IV. New and Revised Standards

[Please label any written comments or e-mailed comments about this section with the subject: New Standards]

A. New Standards

To encourage innovation and promote development, we intend to develop a process that would allow an organization to request a replacement to any adopted standard or standards.

An organization could request a replacement to an adopted standard by requesting a waiver from the Secretary of HHS to test a new standard. The organization, at a minimum, must demonstrate that the new standard clearly offers an improvement over the adopted standard. If the organization presents sufficient documentation that supports testing of a new standard, we want to be able to grant the organization a temporary waiver to test it while remaining in compliance with the law. We do not intend to establish a process that would allow organizations to request waivers as a tool to avoid using any adopted standard.

We would welcome comments on the following: (1) How we should establish this process, (2) the length of time a proposed standard should be tested before we decide whether to adopt it, and (3) other issues and recommendations we should consider in developing this process.

Following is one possible process:

• Any organization that wishes to replace an adopted standard must submit its waiver request to an HHS evaluation committee (not currently established or defined). The organization must do the following for each standard it wishes to replace:
  • Provide a detailed explanation, no more than 10 pages in length, of how the replacement would be a clear improvement over the current standard in terms of the principles listed in section I.D., Process for developing national standards, of this preamble.
  • Provide specifications and technical capabilities on the new standard, including any additional system requirements.
  • Provide an explanation, no more than 5 pages in length, of how the organization intends to test the standard, including the number and types of health care plans and health care providers expected to be involved in the test, geographical areas, and beginning and end dates of the test.
• The committee’s evaluation would, at a minimum, be based on the following:
  • A cost-benefit analysis.
  • An assessment of whether the proposed replacement demonstrates a clear improvement to an existing standard.
  • The extent and length of time of the waiver.
• The evaluation committee would inform the organization requesting the waiver within 30 working days of the committee’s decision on the waiver request. If the committee decides to grant a waiver, the notification may include the following:
  • Committee comments such as the following:
    • The length of time for which the waiver applies if it differs from the waiver request.
    • The sites the committee believes are appropriate for testing if they differ from the waiver request.
    • Any pertinent information regarding the conditions of an approved waiver.
• Any organization that receives a waiver would be required to submit a report containing the results of the study, no later than 3 months after the study is completed.
• The committee would evaluate the report and determine whether the proposed new standard meets the 10 guiding principles and whether the advantages of a new standard would significantly outweigh the disadvantages of implementing it and make a recommendation to the Secretary.

B. Revised Standards

We recognize the very significant contributions that the traditional content committees (the NUCC, the NUBC, the ADA, and the National Council for Prescription Drug Programs) have made to health care transaction content over the years and, in particular, the work they contributed to the content of the standards proposed in this proposed rule. Other Federal and private entities (the National Center for Health Statistics, the Health Care Financing Administration, the AMA, and the ADA) have developed and maintained the medical data code sets proposed as standards in this proposed rule. In a letter dated June 10, 1997, WEDI recommended that the NUBC, NUCC and ADA be recognized as the appropriate organizations to specify data content. We expect that these current committees would continue to play an important role in maintenance of data content for standard health care transactions. The organizations assigned responsibility for maintenance of data content for standard health care transactions will work with X12N data maintenance committees, ensuring that implementation documentation is updated in a consistent and timely fashion.

We intend that the private sector, with public sector involvement, continue to have responsibility for defining the data element content of the administrative transactions. Both Federal agencies and private organizations will continue to be responsible for maintaining medical data code sets. The current data content committees are focused on transactions that involve health care providers and health plans. There may be some organizations that represent employers or other sponsors and health plans and are interested in assuming the burden of maintenance of the data content standards for the X12 820 and 834.

We propose to designate content committees in the final rule and to specify the ongoing activities of these content committees pertaining to the data maintenance of all X12N standards identified in this rule, as well as attachments. All approved changes, not including medical code sets, would need to fit into the appropriate ASC X12N implementation guide(s) and receive ASC X12N approval, with the exception of the NCPDP standard. The NCPDP would continue to operate as currently for data content.

It is important that data content revisions be made timely in this new standards environment. The Secretary of HHS may not revise any standard more frequently than once a year and must permit no fewer than 180 days for implementation for all participants after adopting a revised standard. New values could be added to the code sets for certain data elements in transaction standards more frequently than once a year. For example, alpha- numeric HCPCS and NDC, two of the proposed standard code sets for medical data, now have mechanisms for ongoing addition to new codes as needed to reflect new health services and new drugs. Such ongoing update mechanisms would continue to be needed in the year 2000 and beyond.

The private sector organizations charged with data element content maintenance would have to ensure that the revised standard contains the most recent data maintenance items that have been brought to them and that those new data requirements are adequately documented and communicated to the public. We believe that, at minimum, the data maintenance documentation needs to include the data name, data definition, the status of the data name (that is, required or conditional), written conditions regarding the circumstances under which the data would have to be supplied, a rationale for the new or revised data item, and its placement in an implementation guide. We believe that any data request approved by a body three or more months prior to the adoption of a new or revised standard would have to be included in that new standard implementation, assuming that no major format restructuring would have to be done. (A new data element, code, or segment would not constitute major restructuring.)

We believe that any body with responsibility for maintaining a standard under this proposed rule must allow public access to their decision making processes. We plan to engage standards setting organizations and other organizations responsible for maintenance of data element content and standard code sets to establish a process that will enable timely standards development/updates with appropriate industry input. One approach may be as follows:

• Each of the data maintenance bodies has biannual meetings with the public welcome to attend and participate without payment of fees.
  • These public meetings are announced to the broadest possible audience, at minimum by means of a website. The announcements of the meetings may also be available via widely read publications, such as the Commerce Business Daily or the Federal Register.
  • Annual public meeting schedules are posted on a website not later than 90 days after the effective date of the final rule, and annually on that date thereafter.
  • The data maintenance body establishes a central contact (name and post office and e-mail addresses) to which the public could submit correspondence (such as agenda items or data requests).
  • During these two open meetings, the public has the opportunity to voice concerns and suggest changes.
  • Each data maintenance body drafts procedures for the public to follow in regard to its meeting protocols.
• Each data maintenance body drafts procedures for the public to submit requests for data or for revisions to the standard. These draft procedures are easy to use and are adequately communicated to the public.
• Each designated data maintenance body is also responsible for communicating actions taken on requests to the requestor and the public, in addition to communicating any changes made to a standard. This may be done via mail, e-mail, publications, or newsletters but, at a minimum, are published on the website. (We believe the Internet is the most cost effective way of communicating this type of information.)
• Each data maintenance body responds definitively to each request it receives no later than three months after the request is received.

An alternative approach would be to require an organization which desired to be designated by the Secretary as the official data content maintenance body for a particular transaction to meet the ANSI criteria for due process found at http://www.ansi.org/proc_1.html. Not only would these criteria meet the intent of HIPAA to advocate an open, balanced, consensus process, but once an organization met these criteria, it would be able to apply for ANSI accreditation if it so desired.

It is not our intention to increase any current burdens on data maintenance bodies. Our concern is that the public have a voice in the data maintenance process and that changes to a standard be timely and adequately communicated to the industry. We welcome any comments regarding the approach outlined above and recommendations for data maintenance committees for each X12N transaction standard identified in this rule.

We also solicit comments on the appropriateness of ongoing Federal oversight/monitoring of maintenance processes and procedures.