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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 19. Evidence 45 CFR 150.445
HHS proposes to make conforming amendments to 45 CFR 150.445g, which pertains to admissibility of evidence of acts other than those at issue in the instant case, to add references to the proposed 45 CFR
150.513 which describes factors and mitigating and aggravating circumstances considered in determination of the amount of civil money penalty assessed against a provider or facility, and proposed 45
CFR 150.505 and 150.515 which describe notices sent by CMS to responsible entities regarding potential violations and civil money penalties against a provider or facility. HHS
proposes to make a similar conforming amendment to 45 CFR 150.445j, which pertains to admissibility of evidence of willingness and ability to enter into and complete a corrective action plan, to add a reference to proposed 45 CFR
150.505. These proposed amendments would provide for the same process for administrative hearings regarding civil money penalties assessed against providers and facilities as the process established for non-Federal governmental plans, and issuers in states where CMS directly enforces PHS
Act requirements. In addition, HHS
proposes to amend 45 CFR 150.445h to provide for cross-examination of witnesses, to conform to i the right to cross-examination already implicit in 45
CFR 150.419, and ii section 1128Ac2 of the SSA, as required in section 2799B4 of the PHS Act. The right to cross-examine witnesses is fundamental and is being explicitly included here to ensure that the process for hearings is fair for all parties.
20. Sanctions 45 CFR 150.455
HHS proposes to amend 45 CFR
150.455 to add the payment of an aggrieved partys attorneys fees and other costs as an additional sanction for violations of 45 CFR part 149, to conform to section 1128Ac4 of the SSA. Section 2799B4 of the PHS Act subjects civil money penalties assessed under that section to the requirements in section 1128Ac of the SSA with the exception of the first sentence of section 1128Ac1. Section 1128Ac4 of the SSA provides that an ALJ may sanction parties and attorneys for failing to comply with an order or procedure, failing to defend an action, or other misconduct as would interfere with the speedy, orderly, or fair conduct of the hearing. Subsection g thereof specifically provides for ordering the party or attorney to pay attorneys fees
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and other costs caused by the failure or misconduct.
D. 45 CFR Part 150, Subpart ECMS
Enforcement With Respect to Providers and Facilities HHS proposes to add a new subpart E to 45 CFR part 150, to implement the requirements of section 2799B4 of the PHS Act. This new subpart would specify the CMS enforcement processes with respect to the requirements of Part E of Title XXVII of the PHS Act and its implementing regulations at 45 CFR part 149 that would be applicable to providers and facilities subject to CMSs enforcement authority. With respect to potential violations of these requirements, HHS proposes to follow a similar investigatory process to that which currently exists in subpart C of 45 CFR part 150, which applies to investigations of possible violations by plans and issuers. HHS is proposing to use that similar process to maximize efficiency. HHS believes that the general steps of reviewing complaints or other indications of a potential PHS Act violation, notifying responsible parties of the investigation and directing them to provide information and documentation for CMS to review and assess compliance, and directing the responsible party to take corrective actions to remedy any violations identified are prudent and appropriate to apply to investigations of providers and facilities. HHS believes that this proposed approach would allow CMS to effectively enforce the new requirements and ensure that providers and facilities are sufficiently informed of the steps in and how to comply with the investigation process.
In contrast, HHS is proposing a different civil money penalty process to comply with the statutory requirements of the No Surprises Act. Section 2799B4 of the PHS Act delineates the process for imposition of civil money penalties if a provider or facility is found to be in violation of Part E of Title XXVII of the PHS Act. Section 106e of the No Surprises Act sets forth the process for imposition of civil money penalties if a provider of air ambulance services fails to provide data required in section 106a of the No Surprises Act.
In both cases, the process must follow section 1128A of the SSA.33 Therefore, 33 The applicability of section 1128A of the SSA
varies depending on the applicable enforcement provision. For violations stemming from Section 2799B4 of the PHS Act, provisions of subsections c with the exception of the first sentence of paragraph 1 of such subsection, d, e, g, h, k, and l apply. For violations stemming from Section 106 of the No Surprises Act, all provisions other than subsections a and b and the first sentence of subsection c1 apply.

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although many of the investigative processes applicable to providers and facilities are the same as those applicable to plans and issuers, HHS
proposes to codify the provider and facility enforcement procedures in new subpart E to 45 CFR part 150.
21. General Rule Regarding the Imposition of Civil Money Penalties 45
CFR 150.501
Section 2799B4 of the PHS Act authorizes HHS to apply a civil money penalty with respect to a provider or facility that is found to be in violation of Part E of Title XXVII of the PHS Act.
Section 106e of the No Surprises Act authorizes HHS to apply a civil money penalty with respect to a provider of air ambulance services that fails to submit all information required under section 106a of the No Surprises Act by the required date. HHS proposes to codify those provisions in 45 CFR 150.501.
22. Basis for Initiating an Investigation;
Injunctive Relief 45 CFR 150.503
HHS proposes that CMS may conduct an investigation based on any information that indicates a provider or facility is failing to comply with PHS
Act requirements. Proposed 45 CFR
150.503a would list the same sources of information as those that CMS may consider when investigating potential violations by plans or issuers, including complaints such as complaints received under the process established in 45 CFR
149.150 with respect to plans and issuers or 45 CFR149.450 with respect to providers and facilities, reports from state insurance departments, the NAIC, other Federal and state agencies, and any other information that indicates potential noncompliance with PHS Act requirements. HHS proposes to add state health and medical boards as additional sources in 45 CFR 150.503a, as they may be relevant sources to indicate potential noncompliance by providers and facilities.
HHS proposes language in 45 CFR
150.503b that would clarify who may file a complaint. This would include any entity or individual, or any entity or personal representative acting on that individuals behalf, who believes that a right to which the aggrieved person 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. This would ensure consistency with 45 CFR
150.303b which provides that such individuals or entities may submit a complaint with respect to non-Federal governmental plans and issuers.
HHS proposes in 45 CFR 150.503c to establish CMSs authority to conduct
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