Sec. 102. Requiring consideration of average international market price under drug price negotiation program
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Section 1194(e) of the Social Security Act ( 42 U.S.C. 1320f–3(e) ) is amended by adding at the end the following new paragraph: The average price (which shall be the net average price, if practicable, and volume-weighted, if practicable) for a unit (as defined in subparagraph
(C)) of such drug for sales of such drug (calculated across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type), as computed (as of the date of publication of such drug as a selected drug under section 1192(a)) in all countries described in clause
(ii)of subparagraph
(B)that are applicable countries (as described in clause
(i)of such subparagraph) with respect to such drug. For purposes of subparagraph
(A), a country described in clause
(ii)is an applicable country described in this clause with respect to a drug if there is available an average price for any unit for the drug for sales of such drug in such country. For purposes of this paragraph, the following are countries described in this clause: Australia. Canada. France. Germany. Japan. The United Kingdom. For purposes of this paragraph, term unit means, with respect to a drug, the lowest identifiable quantity (such as a capsule or tablet, milligram of molecules, or grams) of the drug that is dispensed. . The amendment made by subsection
(a)shall apply with respect to negotiations under the Drug Price Negotiation Program under part E of title XI of the Social Security Act ( 42 U.S.C. 1320f et seq. ) for initial price applicability years beginning on or after January 1, 2028, and renegotiations under such program for years beginning on or after such date.
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- 42 USC 1320f–3(e)
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Sec. 102
Requiring consideration of average international market price under drug price negotiation program
Cite42 USC 1320f–3(e)
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