45 CFR 160.408 - Factors considered in determining the amount of a civil money penalty.

§ 160.408 Factors considered in determining the amount of a civil money penalty.
In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:
(a) The nature of the violation, in light of the purpose of the rule violated.
(b) The circumstances, including the consequences, of the violation, including but not limited to:
(1) The time period during which the violation(s) occurred;
(2) Whether the violation caused physical harm;
(3) Whether the violation hindered or facilitated an individual's ability to obtain health care; and
(4) Whether the violation resulted in financial harm.
(c) The degree of culpability of the covered entity, including but not limited to:
(1) Whether the violation was intentional; and
(2) Whether the violation was beyond the direct control of the covered entity.
(d) Any history of prior compliance with the administrative simplification provisions, including violations, by the covered entity, including but not limited to:
(1) Whether the current violation is the same or similar to prior violation(s);
(2) Whether and to what extent the covered entity has attempted to correct previous violations;
(3) How the covered entity has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
(4) How the covered entity has responded to prior complaints.
(e) The financial condition of the covered entity, including but not limited to:
(1) Whether the covered entity had financial difficulties that affected its ability to comply;
(2) Whether the imposition of a civil money penalty would jeopardize the ability of the covered entity to continue to provide, or to pay for, health care; and
(3) The size of the covered entity.
(f) Such other matters as justice may require.

Title 45 published on 2013-10-01

no entries appear in the Federal Register after this date.

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United States Code
Statutes at Large

Title 45 published on 2013-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR 160 after this date.

  • 2014-03-05; vol. 79 # 43 - Wednesday, March 5, 2014
    1. 79 FR 12441 - Administrative Simplification: Certification of Compliance for Health Plans; Extension of Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Proposed rule; extension of the comment period.
      The comment period for the proposed rule published in the January 2, 2014 Federal Register (79 FR 298) is extended to April 3, 2014.
      45 CFR Parts 160 and 162