37
• Utilization Management (UM): Part D Sponsors must indicate any
applicable UM tools (e.g., prior authorization, step therapy, and quantity
limit restrictions) for the drug. A description of the indicator used to
describe the UM tools must be provided somewhere within the document
(e.g., in footnotes). For example, a Part D Sponsor may choose to
designate a prior authorization on a drug by placing an asterisk next to
the name of the drug.
Note: Every enrollee must be able to tell by examining the complete
formulary whether a specific drug is covered—including those drugs
that have varying dosage forms or strengths at different formulary
statuses, tier placements, and/or utilization management
procedures (e.g., prior authorization, step therapy, quantity limit,
or other restrictions). If there are differences in formulary status,
tier placement, quantity limit, prior authorization, step therapy, or
other restrictions for a drug based on its differing dosage forms or
strengths, the formulary must clearly identify how it will treat the
different formulations of that same drug.
- An index listing drugs in alphabetical order that directs the
reader to the page containing complete information for that
drug, (e.g., name, tier placement, and utilization
management strategy)
- A symbol or abbreviation, as well as an explanation, to
identify any utilization management restrictions, drugs that
are available via mail-order, excluded drugs, free first fill
drugs, limited access drugs, drugs covered in the coverage
gap, and drugs covered under the medical benefit (for home
infusion drugs only)
- Part D Sponsors may not include OTC drugs in the formulary
table, but are expected to provide a separate list or table
60.4.2 – Comprehensive Formulary
42 CFR 423.4, 423.120, 423.128(c)(1)(v)
The comprehensive formulary must include the same information provided
within the abridged formulary document, except that the comprehensive
formulary must include the entire list of drugs covered by the Part D
Sponsor (for instance, drugs covered as an enhancement) and would not
inform beneficiaries that they can obtain a comprehensive formulary by
contacting the Part D Sponsor. Drugs adjudicated at the point of sale as
formulary drugs that are not found on the CMS approved HPMS formulary
must be included in the comprehensive formulary. This may include drugs