,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ajbbg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #b1 #bjbf,ms4 ,de,gette 7= h]self1 ,mrs4 ,mill]-,meeks1 ,ms4 ,s*ri]1 ,mr4 ,bresnahan1 & ,ms4 ,craig7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ,education & ,work=ce1 = 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 r$uce ! price ( insul9 & provide = pati5t protections ) respect to ! co/ ( insul94 #a4 ,%ort title ,?is ,act may be cit$ z ! ,improv+ ,ne$$ ,safegu>ds = ,us]s ( ,lifesav+ ,insul9 ,n[ ,act ( #bjbf or ! ,,insul9 ,act ( #bjbf4 #b4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgbi;,a4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide cov]age ( select$ insul9 products1 & ) respect to su* products1 %all n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ requirem5ts 9 excess (1 p] #cj-;day supply-- 7,a7 = any applicable plan ye> beg9n+ be=e ,janu>y #a1 #bjbh1 #ce2 or 7,b7 = any plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbh1 ! less] (-- 7i7 #ce2 or 7ii7 ! am\nt equal to #be p]c5t ( ! negotiat$ price ( ! select$ insul9 product net ( all price concessions receiv$ by or on behalf ( ! plan or issu]1 includ+ price concessions receiv$ by or on behalf ( ?ird-p>ty entities provid+ s]vices to ! plan or issu]1 su* z ph>macy b5efit managem5t s]vices or ?ird p>ty adm9i/rators4 7b7 ,def9itions ,9 ?is section3 7#a7 ,select$ insul9 products ,! t]m select$ insul9 products means1 = any plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbh1 at lea/ "o ( ea* dosage =m & deliv]y device 7su* z vial1 p51 inhal] dosage =ms1 or su* o!r deliv]y devices approv$ by ! ,secret>y7 ( ea* diff]5t type 7su* z rapid-act+1 %ort-act+1 int]m$iate-act+1 long-act+1 & pre-mix$7 ( insul91 :5 su* =m is lic5s$ & m>ket$1 z select$ by ! gr\p heal? plan or heal? insurance issu]4 7#b7 ,insul9 ,! t]m insul9 means insul9 t is lic5s$ "u subsection 7a7 or 7k7 ( section #cea1 includ+ insul9 deem$ to be lic5s$ "u section #cea pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji1 & cont9ues to be m>ket$ pursuant to su* lic5sure4 7c7 ,out-(-,network provid]s ,no?+ 9 ?is section requires a plan or issu] t has a network ( provid]s to provide b5efits = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]1 or precludes a plan or issu] t has a network ( provid]s f impos+ high] co/-%>+ ?an ! levels specifi$ 9 subsection 7a7 = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid] if p]mitt$ "u applicable law4 7d7 ,rules ( con/ruction ,subsection 7a7 %all n be con/ru$ to-- 7#a7 require cov]age (1 or prev5t a gr\p heal? plan or heal? insurance issu] f impos+ co/-%>+ o!r ?an ! levels specifi$ 9 subsection 7a7 on1 insul9 t is n a select$ insul9 product1 to ! ext5t t su* cov]age is n o!rwise requir$ & su* co/-%>+ is o!rwise p]mitt$ "u ,f$]al & applicable ,/ate law2 or 7#b7 p]mit a gr\p heal? plan or heal? insurance issu] to pay any am\nt 9 excess ( ! am\nt specifi$ "u section 7a77#b7 to an entity provid+ ph>maceutical b5efit managem5t s]vices1 a provid]1 or a ph>maceutical manufactur] ) respect to ! provision ( select$ insul9 products4 7e7 ,application ( pati5t protections ,! provisions ( ?is title %all apply to select$ insul9 product b5efits describ$ 9 subsection 7a7 z ?\gh su* b5efits 7 requir$ to be provid$ "u section #bgjg7;a74 7f7 ,o!r requirem5ts ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n impose1 directly or ?r\gh an entity provid+ s]vices to ! plan or cov]age1 any prior au?orization or m$ical managem5t requirem5t1 or o!r simil> conditions1 on select$ insul9 products1 except z cl9ically ju/ifi$ = safety reasons1 to ensure reasonable quantity limits1 & z specifi$ by ! ,secret>y4 4 7b7 ,no effect on o!r co/-,%>+ ,section #acjb7;d77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;d77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,special rule relat+ to insul9 cov]age ,= plans ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 ! exemption ( cov]age ( select$ insul9 products 7z def9$ 9 section #bgbi;,a ( ! ,public ,heal? ,s]vice ,act7 f ! application ( any d$uctible pursuant to section #bgbi7;a77#a7 ( su* ,act1 %all n be treat$ z increas+ ! actu>ial value ( a plan :5 det]m9+ ! actu>ial value ( a qualifi$ heal? plan "u ?is subsection4 4 7c7 ,cov]age ( c]ta9 insul9 products "u cata/rophic plans ,section #acjb7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;e77 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,cov]age ( c]ta9 insul9 products 7,a7 ,9 g5]al ,not)/&+ p>agraph 7#a77;,b77i71 = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 a heal? plan describ$ 9 p>agraph 7#a7 %all provide cov]age ( select$ insul9 products1 9 accordance ) section #bgbi;,a ( ! ,public ,heal? ,s]vice ,act1 be=e an enroll$ individual has incurr$1 dur+ ! plan ye>1 co/-%>+ exp5ses 9 an am\nt equal to ! annual limitation 9 effect "u subsection 7c77#a7 = ! plan ye>4 7,b7 ,t]m9ology ,= purposes ( subp>agraph 7,a7-- 7i7 ! t]m select$ insul9 products has ! mean+ giv5 su* t]m 9 section #bgbi;,a7b7 ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 ! requirem5ts ( section #bgbi;,a ( su* ,act %all be appli$ by deem+ ea* ref]5ce 9 su* section to individual heal? insurance cov]age to be a ref]5ce to a plan describ$ 9 p>agraph 7#a74 4 7d7 ,con=m+ am5dm5ts 7#a7 ,,erisa ,section #gae7;a77#a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;d7a77#a77 is am5d$ by ins]t+ & ! ,,insul9 ,act ( #bjbf aft] ,af=dable ,c>e ,act4 7#b7 ,,irc ,section #ihae7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ & ! ,,insul9 ,act ( #bjbf aft] ,af=dable ,c>e ,act4 #c4 ,adm9i/ration 7a7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury may implem5t ! provisions (1 includ+ ! am5dm5ts made by1 ?is title = plan ye>s t beg9 on or aft] ,janu>y #a1 #bjbh1 & end n lat] ?an ,janu>y #a1 #bjcj1 by subregulatory guidance1 program in/ruction1 or o!rwise4 7b7 ,non-,application ( ! ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,pap]work ,r$uction ,act ( #aiie71 %all n apply to ! provisions (1 includ+ ! am5dm5ts made by1 ?is title4 #d4 ,,gao /udy on un9sur$ individuals :o use insul9 ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy1 9 consultation ) pati5t1 cl9ical1 & provid] gr\ps & o!r exp]ts1 & n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 issue a report1 on ! *>act]i/ics ( un9sur$ individuals :o use insul94 ,su* /udy & report %all1 to ! ext5t data is available1 include consid]ation (-- 7#a7 any ,/ates or regions 9 :i* !re is a high] preval5ce ( su* individuals2 7#b7 any id5tifiable pot5tial reasons = un9sur$ /atus2 7#c7 demographic *>act]i/ics ( su* individuals1 su* z race & e?nicity2 & 7#d7 income level ( su* individuals4 #e4 ,insul9 res\rce c5t] & hotl9e = un9sur$ individuals 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all aw>d a grant to an eligible entity = purposes (-- 7#a7 e/abli%+ & ma9ta9+ a res\rce c5t] ( assi/ance programs (f]$ by manufactures or o!r entities t are available to un9sur$ individuals seek+ af=dable insul92 & 7#b7 conduct+ ! public education activities describ$ 9 subsection 7c77#g74 7b7 ,eligible entities ,to be eligible to receive ! grant "u subsection 7a71 an entity %all-- 7#a7 be a trade1 indu/ry1 or pr(essional association1 community- & consum]-focus$ nonpr(it entity1 or o!r entity1 z det]m9$ by ! ,secret>y t-- 7,a7 is capable ( c>ry+ out ! duties describ$ 9 subsection 7c72 7,b7 meets ! /&>ds describ$ 9 subsection 7e72 & 7,c7 provides in=mation consi/5t ) ! /&>ds develop$ "u subsection 7f72 & 7#b7 submit an application to ! ,secret>y1 at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require1 includ+ in=mation demon/rat+ t ! entity-- 7,a7 has exi/+ relation%ips1 or c\ld readily e/abli% relation%ips1 ) consum]s 7includ+ un9sur$ individuals71 heal? c>e provid]s1 manufactur]s ( insul91 social s]vice provid]s1 ph>macies1 & o!r exp]ts t ! ,secret>y det]m9es appropriate1 to meet ! goals ( ?is section2 & 7,b7 has1 or w e/abli%1 p>tn]%ips )1 & solicit fe$back f1 o!r entities 9 o!r indu/ries1 pr(essional associations1 & community- & consum]-focus$ nonpr(it organizations1 to meet ! goals ( ?is section4 7c7 ,duties ,an entity t receives a grant "u ?is section %all-- 7#a7 di/ribute fair & imp>tial in=mation conc]n+ eligibility = manufactur]1 f\ndational1 & o!r assi/ance programs available to pati5ts seek+ af=dable insul92 7#b7 facilitate enrollm5t 9 manufactur] assi/ance programs or o!r assi/ance programs = un9sur$ individuals2 7#c7 make available to ! public1 ?r\gh a /&>diz$ website1 a cle>+h\se ( support available to pati5ts1 includ+-- 7,a7 a l9k to ,f$]ally-qualifi$ heal? c5t]s & o!r provid]s1 by ,,zip ,code2 7,b7 a l9k to retail community ph>macies1 by ,,zip ,code2 & 7,c7 in=mation ab\t h[ to enroll 9 heal? insurance2 7#d7 provide in=mation 9 a mann] t is culturally & l+ui/ically appropriate2 7#e7 e/abli% a hotl9e ?r\gh :i* individuals may rea* exp]ts ) que/ions ab\t access to insul91 & t-- 7,a7 is a #bd_/g real-"t hotl9e2 7,b7 provides voice & text support2 & 7,c7 is /aff$ by navigators or lic5s$ heal? c>e pr(essionals2 7#f7 provide guidance to hospitals on h[ to %>e ! website & hotl9e ) pati5ts2 & 7#g7 conduct public education activities1 9 collaboration ) ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 to raise aw>5ess ( ! availability ( all manufactur]1 f\ndational1 & o!r assi/ance programs available to pati5ts seek+ af=dable insul91 ) a focus on un9sur$ individuals2 includ+ by-- 7,a7 p>tn]+ ) community heal? c5t]s1 hospitals1 retail community ph>macies1 & community-bas$ organizations ) a focus on access to af=dable m$ic9e2 & 7,b7 work+ ) ,/ate & local heal? dep>tm5ts to t>get ! programs c>ri$ out us+ ! grant to und]s]v$ communities4 7d7 ,duties ( ! ,secret>y ,! ,secret>y %all-- 7#a7 ensure adequate ma9t5ance ( ! res\rce c5t] e/abli%$ by ! entity receiv+ a grant "u subsection 7a72 7#b7 publicize su* res\rce c5t] on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & across ,f$]al ag5cies1 z ! ,secret>y det]m9es appropriate2 & 7#c7 ensure t su* res\rce c5t] meets ! /&>ds "u subsection 7e71 & )draw ! grant & make an aw>d to a diff]5t eligible entity 9 ! case t an eligible entity fails to meet su* /&>ds4 7e7 ,/&>ds ,! ,secret>y %all e/abli% /&>ds = ! res\rce c5t] "u ?is section1 includ+ provisions to ensure t ! entity receiv+ a grant "u ?is section is qualifi$ to engage 9 ! activities describ$ 9 ?is section & to avoid conflicts ( int]e/4 ,"u su* /&>ds1 su* entity-- 7#a7 %all n-- 7,a7 be a manufactur] ( insul9 products2 or 7,b7 receive any consid]ation directly or indirectly f any manufactur] ( insul9 products 9 connection ) ! enrollm5t ( any individuals 9 an assi/ance program2 & 7#b7 %all provide in=mation t is fair1 accurate1 & imp>tial4 7f7 ,data collection & evaluations ,! ,secret>y may collect data & conduct evaluations ) respect to ! s]vices provid$ by ! res\rce c5t] describ$ 9 ?is section = purposes ( assess+ ! ext5t to :i* ! provision ( ! s]vices-- 7#a7 r$uces out ( pocket insul9 co/s = un9sur$ individuals2 7#b7 increases aw>5ess ( assi/ance programs or f\ndational support available = un9sur$ individuals2 & 7#c7 improves utilization ( ! res\rces describ$ 9 p>agraph 7#b7 by un9sur$ individuals4 7g7 ,reports to ,congress ,! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 & make publicly available1 annual reports on ! activities c>ri$ out "u ?is section1 includ+ any *anges 9 ! availability or scope ( assi/ance programs (f]$ by insul9 manufactur]s & in=mation ab\t ! numb] ( individuals :o use ! res\rce c5t]1 includ+ ! website or hotl9e4 7h7 ,def9itions ,9 ?is section-- 7#a7 ! t]m assi/ance program means a program to assi/ pati5ts 9 obta9+ a drug at a r$uc$ co/1 & includes ?ird-p>ty paym5ts1 f9ancial assi/ance1 disc\nts1 product v\*]s1 & o!r r$uctions 9 out-(-pocket exp5ses2 7#b7 ! t]m ,f$]ally-qualifi$ heal? c5t] has ! mean+ giv5 su* t]m 9 section #aije7l77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7l77#b772 7#c7 ! t]m insul9 means insul9 t is lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & cont9ues to be m>ket$ pursuant to su* lic5sure2 7#d7 ! t]m retail community ph>macy has ! mean+ giv5 su* t]m 9 section #aibg7k77#aj7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#aj772 & 7#e7 ! t]m un9sur$ individual means an individual :o is n enroll$ 9 cov]age "u a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f7771 ! heal? program e/abli%$ "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code1 or a gr\p heal? plan or gr\p heal? insurance cov]age 7z def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia774 7i7 ,fund+ ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #b1jjj1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjcb4 #f4 ,exp$it+ biosimil> competition 7a7 ,9 g5]al ,section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 is am5d$ by add+ at ! end ! foll[+3 7#aj7 ,exp$it+ biosimil> competition 7,a7 ,9 g5]al ,! ,secret>y may1 at ! reque/ ( ! sponsor ( an application "u ?is subsection = lic5sure ( a biosimil> biological product t is designat$ z a competitive biosimil> biological product pursuant to subp>agraph 7,b71 exp$ite ! developm5t & review ( su* application "u ?is subsection4 7,b7 ,designation process 7i7 ,reque/ ,! sponsor ( an application "u ?is subsection may reque/ ! ,secret>y to designate ! drug z a competitive biosimil> biological product4 ,a reque/ = su* designation may be made concurr5tly )1 or dur+ ! #fj-;day p]iod imm$iately prior to1 ! submission ( a biosimil> biological product lic5se application "u ?is subsection4 7ii7 ,crit]ia ,a biosimil> biological product is eligible = designation z a competitive biosimil> biological product "u ?is p>agraph if ! ,secret>y det]m9es t !re is inadequate biosimil> competition4 7iii7 ,designation ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u clause 7i71 ! ,secret>y may-- 7,i7 det]m9e :e!r ! biosimil> biological product t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 clause 7ii72 & 7,,ii7 if ! ,secret>y f9ds t su* product meets su* crit]ia1 designate ! biosimil> biological product z a competitive biosimil> biological product4 7,c7 ,inadequate biosimil> competition ,9 ?is p>agraph1 ! t]m inadequate biosimil> competition means t1 ) respect to a biological product lic5s$ "u subsection 7a7-- 7i7 on ! li/ publi%$ "u p>agraph 7#i77;,a7 7n includ+ biological products on ! discont9u$ section ( su* li/71 !re are few] ?an #c biological products lic5s$ "u ?is subsection pursuant to an application t uses su* biological product lic5s$ "u subsection 7a7 z a ref]5ce product2 & 7ii7 n less ?an #c ye>s h pass$ s9ce ! expiration ( all exclusivity p]iods applicable to su* biological product lic5s$ "u subsection 7a71 or applicable to a biosimil> biological product lic5s$ "u ?is subsection us+ su* biological product lic5s$ "u subsection 7a7 z a ref]5ce product1 includ+ any exclusivity p]iods "u-- 7,i7 p>agraph 7#f72 7,,ii7 p>agraph 7#g77;,a72 7,,iii7 section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7,,iv7 subsection 7m74 4