to monitor trends in basic measures of health status and health care utilization, and to address current public health concerns. Information is collected from a nationally representative sample of about 40,000 families, once a year each, involving small subsamples each week.
There was a major redesign to the questionnaire content and format in 1997, and the mode of data collection was changed to CAPI, which results in better and quicker data. The lag time between the end of data collection and release of the annual files is currently about 18 months. The Center hopes to improve on that and release 2000 data by the end of 2001. Information is gotten from everyone in the family.
Turning to the surveillance project, Dr. Hardy said part of the objective is to pull estimates off more quickly, though the frequency has yet to be determined. The CAPI system produces data about a month after collection, and they are cleaner than in the past. This raises the question of what indicators would be most useful, and hundreds were considered before coming up with a candidate list. A meeting was held in November, attended by federal representatives and outside health policy experts, including NCVHS member Dr. Paul Newacheck. Dr. Hardy noted that there are other sources of leading health indicators, such as Healthy People 2010’s ten indicators, those associated with the initiative to eliminate health disparities, others on chronic disease surveillance, and so on. The list developed for this project includes influenza vaccination over age 65, smoking, regular source of medical care, HIV testing, heavy alcohol use, and self-assessed health status, among others. The advisory group convened in November strongly recommended getting information on health insurance coverage. NCHS is now working on resolving problems related to the amount of error in the data on this subject.
After analysis, the team concluded it could produce reliable quarterly or semi-annual estimates for most of the indicators. The information will be posted on the NCHS Website, probably starting with a release of some 2001 data in the summer of this year. They will invite feedback as to the usefulness of the information. Issues the group is grappling with include how to show trends, and generally how to present the data. Dr. Hardy then invited comments from the Committee.
Dr. Friedman praised the idea of releasing data more rapidly, but expressed concern about the potential impact of not using the Healthy People (HP) 2010 leading health indicators, possibly creating the impression that CDC does not support them. Noting that some of the indicators are on the list for this project, he suggested providing an explanation for why other indicators are not used.
Dr. Starfield asked what the notion of sentinel health indicators is meant to convey, and how it is related to HP2010. Dr. Hardy said the main goal is to make the NHIS more useful, and she noted that what is in that survey provides a constraint on what can be estimated. Dr. Starfield observed that the current list is very adult-focused.
Dr. Mays echoed the concerns of her colleagues about the purpose of the project and the utility of the data. She noted that they probably will not provide useful details on racial and ethnic groups. She suggested focusing on areas where little information is available, such as rural health, to augment the data available from other sources. Dr. Hardy observed that NHIS eventually will produce additional data; the focus of this effort is on early and quick data. She agreed with the comments suggesting the need to more carefully think out the connections to the 2010 objectives and leading indicators.
Dr. Newacheck expressed the view that this is an important undertaking that can bring visibility to the Center and address the long turnaround time that has hampered the usefulness of the NHIS. He stressed the importance of a careful dissemination strategy, such as sending out press releases and selected mailings to policy makers when the data are posted on the Website. He also suggested talking to the Data Council about the indicators. Dr. Hardy said the current plan is to “get something out quickly… and then evaluate from there.”
Dr. Lengerich advised caution in the adjectives used for the various indicator projects (sentinel, core, key, etc.). He asked whether a process has been established to address issues about the indicators, identifying trends, and so on. He suggested convening an advisory group to help establish a set of criteria for the indicators.
Mr. Scanlon said the project could be useful in yielding information on changes in the health system. He also suggested reserving time on the HIS for emergent issues on which data could be produced quickly. He offered the Data Council as a sounding board for the general direction of the project, and suggested that the term “indicator” not be used, but rather just “quicker types of data.” Dr. Friedman seconded this and Dr. Lengerich’s points, noting that “sentinel” is usually used when “something bad is going to happen” and therefore that word also should be avoided.
Dr. Mays urged that the proposed project address future trends and “think about where we want to go” rather than repeating past practices and “documenting where we have been.” She noted, for example, the ethnic differences in self-assessed health status reporting.
In conclusion, Dr. Cohn thanked Dr. Hardy and suggested that the proliferation of related projects on indicators seems to suggest the need for the Data Council to develop an overall strategy in this area. Dr. Sondik agreed with this point, noting that it fits with the efforts around 21st century health statistics. He also commented on the Center’s need for ongoing advice, not just on NHIS but on NHANES as well.
The Committee then recessed to meet in Subcommittees, to reconvene the following day.
This day’s proceedings were chaired by Dr. Lumpkin, who began by reorganizing the agenda in view of the impending snowstorm. After introductions, he welcomed Ms. Pickett.
Ms. Pickett began by reviewing the history of ICD (the International Classification of Diseases and Health Related Problems), the latest revision of which is ICD-10. To date, 60 countries have implemented it for morbidity and/or mortality, some using a clinical modification. The U.S. implemented it for mortality data in January 1999. The three main chapters to be changed in ICD-10 (from ICD-9) are those on mental health, injury and poisoning, and external causes of injury. This is the most large-scale revision in the last 100 years, with a major change being a move to alphanumeric codes. New terminology and clinical concepts also have been added, including risk factors, and detail has been expanded. Also, there is now an international updating process which permits periodic revision.
NCHS awarded a contract in 1994 to evaluate ICD-10 as to whether it was a significant enough improvement to warrant implementation for morbidity reporting, to recommend additional improvements, and to develop a crosswalk to ICD-9-CM. The finding was that with a clinical modification (and only with it), ICD-10 would be a significant improvement and worth implementing. Ms. Pickett explained the reasons why a clinical modification is needed, which include the need for expanded distinctions for ambulatory and managed care encounters and the need to include new concepts and emerging diseases, as well as a number of more technical issues.
In creating the CM, the developers looked at uses of the classification beyond the traditional in-hospital setting. They also reviewed the recommendations of all Coordination and Maintenance Committee meetings since 1985. They worked with many physician groups and others to ensure clinical accuracy. There was an open comment period between December 1997 and February 1998, generating about 1,200 comments.
Ms. Pickett described ten “major modifications” in the ICD-10-CM, including adding a sixth character, adding laterality, and combining dagger/asterisk codes. She showed slides illustrating the expansion of detail with different conditions and injuries, noting that this can be collapsed back to ICD-10. Detail was also added to expand out the classification as to place of occurrence of injury and the activity engaged in.
The current status of ICD-10-CM is that the contractor has analyzed all the comments received and included many in the changes, which are being finalized. Another contractor is updating the alphabetic index and revising the crosswalks. The guidelines are also being revised. All will be tested under contract to HCFA, using 3,000 medical records, and it will be tested in several hospitals. Training materials and a database version are under development.
Dr. Starfield asked a series of questions about rule-out, symptom coding, double diagnosis, and extensions for things other than injuries. Ms. Pickett agreed that the revisions have doubled the codes, but she said this was in response to user comments and requests. On the first question, she said the guidelines say to “code what you know.” Dr. Starfield expressed concern about the potential for upcoding.
Dr. Cohn noted the concern in the industry about the cost of implementation, and he encouraged Ms. Pickett and her colleagues to document the benefits of ICD-10-CM over current practices. In that regard, he suggested moving beyond the original “coder-centric” testing to involve others in the health care industry including insurers and managed care. Ms. Pickett agreed with this approach and invited specific suggestions.
A motion was unanimously passed approving the report on the Committee’s 50 years of history.
The Committee passed a motion approving the following process for finalizing the Activity Summary for the Department: Each Subcommittee and Workgroup will submit additional language within the next week; the revised full document will be sent to the full Committee for comments; and those comments and the revised document reflecting them will be reviewed by the Executive Subcommittee, which will adopt the final version of the report.
Regarding the fourth annual report to Congress on HIPAA implementation, Dr. Cohn described the changes that would be made to the draft based on edits suggested the previous day. A motion was unanimously passed authorizing the following process: The Subcommittee will draft the revision and circulate it to the full Committee for comment. The final version of the report will be approved by the Executive Subcommittee.
Dr. Cohn then presented a draft letter to the Secretary on NDC codes, asking for action by the Committee. He explained that the final financial administration rules say that NDC should be used instead of anything else for all uses related to drugs and biologics. The Subcommittee has been made aware of industry concerns that the NDC is not appropriate for reporting drugs and biologics on standard institutional and professional claims. The letter therefore recommends a modification to the final rule of the standards retracting this provision and recommending that HHS work with ANSI X12N on the revised standard. It states the NCVHS belief that no drug coding system in existence today fully meets the needs of the health care industry, and it calls on HHS to develop criteria for such a system.
In response to a question, Ms. Greenberg said she did not expect anyone to object to this NCVHS recommendation as long as reporting NDC code was allowed. After discussion and further explanation, the Committee passed a motion approving the letter, with an addition referring to the goal of assuring patient safety. Dr. Cohn reported that the approved letter on NDC codes will require a revised final rule, which is allowed under HIPAA.
On other business, he said the Subcommittee plans to hold hearings on recommendations and next steps on the PMRI on March 19-20. In May 1-2, and possibly again at the end of the month, it will hold another hearing to take recommendations from the DSMOs on any needed changes or recommendations related to the standards. Any such recommendations will be brought to NCVHS at its June meeting.
Mr. Rothstein reported that the Subcommittee plans to organize a hearing on the implementation of HIPAA privacy regulations, probably to be held prior to the June NCVHS meeting and in Chicago. The meeting will not be held until after the regulations go into effect. The object of the hearing is to hear from early implementers about the issues and problems they are encountering.
The Subcommittee also recommends that Dr. Greg Koski, the new Director of the Office of Human Research at HHS, be invited to the June meeting to discuss privacy and confidentiality issues in research.
Dr. Friedman reported that the Workgroup is moving ahead on its final report, involving a collaboration among three authors from NCVHS and CDC. They will be responsive to the recommendations in past hearings that the report “specify to the greatest extent possible where we are going.” Another theme of the hearings was viewing health statistics as a field whose value needs to be demonstrated. The report will talk about the incentives for data producers to produce timely and accurate data as well as the disincentives for not doing that. Collaboration among multiple partners and taking a broad view of the determinants of population health will be other important themes, along with the need for integrated data collection and analysis.
The tentative deadline for draft one of the final report is July 2001 (to be reviewed by the Data Council, the Committee, and NCHS), with a second draft by early September (to be circulated for external review), and a final report for review in February 2002. At Dr. Lumpkin’s suggestion, Dr. Friedman said he would distribute the draft outline to the full Committee immediately.
Dr. Friedman said the Workgroup is considering how to create a seamless report that reflects the fact that it is the result of a collaborative process (NCVHS/NCHS /Data Council), while some or all recommendations may represent only NCVHS.
Mr. Scanlon asked for a status report at the next Data Council meeting on both this and the NHII report, and the chairs of these groups agreed.
Dr. Lumpkin reported that the Workgroup’s basic approach to the NHII has been affirmed by people at its hearings, and it has learned the people think the federal government has a pivotal role to play in the development of the NHII. The group is now working on its final report, with the unifying theme being getting the right information to the right people at the right time for shared decision-making. Over the next few months, the Workgroup will be working on a series of recommendations for federal, state, and local government, for providers, and for other groups. Dr. Lumpkin invited comments and suggestions from NCVHS members as the process goes forward.
Dr. Friedman reported that at its breakout session the previous day, the Subcommittee discussed its future role and activities and agreed that this is a transition period, pending the appointment of new members. Regarding criteria for new projects, the group agreed that they should have “a very clear client” for new projects, and that projects should explicitly fit within a model of the determinants of population health, the Subcommittee’s main emphasis. There is interest in periodic briefings of the full Committee by the directors of additional statistical agencies besides NCHS and ASPE. The Subcommittee is considering several topics for possible focus in the future, including summary health measures, geocoding, and fair information practices for health statistics, as well as further work on defining and eliminating disparities.
Dr. Newacheck gave a brief update on the functional status report now under development by the Subcommittee. The plan is to present a final draft at the June meeting, circulating it to the full Committee in May with time for comments and refinements. He offered to include anyone interested in the distribution of earlier drafts and in conference calls discussing them. The thrust of the recommendations will be 1) the importance of including functional status information in administrative records and in computerized patient medical records, and 2) that the ICIDH-2 (ICFDH) is worthy of consideration and testing as a possible classification tool for capturing the information.
Dr. Cohn expressed some doubts about the notion of functional status in administrative and financial transactions ¾ under what conditions it would be collected, how it would be coded, whether it would be required, and so on. He suggested that the Populations Subcommittee talk with the “owners of the standards” (e.g., X12) about this subject, and he mentioned the possibility of a meeting co-sponsored by the Standards and Populations Subcommittees. Dr. Lumpkin suggested inviting someone from NEDS to the same meeting because of the relevance of electronic disease surveillance. He and Ms. Greenberg also pointed out that the Populations Subcommittee is recommending a developmental and exploratory process; there is no short-term initiative to insert a new element on transaction forms.
Dr. Mays then reported on the Subcommittee’s recent discussions on the OMB guidance on race and ethnicity data. There is a March 19 deadline for comments on the latest OMB document on this subject, and the Subcommittee would like to get its comments on the record. She moved that a “placeholder letter” be sent from NCVHS to OMB before the deadline, alerting OMB to particular concerns and issues and stating the Committee’s intent to provide substantive comments once it has had a chance to discuss them more fully. The Committee passed a motion approving the following process: a draft letter will be circulated to the full Committee for comments, and the Executive Subcommittee is authorized to approve the final version based on these comments.
Finally, the Committee identified these agenda items for its June meeting:
Dr. Lumpkin then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ John R. Lumpkin 6/11/01
_____________________________________________________________________
Chair Date