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42 U.S.C. § 1320f–4Publication of maximum fair prices

submitted 91 years ago by Pub. L. 117-169 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 351 words · no verdicts yet

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The Secretary must publish each selected drug’s maximum fair price and an explanation of how the required negotiation factors were applied. The section also sets publication deadlines, CPI updates, renegotiated prices, and a 30-day rule for prices determined after the normal deadline.

(a) In general. For a selected drug and an initial price applicability year: (1) By November 30 of the year two years before that initial year, the Secretary must publish the maximum fair price negotiated under this part. (2) By March 1 of the year before that initial year, and subject to section 1320f–2(c), the Secretary must publish an explanation of that maximum fair price and how the factors in section 1320f–3(e) were applied to the drug. (b) Updates. (1) Maximum fair prices for later years. For each year after the first initial price applicability year, if an agreement under section 1320f–2 is in effect, the Secretary must publish the price by November 30 of the year two years before that later year. The price is: (A) unless subparagraph (B) applies, the previous year's published maximum fair price increased by the annual percentage increase in the consumer price index for all urban consumers, all items, United States city average, during the 12 months ending with the July immediately before that November 30; or (B) if the price was renegotiated, the renegotiated maximum fair price for the first year to which that renegotiated price applies. (2) Prices determined after the deadline. If a selected drug's maximum fair price for an initial year is determined after the publication date under this section, the Secretary must publish it no later than 30 days after the date on which it is determined.
the actual law source: uscode.house.gov ↗public domain
(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.

Source credit: (Aug. 14, 1935, ch. 531, title XI, § 1195, as added Pub. L. 117–169, title I, § 11001(a), Aug. 16, 2022, 136 Stat. 1849.)

history & why it existsrecord from the source credit
  • 1935Enacted · Pub. L. 117-169 · 136 Stat. 1849

A history note hasn’t been published yet. The record shows enactment by Pub. L. 117-169 on 1935-08-14.

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