All generics covered on your Medicare Part D plan's Formulary will receive the Donut discount. The discount on generic drugs purchased in the Coverage Gap applies to all generics covered as formulary drugs, regardless of their tier placement. The same is true for all formulary brand-name drugs. (See
chart of both generic and brand-name discounts in the donut hole.)
So if your generic drug was covered by your Medicare Part D plan, as a normal formulary drug before you reached the Donut Hole, you will receive the discount in the Donut Hole.
If you have been granted a
formulary exception for the coverage of a drug – then this drug would also receive the discount in the Donut Hole.
Even if your generic medication is in a brand-name or specialty tier but it is registered with the FDA as a generic (it has an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act), the drug is considered a generic drug and receives the generic drug discount when you are in the Coverage Gap.
In short, the type of application on file with the Food and Drug Administration determines whether or not the drug is considered to be a generic or brand-name drug. Therefore, a drug is considered a generic drug if its approval is based upon an abbreviated new drug application (ANDA).
As noted, this generic definition applies to the Coverage Gap regardless of whether the plan’s formulary includes the same drug on its generic cost-sharing tier or on a higher tier (such as the specialty tier), or how a particular drug is identified by the major drug listing services (the generic drug discount does NOT apply to multi-source brands that are often grouped with generics).
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