5. When referring to the statement about Part D plans offering access to “all or substantially all” drugs in the six defined classes – who defines “substantially”?
CMS released Clarification to the Formulary Guidance which established a definition for the expression, “all or substantially all” means that all drugs in these categories are expected to be included in plan formularies. There are a few specific exceptions:
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Part D plans are not required to cover the cancer drug, Iressa, or the anti-convulsant, Fosphenytoin.
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Part D plan formularies can exclude one of the two antidepressants, Escitalopram (brand name, Lexapro) or Citalopram (brand name, Celexa), but not both.
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The only HIV/AIDS drug subject to utilization management is Fuzeon (brand name, Enfurvitide, a drug used to control HIV; may also be called T-20 or Pentafuside). Fuzeon must be on all formularies but plans may require prior authorization for first-time users.
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Part D plan formularies need not include multi-source brands of identical molecular structure, extended-release products, or all dosages.
Reference Information
(Back to Questions about Plan Formularies)
