renegotiation-eligible drug

Defined in 1 dictionary — U.S. Code

United States Code

42 U.S.C. § 1320f-3 — in this section (2 versions over time)

In this section, the term “renegotiation-eligible drug” means a selected drug that is any of the following:

(A) A selected drug for which a new indication is added to the drug.

(B) A selected drug that—

(i) is not an extended-monopoly or a long-monopoly drug; and

(ii) for which there is a change in status to that of an extended-monopoly drug.

(C) A selected drug that—

(i) is not a long-monopoly drug; and

(ii) for which there is a change in status to that of a long-monopoly drug.

(D) A selected drug for which the Secretary determines there has been a material change of any of the factors described in paragraph (1) or (2) of subsection (e).