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Notes

45 C.F.R. §§ 150.315–150.323

5 sections in range

§150.315. Amount of penalty—General.

45 C.F.R. § 150.315

A civil money penalty for each violation of 42 U.S.C. 300gg et seq. may not exceed $100 as adjusted annually under 45 CFR part 102 for each day, for each responsible entity, for each individual affected by the violation. Penalties imposed under this part are in addition to any other penalties prescribed or allowed by law.
Notes, amendments, and revision history

Amendments

[64 FR 45795, Aug. 20, 1999, as amended at 81 FR 61581, Sept. 6, 2016]

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 81 FR 61581, Sept. 6, 2016]

§150.317. Factors CMS uses to determine the amount of penalty.

45 C.F.R. § 150.317

In determining the amount of any civil money penalty, CMS will identify the lawful purpose or purposes of the penalty, and take into account the following factors as appropriate to the circumstances of the case:
(a)
The entity's previous record of compliance. This may include any of the following:
(1)
Any history of prior violations by the responsible entity, including whether, at any time before determination of the current violation or violations, CMS or any State found the responsible entity liable for civil or administrative sanctions in connection with a violation of PHS Act requirements.
(2)
Documentation that the responsible entity has submitted its policy forms to CMS for compliance review.
(3)
Evidence that the responsible entity has never had a complaint for noncompliance with PHS Act requirements filed with a State or CMS.
(4)
Such other factors as justice may require.
(b)
The gravity of the violation. This may include any of the following:
(1)
The frequency of the violation, taking into consideration whether any violation is an isolated occurrence, represents a pattern, or is widespread.
(2)
The level of financial and other impacts on affected individuals.
(3)
Other factors as justice may require.
Notes, amendments, and revision history

Amendments

[64 FR 45795, Aug. 20, 1999, as amended at 78 FR 13440, Feb. 27, 2013; 91 FR 29864, May 20, 2026]

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; 91 FR 29864, May 20, 2026]

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

45 C.F.R. § 150.319

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 to reflect that fact. As guidelines for taking into account the factors listed in § 150.317, 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, implemented and followed a compliance plan as described in § 150.311(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, and revision history

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]

§150.321. Determining the amount of penalty—aggravating circumstances.

45 C.F.R. § 150.321

For every violation subject to a civil money penalty, if there are substantial or several aggravating circumstances, CMS sets the aggregate amount of the penalty at an amount sufficiently close to or at the maximum permitted by § 150.315 to reflect that fact. CMS considers the following circumstances to be aggravating circumstances:
(a)
The frequency of violation indicates a pattern of widespread occurrence.
(b)
The violation(s) resulted in significant financial and other impacts on the average affected individual.
(c)
The entity does not provide documentation showing that substantially all of the violations were corrected.
Notes, amendments, and revision history

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.

§150.323. Determining the amount of penalty—other matters as justice may require.

45 C.F.R. § 150.323

CMS may take into account other circumstances of an aggravating or mitigating nature if, in the interests of justice, they require either a reduction or an increase of the penalty in order to assure the achievement of the purposes of this part, and if those circumstances relate to the entity's previous record of compliance or the gravity of the violation.
Notes, amendments, and revision history

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.