---
kind: "section"
citation: "42 C.F.R. § 423.502"
title: "42"
number: "423.502"
heading: "Application requirements."
url: "https://uscodex.org/cfr/42/423.502"
---

# §423.502. Application requirements.

- (a) **Scope.** This section sets forth application requirements for an entity that seeks a determination from CMS that it is qualified to contract as a sponsor of a Part D plan.
- (b) **Completion of a notice of intent to apply.**
  - (1) An organization submitting an application under this section for a particular contract year must first submit a completed Notice of Intent to Apply by the date established by CMS. CMS will not accept applications from organizations that do not submit a timely Notice of Intent to Apply.
  - (2) Submitting a Notice of Intent to Apply does not bind that organization to submit an application for the applicable contract year.
  - (3) An organization's decision not to submit an application after submitting an Notice of Intent to Apply will not form the basis of any action taken against the organization by CMS.
- (c) **Completion of an application.**
  - (1) In order to obtain a determination on whether it meets the requirements to become a Part D plan sponsor, an entity, or an individual authorized to act for the entity (the applicant), must fully complete all parts of a certified application in the form and manner required by CMS, including the following:
    - (i) Documentation of appropriate State licensure or State certification that the entity is able to offer health insurance or health benefits coverage that meets State-specified standards as specified in subpart I of this part; or
    - (ii) **A Federal waiver as specified in subpart I of this part.**
  - (2) The authorized individual must describe thoroughly how the entity is qualified to meet the all requirements described in this part.
- (d) **Responsibility for making determinations.**
  - (1) CMS is responsible for determining whether an entity is qualified to contract as a Part D plan sponsor and meets the requirements of this part.
  - (2) A CMS determination that an entity is qualified to act as a Part D plan sponsor is distinct from the bid negotiations that occur under [subpart F of part 423](/cfr/42/part423-subpartF.md) and such negotiations are not subject to the appeals provisions included in [subpart N](/cfr/42/subpartN.md) of this part.
- (e) **Disclosure of application information under the Freedom of Information Act.** An applicant submitting material that he or she believes is protected from disclosure under [5 USC 552](/usc/5/552.md), the Freedom of Information Act, or because of exemptions provided in [45 CFR part 5](/cfr/45/part5.md) (the Department's regulations providing exemptions to disclosure), must label the material “privileged” and include an explanation of the applicability of an exemption specified in [45 CFR part 5](/cfr/45/part5.md).

## Notes

### Amendments

[70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19819, Apr. 15, 2010]

### Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.

### Source

Source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.

### Amendments

[70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19819, Apr. 15, 2010]