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  <FDSYS>
    <CFRTITLE>45</CFRTITLE>
    <CFRTITLETEXT>Public Welfare</CFRTITLETEXT>
    <VOL>1</VOL>
    <DATE>2011-10-01</DATE>
    <ORIGINALDATE>2011-10-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Factors considered in determining the amount of a civil money penalty.</TITLE>
    <GRANULENUM>160.408</GRANULENUM>
    <HEADING>Section 160.408</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 45" SEQ="4">Public Welfare</PARENT>
      <PARENT HEADING="SUBTITLE A" SEQ="3">DEPARTMENT OF HEALTH AND HUMAN SERVICES</PARENT>
      <PARENT HEADING="SUBCHAPTER C" SEQ="2">ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS</PARENT>
      <PARENT HEADING="PART 160" SEQ="1">GENERAL ADMINISTRATIVE REQUIREMENTS</PARENT>
      <PARENT HEADING="Subpart D" SEQ="0">Imposition of Civil Money Penalties</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 160.408</SECTNO>
    <SUBJECT>Factors considered in determining the amount of a civil money penalty.</SUBJECT>
    <P>In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:</P>
    <P>(a) The nature of the violation, in light of the purpose of the rule violated.</P>
    <P>(b) The circumstances, including the consequences, of the violation, including but not limited to:</P>
    <P>(1) The time period during which the violation(s) occurred;</P>
    <P>(2) Whether the violation caused physical harm;</P>
    <P>(3) Whether the violation hindered or facilitated an individual's ability to obtain health care; and</P>
    <P>(4) Whether the violation resulted in financial harm.<PRTPAGE P="819"/>
    </P>
    <P>(c) The degree of culpability of the covered entity, including but not limited to:</P>
    <P>(1) Whether the violation was intentional; and</P>
    <P>(2) Whether the violation was beyond the direct control of the covered entity.</P>
    <P>(d) Any history of prior compliance with the administrative simplification provisions, including violations, by the covered entity, including but not limited to:</P>
    <P>(1) Whether the current violation is the same or similar to prior violation(s);</P>
    <P>(2) Whether and to what extent the covered entity has attempted to correct previous violations;</P>
    <P>(3) How the covered entity has responded to technical assistance from the Secretary provided in the context of a compliance effort; and</P>
    <P>(4) How the covered entity has responded to prior complaints.</P>
    <P>(e) The financial condition of the covered entity, including but not limited to:</P>
    <P>(1) Whether the covered entity had financial difficulties that affected its ability to comply;</P>
    <P>(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</P>
    <P>(3) The size of the covered entity.</P>
    <P>(f) Such other matters as justice may require.</P>
  </SECTION>
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