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

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§ 160.408 Factors considered in determining the amount of a civil money penalty.

In determining the amount of any civil money penalty, the Secretary will consider the following factors, which may be mitigating or aggravating as appropriate:

(a) The nature and extent of the violation, consideration of which may include but is not limited to:

(1) The number of individuals affected; and

(2) The time period during which the violation occurred;

(b) The nature and extent of the harm resulting from the violation, consideration of which may include but is not limited to:

(1) Whether the violation caused physical harm;

(2) Whether the violation resulted in financial harm;

(3) Whether the violation resulted in harm to an individual's reputation; and

(4) Whether the violation hindered an individual's ability to obtain health care;

(c) The history of prior compliance with the administrative simplification provisions, including violations, by the covered entity or business associate, consideration of which may include but is not limited to:

(1) Whether the current violation is the same or similar to previous indications of noncompliance;

(2) Whether and to what extent the covered entity or business associate has attempted to correct previous indications of noncompliance;

(3) How the covered entity or business associate has responded to technical assistance from the Secretary provided in the context of a compliance effort; and

(4) How the covered entity or business associate has responded to prior complaints;

(d) The financial condition of the covered entity or business associate, consideration of which may include but is not limited to:

(1) Whether the covered entity or business associate 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 or business associate to continue to provide, or to pay for, health care; and

(3) The size of the covered entity or business associate; and

(e) Such other matters as justice may require.

[78 FR 5691, Jan. 25, 2013]

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United States Code
Statutes at Large

Title 45 published on 2015-11-20

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

  • 2016-09-06; vol. 81 # 172 - Tuesday, September 6, 2016
    1. 81 FR 61538 - Adjustment of Civil Monetary Penalties for Inflation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Centers for Medicare & Medicaid Services, Administration for Children and Families, Office of the Inspector General
      Interim final rule.
      This rule is effective on September 6, 2016.
      42 CFR Part 3

Title 45 published on 2015-11-20.

The following are only the Rules published in the Federal Register after the published date of Title 45.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-09-06; vol. 81 # 172 - Tuesday, September 6, 2016
    1. 81 FR 61538 - Adjustment of Civil Monetary Penalties for Inflation
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Centers for Medicare & Medicaid Services, Administration for Children and Families, Office of the Inspector General
      Interim final rule.
      This rule is effective on September 6, 2016.
      42 CFR Part 3