42 CFR § 423.2261 - Submission, review, and distribution of materials.
(1) The Health Plan Management System (HPMS) Marketing Module is the primary system of record for the collection, review, and storage of materials that must be submitted for review.
(2) Materials must be submitted to the HPMS Marketing Module by the Part D sponsor.
(1) CMS has reviewed and approved the material.
(2) The material has been deemed approved; that is, CMS has not rendered a disposition for the material within 45 days (or 10 days if using CMS model or standardized marketing materials as outlined in § 422.2267(e) of this chapter) of submission to CMS.
(3) The material has been accepted under File and Use, as follows:
(i) The Part D sponsor may distribute certain types of marketing materials, designated by CMS based on the material's content, audience, and intended use, as they apply to potential risk to the beneficiary, 5 days following the submission.
(1) Certain designated communications materials that are critical to beneficiaries understanding or accessing their benefits (for example, the Evidence of Coverage (EOC).
(2) Communications materials that, based on feedback such as complaints or data gathered through reviews, warrant additional oversight as determined by CMS, to ensure the information being received by beneficiaries is accurate.
(d) Standards for CMS review. CMS reviews materials to ensure the following:
(1) Compliance with all applicable requirements under §§ 423.2260 through 423.2267.
(2) Benefit and cost information is an accurate reflection of what is contained in the Part D sponsor's bid.
(3) CMS may determine, upon review of such materials, that the materials must be modified, or may no longer be used.