Quiero saber acerca de...

Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 26. Liability for Penalties 45 CFR
150.511
In 45 CFR 150.511, HHS proposes to codify the provision in section 1128Ac1 of the SSA that provides that HHS will not commence any action to impose a civil money penalty unless such action is commenced within 6
years from the date when the violation occurred.
HHS also proposes that a principal is liable for penalties for the actions of the principals agent acting within the scope of his or her agency, without limiting the underlying liability of the agent.
27. Amount of Penalty 45 CFR 150.513
At 45 CFR 150.513a1, HHS
proposes to codify the statutory language that permits HHS to impose a civil money penalty in an amount not to exceed the sum of $10,000 per violation if a provider or facility is found to be in violation of a PHS Act requirement. At 45 CFR 150.513a2, HHS proposes to codify the statutory language found in section 106e of the No Surprises Act that permits HHS to impose a civil money penalty in an amount not to exceed the sum of $10,000 if a provider of air ambulance services fails to submit required data. Such civil money penalties would be in addition to any other penalties prescribed or allowed by law.
HHS proposes that CMS would consider all relevant documentation provided when determining whether to impose a civil money penalty, including information from the complainant, provider including a provider of air ambulance services, or facility. In 45
CFR 150.513b, HHS proposes that if CMS were to determine that it would impose a civil money penalty, there are several factors that would be considered when determining the amount of such penalty. CMS would consider the nature of claims of noncompliance and the circumstances under which such claims were presented. CMS would also consider: the degree of culpability of the provider or facility against which a civil money penalty is proposed; the provider or facilitys history of prior violations, including whether CMS or any state previously 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; the frequency of the violation, taking into consideration whether any violation is an isolated occurrence, represents a pattern, or is widespread; and the level of financial and other impacts on affected
VerDate Sep<11>2014

16:57 Sep 15, 2021

Jkt 253001

individuals. CMS would also consider any other matters as justice may require.
In 45 CFR 150.513c, HHS proposes that for every violation subject to a civil money penalty, if there are substantial or several mitigating circumstances, the aggregate amount of the penalty would be set at an amount sufficiently below the statutory maximum of $10,000 to reflect the mitigating circumstance. As guidelines for considering the circumstances listed earlier, CMS would consider several factors as mitigating circumstances. First, CMS would consider the provider or facilitys record of prior compliance. If, for example, the provider or facility implemented and followed a compliance plan before receipt of the notice of potential noncompliance, implementing and following such compliance plan would be considered a mitigating circumstance. If the provider or facility had no previous complaints against it for noncompliance, that would also be considered a mitigating circumstance.
Second, CMS would consider the gravity of the violations. For example, it would be considered a mitigating circumstance if the provider or facility made adjustments to its business practices to come into compliance with PHS Act requirements so that the provider or facility: i Identified all participants, beneficiaries, and enrollees, or all plans or issuers, that are or were wrongly billed; ii withdrew the bill or reimbursed the affected individuals, or plans or issuers, that were wrongly billed so that, to the extent practicable, the affected individuals, plans or issuers are in the same position that they would have been in had the violation not occurred;
and iii completed those adjustments to its business practices in a timely manner. Finally, it would be considered a mitigating circumstance if the provider or facility demonstrated that the violation was an isolated occurrence.
HHS also proposes in 45 CFR
150.513d that CMS would consider certain factors to be aggravating circumstances. HHS proposes that for every violation subject to a civil money penalty, if there are substantial or several aggravating circumstances, CMS
may set the aggregate amount of the penalty at an amount sufficiently close to or at the $10,000 permitted by statute to reflect that fact. If the frequency of violation indicates a pattern of widespread occurrence, that would be considered an aggravating circumstance.
If the violations resulted in significant financial and other impacts on the average affected individuals, plan or issuer, that would also be considered an
PO 00000

Frm 00025

Fmt 4701

Sfmt 4702

51753

aggravating circumstance. Finally, if the provider or facility does not provide documentation showing that substantially all of the violations were corrected, that would be considered an aggravating circumstance.
In 45 CFR 150.513e, HHS proposes that if certain criteria are met, CMS
would waive a penalty. Section 2799B
4b4 of the PHS Act provides that HHS will waive a civil money penalty if the provider or facility does not knowingly violate, and should not have reasonably known it violated, sections 2799B1 and 2799B2 of the PHS Act or, in the case of a provider of air ambulance services, section 2799B5 of the PHS Act, as long as the provider or facility withdraws any erroneous bill and, if necessary, reimburses the plan or enrollee, within 30 days of the violation in an amount equal to the difference between the amount billed and the amount allowed to be billed, plus interest at a rate determined by the Secretary. HHS proposes that the interest rate be the rate established by the Treasury pursuant to 31 U.S.C. 3717.
That is the rate HHS customarily uses for overpayments and underpayments.34
The CAA also provides that HHS will waive a civil money penalty in the case of a provider of air ambulance services that submits only part of the data required in section 106a of the No Surprises Act, if such provider demonstrates a good faith effort in working with HHS to submit any missing information. HHS proposes to codify that waiver language in 45 CFR
150.513e2.
In 45 CFR 150.513f, HHS proposes that nothing in this proposed section limits the authority of CMS to settle any issue or case described in the notice furnished in accordance with 45 CFR
150.505 or to compromise on any penalty provided for in 45 CFR 150.515.
This is consistent with the settlement authority described in 45 CFR 150.325.
HHS recognizes that there may be certain circumstances in which imposition of a civil money penalty would create a significant financial hardship for a provider or facility.
Various circumstances may give rise to 34 See 42 CFR 405.378 which provides that the interest rate on overpayments and underpayments is the higher of: i The rate as fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date of final determination as defined in paragraph c of this section; or ii The current value of funds rate this rate is published annually in the Federal Register by the Secretary of the Treasury, subject to quarterly revisions. See also 45 CFR 30.18b2
which provides unless a different rate is prescribed by statute, contract, or a repayment agreement, the rate of interest charged shall be the rate established annually by the Secretary of the Treasury pursuant to 31 U.S.C. 3717.

E:FRFM16SEP2.SGM

16SEP2