CFR > Title 45 - Public Welfare > SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER C—ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS (parts 160 to 165) > PART 160—GENERAL ADMINISTRATIVE REQUIREMENTS > SUBPART D—Imposition of Civil Money Penalties (§160.400 to §160.426) > 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.