National Committee on Vital & Health Statistics

June 17, 1998

Health Care Financing Administration
Office of Information Services
Information Technology Investment Management Group
Division of HCFA Enterprise Standards
Room C2-26-17
7500 Security Boulevard
Baltimore, MD 21244-1850
ATTN: John Burke, HCFA-0045

Office of Information and Regulatory Affairs
Office of Management and Budget
Room 10235
New Executive Office Building
Washington, DC 20503
ATTN: Allison Herron Eydt, HCFA Desk Officer

Dear Mr. Burke and Ms. Eydt:

The National Committee on Vital and Health Statistics submits the following comments on the Collection of Information Requirements in the Notice of Proposed Rule Making (NPRM), HCFA-0149-P, Standards for Electronic Transactions.

On the issue of the applicability of the Paperwork Reduction Act of 1995:

The purposes of the Paperwork Reduction Act (PRA) and of the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) would appear to be extraordinarily compatible. Both seek to minimize paperwork burden and to ensure public benefit. However, in a practical sense, application of the PRA in this instance becomes contrary to these principles and threatens to impose a substantial barrier to the adoption, implementation, and future modification of health care electronic data interchange (EDI) standards. Under HIPAA, the Congress directed the Secretary of Health and Human Services to rely on the advice of private sector organizations and to adopt consensus standards developed and maintained by accredited standards development organizations, which are private organizations in which the public sector participates. It is inconceivable how this intent can be served or these requirements carried out if they fall under the authority of PRA. To do this in effect limits the authority of the standards development organizations to make and maintain the standards and potentially thwarts the Secretary’s ability to follow the requirements of HIPAA.

Clearly, there may be a role for the PRA in evaluating what Government programs do to implement the standards in their programmatic sphere. It is reasonable to conclude that collection of information using EDI standards by Medicare, the Department of Defense, or other government programs would fall under the PRA and the Office of Management and Budget (OMB) oversight authority. However, we do not believe that the adoption of standards, as required by HIPAA, constitutes an “information collection” in the sense that it is defined under the PRA. Further, it is hard to imagine a more clearcut case of usual and customary business activities than the administrative and financial functions, which include billing, adjudicating claims, and payment for services, covered by these proposed rules. Finally, the PRA regulations (at §1320.18) appear to be clear that OMB has the discretion to apply or not to apply the PRA to these rules. We urge them to follow the intent of both the PRA and HIPAA by not applying the PRA in this instance.


Don E. Detmer, M.D.