It is important to note that the scope of this new rule is quite limited. The preamble reiterates HHS's general approach to enforcement - seeking voluntary compliance, providing technical assistance, responding to complaints, and resolving complaints through informal means. The rule itself establishes procedural rules for investigations and the imposition of civil monetary penalties by HHS. The rule does not include any substantive provisions governing the imposition of civil monetary penalties (such as the criteria that HHS will use to assess whether a penalty will be imposed); nor does it deal with criminal penalties, which will be handled by the Department of Justice.

The procedures set out in this interim rule apply to investigations by HHS (including investigational subpoenas and inquiries) and the imposition of civil monetary penalties by HHS (including hearings before administrative law judges conducted at the request of a "covered entity" as a result of a proposed civil monetary penalty).

This interim final rule will be in effect for only four months: between May 19, 2003, and September 16, 2003. HHS states in the rulemaking that it will issue a more detailed rule by September 16, 2003. This more detailed rule will include substantive provisions impacting the imposition of civil monetary penalties, as well as revisions to this procedural rule. Comments on the interim final rule are due by June 16, 2003, and will be considered by HHS as it prepares the second installment of the Enforcement Rule.

The interim final rule can be found in the April 17, 2003 issue of the Federal Register, which is available in PDF format by clicking here.