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CMS Pub. 100-18, ch. 12, § 20.3.1

Prior Review and Approval of Marketing Materials and Enrollment Forms

activein force · 2026-09-17 – presentas-observed

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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CMS Pub. 100-18, ch. 12, § 20.3.1 — Prior Review and… · binding.law