,,ii #aai? ,,congress #a/ ,session ,s4 #bgef ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,septemb] #aj1 #bjbe,ms4 ,alsobrooks 7= h]self & ,mr4 ,van ,holl57 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xxvii ( ! ,public ,heal? ,s]vice ,act1 ! ,int]nal ,rev5ue ,code ( #aihf1 & ! ,employee ,retirem5t ,income ,security ,act ( #aigd to r$uce pati5t co/-%>+ = prescription drug inhal] products us$ to treat brea?+ disord]s su* z a/hma & *ronic ob/ructive pulmon>y disease1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,af=dable ,inhal]s & ,nebuliz]s ,act ( #bjbe4 #b4 ,r$uc+ pati5t co/-%>+ = prescription drug inhal] products us$ to treat brea?+ disord]s su* z a/hma & *ronic ob/ructive pulmon>y disease 7a7 ,cov]age & co/-,%>+ requirem5ts 7#a7 ,private insurance 7,a7 ,,phsa ,"p ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,cov]age & co/-%>+ requirem5ts = specifi$ inhal] products 7a7 ,9 g5]al ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 %all provide b5efits "u su* plan or cov]age 7z applicable7 = all specifi$ inhal] products &1 ) respect to su* a product1 may n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ requirem5t 9 excess ( #ae p] #cj-;day supply ( su* product4 7b7 ,c\nt+ co/-,%>+ t[>ds d$uctible & out-(-,pocket maximum ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 %all c\nt any co/-%>+ requirem5t describ$ 9 subsection 7a77#b7 incurr$ by a p>ticipant1 b5efici>y1 or enrollee ( su* plan or cov]age ) respect to a specifi$ inhal] product t[>ds any out-(-pocket maximum & any d$uctible t1 b = application ( subsection 7a71 w\ld h appli$ to su* p>ticipant1 b5efici>y1 or enrollee ) respect to su* product4 7c7 ,specifi$ inhal] product def9$ ,= purposes ( ?is section1 ! t]m specifi$ inhal] product means any ma9t5ance or reliev] or rescue inhalation drug 7includ+ inhalation a]osols1 met]$ dose inhal]s1 dry p[d] inhal]s1 inhalation solutions1 bron*odilators1 & cortico/]oids7 ) a m$ically accept$ indication 7z def9$ 9 section #aibg7k77#f7 ( ! ,social ,security ,act7 = ! treatm5t = lung diseases su* z a/hma & *ronic ob/ructive pulmon>y disease4 ,su* t]m includes any equipm5t us$ 9 ! adm9i/ration ( su* drug 7su* z masks & tub+1 spac]s1 nebuliz]s1 & valve-hold+ *amb]s74 4 7,b7 ,,irc 7i7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihbf4 ,cov]age & co/-%>+ requirem5ts = specifi$ inhal] products 7a7 ,9 g5]al ,a gr\p heal? plan %all provide b5efits "u su* plan = all specifi$ inhal] products &1 ) respect to su* a product1 may n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ requirem5t 9 excess ( #ae p] #cj-;day supply ( su* product4 7b7 ,c\nt+ co/-,%>+ t[>ds d$uctible & out-(-,pocket maximum ,a gr\p heal? plan %all c\nt any co/-%>+ requirem5t describ$ 9 subsection 7a77#b7 incurr$ by a p>ticipant or b5efici>y ( su* plan ) respect to a specifi$ inhal] product t[>ds any out-(-pocket maximum & any d$uctible t1 b = application ( subsection 7a71 w\ld h appli$ to su* p>ticipant or b5efici>y ) respect to su* product4 7c7 ,specifi$ inhal] product def9$ ,= purposes ( ?is section1 ! t]m specifi$ inhal] product means any ma9t5ance or reliev] or rescue inhalation drug 7includ+ inhalation a]osols1 met]$ dose inhal]s1 dry p[d] inhal]s1 inhalation solutions1 bron*odialators1 & cortico/]oids7 ) a m$ically accept$ indication 7z def9$ 9 section #aibg7k77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifd-h7k77#f777 = ! treatm5t ( a/hma or ( *ronic ob/ructive pulmon>y disease4 ,su* t]m includes any equipm5t us$ 9 ! adm9i/ration ( su* drug 7su* z masks & tub+1 spac]s1 nebuliz]s1 & valve-hold+ *amb]s74 4 7ii7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbf4 ,cov]age & co/-%>+ requirem5ts = specifi$ inhal] products4 4 7,c7 ,,erisa 7i7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by add+ at ! end ! foll[+ new section3 #gbf4 ,cov]age & co/-%>+ requirem5ts = specifi$ inhal] products 7a7 ,9 g5]al ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 %all provide b5efits "u su* plan or cov]age 7z applicable7 = all specifi$ inhal] products &1 ) respect to su* a product1 may n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ requirem5t 9 excess ( #ae p] #cj-;day supply ( su* product4 7b7 ,c\nt+ co/-,%>+ t[>ds d$uctible & out-(-,pocket maximum ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 %all c\nt any co/-%>+ requirem5t describ$ 9 subsection 7a77#b7 incurr$ by a p>ticipant or b5efici>y ( su* plan ) respect to a specifi$ inhal] product t[>ds any out-(-pocket maximum & any d$uctible t1 b = application ( subsection 7a71 w\ld h appli$ to su* p>ticipant or b5efici>y ) respect to su* product4 7c7 ,specifi$ inhal] product def9$ ,= purposes ( ?is section1 ! t]m specifi$ inhal] product means any ma9t5ance or reliev] or rescue inhalation drug 7includ+ inhalation a]osols1 met]$ dose inhal]s1 dry p[d] inhal]s1 inhalation solutions1 bron*odialators1 & cortico/]oids7 ) a m$ically accept$ indication 7z def9$ 9 section #aibg7k77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifd-h7k77#f777 = ! treatm5t ( a/hma or ( *ronic ob/ructive pulmon>y disease4 ,su* t]m includes any equipm5t us$ 9 ! adm9i/ration ( su* drug 7su* z masks & tub+1 spac]s1 nebuliz]s1 & valve-hold+ *amb]s74 4 7ii7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja note7 is am5d$ by ins]t+ aft] ! item relat+ to section #gbe ! foll[+ new item3 ,sec4 #gbf4 ,cov]age & co/-%>+ requirem5ts = specifi$ inhal] products4 4 7,d7 ,con=m+ am5dm5ts 7i7 ,,hdhp safe h>bor ,section #bbc7;c77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,i7 ,safe h>bor = abs5ce ( d$uctible = specifi$ inhal] products ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 a plan %all n fail to be treat$ z a high d$uctible heal? plan by reason ( fail+ to h a d$uctible = specifi$ inhal] products 7z def9$ 9 section #bgii;,a-#aa ( ! ,public ,heal? ,s]vice ,act74 4 7ii7 ,cata/rophic plan safe h>bor ,section #acjb7;e77#a77;,b77i7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;e77#a77;,b77i77 is am5d$ by ins]t+ or #bgii;,a-#aa ( ! ,public ,heal? ,s]vice ,act aft] section #bgac4 7,e7 ,effective date ,! am5dm5ts made by ?is p>agraph %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf4 7#b7 ,m$ic>e 7,a7 ,"p ,b ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7i7 9 subsection 7a77#a77,s7-- 7,i7 9 clause 7i71 by ins]t+ or 7iii7 aft] clause 7ii72 & 7,,ii7 by add+ at ! end ! foll[+ new clause3 & 7iii7 ) respect to a specifi$ inhal] product 7z def9$ 9 section #bgii;,a-#aa ( ! ,public ,heal? ,s]vice ,act7 furni%$ on or aft] ,janu>y #a1 #bjbf1 ! am\nts paid %all be #ajj p]c5t ( ! less] ( ! actual *>ge or ! paym5t am\nt e/abli%$ 9 section #ahdb7o7 7or1 if applicable1 "u section #ahdg1 #ahdg;,a1 or #ahdg;,b71 less1 p] #cj-;day supply ( su* product1 #ae12 & 7ii7 9 subsection 7b71 9 ! fir/ s5t5ce-- 7,i7 9 p>agraph 7#ab71 by /rik+ 1 &2 & 7,,ii7 by /rik+ 44 & ins]t+ 1 & 7#ad7 su* d$uctible %all n apply ) respect to a specifi$ inhal] product 7z def9$ 9 section #bgii;,a-#aa ( ! ,public ,heal? ,s]vice ,act7 furni%$ on or aft] ,janu>y #a1 #bjbf44 7,b7 ,"p ,d 7i7 ,9 g5]al ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is am5d$-- 7,i7 9 p>agraph 7#a77;,a71 by /rik+ p>agraphs 7#h7 & 7#i7 & ins]t+ p>agraphs 7#h71 7#i71 & 7#aj72 7,,ii7 9 p>agraph 7#b77;,a71 by /rik+ p>agraphs 7#h7 & 7#i7 & ins]t+ p>agraphs 7#h71 7#i71 & 7#aj72 7,,iii7 9 p>agraph 7#d77;,a77i71 by /rik+ p>agraphs 7#h7 & 7#i7 & ins]t+ p>agraphs 7#h71 7#i71 & 7#aj72 & 7,,iv7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,treatm5t ( co/-%>+ = specifi$ inhal] products 7,a7 ,no application ( d$uctible ,= plan ye> #bjbf & subsequ5t plan ye>s1 ! d$uctible "u p>agraph 7#a7 %all n apply ) respect to any specifi$ inhal] product4 7,b7 ,application ( co/-%>+ ,= plan ye> #bjbf & subsequ5t plan ye>s1 ! cov]age provides b5efits = any specifi$ inhal] product ) co/-%>+ = a mon?'s supply t does n exce$ #ae4 7,c7 ,def9ition ,= purposes ( ?is p>agraph1 ! t]m specifi$ inhal] product has ! mean+ giv5 su* t]m 9 section #bgii;,a-#aa ( ! ,public ,heal? ,s]vice ,act4 4 7ii7 ,con=m+ am5dm5t = alt]native prescription drug cov]age ,section #ahfj;,d-#b7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,treatm5t ( co/-%>+ = specifi$ insul9 products ,! cov]age 9 provid$ 9 accordance ) subsection 7b77#aj74 4 7iii7 ,con=m+ am5dm5ts to co/-%>+ = l[-income individuals ,section #ahfj;,d-#ad7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#a77 is am5d$-- 7,i7 9 subp>agraph 7,d77iii71 by add+ at ! end ! foll[+ new s5t5ce3 ,= plan ye> #bjbf & subsequ5t plan ye>s1 ! copaym5t am\nt applicable "u ! prec$+ s5t5ce to a mon?'s supply ( a specifi$ inhal] product 7z def9$ 9 section #ahfj;,d-#b7;b77#aj77 disp5s$ to ! individual may n exce$ #ae42 & 7,,ii7 9 subp>agraph 7,e71 by ins]t+ or "u section #ahfj;,d-#b7;b77#aj7 9 ! case ( a specifi$ inhal] product 7z def9$ 9 su* section7 aft] 7z def9$ 9 subp>agraph 7,c7 ( su* section74 7b7 ,paym5t program = un9sur$ individuals ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #cii,v-#h4 ,specifi$ inhal] product paym5t program 7a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% a program "u :i*-- 7#a7 program-regi/]$ provid]s submit claims to ! ,secret>y ) respect to ! furni%+ ( specifi$ inhal] products 7z def9$ 9 subsection 7b77 to un9sur$ individuals2 & 7#b7 ! ,secret>y1 subject to ! availability ( appropriations1 pays ea* su* provid] = su* products 9 an am\nt det]m9$ appropriate by ! ,secret>y4 7b7 ,def9itions ,9 ?is section3 7#a7 ,program-regi/]$ provid] ,! t]m program-regi/]$ provid] means a heal? c>e provid] t-- 7,a7 is lic5s$ or o!rwise au?oriz$ to adm9i/] or disp5se specifi$ inhal] products 9 ! ,/ate 9 :i* su* provid] s adm9i/]s or disp5ses su* products "u ! program e/abli%$ "u ?is section2 & 7,b7 ent]s into an agreem5t ) ! ,secret>y "u :i* ! provid] agrees n to hold an un9sur$ individual liable = ! co/ ( any su* product adm9i/]$ or disp5s$ to su* individual 9 an am\nt exce$+ #ae = a mon?'s supply ( su* product if a paym5t is made "u subsection 7a77#b7 ) respect to su* product s adm9i/]$ or disp5s$4 7#b7 ,specifi$ inhal] product ,! t]m specifi$ inhal] product has ! mean+ giv5 su* t]m 9 section #bgii;,a-#aa4 7#c7 ,un9sur$ individual ,! t]m un9sur$ individual means1 ) respect to an individual furni%$ a specifi$ inhal] product1 an individual :o is n enroll$ 9-- 7,a7 a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act72 7,b7 a gr\p heal? plan or heal? insurance cov]age (f]$ by a heal? insurance issu] 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia72 or 7,c7 a heal? plan (f]$ "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code4 4 7c7 ,implem5tation ,! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction1 subregulatory guidance1 or o!rwise4