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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
d The entity fails to cooperate with a CMS investigation or market conduct examination.
36. Section 150.325 is revised to read as follows:
150.325

Settlement authority.

Nothing in 150.315 through 150.323 limits the authority of CMS to settle any issue or case described in the notice furnished in accordance with 150.307 or 150.313e, or to compromise on any penalty provided for in 150.315 through 150.323.
37. Section 150.401 is amended by revising the definition of Respondent to read as follows:
150.401

Definitions.

Respondent means an entity that received a notice of proposed assessment of a civil money penalty issued pursuant to 150.343 or 150.515.
38. Section 150.405 is amended by revising paragraph a to read as follows:
150.405

Issues to be heard and decided

b
1 Applies the factors that are identified in 150.317 or 150.513.

40. Section 150.445 is amended by revising paragraphs g, h, and j to read as follows:
150.445

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Subpart ECMS Enforcement with Respect to Providers and Facilities Sec.
150.501 General rule regarding the imposition of civil money penalties.
150.503 Basis for initiating an investigation;
injunctive relief.
150.505 Notice to providers or facilities.
150.507 Request for extension.
150.509 Responses to allegations of noncompliance.
150.511 Liability for penalties.
150.513 Amount of penalty.
150.515 Notice of proposed determination.
150.517 Hearing.
150.519 Failure to request a hearing.
150.521 Collateral estoppel.
150.523 Judicial review.
150.525 Notice to other agencies.

150.501 General rule regarding the imposition of civil money penalties.

g Evidence of acts other than those at issue in the instant case is admissible in determining the amount of any civil money penalty if those acts are used under 150.317, 150.323, or 150.513
to consider the entitys prior record of compliance, to show motive, opportunity, intent, knowledge,
VerDate Sep<11>2014

Sanctions.

b
9 In the case of a violation of part 149 of this subchapter, ordering the party or attorney to pay attorneys fees and other costs caused by the failure or misconduct.
42. Add subpart E to read as follows:

Subpart ECMS Enforcement with Respect to Providers and Facilities
Evidence.

150.455

Filing of request for hearing.

a A respondent has a right to a hearing before an ALJ if it files a request for hearing that complies with 150.407a, within 30 days after the date of issuance of either CMSs notice of proposed determination under 150.343 or 150.515, or notice that an alternative dispute resolution process has terminated. The request for hearing must be addressed as instructed in the notice of proposed determination. Date of issuance is five 5 days after the filing date, unless there is a showing that the document was received earlier.

39. Section 150.417 is amended by revising paragraph b1 to read as follows:
150.417
by ALJ.

preparation, identity, or lack of mistake.
This evidence is admissible regardless of whether the acts occurred during the statute of limitations period applicable to the acts that constitute the basis for liability in the case and regardless of whether CMSs notice sent in accordance with 150.307, 150.313e, 150.343, 150.505, or 150.515
referred to them.
h The ALJ will permit the parties to introduce rebuttal witnesses and evidence, and to cross-examine witnesses.

j The ALJ may not consider evidence regarding the willingness and ability to enter into and successfully complete a corrective action plan when that evidence pertains to matters occurring after CMSs notice under 150.307, 150.313e, or 150.505.
41. Section 150.455 is amended by adding paragraph b9 to read as follows:

a If any provider or facility that is subject to CMSs enforcement authority under 150.101b3 fails to comply with a requirement in Title XXVII, Part E of the PHS Act, such provider or facility may be subject to a civil money penalty as described in this subpart.
b If any provider of air ambulance services fails to timely submit the information required in section 106a of
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the No Surprises Act, such provider may be subject to a civil money penalty as described in this subpart.
150.503 Basis for initiating an investigation; injunctive relief.

a Basis for investigation. Any information that indicates that any provider or facility may be failing to meet the PHS Act requirements or submit the information required in section 106a of the No Surprises Act may warrant an investigation at CMSs discretion. An investigation may include a review of any information CMS identifies as relevant to determine if a violation of the PHS Act or section 106a of the No Surprises Act has occurred. CMS may consider, but is not limited to considering, the following sources or types of information to determine if an investigation is warranted:
1 Complaints.
2 Reports from plans or issuers, State insurance departments, State health departments, medical boards, the National Association of Insurance Commissioners, and any other Federal or State agencies.
3 Any other information that indicates potential noncompliance with PHS Act requirements or section 106a of the No Surprises Act.
b Who may file a complaint. Any aggrieved entity or individual, or any entity or personal representative acting on that individual or entitys behalf, may file a complaint with CMS if he or she believes that a right to which the aggrieved individual or entity is entitled under PHS Act requirements is being, or has been, denied or abridged as a result of any action or failure to act on the part of a provider or facility.
c Random and targeted investigations. CMS may conduct random or targeted investigations to ensure that providers and facilities are in compliance with applicable PHS Act requirements and section 106a of the No Surprises Act.
d Injunctive relief. Whenever CMS
has reason to believe that any provider or facility has engaged, is engaging, or is about to engage in any activity which makes such provider or facility subject to a civil money penalty under this subpart, CMS may bring an action in an appropriate district court of the United States or, if applicable, a United States court of any territory to enjoin such activity, or to enjoin the provider or facility from concealing, removing, encumbering, or disposing of assets which may be required in order to pay a civil money penalty if any such penalty were to be imposed or to seek other appropriate relief.

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