Washington, D.C.
The Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics held a public meeting on March 31, 2000, at the Hubert H. Humphrey Building, Washington, D.C.
Note: The transcript of this meeting is posted on the NCVHS website.
Dr. Cohn convened this open meeting of the Subcommittee on Standards and Security to discuss the Memorandum of Understanding Among the Organizations Designated to Manage the Maintenance of the EDI Standards Adopted Under HIPAA.
HIPAA REGULATIONS UPDATE
Ms. Trudel reported on the status of the following HIPAA regulations: standards for electronic transactions and code sets, unique employer identifier, security requirements, unique provider identifier, privacy, unique health plan identifier, electronic claims attachments, and enforcement.
MEMORANDUM OF UNDERSTANDING
Mr. Nachimson introduced the Memorandum of Understanding Among the Organizations Designated to Manage the Maintenance of the EDI Standards Adopted Under HIPAA (MOU), which will allow for a single entry point for any person or organization to request a change to the standards, for all the relevant organizations to evaluate the request, and for the responses to that request to be forwarded to the NCVHS and the Secretary for consideration and inclusion in the standards.
According to the MOU, HIPAA standard change requests can be submitted at any time via a designated web site available to the public. The web site administrator will forward requests to the Department and the other maintenance organizations. Each organization may decide whether or not to collaborate in the analysis and development of the response to the request, and a schedule will be established for analysis, response, and appeal. Upon agreement of the response to the request, the appropriate standards developing organization will proceed to develop the necessary actions to implement that change. Upon agreement on the changes, the changes will be incorporated into appropriate documentation. The NCVHS will review approved requests and make recommendations to the Secretary, and DHHS will proceed with the rule-making process.
The Federal Register notice is expected to be published at the same time as the final transactions and coding rule, no later than June 30. The change request process could take as long as two years, but most changes would require less time-consuming "tweaks."
PANEL DISCUSSION ON MEMO OF UNDERSTANDING
Representatives of all the signatories to the MOU--American Dental Association, ASC X12, HL7, National Council for Prescription Drug Programs, National Uniform Billing Committee, and National Uniform Claims Committee--presented their views of the MOU's potential benefits to the patients, providers, and the health care system; the timing of the process; and their concerns.
Among the benefits cited were a single point of entry; collaborative, standardized process; and open, public access. Among the concerns were delays in publishing final rules and uncertainties regarding funding of resources for maintenance of the standards and the MOU process. Panelists also discussed the current process vis-à-vis developing standards for patient health records, the need for timeliness in the change process embodied in the MOU, and appropriate timing of Subcommittee hearings on proposed changes to standards.
The panelists signed the MOU.
NEXT STEPS
Next steps were discussed, and the meeting concluded.
Dr. Cohn convened this open meeting of the Subcommittee on Standards and Security to discuss the Memorandum of Understanding Among the Organizations Designated to Manage the Maintenance of the EDI Standards Adopted Under HIPAA.
CALL TO ORDER AND INTRODUCTIONS
Dr. Cohn outlined the order of business for the meeting, and members, staff, and other participants introduced themselves.
HIPAA REGULATIONS UPDATE
Ms. Trudel reported on the status of the HIPAA regulations:
Ms. Trudel reported that WEDI (Workgroup for Electronic Data Interchange) announced its sponsorship of an initiative, Strategic National Implementation Plan (SNIP), to coordinate HIPAA standards implementation activities and to develop industry best practices. The initiative will provide a forum for sharing implementation schedules, identifying resources, and communicating case studies, among other functions.
She noted that although the employer identifier could be published within a month, she could not be more precise other than to state that the other rules, excluding privacy, would be completed before the end of the calendar year.
Members discussed funding for implementation of the transactions to accelerate the process.
Ms. Trudel reported that individuals are working on the possibility of loading an NPI database. Dr. Zubeldia suggested working on the security part now and "piggybacking" the synchronization effort into either another rule or the privacy rule. Ms. Trudel explained the ongoing coordination effort that may result in issuance of the security rules before the privacy rules. Ms. Trudel also acknowledged that an administrative simplification identifier has been considered.
MEMORANDUM OF UNDERSTANDING
Mr. Nachimson introduced the Memorandum of Understanding Among the Organizations Designated to Manage the Maintenance of the EDI Standards Adopted Under HIPAA (MOU), which will allow for a single entry point for any person or organization to request a change to the standards, for all the relevant organizations to evaluate the request, and for the responses to that request to be forwarded to the NCVHS and the Secretary for consideration and inclusion in the standards. The agreement forged will be effective on publication of the final regulation and an associated Federal Register notice.
According to the MOU, HIPAA standard change requests can be submitted at any time via a designated web site available to the public. The web site administrator will forward requests to the Department and the other maintenance organizations. Each organization may decide whether or not to collaborate in the analysis and development of the response to the request, and a schedule will be established for analysis, response, and appeal. Upon agreement of the response to the request, the appropriate standards developing organization will proceed to develop the necessary actions to implement that change. Upon agreement on the changes, the changes will be incorporated into appropriate documentation. The NCVHS will review approved requests and make recommendations to the Secretary, and DHHS will proceed with the rule-making process.
Mr. Nachimson stated that the Department commends the signatories to the MOU for their willingness to work together toward administrative simplification.
In discussion, Mr. Nachimson noted that the Federal Register notice is expected to be published at the same time as the final transactions and coding rule, no later than June 30. The MOU will be posted on the web site. It is expected that NCVHS would hold hearings on proposed changes. The change request process could take as long as two years, which will impact the workings of the Medicare program, but most changes would require less time-consuming "tweaks." Substantive changes to standards will be allowed only once a year, but it is reasonable to assume that minor changes to code sets would be permitted outside the one-year cycle. The Secretary may permit more frequent changes to assure compliance. A change to an individual ICD-9 code would be handled by a single maintenance organization. Mechanisms for publicizing minor changes are under consideration.
PANEL DISCUSSION ON MEMO OF UNDERSTANDING
Representatives of all the signatories to the MOU--American Dental Association (ADA), ASC X12, HL7, National Council for Prescription Drug Programs (NCPDP), National Uniform Billing Committee (NUBC), National Uniform Claims Committee (NUCC), and DHHS--presented their views of the MOU's potential benefits to the patients, providers, and the health care system; the timing of the process; and their concerns.
Mr. Lapp described the ADA's philosophy and involvement in the standards-setting process. He expressed the ADA's concern about delays in publishing final rules, stating the difficulty in motivating dentists to prepare for HIPAA-mandated standards. He noted the information feature of the ADA's web site, which educates users on the benefits of electronic transactions.
Mr. Beatty of X12 noted that the MOU meets the needs originally identified for a change management process. He stated that the process still requires funding of resources to manage the systems and to support paper change requests. Unanswered questions include who will develop and maintain the process, where funding will originate, and will funding be one-time only or ongoing. The X12 Insurance Subcommittee's Business and Information Modeling Task Force has established the HIPAA Implementation and Coordination Workgroup to manage the change request process within X12; Mr. Beatty outlined the organization's internal procedures.
Dr. Beeler described the collaborative nature and activities of HL7 in the standards-setting process. He emphasized the collaborative nature of the process outlined in the MOU. He also identified several unknowns in the process, including uncertainty about the operational funding of the web site and its associated costs and publicity about the new process.
NCPDP's Ms. Stember described the membership of her organization, representatives of every sector of the pharmacy industry. She noted that the MOU provides for open public access, and that a process of education of NCPDP staff and membership must be initiated.
Mr. Arges of the NUBC expressed deep support for the creation of standards and uniformity nationwide. He noted that the process defined in the MOU will facilitate state standardization initiatives and promote dialogue.
Ms. Narcisi of the NUCC itemized several benefits of the MOU: single-point-of-entry web site; a formal, standardized format for maintenance requests; a filtering process for all change requests; public voice in the data maintenance process; consensus approach in evolution of changes. NUCC's membership includes both payers and providers, plus representatives of standards development organizations, regulatory agencies, and the NUBC. Among the NUCC's concerns are funding of the web site, perhaps by DHHS because DHHS currently funds maintenance of implementation guides and establishment of principles regarding potential sponsorship or advertising for the web site. NUCC believes the web site should be maintained by the maintainer of the X12N implementation guide database, in conjunction with NUCC and other data content committees.
In discussion, Dr. Zubeldia suggested consultation with a privacy expert before advertising is added to the web site. Panelists discussed the issue of divergence of standards and the inadvisability of developing "dueling standards." They also noted the option of adding additional SDOs to the process.
Dr. Beeler discussed the expected difficulties in seeking mandated standards for patient health records. He noted the necessity to balance business process decisions with technical solutions, and spoke of the MOU as a model for future discussions. He also suggested that terminologies are dynamic and do not lend themselves to standardization. Mr. Beatty pointed out that the single, consistent process is important in a discussion of clinical information.
Mr. Arges stated that education of the public on the importance of the MOU in terms of furthering uniformity and standardization, and reducing administrative costs, will help the process succeed. Mr. Beatty suggested that the process would be expedited by human resources support to filter the volume of informational and change requests sufficiently to enable the volunteer experts focus on the substantive matters. Mr. Lapp stated that the ADA will allocate some of its resources to this streamlining process. Dr. Beeler noted that until the volume of requests is known, the level of need for resources remains unclear. X12 is currently examining how to answer educational questions, for instance by posting Frequently Asked Questions (and answers) on the web site. Ms. Narcisi suggested that the MOU will help her organization coordinate its educational processes.
Dr. Cohn emphasized the need for the overall process as defined in the MOU to produce timely results. Dr. Beeler stated that his organization can meet the mandates of the MOU. Mr. Lapp noted that some ADA staff members already are dedicated to screening activities. Ms. Narcisi stated that the presence of interested persons on multiple committees will help the process. Mr. Beatty stated that speed is more a problem with the end user in becoming aware of and implementing the change, than with the X12 organization. Mr. Arges suggested that awareness in the industry of impending issues and of predictable ways of handling them can help to prevent logjams. Ms. Stember stated that NCPDP's dedicated staff now handle similar questions. Ms. Trudel identified the potential need to establish and disseminate to the public a schedule, based on NCVHS meetings, for milestones in the process, in order to help them predict the needs of the process.
Dr. Cohn commented that the Subcommittee expects to hold hearings at least annually to hear recommendations, public testimony, and comments, and asked for guidance on scheduling the meetings in the context of the MOU process. Most panelists agreed that fall hearings would conform with their schedules. Mr. Arges urged minimizing initial changes to avoid confusion.
Mr. Nachimson stated that DHHS will conduct an annual review of the process and report to the Subcommittee. Ms. Greenberg stated that the MOU will be posted on the NCVHS web site to support the educational process. The next step is for the signatories to convene.
Gary Claxton, DHHS Deputy Assistant Secretary for Planning and Evaluation, acknowledged the cooperation of the organizations involved in crafting the MOU. The representatives signed the MOU.
A hearing will be scheduled for September or October, the date to be determined in consultation with Subcommittee members. Ms. Fyffe raised the issue of eventual adoption by the Secretary of ICD-10 codes and the importance of hearing a presentation or testimony from a WEDI representative on the topic. A presentation will be scheduled for June and/or the autumn.
At the close of the meeting, Dr. Cohn passed the gavel to Mr. Blair, co-chair of the Workgroup on Computer-based Patient Records.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ Simon P. Cohn 01/31/01
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Chair Date