(a) Time for filing a request. A Part D plan sponsor must file with CMS a request for a hearing official review within 30 calendar days from the date of the independent reviewer's issuance of a determination.

(b) Content of the request.

(1) The request must be in writing and must provide evidence or reasons or both to substantiate the request.

(2) The Part D plan sponsor must submit with its request all supporting documentation, evidence, and substantiation that it wants to be considered.

(3) No new evidence may be submitted.

(4) Documentation, evidence, or substantiation submitted after the filing of the request will not be considered.

(c) CMS rebuttal. CMS may file a rebuttal to the Part D plan sponsor's hearing official review request.

(1) The rebuttal must be submitted within 30 calendar days of the Part D plan sponsor's submission of its hearing official review request.

(2) CMS sends its rebuttal to the Part D plan sponsor at the same time it is submitted to the hearing official.

(d) Conducting a review. A CMS-designated hearing official conducts the hearing on the record.

(1) The hearing is not to be conducted live or via telephone unless the hearing official, in his or her sole discretion, requests a live or telephonic hearing.

(2) In all cases, the hearing official's review is limited to information that meets one or more of the following:

(i) The Part D RAC used in making its determinations.

(ii) The independent reviewer used in making its determinations.

(iii) The Part D plan sponsor submits with its hearing request.

(iv) CMS submits in accordance with paragraph (c) of this section.

(3) Neither the Part D plan sponsor nor CMS may submit new evidence.

(e) Hearing official decision. The CMS hearing official decides the case within 60 days and sends a written decision to the Part D plan sponsor and CMS, explaining the basis for the decision.

(f) Effect of hearing official decision. The hearing official's decision is final and binding, unless the decision is reversed or modified by the CMS Administrator in accordance with §423.2610.