US · guidance
CMS Pub. 100-18, ch. 6, § 20.4
Application of General Exclusion Provisions
In accordance with section 1860D-2(e)(3) of the Act, a Part D sponsor may exclude from
qualified prescription drug coverage any Part D drug:
• For which payment would not be made if items and services are not reasonable and
necessary for the diagnosis or treatment of illness or injury or to improve the functioning
of a malformed body member (except for Part D vaccines); or
• Which is not prescribed in accordance with the Part D plan.
Such exclusions are coverage determinations or redeterminations pursuant to chapter 18 of this
manual, and are subject to appeal.
Unlike other Part D drugs that may be excluded when not reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the functioning of a malformed body
member, Part D vaccines may only be excluded when their administration is not reasonable and
necessary for the prevention of illness.
History
(Rev. 18, Issued: 01-15-16, Effective: 01-15-16; Implementation: 01-15-16)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
b9f485d3c460dc0fd42dc10039349961fec7f46be3349b90cded22bc08669b6a
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