View Rule

Printer-Friendly Version Download RIN Data in XML

HHS/OS

RIN: 0991-AB29

Publication ID: Fall 2003

Title: ●Health Insurance Portability and Accountability Act--Enforcement
Abstract: This rulemaking would seek to establish a framework for enforcing compliance with the "administrative simplification" provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 -- subtitle F of title II of Public Law 104-191 (42 U.S.C. 1320d-5).
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined	Unfunded Mandates: No
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Subtitle F of title II of PL 104-191 42 USC 1320d-5

Legal Deadline: None

Statement of Need: The civil money penalty provisions of the above-cited statute provide, together with the criminal penalties authorized by 42 U.S.C. 1320d-6, the means by which the Federal Government may ensure compliance with the national standards adopted by the HHS Secretary under this statute. Regulation is needed to enable the Department to: 1) determine a basis for and amounts of civil money penalties that may be levied pursuant to the above-cited statute; and 2) establish procedures for the conduct of investigations and hearings with respect to the imposition of such penalties.

Summary of the Legal Basis: This regulation will implement provisions of 42 U.S.C. 1320d-5 and 42 U.S.C. 1320a-7a relating to the imposition of civil money penalties by the Secretary for violations of the rules adopted by the Secretary pursuant to subtitle F.

Alternatives: The proposed procedural provisions of the rule would generally follow the civil money penalty procedures adopted by the Department's Office of the Inspector General (OIG) with respect to the conduct of investigation and hearings regarding the imposition of civil money penalties in cases of fraud and abuse. These procedures are codified at 45 C.F.R. parts 1003, 1005, and 1006. While the Department considered adopting different procedures, it decided not to do this for several reasons: the statutory language in section 1320d-5 specifically referring to the procedures adopted under section 1320a-7a (i.e., the OIG rules); the extensive experience of industry with the OIG rules; and the general agreement within the Department that the OIG rules provide workable procedures.

Anticipated Costs and Benefits: The costs of this rule will consist primarily of the costs incurred by both the Department and any covered entities that are attributable to the investigation and hearing processes. These costs are expected to be minimal. Costs associated with compliance by entities subject to the HIPAA Administrative Simplification standards are not attributable to this rule.

Risks: Not applicable.

Timetable:

Action	Date	FR Cite
NPRM	05/00/2004

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: Yes
Agency Contact: Carol Conrad Department of Health and Human Services Room 5347, Office of the General Counsel, 330 Independence Avenue SW., Washington, DC 20201 Phone:202 690-1840