[Title 42 CFR 422.80]
[Code of Federal Regulations (annual edition) - October 1, 2007 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter IV - CENTERS FOR MEDICARE]
[Subchapter A - GENERAL PROVISIONS]
[Part 422 - MEDICARE ADVANTAGE PROGRAM]
[Subpart B - Eligibility, Election, and Enrollment]
[Sec. 422.80 - Approval of marketing materials and election forms.]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH32007-10-012007-10-01falseApproval of marketing materials and election forms.422.80Sec. 422.80PUBLIC HEALTHCENTERS FOR MEDICAREGENERAL PROVISIONSMEDICARE ADVANTAGE PROGRAMEligibility, Election, and Enrollment
Sec. 422.80  Approval of marketing materials and election forms.

    (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.

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    (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

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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]