,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ghcg ,m>* #e1 #bjbf ,mr4 ,meus] introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,xi ( ! ,social ,security ,act to require ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation to te/ a model implem5t+ mo/-favor$-nation drug pric+4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,mo/ ,favor$ ,pati5t ,act ( #bjbf4 #b4 ,requir+ ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation to te/ a model implem5t+ mo/ favor$ nation drug pric+ ,section #aaae;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7 is am5d$-- 7#a7 9 subsection 7b77#b77;,a71 by ins]t+ 1 &1 beg9n+ ,janu>y #a1 #bjbi1 %all include ! ,mo/ ,favor$ ,nations ,pric+ ,model describ$ 9 subsection 7h7 be=e ! p]iod at ! end2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7h7 ,mo/ ,favor$ ,nations ,pric+ ,model 7#a7 ,9 g5]al ,= purposes ( subsection 7b77#b77;,a71 ! ,mo/ ,favor$ ,nations ,pric+ ,model describ$ 9 ?is subsection is a model "u :i*1 subject to p>agraph 7#b71 ea* specifi$ manufactur]-- 7,a7 provides access to ! mo/-favor$-nation price ( ea* cov]$ drug ( su* manufactur]-- 7i7 to mo/-favor$-nation price eligible individuals :o ) respect to su* drug are describ$ 9 clause 7i7 ( p>agraph 7#e77;,d7 & are disp5s$ su* drug 7& to ph>macies1 mail ord] s]vices1 & o!r disp5s]s1 ) respect to su* individuals :o are disp5s$ su* drugs72 & 7ii7 to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s ) respect to mo/-favor$-nation price eligible individuals :o ) respect to su* drug are describ$ 9 clause 7ii7 ( su* p>agraph furni%$ or adm9i/]$ su* drug2 & 7,b7 reports to ! ,secret>y1 at su* "t & 9 su* mann] z ! ,secret>y %all specify1 su* in=mation z ! ,secret>y det]m9es necess>y = purposes ( calculat+ ! mo/-favor$-nation price ) respect to ea* su* cov]$ drug4 7#b7 ,exception ,! ,secret>y may susp5d ! requirem5ts "u p>agraph 7#a7 ) respect to a cov]$ drug ( a specifi$ manufactur] until ,april #a1 #bjbi1 if ! ,secret>y reasonably believes t su* manufactur] is likely to ent] into a cov]$ agreem5t ) ! ,secret>y be=e su* date4 7#c7 ,duration ,! model describ$ 9 p>agraph 7#a7 %all be c>ri$ out = a p]iod ( #e ye>s4 7#d7 ,def9itions ,9 ?is subsection3 7,a7 ,applicable net price ,! t]m applicable net price means1 ) respect to a cov]$ drug & a ref]5ce c\ntry 9 :i* su* drug 0 sold dur+ a ye>1 ! av]age price paid to ! manufactur] = ! drug across package sizes & package types ( ! drug 9 su* ref]5ce c\ntry dur+ su* ye> across all pur*as]s1 tak+ into acc\nt all manufactur] rebates1 disc\nts1 & price concessions1 & adju/$ to take into acc\nt diff]5ces 9 pur*as+ p[] 9 su* c\ntry comp>$ to ! ,unit$ ,/ates 9 a mann] specifi$ by ! ,secret>y4 7,b7 ,appropriate congressional committees ,! t]m appropriate congressional committees means-- 7i7 ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives2 & 7ii7 ! ,committee on ,f9ance & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7,c7 ,cov]$ agreem5t ,! t]m cov]$ agreem5t means an agreem5t betwe5 a manufactur] ( a cov]$ drug & ! ,secret>y t-- 7i7 provides t su* manufactur]-- 7,i7 w provide access to ! mo/-favor$-nation price ( #a or m cov]$ drugs ( su* manufactur] 9 ! same mann] z describ$ 9 p>agraph 7#a77;,a72 7,,ii7 w report to ! ,secret>y ! in=mation describ$ 9 p>agraph 7#a77;,b7 ) respect to ea* su* drug2 & 7,,iii7 commits1 to ! satisfaction ( ! ,secret>y1 to increas+ manufactur+ op]ations 9 ! ,unit$ ,/ates2 & 7ii7 is-- 7,i7 ent]$ into n lat] ?an ,decemb] #ca1 #bjbh2 & 7,,ii7 report$ by ! ,secret>y to ! appropriate congressional committees-- 7aa7 n lat] ?an ,april #a1 #bjbi2 or 7bb7 9 ! case t su* agreem5t 0 ent]$ into be=e ! date ( ! enactm5t ( ! ,mo/ ,favor$ ,pati5t ,act ( #bjbf1 n lat] ?an ! date t is #cj days aft] su* date ( enactm5t4 7,d7 ,cov]$ drug ,! t]m cov]$ drug means1 ) respect to a ye>1 a specifi$ drug t 0 sold 9 #b or m ref]5ce c\ntries dur+ su* ye>4 7,e7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,a74 7,f7 ,mo/-favor$-nation price ,! t]m mo/-favor$-nation price means1 ) respect to a cov]$ drug & a ye>1 ! second-l[e/ applicable net price = su* drug4 7,g7 ,mo/-favor$-nation price eligible individual ,! t]m mo/-favor$-nation price eligible individual means1 ) respect to a cov]$ drug-- 7i7 9 ! case su* drug is disp5s$ to ! individual at a ph>macy1 by a mail ord] s]vice1 or by ano!r disp5s]1 an individual-- 7,i7 :o is eligible = m$ical assi/ance "u a ,/ate plan 7or a waiv] ( su* plan7 "u title ,,xix if cov]age is provid$ "u su* plan 7or waiv]7 = su* cov]$ drug2 or 7,,ii7 :o is enroll$ 9 a prescription drug plan "u "p ,d ( title ,,xviii or an ,,ma-,,pd plan "u "p ,c ( su* title if cov]age is provid$ "u su* plan = su* cov]$ drug2 & 7ii7 9 ! case su* drug is furni%$ or adm9i/]$ to ! individual by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 an individual :o is enroll$ "u "p ,b ( title ,,xviii1 includ+ an individual :o is enroll$ 9 an ,,ma plan "u "p ,c ( su* title1 if paym5t may be made "u "p ,b = su* select$ drug4 7,h7 ,ref]5ce c\ntry ,! t]m ref]5ce c\ntry means any ( ! foll[+ c\ntries3 7i7 ,canada4 7ii7 ,d5m>k4 7iii7 ,france4 7iv7 ,g]many4 7v7 ,italy4 7vi7 ,japan4 7vii7 ,switz]l&4 7viii7 ,! ,unit$ ,k+dom4 7,i7 ,specifi$ drug ,! t]m specifi$ drug means-- 7i7 a cov]$ outpati5t drug 7z def9$ 9 section #aibg7k772 7ii7 a drug or biological product = :i* paym5t may be made "u "p ,b ( title ,,xviii2 or 7iii7 a cov]$ "p ,d drug 7z def9$ 9 section #ahfj;,d-#b7;e774 7,j7 ,specifi$ manufactur] ,! t]m specifi$ manufactur] means a manufactur] ( a cov]$ drug t does n h a cov]$ agreem5t ) ! ,secret>y4 4