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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
to any other penalties prescribed or allowed by law.
b Factors. Except as otherwise provided in this part, in determining the amount of any penalty in accordance with this part, CMS will consider the following factors 1 The nature of violations and circumstances under which they were presented.
2 The degree of culpability of the provider or facility against which a civil money penalty is proposed.
3 The provider or facilitys history of prior violations, including whether at any time before determination of the current violation or violations, CMS or any State found the provider or facility liable for civil or administrative sanctions in connection with a violation of PHS Act requirements or section 106a of the No Surprises Act, as applicable.
4 The frequency of the violation, taking into consideration whether any violation is an isolated occurrence, represents a pattern, or is widespread.
5 The level of financial and other impacts on affected individuals.
6 Such other matters as justice may require.
c 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 in paragraph a of this section to reflect that fact. As guidelines for taking into account the factors listed in paragraph b of this section, CMS considers the following as mitigating circumstances:
1 Before receipt of the notice issued under 150.505, the provider or facility implemented and followed a compliance plan as described in 150.509.
2 There were no previous complaints of noncompliance against the provider or facility.
3 In the case of a provider or facility responsible for an erroneous bill, the provider or facility made adjustments to business practices to come into compliance with PHS Act requirements, so that the following occur:
i The provider or facility identified all participants, beneficiaries and enrollees who are or were wrongly billed.
ii The provider or facility withdrew the bill or reimbursed the affected individuals who were wrongly billed so that, to the extent practicable, the affected individuals are in the same position that they would have been in had the violation not occurred.

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iii The provider or facility completed the adjustments to business practices in a timely manner.
4 The provider or facility demonstrated that the violation is an isolated occurrence.
d Aggravating circumstances. 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 this section to reflect that fact. CMS considers the following circumstances to be aggravating circumstances:
1 The frequency of violation indicates a pattern of widespread occurrence.
2 The violations resulted in significant financial and other impacts on the average affected individual.
3 The provider or facility does not provide documentation showing that substantially all of the violations were corrected.
e Waiver of the penalty. CMS shall waive a civil money penalty if:
1 The provider or facility does not knowingly violate, and exercising due diligence should not have reasonably known it violated, part 149 of this subchapter with respect to a participant, beneficiary, or enrollee, and such provider or facility withdraws the bill that was in violation of such provision and reimburses the group health plan, health insurance issuer, or affected individual, as applicable, in an amount equal to the difference between the amount billed and the amount allowed to be billed, plus interest at the rate established annually by the Secretary of the Treasury pursuant to 31 U.S.C. 3717, within 30 days of the violation; or 2 In the case of a provider of air ambulance services that submits only part of the information required in 149.460 of this subchapter, if the provider demonstrates a good faith effort in working with the Secretary to submit any missing information.
f Settlement authority. Nothing in this section limits the authority of CMS
to settle any issue or case described in the notice furnished in accordance with 150.505 or to compromise on any penalty provided for in 150.515.
g Hardship exemption. The Secretary may establish a hardship exemption to the penalties under this subpart.
150.515 Notice of proposed determination.

a If CMS proposes a penalty, in accordance with this subpart, CMS will serve on the provider or facility, in any manner authorized by Rule 4 of the
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Federal Rules of Civil Procedure, written notice of CMSs intent to impose a penalty. The notice will include:
1 A description of the PHS Act requirements or the No Surprises Act requirements that CMS has determined the provider or facility violated.
2 A description of any complaint or other information upon which CMS
based its investigation, including the basis for determining the number of violations.
3 The amount of the proposed penalty as of the date of the notice.
4 Any circumstances described in 150.513 that were considered when determining the amount of the proposed penalty.
5 Instructions for responding to the notice, including:
i A specific statement of the provider or facilitys right to a hearing;
and ii A statement that failure to request a hearing within 30 days of receipt of the notice permits the imposition of the proposed penalty without right of appeal in accordance with 150.519.
b Reserved 150.517

Hearing.

a The provisions found in 150.401 through 150.457 shall apply to a hearing conducted under this subpart.
b Any provider or facility upon which CMS has proposed the imposition of a penalty may appeal such proposed penalty by requesting a hearing before an ALJ in accordance with 150.405. The form and content of the request for a hearing must comply with 150.407.
c If the provider or facility fails, within the time period permitted, to exercise the right to a hearing under this section, the proposed penalty becomes final.
150.519

Failure to request a hearing.

If the provider or facility does not request a hearing within 30 days of the issuance of the notice described in 150.515, or show good cause, as determined under 150.405b, for failing to timely exercise its right to a hearing, CMS may assess the proposed civil money penalty. CMS will notify the provider or facility in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure of any penalty that has been assessed and of the means by which the provider or facility may satisfy the judgment. The provider or facility has no right to appeal a penalty with respect to which it has not requested a hearing in accordance with 150.405.

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