Washington, D.C.
The Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics held a public meeting on February 1, 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 Subcommittee’s upcoming report to Congress on HIPAA implementation and the Subcommittee’s work plans for the year 2000.
DEPARTMENT OF HEALTH AND HUMAN SERVICES BRIEFING
Dr. Braithwaite summarized the tentative schedule for publication of several rules of administrative simplification, including transactions and code sets, national employer identifier, national provider identifier, and security (no date set yet for the privacy rule). He also itemized several rules currently under development, including national health plan identifier, claims attachment, and the national identifier for individuals (which is on hold pending implementation of privacy protection). He noted that the Department of Health and Human Services will participate in writing regulations for civil enforcement, and will assist the Department of Justice in writing criminal regulations. No date is set for final publication of enforcement rules. Funds for enforcement will be available.
Ms. Trudel discussed a memorandum of understanding (MOU) on maintaining and changing standards over time agreed to by the National Uniform Billing Committee, National Uniform Claim Committee, the American Dental Association, and three standards development organizations (SDOs), plus the Department of Health and Human Services.
Ms. Trudel discussed plans for implementing standards for Medicare. Although the final rules have not yet been published, implementation guides have been published on the Internet. DHHS has begun developing instructions for implementing transaction standards. A schedule for Medicare standards is being developed, and training for key players is being scheduled.
Participants discussed the need for regular, ongoing data collection regarding the state of implementation and readiness. Ms. Ball described her contacts with Faulkner & Gray, and members suggested additional sources of information, including SDOs, other health care organizations that survey the field, a set of hearings focused on the status of implementation, and use of Washington Publishing Company’s web site to conduct a survey on HIPAA implementation.
REVIEW OF SUBCOMMITTEE WORK PLAN FOR 2000
The Subcommittee soon will discuss the MOU. If any NPRMs are out by the end of March, a draft response can be formulated to be discussed by the full NCVHS. Discussions related to coding systems of the future will be held in May. The June meeting may include a meeting with a Faulkner & Gray representative. A set of hearings is scheduled for July 13-14 on early implementation issues. In late September, a session will be scheduled to discuss revisions to standards and new standards to recommend to the Secretary. A meeting may be necessary to discuss tracking the standards implementation process, identifying new standards, and any changes needed.
NCVHS REPORT TO CONGRESS ON IMPLEMENTATION OF HIPAA ADMINISTRATIVE SIMPLIFICATION
The group discussed the congressionally mandated annual report on the status of the implementation of administrative simplification requirements. The upcoming report will examine some known standards and certain forward-looking issues.
Members of the Subcommittee reviewed the first draft of the report, plus comments from some members of the Data Standards Committee. Subcommittee staff and members commented on the draft document, with the expectation that changes would be made to reflect their discussions. Both the draft document and the document as revised by the Subcommittee are appended to these minutes.
During the course of the discussion on the report, members and staff discussed the advisability of publishing the security rule even though the privacy rule is not ready (no problem) and the need to monitor the state of the industry in terms of readiness.
Dr. Cohn adjourned the meeting.
Dr. Cohn convened this open meeting of the Subcommittee on Standards and Security to discuss its work plans for the year 2000 and the upcoming NCVHS report to Congress on implementation of HIPAA administrative simplification.
Dr. Cohn outlined the order of business for the meeting, and members, staff, and other participants introduced themselves.
DEPARTMENT OF HEALTH AND HUMAN SERVICES BRIEFING
Dr. Braithwaite, Ms. Trudel, and Ms. Ball, respectively, updated members on (1) the tentative schedule for publication of several rules on administrative simplification, (2) a memorandum of understanding (MOU) between the Department of Health and Human Services and standards developing organizations (SDOs) and data content committees, and (3) a plan for data collection to enable the Subcommittee to evaluate future implementation of HIPAA standards as it relates to reporting requirements.
Five Notices of Proposed Rule Making (NPRM) have been published. Four already have passed the dates by which final rules had been expected to be published. The rules on transactions and code sets standards and on the national employer identifier are expected out in March 2000. A June 2000 publication date is expected for the national provider identifier rule. The security rule is expected in May or June 2000. A final date has not been set for the privacy rule, which is open for comment until February 17, 2000.
Several NPRMs are in development. The national health plan identifier NPRM may be published in April 2000, and the NPRM for claims attachment, already into the clearance process, may be published in March 2000. Pending implementation of privacy protection, the national identifier for individuals is on hold.
The above rules are accompanied in the legislation by civil monetary penalties for failure to meet the standards and by criminal penalties for failure to maintain the privacy of information associated with individuals. The Justice Department will enforce the criminal penalties and write rules and regulations for that procedure. DHHS will be involved only peripherally in developing rules that may trigger criminal penalties, but DHHS will be involved in promulgating regulations for the civil penalties.
The current thinking is that the Office of Civil Rights is the appropriate enforcement agency to enforce the civil penalties, and that the central and regional offices will be handling that enforcement. An interagency team is developing the regulations for civil penalties. DHHS believes that this provision is not subject to the two-year delay after the effective date; the effective date will be 60 days after first date on which standards require compliance: May 2002. No prediction has been made as to when the final rule will be published. Funds for enforcement will be available.
Ms. Trudel discussed the MOU on maintaining and changing standards over time. The three content committees mentioned in the standard—National Uniform Billing Committee, National Uniform Claim Committee, and American Dental Association—and three SDOs have established a protocol for how changes will be considered, how they will be processed, how the organizations will be involved in the process, the rules they will use, and ways they will publicize and involve the public in the processes. It will be a collegial process with a focus on efficiency; the process will be field tested before implementation. DHHS will sign the MOU as an observer to ensure that the process carries out the guiding principles established in the regulations. The MOU will be made available upon approval by the general counsel.
Dr. Braithwaite observed that this major achievement has been accomplished with no governmental funding to motivate the cooperative private-sector process.
Mr. Blair solicited guidance from Dr. Braithwaite and Ms. Trudel on the NCVHS report to the Secretary of DHHS due in August 2000. Both agreed to participate in the process, and Dr. Braithwaite commended the Workgroup on CPR on its general message.
Ms. Trudel discussed plans for implementing standards for Medicare. Although the final rules have not yet been published, the implementation guides (available on the Web) are final. DHHS has begun developing instructions for implementing transaction standards. Work has begun on the claim and will proceed in stages. An instruction for the implementation of the professional claim, the A37-40-10, is in the review process; comments from HCFA are being received, and work on it will begin in the fall. The next topic to be addressed will be the institutional claim and then probably the remittance advice. A schedule for Medicare standards is being developed, and training for Medicare state agencies, contractors, carriers, fiscal intermediaries, and regional federal staff is being scheduled. A training syllabus has been developed, and a three-day course is planned for nine locations. In addition, a Medicare HIPAA newsletter has been targeted at state agencies to give them background on relevant issues. The educational materials will be posted on the administrative simplification website as soon as they are available.
Ms. Trudel noted that DHHS will provide some cross-walking between its own formats (such as NSF) and EDI version 4010, so that contractors need not do their own mapping. There will be no changes in implementation vis-à-vis the standards guides. Ms. Trudel pointed out that, at various levels, HCFA is proactively coordinating the activities with which it is involved. Ms. Trudel noted that streamlining the EDI process is secondary to having transactions in place. Several sites are under review regarding new instructions for testing.
Ms. Ball described the positive response from the editor of the Faulkner & Gray Health Data Directory in working with NCVHS. Data sharing for Faulkner & Gray is new territory. Although the content of their instruments is proprietary, Faulkner & Gray revealed to NCVHS staff that they ask their clients (among other information) about numbers of claims or encounters processed, submitted, or received, and the percentage of those claims that are electronic; total transactions processed; claim status or eligibility verification; X12N 4010 transactions in use; use of the public Internet to transfer information; and components of electronic patient records.
Dr. Cohn explained to the Subcommittee that the need has been identified to develop a greater understanding of the current state of implementation. One idea suggested was a focused set of hearings on the status of implementation. Mr. Blair suggested that in addition to soliciting input from Faulkner & Gray, SDOs may also be a good source of information. WEDI may serve as an information coordinator on the implementation issue and may be able to report to the Subcommittee about identified problems and issues with standards. Dr. Zubeldia commented on the desirability of collecting information regarding how both EDI and non-EDI entities migrate to HIPAA, stating that a web site may be a good mechanism and that there may be other appropriate vehicles.
Ms. Ball commented that Faulkner & Gray may welcome the opportunity to expand their sampling frame for their survey. It will be important to find out the cycle of the Faulkner & Grey survey in order to decide on when to schedule a meeting with the editor, and also so that questions may be evaluated that may be of use to the Subcommittee.
Washington Publishing Company, which publishes the implementation guides, will host the common work site for the MOU. Dr. Zubeldia suggested the possibility of using the web site for a survey on HIPAA implementation, including publishing the results of the survey. Ms. Trudel pointed out that this would be a valuable discussion to conduct with industry representatives. Dr. Cohn observed that an educational campaign would be necessary to inform the public about the availability of the web site for this purpose. Dr. Zubeldia suggested conducting a standard survey of standards to be sent to all members of WEDI, AFEC, AMA, ADA, AHA, and pharmacy chains. Dr. Cohn stated his hope that Faulkner & Gray would play a key role in such a survey. Ms. Ball noted that AHA and other organizations also survey health care organizations, and that no federal funds are available for HIPAA implementation. Mr. Blair identified two issues: (1) revising or adding questions to the Faulkner & Gray survey, and (2) devising a mechanism for an additional survey that could be conducted more frequently than annually.
REVIEW OF SUBCOMMITTEE WORK PLAN FOR 2000
Dr. Cohn reviewed the purview of the Subcommittee: (1) to respond to NPRMs as they are produced, (2) to develop the annual report, (3) to focus on monitoring industry readiness, identifying and resolving implementation and enforcement issues, monitoring early implementers, and (4) to identify the need for new and revised standards.
The agenda for either the Subcommittee breakout session at the February NCVHS meeting or the March 31 Subcommittee meeting will include discussion of the MOU. If any of the NPRMs are out by the end of March, a draft response can be formulated to be discussed by the full NCVHS.
In May, either at the hearing or the full NCVHS meeting, discussions related to coding systems of the future will be held.
The June 1-2 meeting may include a session with a Faulkner & Gray representative, if the discussion of recommendations developed by the Workgroup on Computer-based Records goes well.
A set of hearings is scheduled for July 13-14 on early implementation issues.
In late September (possibly September 21 and 22), a session will be scheduled to discuss issues related to revisions to standards and new standards that must be recommended to the Secretary.
Members discussed holding hearings in late spring/early summer 2000 on tracking the standards implementation process, identifying new standards, and changes needed. The issue might call for a meeting in late March/early April, then in mid- to late May, and then in September. A hearing is likely to be scheduled during the summer.
NCVHS REPORT TO CONGRESS ON IMPLEMENTATION OF HIPAA ADMINISTRATIVE SIMPLIFICATION
Mr. Scanlon explained the HIPAA legislative requirement for an annual report to Congress on the status of the implementation of administrative simplification requirements. The upcoming third annual report, which will continue the prior reports’ focus on the pre-implementation stage, will also now examine some known standards and certain forward-looking issues.
The process for Subcommittee approval of the report is expected to involve the inclusion of minority opinions, if any.
Members of the Subcommittee reviewed the first draft of the report, plus comments from some members of the Data Standards Committee. Subcommittee members and staff commented on the draft document, with the expectation that changes would be made to reflect their discussions.
During the course of the discussion on the report, members and staff raised the following related issues: (1) The relationship between the privacy and security rules may be out of synch consistently, but it would not be problematical if the security rule were published when it is ready, and (2) because readiness in the industry is extremely uneven, it would be helpful to monitor the state of the industry in terms of readiness.
At the close of the review of the report, 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, M.D. 11/20/00
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Chair Date