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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 150.505

Notice to providers or facilities.

If CMS receives information under 150.503a that indicates a potential violation of the PHS Act or section 106a of the No Surprises Act, or if CMS selects a provider or facility for investigation under 150.503c, CMS
provides written notice to the provider or facility. The notice does the following:
a Describes the information received under 150.503a that gives rise to the potential violation, notifies the provider or facility that it was selected by CMS
for investigation under 150.503c and the PHS Act requirements that are the focus of the investigation, or describes the data that was required under section 106a of the No Surprises Act and the implementing regulations in part 149 of this subchapter but not submitted by a provider of air ambulance services, as applicable.
b Provides the date by which the provider or facility must respond and forward any documentation CMS
identifies as relevant for purposes of an investigation, including overdue data regarding air ambulance services, and can provide additional information, including documentation of compliance as described in 150.509 that, in the provider or facilitys view, will aid CMS
in evaluating the entitys compliance with the PHS Act or No Surprises Act requirements identified in the notice.
c States that a civil money penalty may be assessed should the entity be found to be out of compliance with applicable PHS Act requirements or section 106a of the No Surprises Act.
d States that CMS may require a plan of corrective action.
150.507

Request for extension.

In circumstances in which a provider or facility cannot prepare a response to CMS or provide the requested information by the deadline provided in the notice under 150.505, the provider or facility may make a written request for an extension from CMS detailing the reason for the extension request and showing good cause. Examples of what CMS would consider good cause include, but are not limited to, when a responsible entity indicates it has limited staffing resources to prepare a response, or when a responsible entity requests clarification from CMS
regarding its request for information. If CMS grants the extension, the provider or facility must respond to the notice within the time frame specified in CMSs letter granting the extension of time. Failure to respond within the initial deadline provided in the notice, or within the extended time frame, may result in CMSs imposition of a civil
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money penalty based upon the complaint or other information alleging or indicating a violation of PHS Act requirements or section 106a of the No Surprises Act.
150.509 Responses to allegations of noncompliance.

In determining whether to impose a civil money penalty, CMS reviews and considers documentation provided in any complaint or other information, as well as any additional information provided by the provider or facility to demonstrate that it has complied with relevant requirements. The following are examples of documentation that a provider or facility may submit for CMSs consideration in determining whether a civil money penalty should be assessed and the amount of any civil money penalty:
a Any documentation indicating a provider or facility complied with the requirements in part 149 of this subchapter, including but not limited to claims, medical bills, notice and consent forms, disclosures, data related to air ambulance services, or any other documents if those documents form the basis of a complaint or allegation of noncompliance, or the basis for the provider or facility to refute the complaint or allegation.
b Any other evidence that refutes an allegation of noncompliance.
c Evidence that the provider or facility did not know, and exercising due diligence could not have known, of the violation, and, if applicable, that the provider or facility undertook a corrective action, such as withdrawing the bill that was in violation and reimbursing the health plan or participant, beneficiary, or enrollee for any payment received in response to the bill that was withdrawn.
d Evidence documenting the development and implementation of internal policies and procedures by a provider or facility to ensure compliance with PHS Act requirements and section 106a of the No Surprises Act, as applicable. Those policies and procedures may include or consist of a voluntary compliance program. Any such program must do the following:
1 Effectively articulate and demonstrate the fundamental mission of compliance and the provider or facilitys commitment to the compliance process.
2 Include the name of an individual responsible for compliance.
3 Describe an effective monitoring process designed to identify practices that do not comply with PHS Act requirements and section 106a of the No Surprises Act, as applicable, and to
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provide reasonable assurances that noncompliant practices are detected in a timely manner.
4 Address procedures to improve internal policies when noncompliant practices are identified.
e Evidence documenting the providers or facilitys record of previous compliance with PHS Act requirements and section 106a of the No Surprises Act, as applicable.
f Evidence documenting a provider of air ambulance services good faith efforts to submit missing information that such providers are required to submit pursuant to 149.460 of this chapter. This must include the submission and implementation of a corrective action plan that does the following:
1 Identifies the cause underlying the submission of incomplete data and effectively articulates and demonstrates the measures that will be taken to submit complete data;
2 Provides the timeline for submitting complete data;
3 Provides the name of the individual in the organization responsible for overseeing the corrective actions and submitting complete data;
and 4 Addresses procedures to improve internal policies to ensure that incomplete data reports are identified and completed prior to submission for future reporting periods.
150.511

Liability for penalties.

a No action under this part will be entertained unless commenced within 6
years from the date when the claim was presented, the request for payment was made, or the violation occurred.
b Under this part, a principal is liable for penalties for the actions of his or her agent acting within the scope of his or her agency. This paragraph b does not limit the underlying liability of the agent.
150.513

Amount of penalty.

a Maximum amount. 1 If a provider or facility is found to be in violation of a PHS Act requirement, CMS may impose a civil money penalty in an amount not to exceed $10,000 per violation, adjusted annually under 45
CFR part 102. Penalties imposed under this part are in addition to any other penalties prescribed or allowed by law.
2 If a provider of air ambulance services is found to be in violation of section 106a of the No Surprises Act, CMS may impose a civil money penalty in an amount not to exceed $10,000 per year of violation, adjusted annually under 45 CFR part 102. Penalties imposed under this part are in addition
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