The formulary, tiering and step-therapy exception
Every Medicare Part D plan, and marketplace plans under the essential-health-benefit rule, must grant an exception to cover a non-formulary drug, charge a lower tier or waive step therapy when the prescriber states that the covered alternatives would be less effective or harmful for you. The prescriber's statement is the whole case; the appeal is the request done properly.
When it applies
- Part D coverage determinations: non-formulary, tiering, step therapy, quantity limits
- Marketplace and individual plans (45 CFR 156.122(c)): 72-hour standard and 24-hour expedited decisions
- Medicare Advantage step therapy for Part B drugs (42 CFR 422.136)
Where it does not
- Drugs excluded from Part D by statute
- A plan-design exclusion of a whole category, which needs a different argument
The sentence to put in the appeal
“I request a [formulary / tiering / step-therapy] exception under [42 CFR 423.578 / 45 CFR 156.122(c)]. The prescriber's attached statement establishes that [the formulary alternatives have been tried and failed / are contraindicated / would be less effective or cause adverse effects for me]. Please decide within the applicable timeframe [72 hours; 24 hours expedited] and, if denied, treat this as a request for redetermination.”
Replace the bracketed parts with your facts. Cite the regulation exactly as written; quote the plan’s own wording next to it.
How to use it
- Step 1
Get the statement, not a note
Which alternatives, what happened, why the requested drug; dates and records.
- Step 2
Ask for expedited handling when waiting hurts
The 24-hour clock applies when the standard timeframe could seriously jeopardise health or the ability to regain function.
- Step 3
Calendar the renewal
Part D approvals generally run through the plan year; commercial plans set their own term.
Worked example
A migraine drug was denied as non-formulary. The neurologist's statement listed three failed preventives with dates; the exception was approved in two days under the 72-hour rule.
Illustrative composite; details vary by plan and record. Outcomes are not guaranteed.
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Sources
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