42 CFR §423.2605

1. (a)Time for filing a request. The request for reconsideration must be filed with the designated independent reviewer within 60 calendar days from the date of the demand letter received by the Part D plan sponsor.
2. (b)Content of request.
   1. (1)The request for reconsideration must be in writing and specify the findings or issues with which the Part D plan sponsor disagrees.
   2. (2)The Part D plan sponsor must include with its request all supporting documentary evidence it wishes the independent reviewer to consider.
      1. (i)This material must be submitted in the format requested by CMS.
      2. (ii)Documentation, evidence, or substantiation submitted after the filing of the reconsideration request will not be considered.
3. (c)CMS Rebuttal. CMS may file a rebuttal to the Part D plan sponsor's reconsideration request.
   1. (1)The rebuttal must be submitted within 30 calendar days of the review entity's notification to CMS that it has received the Part D plan sponsor's reconsideration request.
   2. (2)CMS sends its rebuttal to the Part D plan sponsor at the same time it is submitted to the independent reviewer.
4. (d)Review entity. An independent reviewer conducts the reconsideration. The independent reviewer reviews the demand for repayment, the evidence and findings upon which it was based, and any evidence that the Part D plan sponsor or CMS submitted in accordance with this section.
5. (e)Notification of decision. The independent reviewer informs CMS and the Part D plan sponsor of its decision in writing.
6. (f)Effect of decision. A reconsideration decision is final and binding unless the Part D plan sponsor requests a hearing official review in accordance with § 423.2610.
7. (g)Right to hearing official review. A Part D plan sponsor that is dissatisfied with the independent reviewer's reconsideration decision is entitled to a hearing official review as provided in § 423.2610.