Sec. 2123. Encouraging the development and use of DISARM drugs
1,017 words·~5 min read·
/bill/114/hr/6/eh/section-2123A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 conducted with respect to payment for subsection
(d)hospitals for each fiscal year beginning with fiscal year 2018, the Secretary shall— include a list of the DISARM drugs for such fiscal year; and with respect to discharges by eligible hospitals that involve a drug so listed, 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 list 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 DISARM 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 is an antimicrobial product (as defined in clause (iv)) 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. For purposes of clause (iii), the term antimicrobial product means a product that 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. 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 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 subparagraph, the additional payment under this subparagraph, with respect to a drug, shall be in the amount provided for such drug under section 1847A. As part of the rulemaking referred to in clause
(i)for each fiscal year, the Secretary shall estimate— total add-on payments (as defined in subclause
(I)of clause (ix)); and total hospital payments (as defined in subclause
(II)of such clause). If the total add-on payments estimated pursuant to clause (vii)(I) for a fiscal year exceed 0.02 percent of the total hospital payments estimated pursuant to clause (vii)(II) 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 add-on payments estimated for such fiscal year do not exceed 0.02 percent of the total hospital payments estimated for such fiscal year. In this subparagraph: The term total add-on payments means, with respect to a fiscal year, the total amount of the additional payments under this subsection pursuant to this subparagraph for discharges in such fiscal year without regard to the application of clause (viii). The term total hospital payments means, with respect to a fiscal year, the total amount of payments made under this subsection for all discharges in such fiscal year. . Section 1886(d)(5)(K)(vi) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5)(K)(vi) ) is amended by inserting and if additional payment has never been made under this subsection pursuant to subparagraph
(M)with respect to the service or technology before the period at the end. Section 1927(b)(3)(A) of the Social Security Act ( 42 U.S.C. 1396r–8(b)(3)(A) ) is amended— in clause (ii)— by striking for each and inserting , for each ; and by striking and at the end; in clause (iii)— in subclause (II), by inserting or under section 1886(d) pursuant to paragraph (5)(M) of such section, after 1847A, ; in the matter following subclause (III), by striking or 1881(b)(13)(A)(ii) and inserting , section 1881(b)(13)(A)(ii), or section 1886(d)(5)(M) ; and by striking the period at the end and inserting ; and ; and in clause (iv), by striking the semicolon at the end and inserting a period. 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 DISARM 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). The Director of the Centers for Disease Control and Prevention shall conduct a study to examine the effects of the additional payment for DISARM drugs under the Medicare Program provided under subparagraph
(M)of section 1886(d)(5) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5) ), as added by subsection (a), on— the usage of DISARM drugs (as defined by clause
(iii)of such subparagraph) by subsection
(d)hospitals (as defined in section 1886(d)(1)(B) of such Act); and the development of resistance by individuals to such DISARM drugs. Not later than 3 years after the date of the enactment of this Act, such Director shall submit to Congress a report on the study conducted under paragraph (1).
Connectionstraces to 1
Traces to 1 document
1 reference not yet in our index
- 42 USC 1396r–8(b)(3)(A)
Citation graph
cites case law
Sec. 2123
Encouraging the development and use of DISARM drugs
Cite42 USC 1396r–8(b)(3)(A)
Cites 2Cited by 0 across 0 sources