(a) CMS review of marketing materials. (1) Except as provided in paragraph (a)(2) of this section, a Part D plan may not distribute any marketing materials (as defined in Sec. 423.2260 of this Part), or enrollment forms, or make such materials or forms available to Part D eligible individuals unless--
(1) Except as provided in paragraph (a)(2) of this section, a Part D plan may not distribute any marketing materials (as defined in Sec. 423.2260 of this Part), or enrollment forms, or make such materials or forms available to Part D eligible individuals unless--
(i) At least 45 days (or 10 days if using certain types of marketing materials that use, without modification, proposed model language and format, including standardized language and formatting, as specified by CMS) before the date of distribution, the Part D sponsor submits the material or form to CMS for review under the guidelines in Sec. 423.2264 of this subpart; and
(ii) CMS does not disapprove the distribution of new material or form.
(2) If CMS does not approve or does not disapprove marketing materials within the specified review timeframe, the materials are deemed approved and the Part D sponsor may use the material.
(b) File and use. The Part D sponsor may distribute certain types of marketing material, designated by CMS, 5 days following their submission to CMS if the Part D sponsor certifies that in the case of these marketing materials, it followed all applicable marketing guidelines and, when applicable, used model language specified by CMS without modification.
(c) Standardized model marketing materials. When specified by CMS, organizations must use standardized formats and language in model materials.
(d) Ad hoc enrollee communication materials. Ad hoc enrollee communication materials may be reviewed by CMS, which may upon review determine that such materials must be modified, or may not longer be used. [70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19826, Apr. 15, 2010; 80 FR 7965, Feb. 12, 2015]