42 U.S.C. § 1320f-4

Current through P.L. 118-78 (published on www.congress.gov on 07/30/2024)

Section 1320f-4 - Publication of maximum fair prices

(a) In general

With respect to an initial price applicability year and a selected drug with respect to such year-

(1) not later than November 30 of the year that is 2 years prior to such initial price applicability year, the Secretary shall publish the maximum fair price for such drug negotiated with the manufacturer of such drug under this part; and

(2) not later than March 1 of the year prior to such initial price applicability year, the Secretary shall publish, subject to section 1320f-2(c) of this title, the explanation for the maximum fair price with respect to the factors as applied under section 1320f-3(e) of this title for such drug described in paragraph (1).

(b) Updates

(1) Subsequent year maximum fair prices

For a selected drug, for each year subsequent to the first initial price applicability year of the price applicability period with respect to such drug, with respect to which an agreement for such drug is in effect under section 1320f-2 of this title, not later than November 30 of the year that is 2 years prior to such subsequent year, the Secretary shall publish the maximum fair price applicable to such drug and year, which shall be-

(A) subject to subparagraph (B), the amount equal to the maximum fair price published for such drug for the previous year, increased by the annual percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with the July immediately preceding such November 30; or

(B) in the case the maximum fair price for such drug was renegotiated, for the first year for which such price as so renegotiated applies, such renegotiated maximum fair price.

(2) Prices negotiated after deadline

In the case of a selected drug with respect to an initial price applicability year for which the maximum fair price is determined under this part after the date of publication under this section, the Secretary shall publish such maximum fair price by not later than 30 days after the date such maximum price is so determined.

42 U.S.C. § 1320f-4

Aug. 14, 1935, ch. 531, title XI, §1195, as added Pub. L. 117-169, §11001, 136 Stat. 1849.

United States: The term "United States" means (but only for purposes of subparagraphs (A) and (B) of this paragraph) the fifty States and the District of Columbia.
Secretary: the term "Secretary" means-(A) the Secretary of Education for purposes of subtitle A (other than section 3201),(B) the Secretary of Agriculture for purposes of the amendments made by section 3201, and(C) the Secretary of Health and Human Services for purposes of subtitle B,
drug: the term "drug" means-(A) a beverage containing alcohol,(B) a controlled substance, or(C) a controlled substance analogue,