[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR160.408]

[Page 708]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 160_GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents
 
              Subpart D_Imposition of Civil Money Penalties
 
Sec. 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.