Vice President Gore, in his March 8, 1995 Memorandum to Secretary Shalala, asked the Department of Health and Human Services (HHS) to lead an interagency effort with the long- term goal of promoting evolution toward more shared health data standards. HHS is now implementing that charge through three related efforts:
These efforts are based on the following principles:
(For a more detailed discussion of the principles guiding our activities, and their relationship to related principles articulated pursuant to the Vice President's NII activities, see TAB A).
The Vice President's charge stems in part from the absence of coordination of health data standards activities across federal Departments. Each Department is pursuing its own activities, and links between those activities are often missing. To determine how best to move toward greater coordination of federal policy in this area, we undertook an aggressive outreach program, including inter-Departmental staff-level meetings and correspondence from Secretary Shalala to the heads of the other Cabinet agencies listed in the Vice President's memo. (TAB B includes a detailed description of our outreach efforts, the input we received, and the other models for interagency efforts that we reviewed.)
This outreach effort identified several key barriers to making interagency work effective:
The HHS effort is aimed at eliminating those barriers. The HHS Data Council will provide an organizational locus for Senior level communication and coordination, and for consolidation of staff activities on health data standards. Attached at TAB C is a chart, showing roughly how these efforts will relate to one another.
The organization locus for HHS leadership of this effort is the HHS Data Council. The Data Council consists of all HHS Assistant Secretaries and Agency Administrators who have a direct reporting relationship to the Secretary, a privacy advocate appointed by the Secretary, plus the Secretary's Senior Advisor on Health Statistics. It is co-chaired by the Assistant Secretary for Planning and Evaluation and a rotating Operating Division head; the current OpDiv co-chair is the Administrator of the Health Care Financing Administration. (For a more detailed discussion of the HHS Data Council, see Tab D, which includes Secretary Shalala's Memorandum creating and charging the Data Council.)
As noted above, our outreach efforts indicate a need for a high-level mandate for collaboration on data standards issues from the participating agencies. While the Vice President's charge to HHS provides the beginnings of such a mandate, active participation by senior officials in each agency is needed to make that mandate real. The HHS Data Council will use two mechanisms to bring senior officials from other agencies closer together in data standards activities: the HHS Data Council will hold inter-departmental meetings when there are important action items, and will provide regularly scheduled written communication.
Inter-Departmental Meetings. Actions items triggering meetings will not be limited to disputes, but should include discussion of important staff recommendations, "testimony" type events, etc. These meetings can also authorize ad hoc and standing interdepartmental working groups as may be needed to address particular issues. Any agency can call for such a meeting.<1>
Regular Written Communications. At the same time, we recognize the need for on-going communications (i.e., regardless of whether "action items" are pending). While the interagency staff work will provide an important vehicle for this communication, our outreach efforts indicate that senior-level communication is also important. The Data Council will send regular newsletters, informing other agencies of events, progress, and issues. These newsletters will be "interactive" in that contact persons for each issue will be identified, and comments/suggestions will be solicited. Any Department or working group can contribute to the newsletter. Since the meetings will focus on action items, they may not provide opportunities for communication on matters that do not appear on the agenda; the newsletter is intended to fill that gap.
While Vice President Gore has asked HHS to lead the interagency effort on health data standards issues, there is also an ongoing effort to coordinate electronic data interchange (EDI) generally across federal Departments. The Federal EDI Standards Management Coordinating Committee (FESMCC) is an interagency body charged with a subset of data standards issues -- development and maintenance of implementation conventions (IC) for EDI applications used by federal agencies. While the FESMCC has work groups devoted to EDI for particular industries (i.e., procurement, finance), at present there is no health work group.
The most effective way to organize the inter-Departmental staff work on data standards under the Vice President's directive is to tie the FESMCC and HHS efforts together, by establishing a unified inter-Departmental health work group on data standards. The work group will have a dual mandate:
As last fall's process of revising the Federal Information Processing Standards publication 161 illustrates, a FESMCC health work group to address health EDI issues is urgently needed. It would be unwise for HHS to create a separate staff effort on the broader array of health data standards issues, because EDI issues are not separable from data standards issues (while not all data standards issues are encompassed by the term "EDI," all EDI issues are part of data standards work). The purpose of this effort is improved policy coherence and coordination; consolidation of staff effort will greatly promote this goal. In addition, the HHS Data Council can provide a link to the private sector that the EDI might not otherwise easily have, through its advisory committee (see below).
With the broadened mandate, this group can coordinate federal staff representation at standards development organization meetings (ANSI HISB, X.12, NCPDP, ASTM, etc.) and meetings of related groups (such as WEDI, MRI, CPRI, G7). The fact that the FESMCC, under NIST regulations, includes a regulatory mandate (evaluation of ANSI standards and registration of government-wide implementation conventions for EDI) is an important advantage in encouraging agencies to appoint appropriate people and focus on its activities. Any issues stemming from joint oversight of the FESMCC/HHS unified inter-Departmental health work group can be addressed in the context of the senior level interagency meetings described above.
The lack of shared standards for health data increases paperwork burdens and reduces the analytic potential of health data. There is little ability to share, make multiple uses of, or link data. Many electronic data systems cannot communicate with one another, either within the private sector or between public and private data holders. There is a developing consensus that everyone -- consumers, industry, policy makers -- would be better served by more uniform, voluntary, and shared standards for collection and transmission of health information.
Pursuant to the Vice President's charge, HHS will provide a national forum for the collaboration of interested parties, in the form of a federal advisory committee, with the long-term goal of increasing the interoperability of diverse health information systems.
The Department has an existing and productive federal advisory committee, the National Committee on Vital and Health Statistics (NCVHS), addressing issues closely related to those described by the Vice President. As of March, 1996, a majority of seats on the NCVHS are open. Thus, this is an excellent time for a shift in focus for the NCVHS, and a refocused NCVHS will be an excellent vehicle for this endeavor.
We have revised the charter of the NCVHS, and are well into the process of revising its membership and work plan.
We are also conducting outreach to key constituencies interested in health data standards and privacy (i.e., the Secretary will not be bound by responses to the Federal Register notice). We have solicited suggestions for new members from many interested groups, including WEDI, the Koop Leadership Council, and others.
The Vice President asked HHS to obtain input from the federal advisory committee regarding "How can HHS ensure that the Medicare Transaction System is fully compatible with the multiple health uses of the NII?" However, the Medicare Transaction System (MTS) is on a tight schedule, with key design documents scheduled to be finalized over the next few months. Thus, it is not feasible to expect the advisory committee to provide advice in that time frame.
To obtain equivalent input on the MTS prior to finalization of its design documents, the HHS Data Council has asked HCFA, working with other HHS personnel, to hold "Expert Forums" on particular topics related to MTS and its interface with the NII. The Forums will be "focus group" type sessions.
HCFA has already undertaken extensive outreach efforts in designing the MTS. The purpose of the Expert Forums will be to bring new voices to bear, and to ask new questions.
A. Expert Forum on Managed Care, Status and Next Steps: Planning for an Expert Forum on Managed Care is well underway. The agenda has been approved by the Data Council (prior to submission to the Data Council it was circulated to the HIAWG and others outside HHS for input). This Agenda is attached at Tab G. We are currently in the process of identifying appropriate participants, and will schedule the Forum based on their availability.
B. Expert Forum on Privacy, Status and Next Steps: The Data Council and HCFA have identified privacy as another issue on which an Expert Forum would be useful. HCFA is expecting an interim report on this and related issues from its contractor; an agenda for the Forum will be developed based on the contents of this report.
We anticipate that the activities described in this status report will require significant commitment of FTE resources. However, given the current budget climate, these activities will be accomplished within existing budget ceilings. Just as HHS will be providing FTE support for these activities with existing resources, we will be asking the other participating Departments to do the same.
<1> We considered whether to establish a regular meeting schedule for senior officials, or to call meetings only to address actions items. On balance we decided that it is important to avoid "make work" meetings that can result from a regular meeting schedule. If there is not a meaningful agenda at every meeting, the attendees will lose the sense of significance that regularly scheduled meetings might otherwise promote. In this case, members will begin to send substitutes, and the group will no longer include the persons needed to provide the high-level mandate. We are aware that this approach diminishes the opportunities for unstructured exchange of information between Departments. To facilitate communication about matters that would not otherwise appear on a "action item" type agenda, we decided to include regular written communication as part of our activities. This approach may, of course, be revisited as experience warrants.