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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
financial hardship, potentially including the financial impact of natural disasters or public health emergencies, provider disability or death, and provider solvency concerns. The No Surprises Act allows HHS to establish a hardship exemption to the civil money penalties that would otherwise be imposed for a violation of Part E of Title XXVII of the PHS Act. HHS proposes to codify the hardship exemption in 45
CFR 150.513g. HHS seeks comments regarding this proposal, including examples of additional circumstances that may warrant a hardship exemption.
28. Notice of Proposed Determination 45 CFR 150.515
Section 2799B4b1 of the PHS Act and section 106e of the No Surprises Act require HHS to apply certain subsections of section 1128A of the SSA
when imposing a civil money penalty upon a provider or facility. Specifically, section 1128Ac of the SSA provides that HHS may initiate an action for a civil money penalty by serving notice of the action in any manner authorized under Rule 4 of the Federal Rules of Civil Procedure. HHS proposes to codify that procedural requirement in 45 CFR
150.515 and specify that such written notice would include a description of the requirements that CMS believes the provider or facility has violated; a description of any complaint or other information upon which CMS based its investigation; and the amount of the proposed penalty, including any aggravating or mitigating circumstances described in 45 CFR 150.513 that were considered when determining the amount of the proposed penalty.
HHS proposes that the notice of proposed determination would also include instructions for the provider or facility to respond to the notice, including a specific statement of the provider or facilitys right to a hearing and 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.
29. Hearing 45 CFR 150.517
Section 2799B4b1 of the PHS Act and section 106e3 of the No Surprises Act specify that sections 1128Ac2 and c4 of the SSA apply to any hearing for a violation of this part. Section 1128Ac2 of the SSA
requires HHS to provide written notice and an opportunity for an adverse determination to be made on the record after a hearing at which the provider or facility is entitled to be represented by counsel, to present witnesses, and to cross-examine witnesses.

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Section 1128Ac4 of the SSA allows the official conducting the hearing to sanction a person, including any party or attorney, for failing to comply with an order or procedure, failing to defend an action, or other misconduct that would interfere with the speedy, orderly, or fair conduct of the hearing.
Any such sanctions must reasonably relate to the severity and nature of the failure or misconduct and may include:
a In the case of refusal to provide or permit discovery, drawing negative factual inferences or treating such refusal as an admission by deeming the matter, or certain facts, to be established; b prohibiting a party from introducing certain evidence or otherwise supporting a particular claim or defense; c striking pleadings, in whole or in part; d staying the proceedings; e dismissal of the action;
f entering a default judgment; g ordering the party or attorney to pay attorneys fees and other costs caused by the failure or misconduct; and h refusing to consider any motion or other action which is not filed in a timely manner.
Most of these requirements regarding hearings, insofar as they apply to hearings conducted under 45 CFR part 150, subpart E, are codified in various sections of 45 CFR part 150, subpart D;
and in these proposed rules HHS is additionally proposing amendments to 45 CFR 150.401, 150.405, 150.417, 150.445, and 150.455 to conform to these requirements. Therefore, HHS
proposes in 45 CFR 150.517 to specify that the provisions in 45 CFR 150.401
through 150.457 apply to a hearing conducted under 45 CFR part 150, subpart E.
HHS proposes in 45 CFR 150.517b that if CMS finds a provider or facility to be in violation of a requirement of Part E of Title XXVII of the PHS Act, or section 106a of the No Surprises Act, such provider or facility has a right to a hearing pursuant to section 1128Ac2 of the SSA. HHS proposes that the provider or facility would be required to file a request for hearing within 30 days after the date of receipt of CMSs notice of proposed determination, to facilitate a timely resolution of the matter.
HHS proposes in 45 CFR 150.517c that, consistent with 45 CFR 150.347 as it applies to non-Federal governmental plans and issuers, if the provider or facility fails to request a hearing within the 30 days, any penalty would become final.

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30. Failure To Request a Hearing 45
CFR 150.519
HHS proposes in 45 CFR 150.519 that if the provider or facility does not request a hearing within 30 days of the issuance of the notice of proposed determination, or show good cause, as determined under 45 CFR 150.405b for failing to exercise its right to a hearing, the determination becomes final, and CMS would notify the provider or facility of this fact, and the final civil money penalty may be assessed by CMS. CMS would notify the provider or facility in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure of the means by which the provider or facility may satisfy the judgment. HHS further proposes that the provider or facility would have no right to appeal a penalty with respect to which it has not requested a hearing in accordance with 45 CFR 150.405. This aligns with CMSs enforcement procedures when an issuer or nonFederal governmental plan fails to request a hearing.
31. Collateral Estoppel 45 CFR 150.521
Section 1128Ac3 of the SSA states that a provider or facility that requests a hearing under this part may not deny the essential elements of a criminal offense if that provider or facility has been convicted of a Federal crime charging fraud or false statements whether upon a verdict after trial or upon a plea of guilty or nolo contendere and the hearing under this part involves the same transaction as the criminal action. HHS proposes to codify that statutory language in 45 CFR
150.521.
32. Judicial Review 45 CFR 150.523
HHS proposes in 45 CFR 150.523 that any responsible provider or facility against which a final decision imposing a civil money penalty is entered pursuant to this subpart may obtain review in the United States Court of Appeals for the circuit in which the person resides, or where the violation occurred, by filing in such court within 60 days following the date on which such decision becomes final a written petition requesting the decision be modified or set aside. Such review would be conducted pursuant to section 1128A of the SSA. A copy of the petition would be transmitted by the clerk of the court to CMS, and thereupon CMS would file in the Court the record in the proceeding as provided in 28 U.S.C. 2112.

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