,i #aafth ,,congress #ast ,session ,h4 ,r4 #dajj ,,in ,,the ,,house ,,of ,,representatives ,july #cj1 #bjai,mr4 ,danny ,k4 ,davis of ,illinois 7for himself1 ,mr4 ,marchant1 ,ms4 ,sewell of ,alabama1 ,mr4 ,marshall1 ,mr4 ,holding1 ,mr4 ,michael ,f4 ,doyle of ,pennsylvania1 and ,mrs4 ,walorski7 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 #bjai and as the ,,disarm ,act of #bjai4 #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 7,i7 ,effective for discharges beginning on or after ,october #a1 #bjbj1 or such sooner date as specified by the ,secretary1 subject to subclause 7,,ii71 the ,secretary shall1 after notice and opportunity for public comment 7in the publications required by subsection 7e77#e7 for a fiscal year or otherwise71 provide for an additional payment under a mechanism 7separate from the mechanism established under subparagraph 7,k771 with respect to such discharges involving any ,,disarm antimicrobial drug1 in an amount equal to-- 7aa7 the amount payable under section #ahdg;,a for such drug during the calendar quarter in which the discharge occurred2 or 7bb7 if no amount for such drug is determined under section #ahdg;,a1 an amount to be determined by the ,secretary in a manner similar to the manner in which payment amounts are determined under section #ahdg;,a based on information submitted by the manufacturer or sponsor of such drug 7as required under clause 7v774 7,,ii7 ,in determining the amount payable under section #ahdg;,a for purposes of items 7aa7 and 7bb7 of subclause 7,i71 subparagraphs 7,a7 and 7,b7 of subsection 7b77#a7 of such section shall be applied by substituting #ajb percent for #ajf percent each place it appears and paragraph 7#h77;,b7 of such section shall be applied by substituting #b percent for #f percent4 7ii7 ,for purposes of this subparagraph1 a ,,disarm antimicrobial drug is-- 7,i7 a drug-- 7aa7 that-- 7,,aa7 is approved by the ,food and ,drug ,administration2 7,,bb7 is designated by the ,food and ,drug ,administration as a qualified infectious disease product under subsection 7d7 of section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,,cc7 has received an extension of its exclusivity period pursuant to subsection 7a7 of such section2 and 7bb7 that has been designated by the ,secretary pursuant to the process established under clause 7iv77,i77bb72 or 7,,ii7 an antibacterial or antifungal biological product-- 7aa7 that is licensed for use1 or an antibacterial or antifungal biological product for which an indication is first licensed for use1 by the ,food and ,drug ,administration on or after ,june #e1 #bjad1 under section #cea7;a7 of the ,public ,health ,service ,act for human use to treat serious or life-threatening infections1 as determined by the ,food and ,drug ,administration1 including those caused by1 or likely to be caused by-- 7,,aa7 an antibacterial or antifungal resistant pathogen1 including novel or emerging infectious pathogens2 or 7,,bb7 a qualifying pathogen 7as defined under section #eje;,e7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 and 7bb7 has been designated by the ,secretary pursuant to the process established under clause 7iv77,i77bb74 7iii7 ,the mechanism established pursuant to clause 7i7 shall provide that the additional payment under clause 7i7 shall-- 7,i7 with respect to a discharge1 only be made to a subsection 7d7 hospital that1 as determined by the ,secretary-- 7aa7 is participating in the ,national ,healthcare ,safety ,network ,antimicrobial ,use and ,resistance ,module of the ,centers for ,disease ,control and ,prevention2 and 7bb7 has an antimicrobial stewardship program that aligns with the ,core ,elements of ,hospital ,antibiotic ,stewardship ,programs of the ,centers for ,disease ,control and ,prevention or the ,antimicrobial ,stewardship ,standard set by the ,joint ,commission2 and 7,,ii7 apply to discharges occurring on or after ,october #a of the year in which the drug or biological product is designated by the ,secretary as a ,,disarm antimicrobial drug4 ,for purposes of this clause1 in the case of a similar reporting program described in item 7aa71 a subsection 7d7 hospital shall be treated as participating in such a program if the entity maintaining such program identifies to the ,secretary such hospital as so participating4 7iv7 7,i7 ,the mechanism established pursuant to clause 7i7 shall provide for a process for-- 7aa7 a manufacturer or sponsor of a drug or biological product to request the ,secretary to designate the drug or biological product as a ,,disarm antimicrobial drug2 and 7bb7 the designation 7and removal of such designation7 by the ,secretary of drugs and biological products as ,,disarm antimicrobial drugs4 7,,ii7 ,a designation of a drug or biological product as a ,,disarm antimicrobial drug may be revoked by the ,secretary if the ,secretary determines that-- 7aa7 the drug or biological product no longer meets the requirements for a ,,disarm antimicrobial drug under clause 7ii72 7bb7 the request for such designation contained an untrue statement of material fact2 or 7cc7 clinical or other information that was not available to the ,secretary at the time such designation was made shows that-- 7,,aa7 such drug or biological product is unsafe for use or not shown to be safe for use for individuals who are entitled to benefits under part ,a2 or 7,,bb7 an alternative to such drug or biological product is an advance that substantially improves the diagnosis or treatment of such individuals4 7,,iii7 ,not later than ,october #a1 #bjbj1 the ,secretary shall publish in the ,federal ,register a list of the ,,disarm antimicrobial drugs designated under this subparagraph pursuant to the process established under subclause 7,i77bb74 ,the ,secretary shall annually update such list4 7v7 7,i7 ,for purposes of determining additional payment amounts under clause 7i71 a manufacturer or sponsor of a drug or biological product that submits a request described in clause 7iv77,i77aa7 shall submit to the ,secretary information described in section #aibg7;b77#c77;,a77iii74 7,,ii7 ,the penalties for failure to provide timely information under clause 7i7 of subparagraph 7,c7 section #aibg7;b77#c7 and for providing false information under clause 7ii7 of such subparagraph shall apply to manufacturers and sponsors of a drug or biological product under this section with respect to information under subclause 7,i7 in the same manner as such penalties apply to manufacturers under such clauses with respect to information under subparagraph 7,a7 of such section4 7vi7 7,i7 ,the mechanism established pursuant to clause 7i7 shall provide that-- 7aa7 except as provided in item 7bb71 no additional payment shall be made under this subparagraph for discharges involving a ,,disarm antimicrobial drug if any additional payments have been made for discharges involving such drug as a new medical service or technology under subparagraph 7,k72 7bb7 additional payments may be made under this subparagraph for discharges involving a ,,disarm antimicrobial drug if any additional payments have been made for discharges occurring prior to the date of enactment of this subparagraph involving such drug as a new medical service or technology under subparagraph 7,k72 and 7cc7 no additional payment shall be made under subparagraph 7,k7 for discharges involving a ,,disarm antimicrobial drug as a new medical service or technology if any additional payments for discharges involving such drug have been made under this subparagraph4 4 7#b7 ,conforming amendment ,section #ahhf7;d77#e77,k77ii77,,iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77ii77,,iii77 is amended by striking provide and inserting subject to subparagraph 7,m77vii71 provide4 7b7 ,study and reports on removing barriers to the development of ,,disarm antimicrobial drugs 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subsection referred to as the ,comptroller ,general7 shall1 in consultation with the ,director of the ,national ,institutes of ,health1 the ,commissioner of ,food and ,drugs1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 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 drugs 7as defined in section #ahhf7;d77#e77,m77ii7 of the ,social ,security ,act1 as added by subsection 7a772 and 7,b7 develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph 7,a74 7#b7 ,reports 7,a7 ,interim report ,not later than #c years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress an interim report containing the preliminary results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 7,b7 ,final report ,not later than #e years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4