StacksVerified U.S. regulatory reference

42 CFR §423.650

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Right to a hearing. The following parties are entitled to a hearing:
    1. (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. (2)A Part D sponsor whose contract has been terminated in accordance with § 423.509 of this part.
    3. (3)A Part D sponsor whose contract has not been renewed in accordance with § 423.507 of this part.
    4. (4)A Part D sponsor who has had an intermediate sanction imposed in accordance with § 423.752(a) through (b).
  2. (b)Burden of proof, standard of proof, and standard of review at hearing.
    1. (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. (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. (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. (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.
  3. (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.