,i #aah? ,,congress #a/ ,session ,h4 ,r4 #dhie ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #bf1 #bjbc,mr4 ,pallone 7= himself1 ,mr4 ,neal1 & ,mr4 ,scott ( ,virg9ia7 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 am5d title ,,xi ( ! ,social ,security ,act to exp& ! drug price negotiation program1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,l[]+ ,drug ,co/s = ,am]ican ,families ,act4 #b4 ,exp&+ ! drug price negotiation program 7a7 ,increas+ ! numb] ( drugs subject to negotiation ,section #aaib7;a77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7;a77#d77 is am5d$ by /rik+ #bj ea* place x appe>s & ins]t+ #ej 9 ea* su* place4 7b7 ,expansion ( def9ition ( maximum fair price eligible individual ,section #aaia7;c77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7;c77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ 1 or a p>ticipant1 b5efici>y1 or enrollee :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or disp5s$ aft] su* select$ drug2 & 7#b7 9 subp>agraph 7,b71 by ins]t+ 1 or a p>ticipant1 b5efici>y1 or enrollee :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or adm9i/]$ aft] su* select$ drug4 7c7 ,application ( adm9i/rative proc$ures to new maximum fair price eligible individuals ,section #aaif7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#e7;a77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 maximum fair price eligible individuals n describ$ 9 subp>agraph 7,a7 or 7,b74 4 7d7 ,heal? insur] agreem5ts ,"p ,e ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f et seq47 is am5d$-- 7#a7 by r$esignat+ sections #aaig & #aaih z sections #aaih & #aaii1 respectively2 & 7#b7 by ins]t+ aft] section #aaif ! foll[+ new section3 #aaig4 ,volunt>y p>ticipation by o!r heal? plans 7a7 ,agreem5t ,to p>ticipate "u program 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 "u ! program "u ?is "p ! ,secret>y %all be treat$ z hav+ 9 effect an agreem5t ) a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod-- 7,a7 9 ! case su* select$ drug furni%$ or disp5s$ at a ph>macy or by mail ord] s]vice if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or disp5s$2 & 7,b7 9 ! case su* select$ drug furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli] if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,opt+ out ( agreem5t ,! ,secret>y %all n be treat$ z hav+ 9 effect an agreem5t "u ! program "u ?is "p ) a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod if su* a plan or issu] affirmatively elects1 ?r\gh a process specifi$ by ! ,secret>y1 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 7b7 ,publication ( election ,) respect to ea* price applicability p]iod & ea* select$ drug ) respect to su* p]iod1 ! ,secret>y & ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 z applicable1 %all make public a li/ ( ea* gr\p heal? plan & ea* heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 ) respect to :i* cov]age is provid$ "u su* plan or cov]age = su* drug1 t has elect$ "u subsection 7a7 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 4 7e7 ,application to gr\p heal? plans & heal? insurance cov]age 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 ,drug ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod = :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply-- 7,a7 9 ! case ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to su* plan or cov]age1 & to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ "u su* plan or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to p>ticipants1 b5efici>ies1 & enrollees enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 9 ! case ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to su* plan or cov]age1 & to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ "u su* plan or cov]age1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y1 to p>ticipants1 b5efici>ies1 & enrollees entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 su* p>ticipants1 b5efici>ies1 & enrollees s enroll$ 9 su* plans & cov]age1 & su* hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ 9 su* plans & cov]age4 7b7 ,notification reg>d+ nonp>ticipation 9 ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all publicly disclose1 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y1 any election made "u section #aaig ( ! ,social ,security ,act by su* plan or issu] to n p>ticipate 9 ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7#b7 ,,erisa 7,a7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaha et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gbf4 ,drug ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y ( ,heal? & ,human ,s]vices "u ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod = :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 9 ! case ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to su* plan or cov]age1 & to ! p>ticipants & b5efici>ies enroll$ "u su* plan or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to p>ticipants & b5efici>ies enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 9 ! case ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! gr\p heal? plan or cov]age (f]$ by an issu]1 to ! p>ticipants & b5efici>ies enroll$ "u su* plans or cov]age1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y ( ,heal? & ,human ,s]vices1 to p>ticipants & b5efici>ies entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 & su* p>ticipants & b5efici>ies s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,application to retiree & c]ta9 small gr\p heal? plans ,section #gcb7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaia;a7a77 is am5d$ by /rik+ section #gaa & ins]t+ sections #gaa & #gbf4 7,c7 ,cl]ical am5dm5t ,! table ( sections = subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by add+ at ! end ! foll[+3 ,sec4 #gbf4 ,drug ,price ,negotiation ,program & application ( maximum fair prices4 4 7#c7 ,,irc 7,a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihbf4 ,drug ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y ( ,heal? & ,human ,s]vices "u ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod = :i* cov]age is provid$ "u su* plan-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plan1 & to ! p>ticipants & b5efici>ies enroll$ "u su* plan dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to p>ticipants & b5efici>ies enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 if cov]age ( su* select$ drug is provid$ "u su* plan if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plan1 to ! p>ticipants & b5efici>ies enroll$ "u su* plan1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y ( ,heal? & ,human ,s]vices1 to p>ticipants & b5efici>ies entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan %all apply any co/-%>+ responsibilities "u su* plan1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan & su* p>ticipants & b5efici>ies s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,drug ,price ,negotiation ,program ,a gr\p heal? plan %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan to n p>ticipate 9 ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,application to retiree & c]ta9 small gr\p heal? plans ,section #ihca7;a77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ o!r ?an ) respect to section #ihbf1 be=e any gr\p heal? plan4 7,c7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbf4 ,drug ,price ,negotiation ,program & application ( maximum fair prices4 4 #c4 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket 7a7 ,"p ,b drugs 7#a7 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket ,section #ahdg;,a7i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7i77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a77i71 by /rik+ units & ins]t+ bill+ units2 7,b7 9 p>agraph 7#b77;,a71 by /rik+ = :i* paym5t is made "u ?is "p & ins]t+ t w\ld be payable "u ?is "p if su* drug 7 furni%$ to an individual enroll$ "u ?is "p2 & 7,c7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a77i71 by /rik+ units & ins]t+ bill+ units2 & 7ii7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,total numb] ( bill+ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( bill+ units ) respect to a "p ,b rebatable drug is det]m9$ z foll[s3 7i7 ,det]m9e ! total numb] ( units equal to-- 7,i7 ! total numb] ( units1 z report$ "u subsection 7c77#a77;,b7 = ea* ,national ,drug ,code ( su* drug dur+ ! cal5d> qu>t] t is two cal5d> qu>t]s prior to ! cal5d> qu>t] z describ$ 9 subp>agraph 7,a71 m9us 7,,ii7 ! total numb] ( units ) respect to ea* ,national ,drug ,code ( su* drug = :i* paym5t 0 made "u a ,/ate plan "u title ,,xix 7or waiv] ( su* plan71 z report$ by ,/ates "u section #aibg7;b77#b77;,a7 = ! rebate p]iod t is ! same cal5d> qu>t] z describ$ 9 subclause 7,i74 7ii7 ,conv]t ! units det]m9$ "u clause 7i7 to bill+ units = ! bill+ & paym5t code ( su* drug1 us+ a me?odology simil> to ! me?odology us$ "u ?is section1 by divid+ ! units det]m9$ "u clause 7i7 = ea* ,national ,drug ,code ( su* drug by ! bill+ unit = ! bill+ & paym5t code ( su* drug4 7iii7 ,compute ! sum ( ! bill+ units = ea* ,national ,drug ,code ( su* drug 9 clause 7ii74 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to cal5d> qu>t]s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 7b7 ,cov]$ "p ,d drugs 7#a7 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket ,section #ahfj;,d-#ad;,b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;b7 is am5d$-- 7,a7 9 subsection 7b7-- 7i7 9 p>agraph 7#a7-- 7,i7 9 subp>agraph 7,a77i71 by /rik+ ! total numb] ( units & all t foll[s ?r\gh ! semicolon & ins]t+ ! foll[+3 ! total numb] ( units t are us$ to calculate ! av]age manufactur] price ( su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug1 z report$ by ! manufactur] ( su* drug "u section #aibg = ea* mon?1 ) respect to su* p]iod22 & 7,,ii7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! ,secret>y %all exclude f ! total numb] ( units = a dosage =m & /r5g? ) respect to a "p ,d rebatable drug1 ) respect to an applicable p]iod1 ! foll[+3 7i7 ,units ( ea* dosage =m & /r5g? ( su* "p ,d rebatable drug = :i* paym5t 0 made "u a ,/ate plan "u title ,,xix 7or waiv] ( su* plan71 z report$ by ,/ates "u section #aibg7;b77#b77;,a74 7ii7 ,units ( ea* dosage =m & /r5g? ( su* "p ,d rebatable drug = :i* a rebate is paid "u section #ahdg;,a7i74 7iii7 ,beg9n+ ) plan ye> #bjbf1 units ( ea* dosage =m & /r5g? ( su* "p ,d rebatable drug = :i* ! manufactur] provides a disc\nt "u ! program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act4 2 & 7ii7 9 p>agraph 7#f71 by /rik+ in=mation4--,! ,secret>y & all t foll[s ?r\gh rebatable cov]$ "p ,d drug disp5s$ & ins]t+ ! foll[+3 ,,amp reports4--,! ,secret>y %all provide = a me?od & process "u :i*1 9 ! case ( a manufactur] ( a "p ,d rebatable drug t submits revisions to in=mation submitt$ "u section #aibg by ! manufactur] ) respect to su* drug2 & 7,b7 by /rik+ subsection 7d7 & ins]t+ ! foll[+3 7d7 ,in=mation ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all use in=mation submitt$ by manufactur]s "u section #aibg7;b77#c7 & in=mation submitt$ by ,/ates "u section #aibg7;b77#b77;,a74 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to applicable p]iods 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;b7g77#g777 beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4