[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR422.80]

[Page 845-846]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 422--MEDICARE+CHOICE PROGRAM--Table of Contents
 
            Subpart B--Eligibility, Election, and Enrollment
 
Sec. 422.80  Approval of marketing materials and election forms.

    (a) CMS review of marketing materials. An M+C organization may not 
distribute any marketing materials (as defined in paragraph (b)), or 
election forms, or make such materials or forms available to individuals 
eligible to elect an M+C plan, unless--
    (1) 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 M+C organization has submitted the 
material or form to CMS for review under the guidelines in paragraph 
(c); and
    (2) CMS has not disapproved the distribution of the material or 
form.
    (b) Definition of marketing materials. Marketing materials include 
any informational materials targeted to Medicare beneficiaries which:
    (1) Promote the M+C organization, or any M+C plan offered by the M+C 
organization;
    (2) Inform Medicare beneficiaries that they may enroll, or remain 
enrolled in, an M+C plan offered by the M+C organization;
    (3) Explain the benefits of enrollment in an M+C plan, or rules that 
apply to enrollees;
    (4) Explain how Medicare services are covered under an M+C 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 M+C 
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.

[[Page 846]]

    (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 M+C 
organization with respect to an M+C plan in an area, CMS is deemed not 
to have disapproved the distribution in all other areas covered by the 
M+C plan and organization except with regard to any portion of the 
material or form that is specific to the particular area.
    (e) Standards for M+C organization marketing. (1) In conducting 
marketing activities, M+C 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 
M+C 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 such as, for example, 
attempts to recruit Medicare beneficiaries from higher income areas 
without making comparable efforts to enroll Medicare beneficiaries from 
lower income areas.
    (iii) Solicit door-to-door for Medicare beneficiaries.
    (iv) Engage in activities that could mislead or confuse Medicare 
beneficiaries, or misrepresent the M+C organization. The M+C 
organization may not claim that it is recommended or endorsed by CMS or 
Medicare or that CMS or Medicare recommends that the beneficiary enroll 
in the M+C 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, the M+C organization receives from CMS written notice 
of disapproval because it is inaccurate or misleading, or misrepresents 
the M+C 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 M+C 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 M+C plan names that suggest that a plan is not 
available to all Medicare beneficiaries. This prohibition shall not 
apply to M+C plan names in effect on July 31, 2000.
    (2) In its marketing, the M+C 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 M+C plan, and understand the 
rules applicable under the plan.
    (f) Employer group retiree marketing. M+C organizations may develop 
marketing materials designed for members of an employer group who are 
eligible for employer-sponsored benefits through the M+C 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]