US · guidance
CMS Pub. 100-18, ch. 12, § 20.3.1
Prior Review and Approval of Marketing Materials and Enrollment Forms
Direct Contract and “800 series” Plans
CMS has waived the prior review and approval requirements for marketing materials and
enrollment forms contained in 42 CFR 423.2262, 423.2264, 423.2266, and 423.2268 for all
EGWPs. These include all “800 series” plans as well as Direct Contract plans. This waiver
applies to all marketing materials, including the marketing materials requirements contained
in the Medicare Marketing Guidelines.
Note that as a result of this waiver, Direct Contract plans and PDP sponsors offering “800
series” EGWPs or employer-sponsored individual PDPs are not subject to the annual
restriction against communicating to Medicare eligible beneficiaries before October 1st.
Rather, CMS strongly encourages employer/union sponsors and entities offering these plans
to employers/unions to begin the communication process early with these beneficiaries and to
continue to communicate about their benefits as frequently as possible prior to their particular
annual open enrollment period (which may differ from Medicare’s annual coordinated
election period). More specifically, employers/unions and/or entities that offer employer-sponsored “800 series” or individual plans to employers/unions should be prepared to direct
beneficiaries to available resources and should explain their coverage and how it works with
Medicare.
Employer/Union Group Plan Sponsored Individual PDPs
Note that the waiver of prior review and approval requirements for marketing materials and
enrollment forms contained in 42 CFR 423.2262, 423.2264, 423.2266, and 423.2268 will also
apply to a PDP sponsor that elects to use the waiver outlined in section 20.3.2.1.1 below
which allows PDP sponsors to customize dissemination materials. More specifically, the
waiver will apply to those PDP sponsors that elect to customize dissemination materials for a
particular employer/union group health plan sponsor that offers coverage to its Part D
eligibles using an individual PDP (e.g., individual PDP paired with a non-Medicare
supplemental drug coverage designed to “wrap around” or enhance the individual PDP).
History
(Rev.6, Issued: 11-07-08, Effective/Implementation: 11-07-08)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
65e030a69f353194589d22c6299bdf951de25eb5d461c30df15361b1c73aa500
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