Civil Money Penalties:
Procedures for Investigations, Imposition
of Penalties, and Hearings
(as published in the Federal Register, April 17, 2003;
corrected April 28, 2003)
Regulation Effective Date: May 19, 2003
Comments must be received by
June 16, 2003
This interim final rule will cease to be in effect on
September 16, 2004
HHS SUMMARY: This interim final rule establishes rules of procedure for the imposition, by the Secretary of Health and Human Services, of civil money penalties on entities that violate standards adopted by the Secretary under the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191 ("HIPAA"). We intend that this be the first installment of a rule that we term the "Enforcement Rule." The Enforcement Rule, when issued in complete form, will set forth procedural and substantive requirements for imposition of civil money penalties. In the interim, we are issuing these rules of procedure to inform regulated entities of our approach to enforcement and to advise regulated entities of certain procedures that will be followed as we enforce the Administrative Simplification provisions of HIPAA.
A correction to the Interim HIPAA Enforcement Rule was published in the April 28, 2003 Federal Register. The rule as originally published April 17 had an expiration date of September 16, 2003; the correct expiration date is September 16, 2004.
- Summary and Introduction
- I. Background
- II. General Approach
- III. Provisions of the Interim Final Rule
- Investigational subpoenas and inquiries
- Basis for penalty
- Amount of penalty
- Authority to settle
- Notice of proposed determination
- Failure to request a hearing
- Collection of penalty
- Hearing before an ALJ
- Rights of parties; authority of the ALJ
- Ex-parte contacts
- Prehearing conferences
- Exchange of witness lists, statements, and exhibits
- Subpoenas for attendance at the hearing
- Form, filing, and service of papers; computation of time
- The hearing
- The record
- Post-hearing briefs
- ALJ decision
- Judicial review; stay of ALJ decision
- IV. Impact Statement and Other Required Analyses
- PART 160 - GENERAL ADMINISTRATIVE REQUIREMENTS
- Part 160 Authority Citation
- Add new Subpart E – Civil Money Penalties
- § 160.500 Applicability.
- § 160.502 Definitions.
- § 160.504 Investigational subpoenas and inquiries.
- § 160.506 Basis for penalty.
- § 160.508 Amount of penalty.
- § 160.510 Authority to settle.
- § 160.512 [Reserved]
- § 160.514 Notice of proposed determination.
- § 160.516 Failure to request a hearing.
- § 160.518 Collection of penalty.
- § 160.520 [Reserved]
- § 160.522 Limitations.
- § 160.524 [Reserved]
- § 160.526 Hearing before an ALJ.
- § 160.528 Rights of parties.
- § 160.530 Authority of the ALJ.
- § 160.532 Ex parte contacts.
- § 160.534 Prehearing conferences.
- § 160.536 Settlement.
- § 160.538 Discovery.
- § 160.540 Exchange of witness lists, witness statements, and exhibits.
- § 160.542 Subpoenas for attendance at hearing.
- § 160.544 Fees.
- § 160.546 Form, filing, and service of papers.
- § 160.548 Computation of time.
- § 160.550 Motions.
- § 160.552 Sanctions.
- § 160.554 The hearing.
- § 160.556 Witnesses.
- § 160.558 Evidence.
- § 160.560 The record.
- § 160.562 Post hearing briefs.
- § 160.564 ALJ decision.
- § 160.566 [Reserved]
- § 160.568 Judicial review.
- § 160.570 Stay of ALJ decision.
- § 160.572 [Reserved]