---
kind: "section"
citation: "45 C.F.R. § 150.319"
title: "45"
number: "150.319"
heading: "Determining the amount of the penalty—mitigating circumstances."
url: "https://uscodex.org/cfr/45/150.319"
---

# §150.319. Determining the amount of the penalty—mitigating circumstances.


For every violation subject to a civil money 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 [§ 150.315](/cfr/45/150.315.md) to reflect that fact. As guidelines for taking into account the factors listed in [§ 150.317](/cfr/45/150.317.md), CMS considers the following:

- (a) **Record of prior compliance.** It should be considered a mitigating circumstance if the responsible entity has done any of the following:
  - (1) Before receipt of the notice issued under [§ 150.307](/cfr/45/150.307.md), implemented and followed a compliance plan as described in [§ 150.311(f)](/cfr/45/150.311.md?p=f).
  - (2) **Had no previous complaints against it for noncompliance.**
- (b) **Gravity of the violation(s).** It should be considered a mitigating circumstance if the responsible entity has done any of the following:
  - (1) Made adjustments to its business practices to come into compliance with PHS Act requirements so that the following occur:
    - (i) All employers, employees, individuals and non-Federal governmental entities are identified that are or were issued any policy, certificate of insurance or plan document, or any form used in connection therewith that failed to comply.
    - (ii) All employers, employees, individuals, and non-Federal governmental plans are identified that were denied coverage or were denied a right provided under PHS Act requirements.
    - (iii) Each employer, employee, individual, or non-Federal governmental plan adversely affected by the violation has been, for example, offered coverage or provided a certificate of creditable coverage in a manner that complies with PHS Act requirements that were violated so that, to the extent practicable, that employer, employee, individual, or non-Federal governmental entity is in the same position that he, she, or it would have been in had the violation not occurred.
    - (iv) **The adjustments are completed in a timely manner.**
  - (2) Discovered areas of noncompliance without notice from CMS and voluntarily reported that noncompliance, provided that the responsible entity submits the following:
    - (i) Documentation verifying that the rights and protections of all individuals adversely affected by the noncompliance have been restored; and
    - (ii) **A plan of correction to prevent future similar violations.**
  - (3) **Demonstrated that the violation is an isolated occurrence.**
  - (4) Demonstrated that the financial and other impacts on affected individuals is negligible or nonexistent.
  - (5) Demonstrated that the noncompliance is correctable and that a high percentage of the violations were corrected.

## Notes

### Amendments

[64 FR 45795, Aug. 20, 1999, as amended at 78 FR 13440, Feb. 27, 2013]

### Authority

Authority: 42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92, as amended.

### Source

Source: 64 FR 45795, Aug. 20, 1999, unless otherwise noted.

### Amendments

[64 FR 45795, Aug. 20, 1999, as amended at 78 FR 13440, Feb. 27, 2013]