,i #aadth ,,congress #ast ,session ,h4 ,r4 #eab ,,in ,,the ,,house ,,of ,,representatives ,january #bb1 #bjae ,mr4 ,roskam 7for himself and ,mr4 ,danny ,k4 ,davis of ,illinois7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to encourage the development and use of ,,disarm antimicrobial drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,developing an ,innovative ,strategy for ,antimicrobial ,resistant ,microorganisms ,act of #bjae and as the ,,disarm ,act of #bjae4 #b4 ,encouraging the development and use of ,,disarm antimicrobial drugs 7a7 ,additional payment for ,,disarm antimicrobial drugs under ,medicare 7#a7 ,in general ,section #ahhf7;d77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77 is amended by adding at the end the following new subparagraph3 7,m7 7i7 ,effective for discharges beginning on or after ,october #a1 #bjae1 the ,secretary shall1 after notice and opportunity for public comment 7in the publications required by subsection 7e77#e7 for a fiscal year or otherwise71 recognize the costs of ,,disarm antimicrobial drugs under the payment system established under this subparagraph4 7ii7 ,pursuant to clause 7i71 the ,secretary shall provide for additional payment to be made under this subsection with respect to discharges involving ,,disarm antimicrobial drugs in the amount provided for under section #ahdg;,a for drugs and biological products that are described in section #ahdb7o77#a77;,c74 7iii7 ,for purposes of this subparagraph1 the term ,,disarm antimicrobial drug means a product that is approved or licensed for use1 or a product for which an indication is first approved or licensed for use1 by the ,food and ,drug ,administration on or after ,january #a1 #bjae1 and-- 7,i7 7aa7 is intended to treat an infection caused by1 or likely to be caused by1 a qualifying pathogen 7as defined under section #eje;,e7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 or 7bb7 meets the definition of a qualified infectious disease product under section #eje;,e7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,,ii7 is intended to treat an infection for which there is an unmet medical need as determined by the ,food and ,drug ,administration2 7,,iii7 is intended to treat an infection that is associated with high rates of mortality or significant patient morbidity1 as determined by the ,secretary1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention and the infectious disease professional community2 and 7,,iv7 is used in facilities that1 to the extent available to such facilities1 as determined by the ,secretary1 participate in-- 7aa7 the ,national ,healthcare ,safety ,network of the ,centers for ,disease ,control and ,prevention2 or 7bb7 a similar reporting program relating to antimicrobial drugs1 as specified by the ,secretary4 7iv7 7,i7 ,the manufacturer or sponsor of a drug may request the ,secretary to designate a drug as a ,,disarm antimicrobial drug at any time before or after the submission of an application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of the ,public ,health ,service ,act for such drug4 ,pursuant to the previous sentence1 the ,secretary shall1 not later than #fj days after the submission of such a request1 determine whether the drug will be considered a ,,disarm antimicrobial drug in the case that it is approved or licensed for use1 or is first approved or licensed for an indication4 7,,ii7 ,except as provided in subclause 7,,iii71 a designation under this clause shall not be withdrawn for any reason4 7,,iii7 ,the ,secretary may revoke a designation of a drug as a ,,disarm antimicrobial drug product if the ,secretary finds that the request for such designation contained an untrue statement of material fact4 7v7 ,not later than ,october #a1 #bjaf1 the ,secretary shall first publish in the ,federal ,register a list of the ,,disarm antimicrobial drugs4 7vi7 ,the ,secretary shall make a proportional adjustment in the standardized amount determined under paragraph 7#c7 to assure that the provisions of this subparagraph do not result in aggregate payments under this subsection that are greater or less than those that would otherwise be made under such subsection for a fiscal year4 4 7#b7 ,relationship to ,,ntap payments ,section #ahhf7;d77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e771 as amended by paragraph 7#a71 is further amended in subparagraph 7,k7-- 7,a7 in clause 7i71 by inserting that are not ,,disarm antimicrobial drugs 7as defined in subparagraph 7,m77iii77 after new medical services and technologies2 and 7,b7 in clause 7ii77,i71 by inserting if the service or technology is not a ,,disarm antimicrobial drug and after a new medical service or technology4 7b7 ,study and report on removing barriers to development of ,,disarm antimicrobial drugs 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall1 in consultation with the ,director of the ,national ,institutes of ,health1 the ,commissioner of ,food and ,drugs1 and the ,director of the ,centers for ,disease ,control and ,prevention1 conduct a study to-- 7,a7 identify and examine the barriers that prevent the development of ,,disarm antimicrobial drugs1 as defined in section #ahhf7;d77#e77,m77iii7 of the ,social ,security ,act1 as added by subsection 7a72 and 7,b7 develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph 7,a74 7#b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report on the study conducted under paragraph 7#a74