,i #aahth ,,congress #b;d ,session ,h4 ,r4 #icba ,,in ,,the ,,house ,,of ,,representatives ,august #f1 #bjbd,ms4 ,slotkin 7for herself and ,mr4 ,bacon7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 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 direct the ,secretary of ,health and ,human ,services to conduct a demonstration program to test providing preferential treatment under the ,medicare1 ,medicaid1 and ,,chip programs for certain drugs and biologicals manufactured in the ,united ,states4 #a4 ,short title ,this ,act may be cited as the ,american ,made ,pharmaceuticals ,act of #bjbd4 #b4 ,demonstration program to test providing preferential treatment under the ,medicare1 ,medicaid1 and ,,chip programs for certain drugs and biologicals manufactured in the ,united ,states ,part ,a of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is amended by inserting after section #aaej;,c the following3 #aaej;,d4 ,demonstration program to test providing preferential treatment under the ,medicare1 ,medicaid1 and ,,chip programs for certain drugs and biologicals manufactured in the ,united ,states 7a7 ,in general ,not later than #a year after the date of enactment of this section1 the ,secretary shall conduct a demonstration program 7in this section referred to as the ,program7 under which ,u4,s4 manufactured drugs are given preference under titles ,,xviii1 ,,xix1 and ,,xxi compared to drugs that are not ,u4,s4 manufactured drugs through the use of applicable tools4 7b7 ,sites ,the ,program shall be conducted in at least #h ,states4 7c7 ,duration ,the ,secretary shall conduct the ,program for a period of not less than #g years4 7d7 ,definitions ,in this section3 7#a7 ,applicable drug ,the term applicable drug means-- 7,a7 a drug that is approved and marketed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,b7 a biological product that is licensed and marketed under section #cea7k7 of the ,public ,health ,service ,act2 or 7,c7 a critical drug4 7#b7 ,applicable ,u4,s4-based pharmaceutical company ,the term applicable ,u4,s4-based pharmaceutical company means a manufacturer 7as defined in section #ahfj;,d-#ad;,a7g77#e77-- 7,a7 that has a manufacturing location in the ,united ,states for an applicable drug2 7,b7 beginning #c years after the date of the implementation of the ,program1 for which at least #ej percent of the starter products1 by weight1 for the applicable drugs manufactured by the manufacturer are derived from countries other than covered nations 7as defined in section #dhga7;d77#b7 of title #aj1 ,united ,states ,code72 and 7,c7 that1 as determined by the ,secretary-- 7i7 maintains an appropriate level of transparency on locations of manufacturing2 7ii7 maintains an appropriate level of diversity in sourcing2 7iii7 maintains appropriate levels of inventory and emergency reserves2 7iv7 has in place an appropriate action plan for increases in demand and for when links in the supply chain break down2 and 7v7 meets any other characteristics the ,secretary determines appropriate4 7#c7 ,applicable tools ,the term applicable tools means tools determined appropriate by the ,secretary1 such as-- 7,a7 preferential treatment on a formulary2 7,b7 providing lower cost-sharing2 7,c7 waiving rebates under the ,medicaid program under title ,,xix2 7,d7 establishing a ,medicare ,star ,rating under part ,d of title ,,xviii2 or 7,e7 providing bonus payments to providers of services and suppliers under part ,b of title ,,xviii4 7#d7 ,critical drug ,in this section1 the term critical drug includes the following3 7,a7 ,a medicine1 medical countermeasure1 or critical input identified on the list under section #c7;c7 of ,executive ,order #acidd of ,august #f1 #bjbj 7#he ,fed4 ,reg #diibi2 relating to essential medicines1 medical ,countermeasures1 and critical inputs74 7,b7 ,a drug or biological that-- 7i7 is not described in subparagraph 7,a72 7ii7 is approved and marketed under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or is licensed and marketed under section #cea7;a7 of the ,public ,health ,service ,act 7or is an active pharmaceutical ingredient of such a drug or biological72 7iii7 the ,secretary determines-- 7,i7 is-- 7aa7 likely to be needed for use in a public health emergency2 or 7bb7 at high risk of short supply2 and 7,,ii7 has a vulnerable global supply chain4 7#e7 ,u4,s4 manufactured drug ,the term ,u4,s4 manufactured drug means an applicable drug that is manufactured in the ,united ,states by an applicable ,u4,s4-based pharmaceutical company4 7e7 ,annual report to ,congress ,not later than #a year after the date the ,secretary implements the ,program1 and annually thereafter for as long as the ,program is being conducted1 the ,secretary shall submit to ,congress a report on activities under the ,program1 together with recommendations for such legislation and administrative action as the ,secretary determines to be appropriate4 7f7 ,waivers ,the ,secretary may waive such provisions of this title and titles ,,xviii1 ,,xix1 and ,,xxi as the ,secretary determines necessary in order to implement the ,program4 7g7 ,administrative funding ,there is authorized to be appropriated to the ,secretary such sums as may be necessary for the administrative expenses of carrying out the ,program1 to remain available until expended4 4