# Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test — Federal civil penalty maximums — current inflation-adjusted amounts across agencies

For Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test, agency is HHS; statutory authority is 1395m-1(a); maximum penalty is 13,295, recorded from its source on 2026-08-10.

- **Agency:** HHS _(our reading, not quoted from the source)_
- **Violation:** Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test _(verified: appears in the quote below)_
- **Statutory authority:** 1395m-1(a) _(verified: appears in the quote below)_
- **Maximum penalty:** 13,295 _(verified: appears in the quote below)_

## What the source says

> 1395m-1(a) | <https://www.ecfr.gov/current/title-42/section-414.504#p-414.504(e)> 42 CFR. 414.504(e) | CMS | Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test | 2024 | 12,958 | 13,295

## Source

- https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3

Last verified: 2026-08-10. Review by: 2027-02-26.
Part of [Federal civil penalty maximums — current inflation-adjusted amounts across agencies](https://referencesource.org/federal-civil-penalty-maximums/).