StacksVerified U.S. regulatory reference

45 CFR §158.608

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
For every violation subject to a civil monetary penalty, if there are substantial or several mitigating circumstances, the aggregate amount of the penalty is set at an amount sufficiently below the maximum permitted by § 158.606 of this subpart to reflect that fact. As guidelines for taking into account the factors listed in § 158.607 of this subpart, HHS considers the following:
  1. (a)Record of prior compliance. It should be considered a mitigating circumstance if the responsible entity has done any of the following:
    1. (1)Before receipt of the notice issued under § 158.603 of this subpart, implemented and followed a compliance plan as described in § 158.605(c) of this subpart.
    2. (2)Had no previous complaints against it for noncompliance.
  2. (b)Gravity of the violation(s). It should be considered a mitigating circumstance if the responsible entity has done any of the following:
    1. (1)Made adjustments to its business practices to come into compliance with the requirements of this part so that the following occur:
      1. (i)Each enrollee adversely affected by the violation has been paid any amount of rebate owed so that, to the extent practicable, that enrollee is in the same position that he, she, or it would have been in had the violation not occurred.
      2. (ii)The rebate payments are completed in a timely manner.
    2. (2)Discovered areas of noncompliance without notice from HHS and voluntarily reported that noncompliance, provided that the responsible entity submits the following:
      1. (i)Documentation verifying that the rights and protections of all individuals adversely affected by the noncompliance have been restored; and
      2. (ii)A plan of correction to prevent future similar violations.
    3. (3)Demonstrated that the violation is an isolated occurrence.
    4. (4)Demonstrated that the financial and other impacts on affected individuals is negligible or nonexistent.
    5. (5)Demonstrated that the noncompliance is correctable and that a high percentage of the violations were corrected.