42 C.F.R. § 423.503 Evaluation and determination procedures for applications to be determined qualified to act as a sponsor.
Title 42 - Public Health
(a) Basis for evaluation and determination. (1) CMS evaluates an entity's application on the basis of information contained in the application itself and any additional information that CMS obtains through on-site visits, publicly available information, and any other appropriate procedures. (2) After evaluating all relevant information, CMS determines whether the application meets the applicable requirements specified in §423.504 and §423.505. (b) Use of information from a prior contracting period. If a Part D plan sponsor fails to comply with the terms of a previous year's contract (or in the case of a fallback entity, the previous 3-year contract) with CMS under title XVIII of the Act, or fails to complete a corrective action plan during the term of the contract, CMS may deny an application based on the applicant's failure to comply with that prior contract with CMS even if the applicant currently meets all of the requirements of this part. (c) Notice of determination. Except for fallback entities, which are governed under subpart Q of this part, CMS notifies each applicant that applies to be determined qualified to contract as a Part D plan sponsor, under this part, of its determination on the application and the basis for the determination. The determination may be one of the following: (1) Approval of application. If CMS approves the application, it gives written notice to the applicant, indicating that it qualifies to contract as Part D plan sponsor. (2) Intent to deny. (i) If CMS finds that the applicant does not appear qualified to contract as a Part D plan sponsor and/or has not provided enough information to evaluate the application, it gives the applicant notice of intent to deny the application and a summary of the basis for this preliminary finding. (ii) Within 10 days from the date of the notice, the applicant may respond in writing to the issues or other matters that were the basis for CMS's preliminary finding and may revise its application to remedy any defects CMS identified. (3) Denial of application. If CMS denies the application, it gives written notice to the applicant indicating— (i) That the applicant is not qualified to contract as a Part D sponsor under Part D of title XVIII of the Act; (ii) The reasons why the applicant does is not so qualified; and (iii) The applicant's right to request reconsideration in accordance with the procedures specified in subpart N. (d) Oversight of continuing compliance. (1) CMS oversees a Part D plan sponsor's continued compliance with the requirements for a Part D plan sponsor. (2) If a Part D plan sponsor no longer meets those requirements, CMS terminates the contract in accordance with §423.509.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart K—Application Procedures and Contracts with Part D plan sponsors
§ 423.503 Evaluation and determination procedures for applications to be determined qualified to act as a sponsor.
