,,ii #aafth ,,congress #b;d ,session ,s4 #dgfj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #cj 7legislative day1 ,september #bi71 #bjbj,mr4 ,bennet 7for himself and ,mr4 ,young7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections4 #a4 ,short title ,this ,act may be cited as ,the ,pioneering ,antimicrobial ,subscriptions ,to ,end ,up surging ,resistance ,act of #bjbj or ,the ,,pasteur ,act4 #b4 ,establishment of ,committee2 subscription model2 advisory group 7a7 ,in general ,not later than #fj days after the date of enactment of this ,act1 the ,secretary shall establish a ,committee on ,critical ,need ,antimicrobials and appoint members to the ,committee4 7b7 ,members 7#a7 ,in general ,the ,committee shall consist of at least one representative from each of the ,national ,institute of ,allergy and ,infectious ,diseases1 the ,centers for ,disease ,control and ,prevention1 the ,biomedical ,advanced ,research and ,development ,authority1 the ,food and ,drug ,administration1 the ,centers for ,medicare ,medicaid ,services1 the ,veterans ,health ,administration1 and the ,department of ,defense4 7#b7 ,chair ,the ,secretary shall appoint one of the members of the ,committee to serve as the ,chair of the ,committee4 7c7 ,duties ,not later than #a year after the appointment of all initial members of the ,committee1 the ,secretary1 in collaboration with the ,committee1 and in consultation with the ,critical ,need ,antimicrobials ,advisory ,group established under subsection 7g71 shall do the following3 7#a7 ,develop a list of prioritized infections for which new antimicrobial drug development is needed1 taking into account infections for which there is an unmet medical need1 findings from the most recent report entitled ,antibiotic ,resistance ,threats in the ,united ,states issued by the ,centers for ,disease ,control and ,prevention1 or an anticipated unmet medical need4 ,for the list developed under this paragraph1 the ,secretary1 in collaboration with the ,committee1 may use the infection list in such most recent report for up to #c years following the date of enactment of this ,act and subsequently update the list under this paragraph in accordance with subsection 7e74 7#b7 ,develop regulations1 in accordance with subsection 7d71 outlining favored characteristics of critical need antimicrobial drugs1 that are evidence based1 clinically focused1 and designed to treat the infections described in paragraph 7#a71 and establishing criteria for how each such characteristic will adjust the monetary value of a subscription contract awarded under subsection 7f7 or section #d4 ,the favored characteristics shall be weighed for purposes of such monetary value such that meeting certain characteristics1 or meeting more than one such characteristic1 increases the monetary value4 ,such favored characteristics of an antimicrobial drug shall include-- 7,a7 treating infections on the list under paragraph 7#a72 7,b7 improving clinical outcomes for patients with multi-drug resistant infections2 7,c7 being a first-approved drug that treats certain multi-drug resistant infections1 and1 to a lesser extent1 second and third drugs that treat such infections2 7,d7 addressing an infection located in an organ or other location that is challenging to treat2 7,e7 addressing a multi-drug resistant infection through a novel chemical scaffold or mechanism of action1 especially through oral administration2 7,f7 having received a transitional subscription contract under subsection 7f72 and 7,g7 any other characteristic the ,secretary1 in collaboration with the ,committee1 determines necessary4 7d7 ,regulations 7#a7 ,in general ,not later than #a year after the appointment of the initial members of the ,committee1 the ,secretary shall issue proposed regulations which shall include-- 7,a7 a process by which the sponsors can apply for an antimicrobial drug to become a critical need antimicrobial drug under section #c2 7,b7 how subscription contracts under such section shall be established and paid2 7,c7 the favored characteristics under subsection 7c77#b71 how such characteristics will be weighed1 and the minimum number and kind of favored characteristics needed for an antimicrobial drug to be designated a critical need antimicrobial drug2 and 7,d7 other elements of the subscription contract process1 in accordance with this ,act4 7#b7 ,development of final regulations ,before finalizing the regulations under paragraph 7#a71 the ,secretary shall solicit public comment and hold public meetings for the period beginning on the date on which the proposed regulations are issued and ending on the date that is #abj days after such date of issuance1 and shall finalize and publish the regulations #fj days after the close of such period of public comment and meetings4 7#c7 ,subscription contract office ,not later than #f months after the date of enactment of this ,act1 the ,secretary shall propose an agency or office in the ,department of ,health and ,human ,services to manage the establishment and payment of subscription contracts awarded under section #d1 including eligibility1 requirements1 and contract amounts4 ,the ,secretary shall solicit public comment and finalize the agency or office no later than #de days following the proposed agency or office4 7e7 ,list of infections ,the ,secretary1 in collaboration with the ,committee1 shall update the list of infections under subsection 7c77#a7 at least every #b years4 7f7 ,transitional subscription contracts 7#a7 ,in general ,not earlier than #cj days after the date of enactment of this ,act and ending on the date that the ,secretary finalizes the subscription contract regulations under subsection 7d71 the ,secretary may use up to #a1jjj1jjj1jjj of the amount appropriated under section #f7;a7 to engage in transitional subscription contracts of up to #c years in length with antimicrobial developers1 as determined by the ,secretary1 that have developed antimicrobial drugs treating infections listed in the most recent report entitled ,antibiotic ,resistance ,threats in the ,united ,states issued by the ,centers for ,disease ,control and ,prevention1 and may include antimicrobial drugs that are qualified infectious disease products 7as defined in section #eje;,e7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7g7771 similarly innovative biologic antimicrobial drugs1 or innovative drugs that achieve an antimicrobial outcome through immunomodulation4 ,funds made available under such contracts may be used for a variety of purposes including to support the completion of postmarketing clinical studies1 manufacturing1 and other preclinical and clinical efforts4 7#b7 ,requirements 7,a7 ,in general ,the ,secretary1 through the office described in paragraph 7#d71 may enter into a contract under paragraph 7#a7-- 7i7 if the ,secretary determines that the antimicrobial drug demonstrates a significant clinical advancement in treating an infection for which there is an unmet clinical need1 an anticipated clinical need1 or multidrug resistance2 7ii7 subject to terms including-- 7,i7 that the ,secretary shall cease any payment installments under a transitional subscription contract if the sponsor does not-- 7aa7 ensure commercial and ,federal availability of the antimicrobial drug within #cj days of receiving first payment under the contract2 7bb7 identify1 track1 and publicly report drug resistance data and trends using available data related to the antimicrobial drug2 7cc7 develop and implement education and communications strategies1 including communications for individuals with limited ,english proficiency and individuals with disabilities1 for health care professionals and patients about appropriate use of the antimicrobial drug2 7dd7 submit a plan for registering the antimicrobial drug in additional countries where an unmet medical need exists2 7ee7 subject to subparagraph 7,b71 ensure a reliable drug supply chain1 thus leading to an interruption of the supply of the antimicrobial drug in the ,united ,states for more than #fj days2 or 7ff7 make meaningful progress toward completion of ,federal ,drug ,administration-required postmarketing studies1 including such studies that are evidence based2 and 7,,ii7 other terms as determined by the ,secretary2 and 7iii7 if-- 7,i7 a phase #c clinical study has been initiated for the antimicrobial drug2 or 7,,ii7 the antimicrobial drug has been approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or licensed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 7,b7 ,waiver ,the requirement under subparagraph 7,a77ii77,i77ee7 may be waived in the case that an emergency prohibits access to a reliable drug supply chain4 7#c7 ,transitional guidance ,not later than #cj days after the appointment of the initial members of the ,committee1 the ,secretary shall issue1 in consultation with the ,committee1 transitional guidance outlining the antimicrobial drugs that are eligible for transitional subscription contracts under paragraph 7#a71 the requirements to enter into a transitional subscription contract under paragraph 7#b71 and the process by which drug developers can enter into transitional subscription contracts with the ,secretary under this subsection4 7#d7 ,payment office and mechanism ,not later than #cj days after the date of enactment of this ,act1 the ,secretary shall determine the agency or office in the ,department of ,health and ,human ,services that will manage the transitional subscription contracts1 including eligibility1 requirements1 and contract amounts1 during the period described in paragraph 7#a74 7g7 ,critical need antimicrobial advisory group 7#a7 ,in general ,not later than #cj days after the appointment of all initial members of the ,committee1 the ,secretary1 in collaboration with the ,committee1 shall establish a ,critical ,need ,antimicrobial ,advisory ,group 7referred to in this subsection as the ,advisory ,group7 and appoint members to the ,advisory ,group4 7#b7 ,members ,the members of the ,advisory ,group shall include-- 7,a7 #f individuals who are-- 7i7 infectious disease specialists2 or 7ii7 other health experts with expertise in researching antimicrobial resistance1 health economics1 or commercializing antimicrobial drugs2 and 7,b7 not less than #e patient advocates4 7#c7 ,chair ,the ,secretary shall appoint one of the members of the ,advisory ,group to serve as the ,chair4 7#d7 ,conflicts of interest ,in appointing members under paragraph 7#b71 the ,secretary shall ensure that no member receives compensation in any manner from a commercial or for-profit entity that develops antimicrobials or that might benefit from antimicrobial development4 7#e7 ,applicability of ,,faca ,except as otherwise provided in this subsection1 the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,advisory ,group4 #c4 ,critical need antimicrobial drug application and payment through subscription contracts 7a7 ,in general 7#a7 ,submission of request ,the sponsor of an application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 for an antimicrobial drug may request that the ,secretary designate the drug as a critical need antimicrobial4 ,a request for such designation may be submitted after the ,secretary grants for such drug an investigational new drug exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act1 and shall be submitted not later than #e years after the date of approval under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea7;a7 of the ,public ,health ,service ,act4 7#b7 ,content of request ,a request under paragraph 7#a7 shall include information1 such as clinical1 preclinical and postmarketing data1 a list of the favorable characteristics described in section #b7;c77#b71 and any other material that the ,secretary in consultation with the ,committee requires4 7#c7 ,review by secretary ,the ,secretary shall promptly review all requests for designation submitted under this subsection1 assess all required application components1 and determine if the antimicrobial drug is likely to meet the favorable characteristics identified in the application upon the completion of clinical development4 ,after review1 the ,secretary shall approve or deny each request for designation no later than #ij days after receiving a request4 ,if the ,secretary approves a request1 it shall publish the value of the contract that the critical need antimicrobial developer would be eligible to receive if such developer successfully demonstrates that the drug meets the maximum value of the favored characteristics listed in the application4 7#d7 ,length of designation period ,a designation granted under this section shall be in effect for a period of #aj years after the date that the designation is approved1 and shall remain in effect for such period even if the infection treated by such drug is later removed from the list of infections under section #b7;c77#a74 7#e7 ,subsequent reviews ,no sooner than #b years after a designation approval or denial under subsection 7#c71 the sponsor may request a subsequent review to re-evaluate the value of a contract to include any new information4 7b7 ,development of designated drugs ,if a critical need antimicrobial designation is granted during clinical development of an antimicrobial drug1 the ,secretary may work with the sponsor to maximize the opportunity for the sponsor to successfully demonstrate that the antimicrobial drug possesses the favored characteristics of high-monetary valued products identified under section #b7;c77#b74 7c7 ,appropriate use of critical need antimicrobial 7#a7 ,in general ,the sponsor of an antimicrobial drug that receives designation under subsection 7a7 shall submit an appropriate use plan to the ,secretary within #ij days of application approval for appropriate use of diagnostics for consideration by the ,secretary and ,committee to develop clinical guidelines4 ,a diagnostic plan-- 7,a7 shall include-- 7i7 the appropriate use of the drug2 and 7ii7 the appropriate use of diagnostic tools such as diagnostic testing for biomarkers related to antimicrobial-resistant pathogens1 or other targeted diagnostic approaches1 to inform use of the drug2 and 7,b7 may be developed in partnership with the ,secretary1 infectious disease experts1 diagnostic experts1 or another entity4 7#b7 ,consultation ,the ,secretary shall work with relevant professional societies and the ,critical ,need ,antimicrobial ,advisory ,group established under section #b7;g7 to ensure that clinical guidelines issued by the ,secretary under paragraph 7#c71 with respect to an antimicrobial drug designated under subsection 7a71 includes the use of appropriate diagnostic approaches1 taking into consideration the diagnostic plan submitted by a sponsor under paragraph 7#a74 7#c7 ,publication of clinical guidelines ,not later than #a year after the ,secretary makes the first designation under subsection 7a71 and not less than every #c years thereafter1 the ,secretary shall publish clinical guidelines in collaboration with relevant professional societies with respect to each antimicrobial drug designated under subsection 7a7 which shall set forth the evidence-based recommendations for prescribing the drug1 in accordance with the submissions of the sponsor under paragraph 7#a7 and after consultation under paragraph 7#b71 as appropriate4 #d4 ,subscription contracts 7a7 ,application for a subscription contract 7#a7 ,submission of applications ,after approval under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or licensure under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 the sponsor of an antimicrobial drug designated as a critical need antimicrobial under section #c may submit an application for a subscription contract with the ,secretary1 under a procedure established by the ,secretary4 7#b7 ,review of applications ,the ,secretary shall1 in consultation with the ,committee-- 7,a7 review all applications for subscription contracts under paragraph 7#a7 and assess all required application components2 7,b7 determine the extent to which the critical need antimicrobial meets the favored characteristics identified under section #b7;c77#b71 and deny any application for a drug that meets none of such characteristics2 and 7,c7 assign a monetary value to the contract based on the regulations developed under section #b7;d74 7b7 ,criteria ,to qualify for a subscription contract under this section1 the sponsor of an antimicrobial drug designated as a critical need antimicrobial shall agree to-- 7#a7 ensure commercial and ,federal availability of the antimicrobial drug within #cj days of receiving first payment under the contract1 and sufficient supply for susceptibility device manufacturers2 7#b7 identify1 track1 and publicly report drug resistance data and trends using available data related to the antimicrobial drug2 7#c7 develop and implement education and communications strategies1 including communications for individuals with limited ,english proficiency and individuals with disabilities1 for health care professionals and patients about appropriate use of the antimicrobial drug2 7#d7 submit an appropriate use assessment to the ,secretary1 ,committee1 ,food and ,drug ,administration1 and ,centers for ,disease ,control and ,prevention every #b years regarding use of the antimicrobial drug1 including how the drug is being marketed2 7#e7 submit a plan for registering the drug in additional countries where an unmet medical need exists2 7#f7 ensure a reliable drug supply chain1 where any interruption to the supply chain will not last for more than #fj days in the ,united ,states2 7#g7 complete any postmarketing studies required by the ,food and ,drug ,administration in a timely manner2 7#h7 produce the drug at a reasonable volume determined with the ,secretary to ensure patient access to the drug2 7#i7 price the drug at a price that is not lower than a comparable generic drug2 and 7#aj7 abide by other terms as the ,secretary may require4 7c7 ,term and amount of contracts 7#a7 ,amounts ,a subscription contract under this section shall be for the sale to the ,secretary of any quantity of the antimicrobial drug needed over the term of the contract under paragraph 7#b71 at an agreed upon price1 for a total projected amount determined by the ,secretary that is not less than #gej1jjj1jjj and not more than #c1jjj1jjj1jjj1 adjusted for inflation1 accounting for the favored characteristics of the drug1 as determined by the ,secretary1 in consultation with the ,committee1 under subsection 7a77#b71 and shall be allocated from the amount made available under section #f7;a74 ,not later than #f months after the subscription contract is granted under subsection 7a71 the ,secretary shall provide payments for purchased drugs in installments established by the ,secretary in consultation with the sponsor of the antimicrobial drug and in accordance with subsection 7d77#c74 ,funds received by the sponsor may be used to support criteria qualification under subsection 7b71 the completion of postmarketing clinical studies1 manufacturing1 and other preclinical and clinical activities agreed to by the ,secretary and sponsor in the contract4 7#b7 ,terms 7,a7 ,initial term ,the initial term of a contract under this subsection shall be no less than #e years or greater than the greater of #aj years or the remaining period of time during which the sponsor has patent protections or a remaining exclusivity period with respect to the antimicrobial drug in the ,united ,states1 as listed in the publication of the ,food and ,drug ,administration entitled ,approved ,drug ,products with ,therapeutic ,equivalence ,evaluations4 ,payments may be in equal annual installments with the option to redeem #ej percent of the last year's reimbursement in year #a of the contract in order to offset costs of establishing manufacturing capacity1 or another subscription arrangement to which the ,secretary and sponsor agree4 ,subscription contracts shall remain in effect for such period even if the infection treated by such antimicrobial drug is later removed from the list of infections under section #b7;c77#a74 7,b7 ,extension of contracts ,the ,secretary may extend subscription contracts beyond the initial contract period with a generic or biosimilar brand manufacturer of the antimicrobial drug receiving a subscription contract or the original drug manufacturer4 ,a single contract extension may be in effect not later than the date on which all periods of exclusivity granted by the ,food and ,drug ,administration expire and shall be in an amount not to exceed #be1jjj1jjj per year4 ,all other terms of an extended contract shall be the same as the terms of the initial contract4 ,the total amount of funding used on such contract extensions shall be no more than #a1jjj1jjj1jjj1 and shall be allocated from the amount made available under section #f4 7,c7 ,modification of contracts ,the ,secretary or sponsor1 every #b years after the start of the contract period under this subsection1 may request a modification of the amount of the contract based on information that adjusts favored characteristics in section #b7;c77#b74 7#c7 ,adjustment ,in the case of an antimicrobial drug that received a transitional subscription contract under section #b7;f71 the amount of a subscription contract for such drug under this section shall be reduced by the amount of the transitional subscription contract under such section #b7;f7 for such drug4 7d7 ,annual antimicrobial drug sponsor revenue limitations 7#a7 ,reporting requirement 7,a7 ,in general ,not later than a date determined appropriate by the ,secretary following the end of each calendar year1 the head 7or a designee of such head7 of each ,federal agency carrying out a specified government program shall1 in accordance with this paragraph1 report to the ,secretary of ,health and ,human ,services the total prescription drug sales for each applicable antimicrobial drug under contract with respect to such program for such calendar year4 7,b7 ,medicare ,part ,d program ,for purposes of subparagraph 7,a71 the ,secretary shall report1 for each applicable antimicrobial drug covered under part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq471 the product of-- 7i7 the per-unit ingredient cost1 as reported to the ,secretary by prescription drug plans and ,medicare ,advantage prescription drug plans1 minus any per-unit rebate1 discount1 or other price concession provided1 as reported to the ,secretary by the prescription drug plans and the ,medicare ,advantage prescription drug plans2 and 7ii7 the number of units of such applicable antimicrobial drug paid for under such part ,d4 7,c7 ,medicare ,part ,b program ,for purposes of subparagraph 7,a71 the ,secretary shall report1 for each applicable antimicrobial drug covered under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 the product of-- 7i7 the per-unit average sales price 7as defined in section #ahdg;,a7c7 of such ,act 7#db ,u4,s4,c4 #aciew-#c;a7c777 or the per-unit payment rate under such part ,b for a separately paid prescription drug without a reported average sales price2 and 7ii7 the number of units of such applicable antimicrobial drug paid for under such part ,b4 7,d7 ,medicare ,part ,a program 7i7 ,in general ,for purposes of subparagraph 7,a71 the ,secretary shall report1 for each applicable antimicrobial drug covered under part ,a of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq471 the product of-- 7,i7 the per-unit price under such part ,a for the antimicrobial drug2 and 7,,ii7 the number of units of such antimicrobial drug paid for under such part ,a4 7ii7 ,special rule ,for purposes of clause 7i71 the ,secretary shall establish a process for determining the units and the allocated price for those prescription drugs that are not separately payable or for which ,national ,drug ,codes are not reported in the diagnosis-related groups4 7,e7 ,medicaid program ,under the authority of section #aijb7;a77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#f771 the ,secretary shall require each ,state that makes medical assistance available under the ,state ,medicaid program for an applicable antimicrobial drug 7including1 if applicable1 any such drug which is a covered outpatient drug under a rebate agreement entered into under section #aibg of such ,act 7#db ,u4,s4,c4 #acifr-#h77 to report to the ,secretary1 not later than the date established under subparagraph 7,a71 for each dosage form and strength and package size of each such drug dispensed during the preceding calendar year under the ,state ,medicaid program1 the amount equal to-- 7i7 the product of-- 7,i7 the per-unit ingredient cost paid by the ,state for each such drug2 and 7,,ii7 the number of units of such drug paid for under the ,state ,medicaid program2 minus 7ii7 any discounts or other price concessions provided and rebates paid to the ,state with respect to such drug and such calendar year 7including rebates paid under a rebate agreement under section #aibg of such ,act 7#db ,u4,s4,c4 #acifr-#h7 and any ,state supplemental rebates paid under a supplemental rebate agreement74 7,f7 ,department of ,veterans ,affairs ,for purposes of subparagraph 7,a71 the ,secretary of ,veterans ,affairs shall report the total amount paid for each applicable antimicrobial drug procured by the ,veterans ,health ,administration for individuals who receive health care from the ,administration4 7,g7 ,department of ,defense and ,,tricare program ,for purposes of subparagraph 7,a71 the ,secretary of ,defense shall report the sum of-- 7i7 the total amount paid for each applicable antimicrobial drug procured by the ,department of ,defense for individuals who receive health care from the ,department2 and 7ii7 for each applicable antimicrobial drug dispensed under the ,,tricare retail pharmacy program1 the product of-- 7,i7 the per-unit ingredient cost1 minus any per-unit rebate paid by the covered entity2 and 7,,ii7 the number of units of such applicable antimicrobial drug dispensed under such program4 7,h7 ,department of ,homeland ,security ,for purposes of subparagraph 7,a71 the ,secretary of ,homeland ,security shall report the total amount paid for each applicable antimicrobial drug procured by the ,department of ,homeland ,security for individuals who receive health care through a program carried out by the ,department4 7,i7 ,bureau of ,prisons ,for purposes of subparagraph 7,a71 the ,director of the ,bureau of ,prisons shall report the total amount paid for each applicable antimicrobial drug procured by the ,bureau of ,prisons for individuals who receive health care through the ,bureau4 7,j7 ,indian ,health ,service ,for purposes of subparagraph 7,a71 the ,secretary1 acting through the ,indian ,health ,service1 shall report the total amount paid for each applicable antimicrobial drug procured by the ,service for individuals who receive health care through the ,service4 7#b7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall publish guidance to assist the heads 7or designees7 of ,federal agencies carrying out specified government programs in carrying out the requirements under this section4 7#c7 ,subscription contract adjustment ,pursuant to the contract entered into under this section with respect to an applicable antimicrobial drug1 for each year of the term of such contract1 the ,secretary shall subtract from the payment installments determined for such contract under subsection 7c77#a7 for such year the revenue of the sponsor of such drug from the previous year from sales of the applicable antimicrobial drug reported under paragraph 7#a7 for specified government programs4 7#d7 ,definitions ,in this subsection3 7,a7 ,applicable antimicrobial drug ,the term applicable antimicrobial drug means an antimicrobial drug for which the sponsor of such drug receives a subscription contract under subsection 7a74 7,b7 ,specified government program ,the term specified government program means-- 7i7 the ,medicare part ,d program under part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq472 7ii7 the ,medicare ,part ,b program under part ,b of such title ,,xviii 7#db ,u4,s4,c4 #acie;j et seq472 7iii7 the ,medicare ,part ,a program under part ,a of such title ,,xviii 7#db ,u4,s4,c4 #acie;c et seq472 7iv7 the ,medicaid program established under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 and includes1 with respect to a ,state1 any waiver in effect with respect to such program2 7v7 any program under which prescription drugs are procured by the ,department of ,veterans ,affairs2 7vi7 any program under which branded prescription drugs are procured by the ,department of ,defense2 7vii7 the ,,tricare retail pharmacy program under section #ajgd;g of title #aj1 ,united ,states ,code2 7viii7 any program under which prescription drugs are procured by the ,department of ,homeland ,security2 7ix7 any program under which prescription drugs are procured by the ,bureau of ,prisons2 or 7x7 any program under which prescription drugs are procured by the ,indian ,health ,service4 7e7 ,failure ,to adhere to terms ,the ,secretary shall cease any payment installments under a contract under this section if-- 7#a7 the sponsor-- 7,a7 permanently withdraws the antimicrobial drug from the market in the ,united ,states2 7,b7 fails to meet criteria under subsection 7b72 or 7,c7 does not complete a postmarket study required by the ,food and ,drug ,administration during the length of the term of the contract2 or 7#b7 the annual international and private insurance market revenues with respect to an antimicrobial drug 7not counting any subscription revenues from any source pursuant to a contract under this section or other international or private entities7 exceed #e times the average annual amount of the subscription contract paid by the ,secretary as certified by the sponsor annually4 7f7 ,private payer and international payer participation ,the ,secretary shall make efforts to increase the participation of domestic private payors and international payors in subscription contracts or other types of pull incentives that are similar to the subscription contracts authorized under this section4 #e4 ,encouraging appropriate use of antibiotics and combating resistance 7a7 ,establishment of hospital grant program 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary and the ,director of the ,centers for ,disease ,control and ,prevention shall coordinate with the ,administrator of the ,health ,resources and ,services ,administration1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,national ,coordinator for ,health ,information ,technology1 and other relevant agencies1 to establish a grant program under the ,centers for ,disease ,control and ,prevention to support hospital and other inpatient facility efforts-- 7,a7 to judiciously use antimicrobial drugs1 such as by establishing or implementing appropriate use programs1 including infectious disease telehealth programs1 using appropriate diagnostic tools1 partnering with academic hospitals1 increasing health care-associated infection reporting1 and monitoring antimicrobial resistance2 and 7,b7 to participate in the ,national ,healthcare ,safety ,network ,antimicrobial ,use and ,resistance ,module or the ,emerging ,infections ,program ,healthcare-,associated ,infections ,community ,interface activity of the ,centers for ,disease ,control and ,prevention or a similar reporting program1 as specified by the ,secretary1 relating to antimicrobial drugs4 7#b7 ,prioritization ,in awarding grants under paragraph 7#a71 the ,secretary shall prioritize hospitals without an existing program to judiciously use antimicrobial drugs1 subsection 7d7 hospitals 7as defined in subparagraph 7,b7 of section #ahhf7;d77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#b777 that are located in rural areas 7as defined in subparagraph 7,d7 of such section71 critical access hospitals 7as defined in section #ahfa7mm77#a7 of such ,act 7#db ,u4,s4,c4 #aciex7mm77#a7771 hospitals serving ,tribal-populations1 and safety-net hospitals4 7#c7 ,funding ,of the amounts appropriated under section #f1 the ,secretary shall reserve #ejj1jjj1jjj to carry out this subsection4 7b7 ,surveillance and reporting of antibiotic use and resistance 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall use the ,national ,healthcare ,safety ,network and other appropriate surveillance systems to assess-- 7,a7 appropriate conditions1 outcomes1 and measures causally related to antibacterial resistance1 including types of infections1 the causes for infections1 and whether infections are acquired in a community or hospital setting1 increased lengths of hospital stay1 increased costs1 and rates of mortality2 and 7,b7 changes in bacterial resistance to antimicrobial drugs in relation to patient outcomes1 including changes in percent resistance1 prevalence of antibiotic-resistant infections1 and other such changes4 7#b7 ,antibiotic use data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall work with ,federal agencies 7including the ,department of ,veterans ,affairs1 the ,department of ,defense1 the ,department of ,homeland ,security1 the ,bureau of ,prisons1 the ,indian ,health ,service1 and the ,centers for ,medicare ,medicaid ,services71 private vendors1 health care organizations1 pharmacy benefit managers1 and other entities as appropriate to obtain reliable and comparable human antibiotic drug consumption data 7including1 as available and appropriate1 volume antibiotic distribution data and antibiotic use data1 including prescription data7 by ,state or metropolitan areas4 7#c7 ,antibiotic resistance trend data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall intensify and expand efforts to collect antibiotic resistance data and encourage adoption of the antibiotic resistance and use module within the ,national ,healthcare ,safety ,network among all health care facilities across the continuum of care1 including1 as appropriate1 acute care hospitals1 dialysis facilities1 nursing homes1 ambulatory surgical centers1 and other ambulatory health care settings in which antimicrobial drugs are routinely prescribed4 ,the ,secretary shall seek to collect such data from electronic medication administration reports and laboratory systems to produce the reports described in paragraph 7#d74 7#d7 ,public availability of data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 for the purposes of improving the monitoring of important trends in patient outcomes in relation to antibacterial resistance-- 7,a7 make the data derived from surveillance under this subsection publicly available through reports issued on a regular basis that is not less than annually2 and 7,b7 examine opportunities to make such data available in near real time4 #f4 ,appropriations 7a7 ,in general ,to carry out this ,act1 there are hereby appropriated to the ,secretary1 out of amounts in the ,treasury not otherwise appropriated1 #aa1jjj1jjj1jjj1 for fiscal year #bjba1 to remain available until expended4 7b7 ,emergency designation 7#a7 ,in general ,the amounts provided by this section are designated as an emergency requirement pursuant to section #d7;g7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj 7#b ,u4,s4,c4 #icc7;g774 7#b7 ,designation in senate ,in the ,senate1 this section is designated as an emergency requirement pursuant to section #daab7;a7 of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress71 the concurrent resolution on the budget for fiscal year #bjah4 #g4 ,studies and reports 7a7 ,in general ,not later than #f years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall complete a study on the effectiveness of this ,act in developing priority antimicrobial drugs4 ,such study shall examine the indications for1 usage of1 development of resistance with respect to1 and private and societal value of critical need antimicrobial drugs1 and the impact of the programs under this ,act on patients and markets of critical need antimicrobial drugs4 ,the ,comptroller ,general shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the findings of such study4 7b7 ,antibiotic use in the ,united ,states2 annual reports ,the ,director of the ,centers for ,disease ,control and ,prevention shall1 each year1 update the report entitled ,antibiotic ,use in the ,united ,states to include updated information on progress and opportunities with respect to data1 programs1 and resources for prescribers to promote appropriate use of antimicrobial drugs4 7c7 ,reports on antifungal resistance and antimicrobial prophylactics ,not later than #c years after the date of enactment of this ,act1 the ,director of the ,centers for ,disease ,control and ,prevention shall publish-- 7#a7 a report on antifungal resistance in the ,united ,states2 and 7#b7 a report on antimicrobial prophylactics4 #h4 ,definitions ,in this ,act-- 7#a7 the term antimicrobial drug-- 7,a7 subject to subparagraph 7,b71 means-- 7i7 an antibiotic drug1 as defined in section #bja7;jj7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;jj772 or 7ii7 a biological product1 as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i771 that exhibits antimicrobial activity2 and 7,b7 excludes-- 7i7 any antifungal drug2 and 7ii7 any vaccine2 7#b7 the term ,committee means the ,committee on ,critical ,need ,antimicrobials established under section #b2 and 7#c7 the term ,secretary means the ,secretary of ,health and ,human ,services4