The National Committee on Vital and Health Statistics was convened on Tuesday and Wednesday, June 24 and 25, in the Washington Marriott Hotel. The meeting was open to the public. Present:
Committee members
Don E. Detmer, M.D., Chair
Hortensia Amaro, Ph.D.
Jeffrey Blair
Simon P. Cohn, M.D., M.P.H.
Kathryn L. Coltin, M.P.H.
Kathleen Frawley
Robert M. Gellman, J.D.
Richard Harding, M.D.
Lisa Iezzoni, M.D., M.S.
John R. Lumpkin, M.D., M.P.H.
Clement Joseph McDonald, M.D.
Vincent Mor, Ph.D.
Barbara Starfield, M.D.
George H. Van Amburg
M. Elizabeth Ward
Staff and liaisons
Marjorie Greenberg, National Center for Health Statistics (NCHS), Executive Secretary
Lynnette Araki, NCHS
Harvey Schwartz, Ph.D., Agency for Health Care Policy and Research liaison
Bob Moore, Health Care Financing Administration liaison
James Scanlon, HHS Executive Staff Director
Bill Braithwaite, Ph.D., ASPE
Others
Jackie Adler, NCHS
Robert Sherrill, MD, AL Quality Assurance Fndn.
Gracie White, DCHS
Traci Ramirez, NCHS
Jim Schuping, WEDI
Donna Pickett, NCHS
Robert Tennant, MOMA
Rick Rubin, Fndn. for Health Care Quality
Violet Woo, Health Policy & Strategy Assn.
Helene Guilfoy, Catholic Health Initiatives
Jean Narcisi, AMA
Robert Beck, MultiState Assoc.
Jennifer Cook, NAIC
Chris Birgsten, AAHP
Paul Tang, Northwestern Mem. Hospital
Mark Epstein, NAHDO
Wayne Jones, Optimum, Inc.
Walter Suarez, MN Health Data Institute
Susan Seare, Medicode, Inc.
Mary Emerson, HCFA
Jeanne Gilliland, CDC
Margret Amatayakul, CPRI
Larri Short, Amer. Assn. of Occupational Health Nurses
P. Smita, MGMA
Eric Stas, MBS
Kristin Stewart, AAHP
Hemi Tewarson, McDermott Will & Emery
Marty Geiser, First Consulting Group
Joel Rlsenblatt, MBS Inc.
Dr. James Moon, Optimum
Scott Richardson, TWC
Robert Borger, Natl. Wholesale Druggists' Assn.
Stacey Long, NAHDO
Mary Siffermann, Gordon & Barnett
Diedre Abbott, College of American Pathologists
Janet Spinks, Aquas, Inc.
William Weber, Bureau of Labor Stats.
Michael Hamm, NAPHSIS
Chris Plaushin, Amer. Soc. of Clinical Path.
Michael Garner, Blue Cross Blue Shield of FL
Michael Tate, ADA
Kathleen Fyffe, HIAA
Henry Heffernan, EDPNS
Timothy Brogan, PhRMA
Judith Zink, PMA
Dawn Jackson, BCBSA
Elliot Stone, MA Health Data Consortium
David Berglund, NCHS
Stanley Edinger, USPHS
Jack Emery, AMA
Lewis Lorton, HOST
Stanley Nachimson, HCFA
Julie Childress, HIAA
Carolyn Rimes, HCFA
Louisa Smith, NIH
Sarah Comley, International Observers
Cathy Brady, Amer. Council of Life Insurance
Gwen Moulton, BNA
Kelly Rand, AIDS/STD News Report
Karen Selander, Intermountain Health Care
Gaile Snider, NCQA
John Budetti, Powers, Pyles, Sutter & Verville
Sharon Barr, HCFA
Jane Harmon, NCHS
Amy Anderson, NCHS
Amy Anderson, AIDS Action Council
India Peterson, AIDS Action Council
Lynn Morrison, Amer. Med. Informatics Assn.
Gary Friend, IMS America
Steve Bass
Solomon Appayu, Center for Health Care Automation
Robert Kolodner, Dept. of Veterans Affairs
Robert Bolan
Alison Hall, McDermott Will & Emery
Meg Johantzen, HSS
Robert Iadicicco, Gordon & Barnett
Pat Hamby, HBO & Co.
Douglas Mann, Battelle Memorial Insti.
Constance Percy, NCI
Brian Thiel, PMA
Robert Borger, NWDA
Jan Loudin, ASTM
Katherine Wallman, OMB
Suzanne Evinger, OMB
Leigh Ann Albers, MEDSTAT
Guy Toscano, BLS
Lawrence O'Brien
Michael Pretzer, Medical Economics Magazine
The National Committee met in plenary session for a day and one half, and broke out into Subcommittee meetings for a half-day. On day one, the Committee was briefed by three HHS representatives. Mr. Scanlon reported on the Department and the HHS Data Council; Mr. Fanning reported on the forthcoming HHS report on privacy and confidentiality, and Dr. Braithwaite gave an update on the data standards component.
Dr. Lumpkin then reported on the K2 Workgroup's proposed recommendations on health data standards. The Committee's comments were incorporated into the final recommendations which were approved on day two.
The Committee heard three reports on state-based standards and privacy initiatives, from Elliot Stone (Massachusetts), Walter Suarez, M.D. (Minnesota), and Rick Rubin (Washington). The plenary session concluded with a discussion of the proposed recommendations on privacy of the Subcommittee on Privacy and Confidentiality, led by Mr. Gellman.
The afternoon of day one was spent in Subcommittee meetings.
Day two began with a report from the Executive Subcommittee on planning and implementation and public education. The group discussed future meeting dates and agenda topics. Dr. Cohn then presented a redraft of the recommendations on health data standards, which were approved as revised.
Following a brief status report by Katherine Wallman on the OMB Directive 15 revision, the Committee discussed the revised recommendations on privacy and confidentiality, which they approved.
The Committee also approved a report on State and Community health assessment and letters on the National Provider Identifier and the OASIS home health data collection instrument. All of the Committee's reports, recommendations and letters will be sent to the Secretary.
1. On the occasion of her retirement as Executive Secretary, the Committee passed a motion of commendation and thanks to Dr. Gail Fisher. Dr. Detmer introduced the new Executive Secretary, Marjorie S. Greenberg.
2. The Committee approved a new composition of the work group on planning and implementation, now comprising Subcommittee chairs, as well as a plan for the migration of subcommittee responsibilities. It made one change in the structure proposed by Ms. Coltin, folding the work group on population-based data back into the Subcommittee on Health Data Needs, Standards and Security.
3. Dr. Detmer asked the Committee's staff to study HIPAA implementation tracking questions and bring back suggestions to the Committee.
4. Members who are asked to write articles for the media or professional publications can review their materials with Dr. Detmer, Mr. Scanlon, and/or Ms. Greenberg. To facilitate writing on subjects that touch on the Committee's business, the staff will provide members with a compendium of messages that have gone out and a list of key messages and caveats.
5. Members were asked to supply lists of individuals, groups and publications that are good targets for the Committee's outreach, and to do so within two weeks.
6. The Committee's work plans and reports will be put on the Web.
7. The staff will investigate establishing an intranet for the Committee. Meanwhile, Ms. Greenberg is the "server" for messages that are to be broadcast among members.
8. Dr. Detmer will convey to the Data Council the Committee's concern about regulations being issued by individual agencies that may not be consistent with the HIPAA process. Ms. Frawley will brief Committee members regularly on relevant notices in the Federal Register and in trade publications.
9. The next two full Committee meetings are September 8-9 and November 5-6.
10. The Subcommittee on Population-Specific Issues will meet July 21 and September 29- 30. It and the Subcommittee on Health Data Needs, Standards and Security will jointly address two issues: 1) mental health enrollment/encounter standardized core data and 2) diagnostic coding on people with disabilities, looking at both ICD-10-CM and ICIDH.
11. The group agreed to hold a meeting outside Washington, D.C. in the coming year.
12. Mr. Scanlon asked for an indication by September of needs for consultants.
13. The Committee approved a letter to the Secretary from the Committee concerning the proposed National Provider Identifier.
14. The Committee unanimously approved a letter to the Secretary outlining its recommendations for health data standards, in accordance with the administrative simplification provisions in HIPAA.
15. The Committee approved a report and recommendations concerning community health assessments, the role of state health agencies, and the role of the federal government.
16. The Committee approved a report and recommendations on health privacy and confidentiality with one abstention.
17. The Committee approved a letter to the HCFA Administrator on the OASIS outcome measurement data collection tool.
18. The possibility of using LCD panels at NCVHS meetings will be investigated, to facilitate the editing of documents.
Dr. Detmer introduced the newly-appointed Executive Secretary of the National Committee, Marjorie Greenberg, who succeeds Dr. Gail Fisher, who has retired from this position. The Committee passed a motion commending Dr. Fisher for her service as Executive Secretary, which extended over roughly half of the Committee's existence. Following introductions, the minutes of the March 13-14 meeting were approved.
Dr. Detmer reviewed the Committee's work on standardization mandated by the Kennedy-Kassebaum ("K2") legislation, as it has prepared for forthcoming recommendations to the Secretary. The Subcommittee on Health Data Needs, Standards and Security heard from a total of 134 witnesses in eight days of public hearings, including two in San Francisco, and at full NCVHS meetings. Dr. Detmer added that the Executive Subcommittee developed an executive work plan at the San Francisco meeting. Two additional days of hearings on security standards are scheduled for August, with attention to the NRC report. The Subcommittee on Privacy and Confidentiality heard from 42 witnesses at six days of public hearings plus an additional 40 at the San Francisco hearings on cross-cutting issues. Dr. Detmer commented that the effort to get out of Washington, D.C. and communicate with people in the West was very worthwhile.
Mr. Scanlon reminded the Committee of the six major themes in the Council's work plan: health data standards, health information privacy, serving as the focal point for work with NCVHS, coordinating the Department's positions on ad hoc issues, developing a data collection strategy for the Department, and health information applications of the national information infrastructure (NII). He focused his remarks on the last two of these.
Developing and overseeing an HHS data collection strategy is a challenge because of the Department's size and diversity. The Council is working on a multi-year plan for FY 1997 through 2001, covering survey content, periodicity and budget planning as well as doing a data "cross-cut" to identify gaps and redundancies. The survey integration plan, on which the Committee has been briefed several times, is part of this broader effort. Its major feature is using the National Health Interview Survey as the hub for other population surveys. NHANES will go into the field in 1998; the Medical Expenditure Panel Survey will be in the field most of the time. Other components of the data collection strategy are the HHS research planning initiative, strategies for state level data, and work on special populations and race/ethnicity data. An inventory of surveys and survey plans will be available on the HHS website. HHS is also reconceptualizing the area of data on providers, resources and capacities, with reference to the changing nature and structure of the health care system.
The research planning initiative began in HHS last year, associated closely with welfare reform, the chief question being whether the nation has the capacity to monitor the changes occurring through devolution and reform, particularly at the state level. Developing strategies for state level data is a key effort in the Department -- for example, for a state and local area integrated telephone survey system.
The Data Council also has a workgroup on race and ethnicity data that has been reviewing all the previous recommendations. It is heading the Department's review of OMB's recommendations on Directive 15.
Dr. Starfield asked about the input of NIDA and SAMHSA into planning for the NHANES and other surveys. Mr. Scanlon replied that these agencies should be included; the idea behind survey integration is to bring the various facets together. Dr. Detmer said the Committee hopes to interface with the Council on issues such as this, spearheaded by the Subcommittee on Population Specific Issues.
Regarding the NII, Mr. Scanlon noted that the Council is charged by the Vice President with leading interagency efforts on data standards, privacy, telemedicine, and consumer information. It formed an interagency working group on telemedicine which is looking at regulatory barriers, co-sponsoring a demonstration project, and developing an inventory of telemedicine efforts.
In the area of consumer health information, HHS has developed a project called HealthFinder to help consumers get reliable health information over the Internet.
Asked about the evaluation of telemedicine, Mr. Scanlon said the Data Council's broad focus is to develop a methodology that can identify the boundary and effectiveness of this technology and to compare its outcomes to other methods. Dr. Detmer observed that the country lacks, and could benefit from, a robust and comprehensive strategy for the health applications of the NII, which he suggested the Committee can help develop. He noted that the context is global, and the U.S. must see its role in terms of partnerships.
The Secretary's recommendations for the protection of health privacy are being drafted and will be presented to Congress by August 21. The National Committee's recommendations will be fed into that process. In addition, the Department has commissioned a report on privacy and health research, which is available on the Data Council's website.
On June 11, the Data Council heard from the implementation teams that are developing regulations on the K2 standards. A public meeting will be held on July 9 at which the teams' co-chairs will present the information and elicit feedback about the Department's positions. The draft regulations will be ready by October, and the final rules in February, 1998. Dr. Braithwaite expressed appreciation for the Committee's hearings, which have provided important input into the Department's recommendations.
The crux of those recommendations is that the ANSI X12-N version 3070 standards be used for all but a few transactions in the claims area. Pharmacy claims will use NCPDP standards and dental claims, the 837. HCFA's National Provider Identifier and National Payer ID will be recommended as the proposed standards. In the coding area, the Department will recommend the continued use of ICD-9-CM, adding that systems should be ready to move to the ICD-10-CM by 2001. For procedures, the Department recommends the continued use of the ICD-9 Vol. 3 and CPT-4 and HCPCS, but with the goal of moving to an as yet undetermined single procedure coding system by 2002 or 2003. Recommended security standards will be policy (not technical) standards. Implementation guides will be available free on the Internet for all the standards.
Dr. Detmer commented that both the Department and the Committee have worked hard on responding to the legislation, along with the industry and the states. He expressed appreciation for the Department's support and cooperation.
Dr. Iezzoni asked if a process for moving to a single procedure classification system would be proposed, and Dr. Braithwaite said he hoped so but it is uncertain whether it will be possible to reach consensus on that. A statement from NCVHS on this matter would help move things in that direction.
In addition to its extensive hearings, the Data Subcommittee and its K2 Workgroup have worked closely with several Departmental committees, and their two proposals closely parallel each other. A key principle has been to use the standards being developed by the standard development organizations. ANSI X-12 standards received overwhelming support from people at the hearings. In addition to the recommendations outlined by Dr. Braithwaite, the Committee recommends easing the transition for providers and payers now relying on flat file formats by allowing trading partners by mutual agreement to continue to use these mechanisms until February 2002.
In August, the Subcommittee will review the data content and data dictionary now being developed by HHS. For supporting standards, it supports HCFA's NPI and Payer ID. A recommendation on an individual identifier may follow. The recommendations on diagnostic and procedural coding parallel those of the Department. The Subcommittee will work in the near future on a recommendation on the adoption of a single procedure classification system.
Dr. Detmer invited discussion of these recommendations, and points were raised which the Subcommittee will take into consideration in modifying its recommendations for action later in the meeting. Dr. Iezzoni urged that the Committee's letter to the Secretary state that it will be looking at issues concerning nursing classification and handicapped, disability and functional status classification systems, and developing recommendations in these areas. Dr. Starfield noted that this is part of the broader issue of core data elements, and Dr. Cohn added that it connects to electronic medical record development.
At Dr. Cohn's suggestion, the group agreed to clarify the recommendations to indicate that standards for attachments will not be proposed for another year.
Dr. Mor urged the inclusion of language suggesting a process for periodic review of the code sets and standards, as HCFA does for its long-term care MDS. Dr. Detmer noted that the matter of periodic review is a generic issue with broader application, and one for which an additional set of recommendations might be in order. Bob Mayes, chair of the cross- cutting infrastructure team, urged the Committee to address these implementation issues both in the context of its letter to the Secretary and as a separate document, as his group hopes to create a boilerplate that will apply to all the regulations. The Committee favored this solution.
Turning to the unique provider identifier, Dr. Detmer noted that the Department recommends that an 8-digit alpha-numeric identifier be assigned to all providers, with identifying information. It is proposed that NCVHS endorse this proposal and recommend that HHS publish it for public comment. A question has arisen, however, about a suggestion to evaluate a 10-digit numeric identifier, and he asked for discussion of this matter. Following a few comments, the group agreed with Mr. Van Amburg that there is no reason to include the latter point in the Committee's letter if there is no strong rationale for suggesting it. Mary Emerson of HCFA said the Department plans to assign only numeric identifiers at the beginning, and to introduce alphas into the identifiers when the numbers are all used up.
Mr. Van Amburg presented a report on community assessment prepared by members of the former Subcommittee on State and Community Health Statistics, based on a multi-year series of hearings. The report contains recommendations and if approved will be distributed to the Secretary, state health agencies, NACHO and other groups involved in community assessment. The principal topics are the community assessment process (general principles), state health agencies (encouraging them to improve the availability of community data), and the federal role (technical support and improving state and community data in national data sets).
Committee members responded favorably to the report and recommendations, and focused their comments on the question of whether privacy issues should be addressed in this context, and if so, how. It was also suggested that the document encourage state agencies to use national surveys and community agencies to follow the recommendations. The revised version, to be acted on later in the meeting, will reflect this discussion.
Mr. Stone set the tone by declaring humorously, "We are from the states and we're here to help." His organization, like those of the other panelists, is a nonprofit, private/public partnership. His key message was asking NCVHS to recommend that the Secretary establish regional technical assistance centers to help implement K2 standards. He described the activities the Consortium has put in place in anticipation of NCVHS recommendations, developed over 2 years of monthly meetings among the CIOs of the state's largest health plans and hospital systems and their joint project, the Affiliated Health Information Networks of New England. This group has five work groups, on clinical EDI, business EDI, confidentiality/privacy, health care identifiers, and network infrastructure standards. Each has developed a partnership with a national organization and has presented recommendations on standards and implementation issues at major public forums. A document on their work is downloadable from the website (www.mahealthdata.org.). The Commissioner of the state's Medicaid program has agreed to expedite the use of national standards on Medicaid's agents.
All the relationships among stakeholders have been crafted by the MA Health Data Consortium, and they all have a vested interest in seeing that the national standards are implemented expeditiously. The Affiliated Networks do not advocate building centralized regional data repositories, but instead favor standardizing components of private data bases held by individual providers. A comprehensive health data system will be achievable once national standards are recommended by the Secretary.
The Consortium staff and Affiliated Networks work group on confidentiality meet with local advocacy groups and legislators on confidentiality and privacy issues. Several bills on consent are pending, and the state has a strong fair information practices act. They do not want the strong state laws weakened by federal preemptive legislation.
Mr. Stone explained the reasons for his recommendation of regional technical assistance centers. Such TA centers can build local awareness, facilitate regional education, identify test sites, provide feedback to the Department on barriers, and build trust and collegial relationships.
The Institute has programs on standardization, performance measurement, and the provision of information to purchasers. Standardization is at the heart of its activities and mission. State efforts began in 1993 to promote standardization in several key areas, starting with unique identifiers. After some preliminary work, the state has tied its efforts to the national HCFA identifier projects and the recommendations coming out of the HIPAA legislation. Similarly, implementation of core EDI transactions have now been tied to the HIPAA implementation schedule. Initially, Minnesota decided to create its own implementation guide for the standards, but it has since shifted its focus to play a proactive role in ANSI activities.
Dr. Suarez stressed that education and technical assistance are critical complements to standardization. The State legislature created the Center for Health Care EDI, the first such center in the nation. In addition to doing local education, the Center is actively involved in national SDOs.
The Center believes a standard coding system should be adopted, one that goes beyond current systems to deal with nursing and home health care and to provide more clinical data.
Dr. Suarez identified four key roles for state organizations in implementing federal legislation: education and resource center activities, technical assistance, testing of implementation efforts, and evaluation and monitoring. He stressed the importance of a consensus building process in these activities.
Regarding privacy and confidentiality, he noted that Minnesota has stringent data privacy legislation and argued for a national legislative framework that states can build upon.
He presented the preliminary results of the 1997 Health Care Electronic Commerce Survey, which will be released in a comprehensive report. It identifies major barriers (e.g., cost, complexity, and the failure to understand the benefits) and benefits (e.g., improved customer service) of automation.
Finally, he stressed his organization's support for HIPAA's administrative simplification and national privacy framework efforts, and he offered its assistance in developing a comprehensive education and technical assistance plan.
Mr. Rubin said his Foundation is "a United Nations of the health care community," like the organizations of Dr. Suarez and Mr. Stone. This one operates the Quality Measurement Advisory Service nationally and also works on local and regional health information partnerships and performance measurement. He noted that the latter is closely linked to progress on the electronic infrastructure.
Washington State, after a turbulent time around health care reform, now has a strong emphasis on managed care. All the major plans there are regional, which increases the interest in standardization. The Internet has had a major positive impact on receptivity to standards.
Mr. Rubin then described several state activities. One of the activities of the Foundation is the Community Health Information Technology Alliance (CHITA), a private activity among most of the major health plans that invites public participation. Ms. Ward sits on the management committee representing the state's Department of Health. The group works on business modeling and is moving into standards and conventions (the latter involving implementation of standards), as well as pilots and demonstrations and education and outreach.
The Interagency Quality Committee is a public effort with private participation that involves all state health care agencies. In this regard, Mr. Rubin noted that state and federal agencies can promote standards by exercising their market clout. The Public Health Improvement Plan (a rare "survivor" of the state's short-lived 1993 health care reform) focuses on linking public health and health care and on the overlap between personal and population health data. Several performance measurement projects are working on quality improvement and development of clinical standards, as well as accountability through three demonstration sites. In the context of accountability, Mr. Rubin stressed the importance of the Committee's education function -- for example, to build awareness of the connection between accountability and the electronic infrastructure and standards.
One of the major lessons learned through these activities concerns the need to make the business case in order to generate progress. Organizations need to be shown how their investments can be leveraged to increase their value. Another lesson is the essential role of partnerships in this process, and a third is the strategic importance to the process of having neutral ground in the form of organizations like the three represented in this panel. Mr. Rubin also stressed the centrality of identifiers and the need for preemptive privacy legislation and for education on privacy trade-offs and the benefits of automation. He lauded efforts to forge cooperation among states and between states and the federal government. Regarding the boundary between collaboration and competition, he noted the positive trend toward "looser couplings" among organizations.
Dr. Starfield asked what had not gone well for the states, and Mr. Rubin noted the fallacy in the original goal of a large central data repository, something the market did not favor. There were also privacy issues, and he congratulated the Committee for addressing privacy "right up front." Also, Washington's original efforts were "too big to be [regarded as] true," and he predicted that current efforts under HIPAA would raise credibility and promote the belief that standards will really happen.
On the same question, Mr. Stone pointed out that HIPAA "came out of a groundswell from the states and a lot of national organizations." Massachusetts is at the "very early adopter stage" and has not yet achieved critical mass in innovation, which he expects federal legislation to accomplish. He stressed the importance of following the imposition of standards with work on implementation and evaluation as well as education, and Dr. Detmer said an NCVHS Subcommittee would focus on planning and implementation. Mr. Stone noted the widespread support for community-wide master patient index projects and suggested focusing on this and letting the unique patient identifier develop over time, rather than focusing on the number (which he called "a non-starter").
Mr. Gellman asked the panelists to elaborate on their comments on federal privacy legislation and the issue of preemption versus allowing more stringent state laws to prevail. Dr. Suarez spoke in support of a more stringent federal standard rather than a lower common denominator, so that states are not inclined to push it higher. Mr. Rubin said that despite the obvious tradeoffs, he supports preemptive federal law that does not allow state-level customization because so much health care is delivered on a regional basis. Dr. Suarez noted that states can act independently in ways such as moving faster, or implementing more transactions, than federal law requires. Mr. Stone urged the Committee to consult with Massachusetts' Attorney General and his staff, a good resource, and noted that the most important issue has to do with employer access to information.
Dr. Amaro asked what the panelists have observed about the ability of providers with limited technology to adapt to the new requirements and what they think is needed to build readiness. The panelists responded that EDI is useful at whatever level it can be implemented; that providers are key in implementing EDI; that states and plans are being encouraged to help smaller providers; and that providers have several options for communicating electronically, such as clearinghouses. Dr. Suarez stressed that providers in general are at a very early stage in automating clinical data. Mr. Rubin noted that many more providers have computers than know how to use them; persuading them to use them depends on making the business case for the benefits of automation. An educational effort must be combined with development of content, applications and services that providers find useful -- with extra effort needed in rural areas, where the problem is more profound. Mr. Stone noted that every provider, large or small, has a relationship with a health plan or Medicaid, and these relationships can assist their connectivity. Returning to the subject of a single national privacy law versus multiple ones, Dr. McDonald asserted that it is contradictory to support standards and argue for individual state privacy laws. Mr. Rubin agreed, noting that many Washington health plans are becoming regional or national. The other panelists said they saw this trend in their states as well, along with the facts that most physicians belong to more than one plan and patients are expected to move from plan to plan. Mr. Rubin added that people are also starting to see the merits of standardization in the security area.
On the need for portable patient records, Mr. Stone encouraged the Committee to address the issue of archival and record retention, for which standards are needed. Dr. Detmer said the Committee would indeed address this.
Asked to comment on the regional TA site idea, Mr. Stone said the sites should be regional because that is where the relationships are, and because people are more likely to go to educational events if they are nearby. He noted that the ANSI X-12 837 manual is virtually unintelligible. Implementation guides should be done at the national level, but education should take place locally, where discretionary aspects also can be worked out. Another important aspect is maintaining regional test sites for providing feedback, along with monitoring compliance. Dr. Suarez cited the National Electronic Commerce Resource Center maintained by the Department of Defense as a good model, with their regional DCRC sites. Mr. Rubin cited AHCPR's work on the CAPS survey as another good model of a federal-local relationship, with tools developed nationally and distribution and assistance provided locally.
Mr. Scanlon asked for comments about incentives. Dr. Suarez said that in Minnesota, they found that incentives must be found within the market. The greatest one is simply providers' ability to be paid sooner. Mr. Stone noted that accrediting bodies can provide incentives. His organization is talking to local health care purchasers group about including language in their model contracts with health plans. He added that conditions will be improved if the Committee and Department do not bend the requirements. Mr. Rubin noted the purchasing clout of the federal government and also suggested "leaning on the big gorillas in the marketplace" to move first, thereby making conditions more attractive for smaller plans.
Mr. Gellman presented the draft recommendations prepared by the Subcommittee on Privacy and Confidentiality, explaining that the document emphasizes the urgent need for federal legislation. It also takes positions on subjects about which the Subcommittee is in agreement (e.g., liberal access for research and public health) and identifies the areas where it is not (e.g., preemption and disclosures with written authorizations).
Committee members were essentially positive about the report and recommendations. They suggested a few minor modifications that will be taken into consideration in preparing the final draft, to be acted upon the following day. One member suggested using the word "append" for patient corrections of their records. Another suggested leaving the door open to public health use of patient records in ways that may limit individual freedom but are necessary for the common good. The group discussed ways that public health agencies might go beyond federal legislation in stringency without hampering standardization, generally agreeing that the legislation has to be general enough to permit responses to unforeseen diseases and other factors.
An extended discussion concerned the call for a strong statement about discrimination, which Dr. Starfield said is "the biggest issue in privacy." Members agreed that the connection between the two should be clearly noted, but most agreed with Mr. Gellman that this set of recommendations should not try to propose solutions. He noted that much of the work on discrimination has yet to be done. Moreover, he and others were concerned that loading the privacy legislation with anti-discrimination language would be too cumbersome and bog it down. The group agreed to urge the Secretary to go as far as possible in starting to deal with the discrimination problem, recognizing that a comprehensive solution is not likely in the short term. Dr. Starfield also suggested a statement to the effect that properly chosen patient identification systems have the potential to enhance privacy.
The question of whether, or how, to segregate sensitive aspects of records also generated considerable discussion, with most members agreeing with Mr. Blair and others that uniformity among the states is needed in this area. Mr. Gellman pointed out that states can add restrictions to internal access to records, and furthermore that many things will have to be worked out on a case by case basis over time.
Dr. Harding expressed a number of reservations about the document, which he characterized as tilting toward accessibility and administrative simplification rather than toward privacy. A psychiatrist, he described the widespread concern about privacy among his patients and his own "bias" that the chief purpose of the patient chart is treatment, with everything else being secondary. He noted that quality care depends on people's willingness "to come in and tell you the truth." He will submit his specific suggestions to the Subcommittee; they relate primarily to informed consent, preemption, and protection for sensitive patient records. Based on the testimony he heard as a member of the Subcommittee, he observed that "a lot of people feel the way I do" that privacy should be given precedence over other goals. He later added that no one at the hearings opposed disclosure for treatment or payment, except when the payor is the employer -- a scenario that needs more aggressive treatment in the document. He also noted the unclear distinction between research and administrative, cost-oriented investigations and questioned the validity of invading patient privacy for the latter purpose.
Ms. Frawley noted that the Subcommittee struggled with all of these issues. She pointed out that special treatment of records can actually reveal more than it conceals about the individual. Dr. Lumpkin pointed out, however, that unobtrusive special protections are possible electronically that were not possible with paper records. Dr. McDonald noted the caregiver's need to know and urged that any special protections be handled uniformly rather than negotiated by individual physicians and patients. He pointed out that the chief underlying issue in this area is privacy in the context of eligibility determination. Mr. Gellman stressed the great and growing complexity of these issues, many of which are already addressed in the report. He noted that experience shows a clear tradeoff in privacy legislation between absolute restrictions on access to records and accepting some exceptions in order to get something passed. He also noted the need for some generality in the language, as all circumstances cannot be anticipated.
Dr. McDonald pointed out that the recommendation to give patients full access to records runs counter to tradition and should be carefully considered, given that patients sometimes take offense at characterizations in their profile and history. Others noted that full patient access is not causing problems where it is practiced. It was agreed that med schools should do a better job of teaching people how to chart. Ms. Frawley noted that patients usually are looking for specific parts of the record, not the entire record.
At Dr. Detmer's request, the group discussed the question of an oversight function -- its nature and location. It was noted that many European countries have a person or entity to which consumers can relate, while in the U.S. they have to "maneuver the legal system" to exercise their rights. She referred to the NRC report's discussion of this subject. Ms. Ward noted that Canada has a successful advocate position, and many states have created something similar. Regarding a federal office of this kind, the group stressed ensuring its independence and also the value of content expertise. Several spoke in favor of basing it within HHS, which they agreed is not monolithic and has similar functions already. Mr. Fanning said OMB has published for comment a paper proposing a government-wide entity for this purpose; he agreed with Mr. Scanlon that this would not preclude also having one for health.
Finally, the group discussed the report's recommendation of a safety valve (Section O) and agreed that the power to override the legislation is critical but should be reserved for exceptional circumstances, vested at a high level, temporary, and subject to Congressional review.
The Committee recessed to reconvene in Subcommittee meetings.
Following introductions, Dr. Detmer asked Ms. Coltin to report on the Executive Subcommittee's work on planning and implementation. The work group on that topic is to be part of the Executive Subcommittee and composed of her (Chair of the group), Dr. Detmer, and the Subcommittee chairs. Its aim is to track Subcommittee activities and identify cross- cutting issues, and to follow the outcomes of Committee reports and recommendations, notably those mandated by HIPAA. Dr. Detmer noted that HIPAA implementation issues also should be tracked by individual Subcommittees in their areas of interest.
The Committee generally approved the proposed Committee composition and the transition to the new NCVHS structure. The group struggled over the status of the proposed Work Group on Population-based Data, tentatively a subset of the Subcommittee on Health Data Needs, Standards and Security. The issues of concern were the overlaps between its purview and that of the Subcommittee on Population-Specific Issues, the desire not to dilute the latter Subcommittee's work plan, the shortage of members for sustaining an additional group, and the lack of a defined task for that group at present. In general, members agreed that work groups should have defined and time-limited tasks.
Following this discussion, the Committee agreed to fold the work group's charge back into the larger Data Subcommittee and only to mobilize a work group if new NCVHS members are available to serve on it and it has a specific task (e.g., connected to Dr. Sondik's planning effort for NCHS). Mr. Scanlon stated that the search for four new NCVHS members is taking into account current shortages and areas of underrepresentation.
Dr. Iezzoni announced that the Subcommittee on Population-Specific Issues will meet with Dr. Sondik on July 21 to discuss NHANES-IV, particularly race/ethnicity data issues raised by Dr. Amaro.
The group discussed how to avoid holding conflicting Subcommittee meetings. Regarding the allocation of meeting time, Ms. Frawley urged that the group's time together as a full committee not be short-changed. She suggested close coordination of agendas by Subcommittee and work group chairs to ensure maximum time together and to avoid clashing meetings. Ms. Coltin also pointed out the merits of joint meetings, which have worked well in the past.
The major activities of the Planning and Implementation Work Group are developing a public education strategy (spearheaded by Ms. Ward -- see below), updating Subcommittee work plans, and tracking the implementation of HIPAA recommendations and preparing the annual report to Congress. In developing their work plans, Ms. Coltin asked the Subcommittees to consider unfinished business of the current and prior Subcommittees as well as information gaps that need filling to get a complete picture.
The group also discussed how to inform non-Subcommittee members of Subcommittee agendas, and agreed to send meeting announcements and agendas to all NCVHS members through Ms. Greenberg. They discussed members' current difficulties with e-mail and attachments and agreed to press forward on resolving them and developing a functioning intranet for the Committee.
On the subject of gaps, Dr. Mor urged the Committee to look beyond ambulatory and hospital data and to keep data from other sources on its radar screen -- e.g., those having to do with disability and long-term care. Mr. Scanlon noted the Department's review of its provider surveys and its desire for the Committee's advice on such questions as what and who is a provider and what information the nation needs on them.
Ms. Frawley commented that alongside the major changes stimulated by HIPAA, and sometimes in direct conflict with them, there are "tons of regulations kicking out" from within HHS that Committee members are unaware of and that the industry is having difficulty integrating. The requirements for OASIS are a major case in point; another is the FMDRG. Dr. Detmer said there should be a way for the Committee to know about such developments so it can at least make timely comments. Members stressed the interconnection between health policy and data, and the impossibility of making sound decisions and recommendations with incomplete information. They asked Dr. Detmer to convey this concern to the Data Council. Until better communication can be standardized, Ms. Frawley offered to send fellow members weekly e-mail notices about relevant things gleaned from Federal Register notices and trade publications.
Members then discussed how best to track the field's response to standardization. Some stressed the need to go beyond hearings to follow an appropriate crossection of the field, particularly those with the least resources. The Executive Subcommittee will consider whether to subcontract out the surveillance function once a decision has been made about what information is needed. Dr. Detmer asked the Committee's staff to study these implementation tracking questions and bring back suggestions to the Committee. Mr. Mayes noted that the public comment period following publication of the regulations may afford some guidance in identifying problematic areas.
Ms. Ward said a communication plan would be developed this summer, covering such issues as target audiences, target behavior changes, and key messages. Ms. Frawley noted that the San Francisco hearings brought home the fact that huge segments of the provider community are still unaware of the impact of HIPAA on them. A related issue is the continuing need for consumer education.
Mr. Mayes commented that the HHS implementation team has started talking with groups like the ECRC; the group that needs special attention is the one that mistakenly thinks the legislation only pertains to billing. He suggested that the Committee focus its public education campaign on that group -- many sectors of which are those represented by Committee members.
Dr. Cohn observed that Committee members are already communicating with their constituencies; now that the recommendations are being finalized, a clear plan and set of clear and consistent messages can be developed. Dr. Mor expressed special concern for small providers, who are vulnerable to buying the wrong systems from the wrong vendors. He also asked for a set of presentation materials and stressed the need to disseminate information to the health services research community. Mr. Mayes said HHS has developed a standard package of slides that could be expanded with NCVHS-specific information. He offered to coordinate the Committee's outreach efforts so they are compatible with those of the Department.
Mr. Blair suggested the following professional organizations and trade associations as strategic early targets: Center for Health Care Information Management, American College of Health Care Executives, HIMSS, and AMIA.
The group then discussed how members who are asked to speak or write in their area of expertise should handle talking about the Committee's affairs. They agreed on a multi-faceted approach that includes developing standard materials to assist members in preparing speeches or articles, quick review by Dr. Detmer, Mr. Scanlon and/or Ms. Greenberg of fast- turnaround assignments, and ongoing, proactive cultivation of media contacts. Ms. Frawley cited NRC activities and resources as a good model, and she offered to provide a list of key reporters who cover IT issues. A packet of talking points, sample editorial and pointers will be prepared promptly for Committee members. Generally, the press is to be referred to Mr. Scanlon or Dr. Detmer.
The list of potential target communities includes providers, the general public, the research community, consultants, vendors, and state health groups. Ms. Coltin pointed out that often the most effective communication is to subsets of people in these "buckets," with more finely-tuned messages. Dr. Amaro noted that local health agencies should be targeted separately. Members were asked to send the names of target groups and individuals to Ms. Ward within two weeks, along with the names of the journals on whose editorial boards they sit.
An audience member asked the Committee to put a comprehensive calendar of deadlines, meetings, etc. on its web site.
Dr. Detmer queried the group about co-sponsoring events within its purview. It was concluded that this might be useful for getting the message out, provided it was done within the Committee's guidelines. Mr. Scanlon also suggested sending a standard article or letter to newsletters.
Dr. Braithwaite observed that many people still are unaware of the existence of a public sector advisory body in the standards process. It will be useful to let people know what a broad and open process has been going on. He reported that the Committee is getting hundreds of hits per week on its Web site, and suggested putting some provisional educational messages on the Web and asking for feedback.
The full Committee meetings on the schedule are September 8-9 and November 5-6. The Subcommittee on Population-Specific Issues will meet on July 21 and September 29-30. Members will be canvassed as to their schedules, and 1998 meetings will be scheduled as soon as possible. The group agreed to schedule four full Committee meetings in the next year, in the expectation that the work load will be at least as heavy as this year's.
Regarding agendas, Dr. Detmer expressed a desire for a briefing and discussion on the camera metaphor developed by Dr. Iezzoni and Ms. Coltin. Dr. Iezzoni said her Subcommittee would be using the schema at its July meeting, and this experience could then be offered as an example.
Dr. Iezzoni noted that her Subcommittee would like to partner with the Data Subcommittee for meetings on encounter and enrollment standards for mental health services now being developed by SAMHSA, and on coding issues related to ICD-10-CM and ICIDH. The Subcommittee thinks the shared issue of HCFA's data release policies should be addressed by the full Committee.
Other cross-cutting issues mentioned are security, which concerns both the Data and Privacy Subcommittees, and data content, which affects the Data and Population-Specific Issues Subcommittees along with the whole issue of surveys. Regarding the timing and disposition of joint meetings, the group agreed that break-out sessions should be reserved for working through action items and other business that needs closure by the full Committee, and that separate meetings should be scheduled for presentations, hearings and panels. It was suggested that hearings be "tacked on" to full Committee meetings, but some members said they could not be out of the office more than 3 days in a week, including travel time.
Finally, the Committee and staff were in full agreement about the merits of holding at least one meeting outside of Washington, D.C., based on the very positive response to the San Francisco meetings. The possibility of geographically dispersed hearings on the impact of HIPAA standards was mentioned. Dr. Amaro also observed that the impact study should hear from people in different functional areas.
Mr. Scanlon asked for an indication soon of the anticipated need for contract work, and members agreed on the need for help on implementation and public education.
Concluding this portion of the meeting, Ms. Frawley noted the openness of the dialogue with HHS and its staff's effort to get to meetings and talk to people around the standards effort. She and Dr. Detmer commended and thanked the Department for its hard work and support.
First, the Committee reviewed a slightly revised version of the NPI letter discussed the previous day. After Dr. Cohn described the changes made, the Committee voted unanimously to approve the revised version and send it to the Secretary.
The group then reviewed the revised version of the recommendations on health data standards, presented in the form of a letter to the Secretary. Dr. Cohn described the changes made to the document presented the previous day in response to Committee suggestions.
The group agreed on several minor modifications to the redraft. They engaged in a lengthy discussion of a proposal to recommend changing the compliance deadline so that all plans, large and small, have three years to complete implementation. The issues raised in favor of this change included the anticipated difficulty of implementation and the complications of having two timelines. The principal argument against "tweaking the deadlines" was the danger of weakening the legislation and sending mixed messages to the industry. Ms. Greenberg noted that ANSI HISB has asked that the dates not be changed, and the Department is going forward in accordance with the legislation. If the Committee finds a large volume of public comment about the difficulty of implementation, the deadlines can still be revisited. From the audience, a practice management vendor said he expects standardization to save him money, and he'd like to get started. Dr. Cohn added that his health plan's technical staff is comfortable with the deadlines. The Committee agreed to support the dual deadlines as specified in HIPAA.
Another focus of discussion was the issue of transaction data content and whether, or how, to make explicit the links between content and supporting standards without disrupting existing reimbursement-related practices. Members agreed to recommend that the approach to diagnosis and procedure coding be developed in the context of transaction data content -- i.e., that the processes for data content and code sets be parallel.
The Committee then discussed how to express its desire for a continued role in the development of standards, code sets and other data elements, consistent with its mandate. They then unanimously approved the document, as revised. It will be sent to the Secretary and thereafter made available on the Website and in the Federal Register.
Dr. Cohn observed that the process of editing this document would have been far simpler with the use of LCD panels, and Dr. Detmer said this technology would be explored for use in subsequent meetings.
Mr. Van Amburg reviewed the changes to the recommendations made in accordance with Committee suggestions. The Committee then unanimously approved the document as presented.
Dr. Iezzoni explained that HCFA representatives recently informed the Subcommittee on Population Specific Issues of a new data collection initiative announced in the Federal Register on March 10, with a 60-day comment period, requiring home health agencies participating with Medicare to collect data using a system called OASIS. The Subcommittee wants to convey its concerns to HCFA and has been assured that although the comment period is over, their comments are welcome.
Ms. Frawley said the OASIS data set was developed 12 years ago. It does not link any of the data sets used to capture information about patients; it also does not recognize the necessary degree of coding specificity. The data quality the tool would capture is poor because it doesn't integrate to other systems, making it impossible to track patients across the continuum of care. OASIS is only being tested in 50 home health agencies; to make matters worse, they are ones with sophisticated technological capacities that are not typical of the field.
Mr. Mayes said this represents an ongoing issue within HCFA, which traditionally has not been good about cross-referencing either internally or to broader sets. It is hoped that the recent reorganization will address this problem.
Dr. Mor expressed puzzlement about the reasons for the rush, which is contrary to the usual process.
Dr. Iezzoni added that OASIS is explicitly for quality assurance, with nurses essentially evaluating themselves. The impact of this self-evaluation has not been tested. She added that HCFA started a three-year demonstration project in 1996 and, inexplicably, is starting implementation prior to its conclusion.
In discussing the proposed letter from the Committee, the group focused on what they should recommend. Ms. Frawley suggested supporting the goal of improving documentation and promoting automation of records in the home health arena, but doing so in a manner that does not force 9,200 home health agencies to "go jump" without knowing what their experience would be. Dr. Mor noted that the industry is said to favor the change. Dr. McDonald urged that the mechanical problems be separated in the Committee's letter from the question of whether the whole idea is any good. Dr. Iezzoni said the Subcommittee would present a redraft in response to these comments later in the meeting.
Following a break for lunch and other Committee business, a revised version of the letter was presented and discussed, essentially urging HCFA to reconsider implementing the OASIS until completion of its 3-year review. After making a few further modifications, the Committee approved the letter and asked Dr. Detmer to send it to those designated for comments plus the co-chairs of the Data Council.
Dr. Detmer welcomed Katherine Wallman, Chief Statistician at OMB. In view of the fact that OMB had not yet released the recommendations of its interagency committee, she provided the Committee some background and a general idea of what they could expect.
The administration has had standards for collecting race/ethnicity data since 1977. Particularly since the 1990 census, the standards have been criticized as not in tune with changes in the demographic composition of the population. In 1993, OMB undertook a comprehensive review of the standards in cooperation with other agencies that use and produce data, to culminate in recommendations for any modifications to be incorporated beginning with the next decennial census. Decisions must be made by fall 1997.
The agency has made an effort to go out to diverse constituencies and elicit their concerns and suggestions, and also to ensure that extensive research was conducted. There were four public hearings and an extensive Federal Register notice with comment period in summer 1994, resulting in testimony from 100 people and some 800 letters. OMB published another major notice a year later that provided a synopsis of the issues raised and laid out research plans. The research involved three major studies: the CPS supplement, the National Content Survey, and the Race and Ethnicity Targeted Test. There also have been focused studies in specific areas such as health, education and civil rights.
The research results and public comments have been studied by the interagency committee, which has just issued a report and recommendations. This will be the subject of the Federal Register announcement to be released in early July, followed by a 60 day comment period. On the basis of these comments and further analysis, OMB plans to release its recommendations by mid-October.
Ms. Wallman stressed that the standard is intended as a minimum set of categories for cross-government use; more detailed categories can be used as needed in specific contexts.
Dr. Iezzoni commented on the thoroughness of the research and analysis on these matters, and explained that the Subcommittee will draft a response under the leadership of Dr. Amaro. This will be circulated for full Committee approval and submission to OMB. Ms. Wallman said the agency welcomes a continuing dialogue with the Committee, through formal and informal means.
Dr. Carter-Pokras described the plans of the Office of Minority Health and the Census Bureau for disseminating the OMB report to a combined mailing list of more than 13,000 individuals and organizations. All members of NCVHS will be sent a copy of the notice.
Mr. Gellman presented the revised draft of the recommendations, prepared by the Privacy Subcommittee in response to the previous day's discussion. Its major points remain the same: that the nation is in a health privacy crisis, that privacy protection has eroded over the last 20 years, and that the issue urgently needs attention. It asks for legislation by the end of this Congress. He and Ms. Frawley described the changes in detail; in some, they strengthen some recommendations (e.g., on discrimination) and clarify various positions in the areas of disagreement.
Members discussed Dr. McDonald's concerns about the patient access language. Mr. Gellman noted that the document offers strong support for research use of records without patient consent. A long discussion centered on questions about the language on registries and whether it risks undermining public health registries. Privacy Subcommittee members explained that current abuses of registries have made them a lightening rod and made it necessary to impose some restrictions in order to protect the uses that are in the public interest. Mr. Gellman reminded his colleagues that the function of this document is to flag and clarify issues, not to write statutes.
The Committee then discussed the question of whether to recommend an advisory and oversight mechanism for quality assurance/cost review practices, something akin to the IRB for research and possibly involving health professionals not affiliated with the organization under review and/or patients. Ultimately, they decided not to recommend a specific review process in this area because there is no clear and practical solution. Instead, the document takes note of this issue as worthy of attention and offers one possible approach.
Dr. Harding (who participated in the revision process on the previous day as a member of the Subcommittee) said he regards the revised report as improved but still not sufficiently pro-privacy. In particular, he noted that lack of recommendations for higher protection for the most sensitive information, the lack of a statement about informed consent as the backbone of the legislation, and the failure to clearly distinguish between clinical and secondary uses of health information. However, he declined to offer amendments, recognizing that most of his fellow Committee members support the present version of the document. He expressed hope that the Committee will continue to push for action on discrimination, tougher regulations on the secondary use of information, and special protections for sensitive information.
Mr. Gellman expressed agreement with many of these points, but pointed out that the draft does not take positions on difficult issues on which the Committee is not in agreement and/or for which no clearly beneficial solutions have emerged. He stressed that privacy legislation has been "sitting around Capitol Hill for 20 years" while protections have seriously deteriorated, and asserted that it is better now to have "half a loaf" than none at all. The Committee is at least united on the basic principle that this is an important issue and it needs prompt action.
Dr. Amaro spoke in support of Dr. Harding's concerns about special protections, noting that members of less advantaged groups are at the greatest risk of loss of privacy as well as at high risk for such sensitive conditions as substance abuse, STDs and HIV. She urged that the Committee offer language to move toward solutions. Mr. Gellman responded that despite the widespread awareness of this problem, no solution has been found. Several members observed that here the Committee is struggling with the result of social inequities, including the lack of universal health care. Dr. Detmer expressed agreement with these concerns but stressed the need to move forward with the overall recommendations and not let them founder on this issue. He noted that the full Committee, the Privacy Subcommittee, and those working on security, as well as parallel processes in the Department, will continue to struggle with these concerns. Non-discrimination policies are critical, given society's decision to limit access to basic health care. The Committee then voted to adopt the report with the changes discussed, with one member abstaining and the others approving the document.
Following concluding comments and thanks, Dr. Detmer adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ Don Detmer 11/19/97
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Chair Date