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) > 160.410—Affirmative defenses.

160.410—Affirmative defenses.

(a) For violations occurring prior to February 18, 2009, the Secretary may not impose a civil money penalty on a covered entity for a violation if the covered entity establishes that an affirmative defense exists with respect to the violations, including the following:
(1) The violation is an act punishable under 42 U.S.C. 1320d-6 ;
(2) The covered entity establishes, to the satisfaction of the Secretary, that it did not have knowledge of the violation, determined in accordance with the federal common law of agency, and, by exercising reasonable diligence, would not have known that the violation occurred; or
(3) The violation is—
(i) Due to reasonable cause and not willful neglect; and
(ii) Corrected during either:
(A) The 30-day period beginning on the first date the covered entity liable for the penalty knew, or by exercising reasonable diligence would have known, that the violation occurred; or
(B) Such additional period as the Secretary determines to be appropriate based on the nature and extent of the failure to comply.
(b) For violations occurring on or after February 18, 2009, the Secretary may not impose a civil money penalty on a covered entity for a violation if the covered entity establishes that an affirmative defense exists with respect to the violations, including the following:
(1) The violation is an act punishable under 42 U.S.C. 1320d-6; or
(2) The covered entity establishes to the satisfaction of the Secretary that the violation is—
(i) Not due to willful neglect; and
(ii) Corrected during either:
(A) The 30-day period beginning on the first date the covered entity liable for the penalty knew, or, by exercising reasonable diligence, would have known that the violation occurred; or
(B) Such additional period as the Secretary determines to be appropriate based on the nature and extent of the failure to comply.
[74 FR 56131, Oct. 30, 2009]