{"identifier":"/us/usc/t42/s1320f","title":42,"num":"\u00a7\u202f1320f.","heading":"Establishment of program","text":"\u00a7\u202f1320f.\nEstablishment of program\n(a)\nIn general\nThe Secretary shall establish a Drug Price Negotiation Program (in this part referred to as the \u201cprogram\u201d). Under the program, with respect to each price applicability period, the Secretary shall\u2014\n(1) publish a list of selected drugs in accordance with\nsection 1320f\u20131 of this title\n(2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with\nsection 1320f\u20132 of this title\n(3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with\nsection 1320f\u20133 of this title\n1\n1 So in original. Probably should be followed by \u201cand\u201d.\n(4) carry out the publication and administrative duties and compliance monitoring in accordance with sections 1320f\u20134 and 1320f\u20135 of this title.\n(b)\nDefinitions relating to timing\nFor purposes of this part:\n(1)\nInitial price applicability year\nThe term \u201cinitial price applicability year\u201d means a year (beginning with 2026).\n(2)\nPrice applicability period\nThe term \u201cprice applicability period\u201d means, with respect to a qualifying single source drug, the period beginning with the first initial price applicability year with respect to which such drug is a selected drug and ending with the last year during which the drug is a selected drug.\n(3)\nSelected drug publication date\nThe term \u201cselected drug publication date\u201d means, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year.\n(4)\nNegotiation period\nThe term \u201cnegotiation period\u201d means, with respect to an initial price applicability year with respect to a selected drug, the period\u2014\n(A) beginning on the sooner of\u2014\n(i) the date on which the manufacturer of the drug and the Secretary enter into an agreement under\nsection 1320f\u20132 of this title\n(ii) February 28 following the selected drug publication date with respect to such selected drug; and\n(B) ending on November 1 of the year that begins 2 years prior to the initial price applicability year.\n(c)\nOther definitions\nFor purposes of this part:\n(1)\nManufacturer\nThe term \u201cmanufacturer\u201d has the meaning given that term in\nsection 1395w\u20133a(c)(6)(A) of this title\n(2)\nMaximum fair price eligible individual\nThe term \u201cmaximum fair price eligible individual\u201d means, with respect to a selected drug\u2014\n(A) in the case such drug is dispensed to the individual at a pharmacy, by a mail order service, or by another dispenser, an individual who is enrolled in a prescription drug plan under part D of subchapter XVIII or an MA\u2013PD plan under part C of such subchapter if coverage is provided under such plan for such selected drug; and\n(B) in the case such drug is furnished or administered to the individual by a hospital, physician, or other provider of services or supplier, an individual who is enrolled under part B of subchapter XVIII, including an individual who is enrolled in an MA plan under part C of such subchapter, if payment may be made under part B for such selected drug.\n(3)\nMaximum fair price\nThe term \u201cmaximum fair price\u201d means, with respect to a year during a price applicability period and with respect to a selected drug (as defined in\nsection 1320f\u20131(c) of this title\nsection 1320f\u20133 of this title\nsection 1320f\u20134(b) of this title\n(4)\nReference product\nThe term \u201creference product\u201d has the meaning given such term in\nsection 262(i) of this title\n(5)\nTotal expenditures\nThe term \u201ctotal expenditures\u201d includes, in the case of expenditures with respect to part D of subchapter XVIII, the total gross covered prescription drug costs (as defined in\nsection 1395w\u2013115(b)(3) of this title\n(6)\nUnit\nThe term \u201cunit\u201d means, with respect to a drug or biological product, the lowest identifiable amount (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological product that is dispensed or furnished.\n(d)\nTiming for initial price applicability year 2026\nNotwithstanding the provisions of this part, in the case of initial price applicability year 2026, the following rules shall apply for purposes of implementing the program:\n(1) Subsection (b)(3) shall be applied by substituting \u201c\nSeptember 1, 2023\n(2) Subsection (b)(4) shall be applied\u2014\n(A) in subparagraph (A)(ii), by substituting \u201c\nOctober 1, 2023\n(B) in subparagraph (B), by substituting \u201c\nAugust 1, 2024\n(3)\n(A) in subsection (b)(1)(A), by substituting \u201cduring the period beginning on\nJune 1, 2022\nMay 31, 2023\n(B) in subsection (d)(1)(A), by substituting \u201cduring the period beginning on\nJune 1, 2022\nMay 31, 2023\n2\n2 So in original. Probably should read as follows: \u201cduring the most recent 12-month period for which data are available prior to such selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date)\u201d.\n(4) Section 1320f\u20132(a) of this title\nOctober 1, 2023\n(5)\n(A) in subparagraph (A), by substituting \u201c\nOctober 2, 2023\n(B) in subparagraph (B), by substituting \u201c\nFebruary 1, 2024\n(C) in subparagraph (E), by substituting \u201c\nAugust 1, 2024\n(6) Section 1320f\u20134(a)(1) of this title\nSeptember 1, 2024","url":"https://projectusc.org/usc/t42/s1320f.html","content":[{"t":"sec","id":"/us/usc/t42/s1320f","children":[{"t":"num","text":"\u00a7\u202f1320f."},{"t":"heading","text":"Establishment of program"},{"t":"subsec","id":"/us/usc/t42/s1320f/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"chapeau","text":"The Secretary shall establish a Drug Price Negotiation Program (in this part referred to as the \u201cprogram\u201d). Under the program, with respect to each price applicability period, the Secretary shall\u2014"},{"t":"para","id":"/us/usc/t42/s1320f/a/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" publish a list of selected drugs in accordance with ","children":[{"t":"ref","text":"section 1320f\u20131 of this title","href":"/us/usc/t42/s1320f\u20131","tail":";"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/a/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with ","children":[{"t":"ref","text":"section 1320f\u20132 of this title","href":"/us/usc/t42/s1320f\u20132","tail":";"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/a/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with ","children":[{"t":"ref","text":"section 1320f\u20133 of this title","href":"/us/usc/t42/s1320f\u20133","tail":";\u202f"},{"t":"ref","text":"1"},{"t":"num","text":"1","tail":"\u202fSo in original. Probably should be followed by \u201cand\u201d."},{"t":"text","text":"\u202fSo in original. Probably should be followed by \u201cand\u201d."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/a/4","children":[{"t":"num","text":"(4)"},{"t":"content","text":" carry out the publication and administrative duties and compliance monitoring in accordance with sections 1320f\u20134 and 1320f\u20135 of this title.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320f/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Definitions relating to timing"},{"t":"chapeau","text":"For purposes of this part:"},{"t":"para","id":"/us/usc/t42/s1320f/b/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"Initial price applicability year"},{"t":"content","children":[{"t":"p","text":"The term \u201cinitial price applicability year\u201d means a year (beginning with 2026).","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/b/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Price applicability period"},{"t":"content","children":[{"t":"p","text":"The term \u201cprice applicability period\u201d means, with respect to a qualifying single source drug, the period beginning with the first initial price applicability year with respect to which such drug is a selected drug and ending with the last year during which the drug is a selected drug.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/b/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Selected drug publication date"},{"t":"content","children":[{"t":"p","text":"The term \u201cselected drug publication date\u201d means, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/b/4","children":[{"t":"num","text":"(4)"},{"t":"heading","text":"Negotiation period"},{"t":"chapeau","text":"The term \u201cnegotiation period\u201d means, with respect to an initial price applicability year with respect to a selected drug, the period\u2014"},{"t":"subpara","id":"/us/usc/t42/s1320f/b/4/A","children":[{"t":"num","text":"(A)"},{"t":"chapeau","text":" beginning on the sooner of\u2014"},{"t":"clause","id":"/us/usc/t42/s1320f/b/4/A/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" the date on which the manufacturer of the drug and the Secretary enter into an agreement under ","children":[{"t":"ref","text":"section 1320f\u20132 of this title","href":"/us/usc/t42/s1320f\u20132","tail":" with respect to such drug; or"}],"tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t42/s1320f/b/4/A/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" February 28 following the selected drug publication date with respect to such selected drug; and","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t42/s1320f/b/4/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" ending on November 1 of the year that begins 2 years prior to the initial price applicability year.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320f/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Other definitions"},{"t":"chapeau","text":"For purposes of this part:"},{"t":"para","id":"/us/usc/t42/s1320f/c/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"Manufacturer"},{"t":"content","children":[{"t":"p","text":"The term \u201cmanufacturer\u201d has the meaning given that term in ","children":[{"t":"ref","text":"section 1395w\u20133a(c)(6)(A) of this title","href":"/us/usc/t42/s1395w\u20133a/c/6/A","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/c/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Maximum fair price eligible individual"},{"t":"chapeau","text":"The term \u201cmaximum fair price eligible individual\u201d means, with respect to a selected drug\u2014"},{"t":"subpara","id":"/us/usc/t42/s1320f/c/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" in the case such drug is dispensed to the individual at a pharmacy, by a mail order service, or by another dispenser, an individual who is enrolled in a prescription drug plan under part D of subchapter XVIII or an MA\u2013PD plan under part C of such subchapter if coverage is provided under such plan for such selected drug; and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t42/s1320f/c/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" in the case such drug is furnished or administered to the individual by a hospital, physician, or other provider of services or supplier, an individual who is enrolled under part B of subchapter XVIII, including an individual who is enrolled in an MA plan under part C of such subchapter, if payment may be made under part B for such selected drug.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/c/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Maximum fair price"},{"t":"content","children":[{"t":"p","text":"The term \u201cmaximum fair price\u201d means, with respect to a year during a price applicability period and with respect to a selected drug (as defined in ","children":[{"t":"ref","text":"section 1320f\u20131(c) of this title","href":"/us/usc/t42/s1320f\u20131/c","tail":") with respect to such period, the price negotiated pursuant to "},{"t":"ref","text":"section 1320f\u20133 of this title","href":"/us/usc/t42/s1320f\u20133","tail":", and updated pursuant to "},{"t":"ref","text":"section 1320f\u20134(b) of this title","href":"/us/usc/t42/s1320f\u20134/b","tail":", as applicable, for such drug and year."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/c/4","children":[{"t":"num","text":"(4)"},{"t":"heading","text":"Reference product"},{"t":"content","children":[{"t":"p","text":"The term \u201creference product\u201d has the meaning given such term in ","children":[{"t":"ref","text":"section 262(i) of this title","href":"/us/usc/t42/s262/i","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/c/5","children":[{"t":"num","text":"(5)"},{"t":"heading","text":"Total expenditures"},{"t":"content","children":[{"t":"p","text":"The term \u201ctotal expenditures\u201d includes, in the case of expenditures with respect to part D of subchapter XVIII, the total gross covered prescription drug costs (as defined in ","children":[{"t":"ref","text":"section 1395w\u2013115(b)(3) of this title","href":"/us/usc/t42/s1395w\u2013115/b/3","tail":"). The term \u201ctotal expenditures\u201d excludes, in the case of expenditures with respect to part B of such subchapter, expenditures for a drug or biological product that are bundled or packaged into the payment for another service."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/c/6","children":[{"t":"num","text":"(6)"},{"t":"heading","text":"Unit"},{"t":"content","children":[{"t":"p","text":"The term \u201cunit\u201d means, with respect to a drug or biological product, the lowest identifiable amount (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological product that is dispensed or furnished.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320f/d","children":[{"t":"num","text":"(d)"},{"t":"heading","text":"Timing for initial price applicability year 2026"},{"t":"chapeau","text":"Notwithstanding the provisions of this part, in the case of initial price applicability year 2026, the following rules shall apply for purposes of implementing the program:"},{"t":"para","id":"/us/usc/t42/s1320f/d/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" Subsection (b)(3) shall be applied by substituting \u201c","children":[{"t":"text","text":"September 1, 2023","tail":"\u201d for \u201c,\u2000with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year\u201d."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/d/2","children":[{"t":"num","text":"(2)"},{"t":"chapeau","text":" Subsection (b)(4) shall be applied\u2014"},{"t":"subpara","id":"/us/usc/t42/s1320f/d/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" in subparagraph (A)(ii), by substituting \u201c","children":[{"t":"text","text":"October 1, 2023","tail":"\u201d for \u201cFebruary 28 following the selected drug publication date with respect to such selected drug\u201d; and"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t42/s1320f/d/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" in subparagraph (B), by substituting \u201c","children":[{"t":"text","text":"August 1, 2024","tail":"\u201d for \u201cNovember 1 of the year that begins 2 years prior to the initial price applicability year\u201d."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/d/3","children":[{"t":"num","text":"(3)"},{"t":"chapeau","text":" ","children":[{"t":"ref","text":"Section 1320f\u20131 of this title","href":"/us/usc/t42/s1320f\u20131","tail":" shall be applied\u2014"}]},{"t":"subpara","id":"/us/usc/t42/s1320f/d/3/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" in subsection (b)(1)(A), by substituting \u201cduring the period beginning on ","children":[{"t":"text","text":"June 1, 2022","tail":", and ending on "},{"t":"text","text":"May 31, 2023","tail":"\u201d for \u201cduring the most recent period of 12 months prior to the selected drug publication date (but ending not later than October 31 of the year prior to the year of such drug publication date), with respect to such year, for which data are available\u201d; and"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t42/s1320f/d/3/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" in subsection (d)(1)(A), by substituting \u201cduring the period beginning on ","children":[{"t":"text","text":"June 1, 2022","tail":", and ending on "},{"t":"text","text":"May 31, 2023","tail":"\u201d for \u201cduring the most recent period for which data are available of at least 12 months prior to the selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date), with respect to such year\u201d."},{"t":"ref","text":"2"},{"t":"num","text":"2","tail":"\u202fSo in original. Probably should read as follows: \u201cduring the most recent 12-month period for which data are available prior to such selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date)\u201d."},{"t":"text","text":"\u202fSo in original. Probably should read as follows: \u201cduring the most recent 12-month period for which data are available prior to such selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date)\u201d."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/d/4","children":[{"t":"num","text":"(4)"},{"t":"content","text":" ","children":[{"t":"ref","text":"Section 1320f\u20132(a) of this title","href":"/us/usc/t42/s1320f\u20132/a","tail":" shall be applied by substituting \u201c"},{"t":"text","text":"October 1, 2023","tail":"\u201d for \u201cFebruary 28 following the selected drug publication date with respect to such selected drug\u201d."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/d/5","children":[{"t":"num","text":"(5)"},{"t":"chapeau","text":" ","children":[{"t":"ref","text":"Section 1320f\u20133(b)(2) of this title","href":"/us/usc/t42/s1320f\u20133/b/2","tail":" shall be applied\u2014"}]},{"t":"subpara","id":"/us/usc/t42/s1320f/d/5/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" in subparagraph (A), by substituting \u201c","children":[{"t":"text","text":"October 2, 2023","tail":"\u201d for \u201cMarch 1 of the year of the selected drug publication date, with respect to the selected drug\u201d;"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t42/s1320f/d/5/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" in subparagraph (B), by substituting \u201c","children":[{"t":"text","text":"February 1, 2024","tail":"\u201d for \u201cthe June 1 following the selected drug publication date\u201d; and"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t42/s1320f/d/5/C","children":[{"t":"num","text":"(C)"},{"t":"content","text":" in subparagraph (E), by substituting \u201c","children":[{"t":"text","text":"August 1, 2024","tail":"\u201d for \u201cthe first day of November following the selected drug publication date, with respect to the initial price applicability year\u201d."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320f/d/6","children":[{"t":"num","text":"(6)"},{"t":"content","text":" ","children":[{"t":"ref","text":"Section 1320f\u20134(a)(1) of this title","href":"/us/usc/t42/s1320f\u20134/a/1","tail":" shall be applied by substituting \u201c"},{"t":"text","text":"September 1, 2024","tail":"\u201d for \u201cNovember 30 of the year that is 2 years prior to such initial price applicability year\u201d."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}