Title 42 — The Public Health and WelfareRelease 119-73

§1320f–4 Publication of maximum fair prices

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

Last updated Apr 6, 2026|Official source

Summary

The Secretary must publish the maximum fair price for each selected drug. For the first year the price will apply, that price must be posted by November 30 two years before the year it starts. An explanation of how that price was set must be posted by March 1 of the year before the price starts, following any rules that limit what can be shown. For each later year that a pricing agreement is in effect, the Secretary must post the next year’s maximum fair price by November 30 two years before that year. Normally that price equals the previous year’s price increased by the annual percent change in the Consumer Price Index for All Urban Consumers (all items; U.S. city average) measured over the 12 months ending in July just before that November 30. If the price was renegotiated, the new renegotiated price is used for the first year it applies. If a maximum fair price is set after the usual posting date, it must be published within 30 days of that determination.

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 6, 2026

Release point: 119-73