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IV. New and Revised Standards

[Please label written and e-mailed comments about this section with the subject: REVISIONS.]

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

An organization could request a revision or replacement to an adopted standard by requesting a waiver from the Secretary of Health and Human Services to test a revised or new standard. The organization must, at a minimum, demonstrate that the revised or new standard offers an improvement over the adopted standard. If the organization presents sufficient documentation that supports testing of a revised or new standard, we want to be able to grant the organization a temporary waiver to test while remaining in compliance with the law. The waiver would be applicable to standards that could change over time; for example, transaction standards. We do not intend to establish a process that would allow an organization 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, (3) whether we should solicit public comments before implementing a change in a standard, and (4) other issues and recommendations we should consider in developing this process.

Following is one possible process:

• Any organization that wishes to revise or 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 revise or replace
  • Provide a detailed explanation, no more than 10 pages in length, of how the revision or replacement would be a clear improvement over the current standard in terms of the principles listed in section I.B., Process for developing national standards, of this preamble.
  • Provide specifications and technical capabilities on the revised or new standard, including any additional system requirements.
  • An explanation, no more than 5 pages in length, of how the organization intends to test the standard.
• The committee’s evaluation would, at a minimum, be based on the following:
  • A cost-benefit analysis
  • An assessment of whether the proposed revision or 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 benefits of the proposed revision or new standard significantly outweigh the disadvantages of implementing it and make a recommendation to the Secretary.

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