Title 42, The Public Health and WelfareRelease 119-73not60

§1320f–4 Publication of Maximum Fair Prices

Title 42 › Chapter 7— SOCIAL SECURITY › Subchapter XI— GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION › Part E— Price Negotiation Program To Lower Prices for Certain High-Priced Single Source Drugs › § 1320f–4

Last updated Apr 5, 2026|Official source

Summary

Require the Secretary to publish the maximum fair price for a selected drug well before it takes effect. For the first year a price applies, the Secretary must publish that maximum fair price by November 30 of the year that is two years before the price year. The Secretary must also publish, by March 1 of the year before the price year, an explanation of how the price was set, subject to section 1320f–2(c). For later years while an agreement is in effect, the Secretary must publish the next year’s maximum fair price by November 30 two years before that year. That price is usually last year’s price increased by the annual percent change 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. If the price was renegotiated, the new renegotiated price applies for its first year. If a price is determined after its normal publication date, the Secretary must publish it within 30 days.

Full Legal Text

Title 42, §1320f–4

The Public Health and Welfare, Source: USLM XML via OLRC

(a)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)(1)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)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.

Reference

Citations & Metadata

Citation

42 U.S.C. § 1320f–4

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60