42. Add subpart E to read as follows:
If CMS receives information under § 150.503(a) that indicates a potential violation of the PHS Act or section 106(a) of the No Surprises Act, or if CMS selects a provider or facility for investigation under § 150.503(c), CMS provides written notice to the provider or facility. The notice does the following:
(a) Describes the information received under § 150.503(a) that gives rise to the potential violation, notifies the provider or facility that it was selected by CMS for investigation under § 150.503(c) and the PHS Act requirements that are the focus of the investigation, or describes the data that was required under section 106(a) 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 facility's view, will aid CMS in evaluating the entity's 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 106(a) of the No Surprises Act.
(d) States that CMS may require a plan of corrective action.