# Prop. Treas. Reg. § 150.509: Responses to allegations of noncompliance.

Proposed regulation, not in force. REG-114676-21, 86 FR 51730, published 2021-09-16 <https://www.federalregister.gov/documents/2021/09/16/2021-19797/requirements-related-to-air-ambulance-services-agent-and-broker-disclosures-and-provider-enforcement>.

42. Add subpart E to read as follows:

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 CMS's 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the health plan or participant, beneficiary, or enrollee for any payment received in response to the bill that was withdrawn.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 106(a) 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 facility's 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 106(a) of the No Surprises Act, as applicable, and to 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 provider's or facility's record of previous compliance with PHS Act requirements and section 106(a) 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.