---
kind: "section"
citation: "42 C.F.R. § 3.408"
title: "42"
number: "3.408"
heading: "Factors considered in determining the amount of a civil money penalty."
url: "https://uscodex.org/cfr/42/3.408"
---

# §3.408. 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.**
- (b) **The circumstances, including the consequences, of the violation, including—**
  - (1) The time period during which the violation(s) occurred; and
  - (2) Whether the violation caused physical or financial harm or reputational damage;
- (c) **The degree of culpability of the respondent, including—**
  - (1) Whether the violation was intentional; and
  - (2) **Whether the violation was beyond the direct control of the respondent.**
- (d) Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:
  - (1) Whether the current violation is the same or similar to prior violation(s);
  - (2) Whether and to what extent the respondent has attempted to correct previous violations;
  - (3) How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
  - (4) **How the respondent has responded to prior complaints.**
- (e) **The financial condition of the respondent, including—**
  - (1) Whether the respondent had financial difficulties that affected its ability to comply;
  - (2) Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or patient safety activities; and
  - (3) **The size of the respondent.**
- (f) Such other matters as justice may require.

## Notes

### Authority

Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.

### Source

Source: 73 FR 70796, Nov. 21, 2008, unless otherwise noted.