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: As part of the annual rulemaking under this subsection for payment for subsection
(d)hospitals for each fiscal year beginning with fiscal year 2018, the Secretary shall— include publication of a list of the new antimicrobial drugs for such fiscal year; and with respect to discharges by eligible hospitals that involve a drug so published, provide for an additional payment to be made under this subsection in accordance with the provisions of this subparagraph. Additional payments may not be made for a drug under this subparagraph— other than during the 5-fiscal-year period beginning with the fiscal year for which the drug is first included in the publication described in clause (i)(I); and with respect to which payment has ever been made pursuant to subparagraph (K). 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; and is intended to treat an infection— for which there is an unmet medical need; and which is associated with high rates of mortality or significant patient morbidity, as determined in consultation with the Director of the Centers for Disease Control and Prevention and the infectious disease professional community. Such determination may be revoked only upon a finding that the request for such determination contained an untrue statement of material fact. For purposes of this subparagraph, the term eligible hospital means a subsection
(d)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). Subject to the succeeding provisions of this clause, the additional payment under this subparagraph, with respect to a drug, shall be in the amount provided for such drug under section 1847A. The Secretary shall, as part of the rulemaking referred to in clause
(i)for each fiscal year, estimate— the total amount of the additional payments that will be made under this subsection pursuant to this subparagraph for discharges in such fiscal year without regard to the application of subclause (III); and the total program payments to be made under this subsection for all discharges in such fiscal year. If the estimated total amount described in subclause (II)(aa) for a fiscal year exceeds the applicable percentage of the estimated total program payments described in subclause (II)(bb) for such fiscal year, the Secretary shall reduce in a pro rata manner the amount of each additional payment under this subsection pursuant to this subparagraph for such fiscal year in order to ensure that the total amount of the additional payments under this subsection pursuant to this subparagraph for such fiscal year do not exceed the applicable percentage of the estimated total program payments described in subclause (II)(bb) for such fiscal year. For purposes of subclause (III), the term applicable percentage means 0.03 percent. . Section 1886(d)(5)(K)(vi) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5)(K)(vi) ) is amended by inserting if additional payment has never been made under this subsection pursuant to subparagraph
(M)with respect to the service or technology after if the service or technology . 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, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the Director of the Centers for Disease Control and Prevention, 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) ), as added by subsection (a)(1); and develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A). 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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