(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 Sec. 423.502 and Sec. 423.503 of this part.
(2) A Part D sponsor whose contract has been terminated in accordance with Sec. 423.509 of this part.
(3) A Part D sponsor whose contract has not been renewed in accordance with Sec. 423.507 of this part.
(4) A Part D sponsor who has had an intermediate sanction imposed in accordance with Sec. 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 Sec. 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 Sec. 423.502 and Sec. 423.503 of this part.
(1) During a hearing to review a contract determination as described at Sec. 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 Sec. 423.502 and Sec. 423.503 of this part.
(2) During a hearing to review a contract determination as described at Sec. 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 Sec. 423.507 of this part.
(3) During a hearing to review a contract determination as described at Sec. 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 Sec. 423.509 of this part.
(4) During a hearing to review the imposition of an intermediate sanction as described at Sec. 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 Sec. 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]