Sec. 2123. Encouraging the development and use of new antimicrobial drugs
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Section 1886(d)(5) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5) ) is amended by adding at the end the following new subparagraph: Effective for discharges beginning on or after October 1, 2017, the Secretary shall, after notice and opportunity for public comment (in the publications required by subsection (e)(5) for a fiscal year or otherwise), provide for additional payment to be made under this subsection in accordance with the provisions of this subparagraph with respect to discharges by eligible hospitals that involve new antimicrobial drugs in the amount, subject to clause (vi), provided for under section 1847A.
Additional payments to be made under this subsection shall be with respect to discharges involving a new antimicrobial drug that occur during the four-fiscal-year period beginning on which an inpatient hospital code is issued with respect to the drug. For purposes of this subparagraph, the term new antimicrobial drug means a product that is approved for use, or a product for which an indication is first approved for use, by the Food and Drug Administration on or after December 1, 2014, and that the Food and Drug Administration determines— either— is intended to treat an infection caused by, or likely to be caused by, a qualifying pathogen (as defined under section 505E(f) of the Federal Food, Drug, and Cosmetic Act); or meets the definition of a qualified infectious disease product under section 505E(g) of the Federal Food, Drug, and Cosmetic Act; is intended to treat an infection for which there is an unmet medical need ; and is intended to treat an infection associated with high rates of mortality or significant patient morbidity, as determined in consultation with the infectious disease professional community.
For purposes of this subparagraph, the term eligible hospital means a hospital that participates in the National Healthcare Safety Network of the Centers for Disease Control and Prevention (or, to the extent a similar surveillance system reporting program that includes reporting about antimicrobial drugs is determined by the Secretary to be available to such hospitals, such similar surveillance system as the Secretary may specify). The Secretary may only revoke a determination of a product under this subparagraph as a new antimicrobial drug if the Secretary finds that the request for such determination contained an untrue statement of material fact.
Not later than October 1, 2017, the Secretary shall first publish in the Federal Register a list of the new antimicrobial drugs. Each fiscal year thereafter, the Secretary shall publish a list of the new antimicrobial drugs for such fiscal year as part of the annual rulemaking under this subsection. The total of the additional payments made under this subsection pursuant to this subparagraph for discharges in a fiscal year (as estimated by the Secretary as part of the rulemaking under this subsection for the fiscal year) may not exceed the applicable percentage (specified in subclause (II)) of the total program payments estimated to be made under this subsection for all discharges in such fiscal year (as calculated by the Secretary as part of the rulemaking under this subsection for the fiscal year).
For purposes of the preceding sentence, in the case that, with respect to a fiscal year, such additional payments are made only with respect to discharges during a portion of such fiscal year, the reference to all discharges in such fiscal year shall be considered a reference to all discharges during such portion of such fiscal year. For purposes of subclause (I), the term applicable percentage means, for fiscal year 2018 and each fiscal year thereafter, 0.06807 percent. If the Secretary estimates before the beginning of a fiscalyear that the amount of the additional payments under this subsection pursuant to this subparagraph for the fiscal year (or portion thereof) as determined under subclause
(I)will exceed the limit established under such subclause, the Secretary shall reduce pro rata the amount of each of the additional payments under this subsection pursuant to this subparagraph for such fiscal year (or portion thereof) in order to ensure that the aggregate additional payments under this subsection pursuant to this paragraph (as so estimated) do not exceed such limit. . Section 1886(d)(5)(K)(i) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5)(K)(i) ) is amended by inserting and with respect to which an additional payment is not made pursuant to subparagraph (M), after 2001, . Section 1927(b)(3)(A)(iii) of the Social Security Act ( 42 U.S.C. 1396r–8(b)(3)(A)(iii) ) is amended— in subclause (II), by inserting , or under section 1886(d) pursuant to paragraph (5)(M) of such section, after 1847A, ; and in the matter following subclause (III), by inserting or section 1886(d)(5)(M) after 1881(b)(13)(A)(ii) . The Comptroller General of the United States shall conduct a study to— identify and examine the barriers that prevent the development of new antimicrobial drugs, as defined in section 1886(d)(5)(M)(iii) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5)(M)(iii) ); and develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A). In conducting such study, the Comptroller General shall take into account the perspectives of the Director of the National Institutes of Health, the Commissioner of the Food and Drugs, and the Director of the Centers for Disease Control and Prevention. Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1).
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- 42 USC 1396r–8(b)(3)(A)(iii)
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Sec. 2123
Encouraging the development and use of new antimicrobial drugs
Cite42 USC 1396r–8(b)(3)(A)(iii)
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