42. Add subpart E to read as follows:
(a) If CMS proposes a penalty, in accordance with this subpart, CMS will serve on the provider or facility, in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure, written notice of CMS's intent to impose a penalty. The notice will include:
(1) A description of the PHS Act requirements or the No Surprises Act requirements that CMS has determined the provider or facility violated.
(2) A description of any complaint or other information upon which CMS based its investigation, including the basis for determining the number of violations.
(3) The amount of the proposed penalty as of the date of the notice.
(4) Any circumstances described in § 150.513 that were considered when determining the amount of the proposed penalty.
(5) Instructions for responding to the notice, including:
(i) A specific statement of the provider or facility's right to a hearing; and
(ii) 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 in accordance with § 150.519.
(b) [Reserved]