42 C.F.R. § 422.501 Application requirements.
Title 42 - Public Health
(a) Scope. This section sets forth application requirements for entities that seek a contract as an MA organization offering an MA plan. (b) Completion of an application. (1) In order to obtain a determination on whether it meets the requirements to become an MA organization and is qualified to provide a particular type of MA plan, an entity, or an individual authorized to act for the entity (the applicant) must complete 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 applicable to MA plans, and is authorized by the State to accept prepaid capitation for providing, arranging, or paying for the comprehensive health care services to be offered under the MA contract; or (ii) For regional plans, documentation of application for State licensure in any State in the region that the organization is not already licensed. (2) The authorized individual must thoroughly describe how the entity and MA plan meet, or will meet, the requirements described in this part. (c) Responsibility for making determinations. (1) CMS is responsible for determining whether an entity qualifies as an MA organization and whether proposed MA plans meet the requirements of this part. (2) A CMS determination that an entity is qualified to act as an MA organization is distinct from the bid negotiation that occurs under subpart F of this part and such negotiation is not subject to the appeals provisions included in subpart N of this part. (d) Resubmittal of application. An application that has been denied by CMS may not be resubmitted for 4 months after the date of the notice from CMS denying the application. (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 U.S.C. 552, the Freedom of Information Act, or because of exemptions provided in 45 CFR part 5 (the Department's regulations providing exceptions to disclosure), must label the material “privileged” and include an explanation of the applicability of an exception described in 45 CFR part 5. Any final decisions as to whether material is privileged is the final decision of the Secretary. [70 FR 4736, Jan. 28, 2005]
Title 42: Public Health
PART 422—MEDICARE ADVANTAGE PROGRAM
Subpart K—Contracts With Medicare Advantage Organizations
§ 422.501 Application requirements.

