42 C.F.R. § 423.50 Approval of marketing materials and enrollment forms.
Title 42 - Public Health
(a) CMS review of marketing materials. (1) Except as provided in paragraph (a)(2) and (a)(3) of this section, a Part D plan may not distribute any marketing materials (as defined in paragraph (b) of this section), 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 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 paragraph (c) of this section; and (ii) CMS does not disapprove the distribution of the material or form. (2) If the Part D sponsor is deemed by CMS to meet certain performance requirements established by CMS, the Part D sponsor may distribute designated marketing materials 5 days following their submission to CMS. (3) Prior to distribution, the Part D sponsor submits and certifies that for certain types of marketing materials it followed all applicable marketing guidelines, or for certain other marketing materials that it used, without modification, proposed model language as specified by CMS. (b) Definition of marketing materials. Marketing materials include any informational materials targeted to Medicare beneficiaries which— (1) Promote the Part D plan. (2) Inform Medicare beneficiaries that they may enroll, or remain enrolled in a Part D plan. (3) Explain the benefits of enrollment in a Part D plan, or rules that apply to enrollees. (4) Explain how Medicare services are covered under a Part D plan, including conditions that apply to such coverage. (c) Examples of marketing materials. Examples of marketing materials include, but are not limited to— (1) General audience materials such as general circulation brochures, newspapers, magazines, television, radio, billboards, yellow pages, or the Internet. (2) Marketing representative materials such as scripts or outlines for telemarketing or other presentations. (3) Presentation materials such as slides and charts. (4) Promotional materials such as brochures or leaflets, including materials for circulation by third parties (for example, physicians or other providers). (5) Membership communication materials such as membership rules, subscriber agreements, member handbooks and wallet card instructions to enrollees. (6) Letters to members about contractual changes; changes in providers, premiums, benefits, plan procedures etc. (7) Membership or claims processing activities. (d) Guidelines for CMS review. In reviewing marketing material or enrollment forms under paragraph (a) of this section, CMS determines (unless otherwise specified in additional guidance) that the marketing materials— (1) Provide, in a format (and, where appropriate, print size), and using standard terminology that may be specified by CMS, the following information to Medicare beneficiaries interested in enrolling— (i) Adequate written description of rules (including any limitations on the providers from whom services can be obtained), procedures, basic benefits and services, and fees and other charges. (ii) Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each. (iii) Any other information necessary to enable beneficiaries to make an informed decision about enrollment. (2) Notify the general public of its enrollment period in an appropriate manner, through appropriate media, throughout its service area. (3) Include in the written materials notice that the Part D plan is authorized by law to refuse to renew its contract with CMS, that CMS also may refuse to renew the contract, and that termination or non-renewal may result in termination of the beneficiary's enrollment in the Part D plan. In addition, the Part D plan may reduce its service area and no longer be offered in the area where a beneficiary resides. (4) Are not materially inaccurate or misleading or otherwise make material misrepresentations. (5) For markets with a significant non-English speaking population, provide materials in the language of these individuals. (e) Deemed approval. If CMS has not disapproved the distribution of a marketing materials or form submitted by a Part D sponsor for a Part D plan in a Part D region, CMS is deemed to not have disapproved the distribution of the marketing material or form in all other Part D regions covered by the Part D plan, with the exception of any portion of the material or form that is specific to the Part D region. (f) Standards for Part D marketing. (1) In conducting marketing activities, a Part D plan may not— (i) Provide for cash or other remuneration as an inducement for enrollment or otherwise. This does not prohibit explanation of any legitimate benefits the beneficiary might obtain as an enrollee of the Part D plan. (ii) Engage in any discriminatory activity such as, including targeted marketing to Medicare beneficiaries from higher income areas without making comparable efforts to enroll Medicare beneficiaries from lower income areas. (iii) Solicit Medicare beneficiaries door-to-door. (iv) Engage in activities that could mislead or confuse Medicare beneficiaries, or misrepresent the Part D sponsor or its Part D plan. The Part D organization may not claim that it is recommended or endorsed by CMS or Medicare or the Department of Health and Human Services or that CMS or Medicare or the Department of Health and Human Services recommends that the beneficiary enroll in the Part D plan. The Part D organization may explain that the organization is approved for participation in Medicare. (v) Use providers, provider groups, or pharmacies to distribute printed information comparing the benefits of different Part D plans unless providers, provider groups or pharmacies accept and display materials from all Part D plan sponsors. (vi) Accept Part D plan enrollment forms in provider offices, pharmacies or other places where health care is delivered. (vii) Employ Part D plan names that suggest that a plan is not available to all Medicare beneficiaries. (viii) Engage in any other marketing activity prohibited by CMS in its marketing guidance. (2) In its marketing, the Part D organization must— (i) Demonstrate to CMS's satisfaction that marketing resources are allocated to marketing to the disabled Medicare population as well as beneficiaries age 65 and over. (ii) Establish and maintain a system for confirming that enrolled beneficiaries have in fact enrolled in the PDP and understand the rules applicable under the plan.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart B—Eligibility and Enrollment.
§ 423.50 Approval of marketing materials and enrollment forms.
