Right to a hearing, burden of proof, standard of proof, and standards of review.

(a) Right to a hearing. The following parties are entitled to a hearing: (1) A contract applicant that has been determined to be unqualified to enter into a contract with CMS under Part D of Title XVIII of the Act in accordance with § 423.502 and § 423.503 of this part. (2) A Part D sponsor whose contract has been terminated in accordance with § 423.509 of this part. (3) A Part D sponsor whose contract has not been renewed in accordance with § 423.507 of this part. (4) A Part D sponsor who has had an intermediate sanction imposed in accordance with § 423.752(a) through (b). (b) Burden of proof, standard of proof, and standard of review at hearing. (1) During a hearing to review a contract determination as described at § 423.641(a) of this subpart, the applicant has the burden of proving by a preponderance of the evidence that CMS' determination was inconsistent with the requirements of § 423.502 and § 423.503 of this part. (2) During a hearing to review a contract determination as described at § 423.641(b) of this part, the Part D plan sponsor has the burden of proving by a preponderance of the evidence that CMS' determination was inconsistent with the requirements of § 423.507 of this part. (3) During a hearing to review a contract determination as described at § 423.641(c) of this subpart, the Part D plan sponsor has the burden of proving by a preponderance of the evidence that CMS' determination was inconsistent with the requirements of § 423.509 of this part. (4) During a hearing to review the imposition of an intermediate sanction as described at § 423.750 of this part, the Part D sponsor has the burden of proving by a preponderance of the evidence that CMS' determination was inconsistent with the requirements of § 423.752 of this part. (c) Timing of favorable decision. Notice of any decision favorable to the Part D sponsor appealing a determination that it is not qualified to enter into a contract with CMS must be issued by September 1 for the contract in question to be effective on January 1 of the following year. [75 FR 19824, Apr. 15, 2010, as amended at 80 FR 7965, Feb. 12, 2015]