42 C.F.R. § 422.80 Approval of marketing materials and election forms.
Title 42 - Public Health
(a) CMS review of marketing materials. (1) Except as provided in paragraph (a)(2) of this section, an MA organization may not distribute any marketing materials (as defined in paragraph (b) of this section ), or election forms, or make such materials or forms available to individuals eligible to elect an MA organization unless— (i) At least 45 days (or 10 days if using marketing materials that use, without modification, proposed model language as specified by CMS) before the date of distribution the MA organization has submitted the material or form to CMS for review under the guidelines in paragraph (c); and (ii) CMS does not disapprove the distribution of new material or form. (2) The MA organization may distribute the marketing materials 5 days following their submission to CMS if— (i) The MA organization is deemed by CMS to meet certain performance requirements established by CMS; or (ii) The MA organization certifies that in the case of certain marketing materials designated by CMS, it followed all applicable marketing guidelines or used model language specified by CMS without modification. (b) Definition of marketing materials. Marketing materials include any informational materials targeted to Medicare beneficiaries which: (1) Promote the MA organization, or any MA plan offered by the MA organization; (2) Inform Medicare beneficiaries that they may enroll, or remain enrolled in, an MA plan offered by the MA organization; (3) Explain the benefits of enrollment in an MA plan, or rules that apply to enrollees; (4) Explain how Medicare services are covered under an MA plan, including conditions that apply to such coverage; (5) Examples of marketing materials include, but are not limited to: (i) General audience materials such as general circulation brochures, newspapers, magazines, television, radio, billboards, yellow pages, or the internet. (ii) Marketing representative materials such as scripts or outlines for telemarketing or other presentations. (iii) Presentation materials such as slides and charts. (iv) Promotional materials such as brochures or leaflets, including materials for circulation by third parties (e.g., physicians or other providers). (v) Membership communication materials such as membership rules, subscriber agreements (evidence of coverage), member handbooks and wallet card instructions to enrollees. (vi) Letters to members about contractual changes; changes in providers, premiums, benefits, plan procedures etc. (vii) Membership or claims processing activities (e.g., materials on rules involving non-payment of premiums, confirmation of enrollment or disenrollment, or annual notification information). (c) Guidelines for CMS review. In reviewing marketing material or election forms under paragraph (a) of this section, CMS determines 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 description of any supplemental benefits and services. (iii) Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each. (iv) Any other information necessary to enable beneficiaries to make an informed decision about enrollment. (2) Notify the general public of its enrollment period (whether time-limited or continuous) in an appropriate manner, through appropriate media, throughout its service and continuation area. (3) Include in the written materials notice that the MA organization 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 plan. (4) Are not materially inaccurate or misleading or otherwise make material misreprepresentations. (5) For markets with a significant non-English speaking population, provide materials in the language of these individuals. (d) Deemed approval (one-stop shopping). If CMS has not disapproved the distribution of marketing materials or forms submitted by an MA organization with respect to an MA plan in an area, CMS is deemed not to have disapproved the distribution in all other areas covered by the MA plan and organization except with regard to any portion of the material or form that is specific to the particular area. (e) Standards for MA organization marketing. (1) In conducting marketing activities, MA organizations may not: (i) Provide for cash or other monetary rebates 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 MA plan, such as eligibility to enroll in a supplemental benefit plan that covers deductibles and coinsurance, or preventive services. (ii) Engage in any discriminatory activity, 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 MA organization. The MA organization may not claim 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 MA plan. It may, however, explain that the organization is approved for participation in Medicare. (v) Distribute marketing materials for which, before expiration of the 45-day period (or 10 days as provided in paragraph (a)(1) of this section), the MA organization receives from CMS written notice of disapproval because it is inaccurate or misleading, or misrepresents the MA organization, its marketing representatives, or CMS. (vi) Use providers or provider groups to distribute printed information comparing the benefits of different health plans unless the materials have the concurrence of all MA organizations involved and have received prior approval by CMS. Physicians or providers may distribute health plan brochures (exclusive of application forms) at a health fair or in their offices. Physicians may discuss, in response to an individual patient's inquiry, the various benefits in different health plans. (vii) Accept plan applications in provider offices or other places where health care is delivered. (viii) Employ MA plan names that suggest that a plan is not available to all Medicare beneficiaries. This prohibition shall not apply to MA plan names in effect on July 31, 2000. (ix) Engage in any other marketing activity prohibited by CMS in its marketing guidance. (2) In its marketing, the MA 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 MA plan, and understand the rules applicable under the plan. (f) Employer group retiree marketing. MA organizations may develop marketing materials designed for members of an employer group who are eligible for employer-sponsored benefits through the MA organization, and furnish these materials only to the group members. While the materials must be submitted for approval under paragraph (a) of this section, CMS will not review portions of these materials that relate to employer group benefits. [63 FR 35071, June 26, 1998; 63 FR 52612, Oct. 1, 1998, as amended at 65 FR 40318, June 29, 2000; 67 FR 13288, Mar. 22, 2002; 70 FR 4719, Jan. 28, 2005]
Title 42: Public Health
PART 422—MEDICARE ADVANTAGE PROGRAM
Subpart B—Eligibility, Election, and Enrollment
§ 422.80 Approval of marketing materials and election forms.
