42 CFR § 423.2261 - Submission, review, and distribution of materials.

§ 423.2261 Submission, review, and distribution of materials.

(a) General requirements. Part D sponsors must submit all marketing materials, all election forms, and certain designated communications materials for CMS review.

(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.

(3) Unless specified by CMS, third party and downstream entities are not permitted to submit materials directly to CMS.

(b) CMS review of marketing materials and election forms. Part D sponsors may not distribute or otherwise make available any marketing materials or election forms unless one of the following occurs:

(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.

(ii) The Part D sponsor must certify that the material meets all applicable CMS communications and marketing requirements in §§ 423.2260 through 423.2267.

(c) CMS review of non-marketing communications materials. CMS does not require submission, or submission and approval, of communications materials prior to use, other than the following exceptions.

(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.

[86 FR 6122, Jan. 19, 2021]