,,ii ,cal5d> ,no4 #ebc #aaf? ,,congress #b;d ,session ,h4 ,r4 #adbe ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #cj1 #bjbj,receiv$ ,augu/ #ac1 #bjbj ,read ! fir/ "t ,septemb] #h1 #bjbj,read ! second "t & plac$ on ! cal5d> ,,an ,,act ,to am5d ! ,pati5t ,protection & ,af=dable ,c>e ,act to provide = a ,improve ,heal? ,insurance ,af=dability ,fund to provide = c]ta9 re9surance paym5ts to l[] premiums 9 ! individual heal? insurance m>ket4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pati5t ,protection & ,af=dable ,c>e ,enhancem5t ,act4 #b4 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4,sec4 #b4 ,table ( cont5ts4,title ,i--,l[]+ ,heal? ,c>e ,co/s & ,protect+ ,p ) ,preexi/+ ,conditions,sec4 #aja4 ,improv+ af=dability by exp&+ premium assi/ance = consum]s4,sec4 #ajb4 ,improv+ af=dability by r$uc+ out-(-pocket & premium co/s = consum]s4,sec4 #ajc4 ,exp&+ af=dability = work+ families to fix ! family glit*4,sec4 #ajd4 ,tax cr$it reconciliation protections = individuals receiv+ social security lump-sum paym5ts4,sec4 #aje4 ,pres]v+ ,/ate option to implem5t heal? c>e ,m>ketplaces4,sec4 #ajf4 ,e/abli%+ a ,heal? ,insurance ,af=dability ,fund4,sec4 #ajg4 ,resc9d+ ! %ort-t]m limit$ duration insurance regulation4,sec4 #ajh4 ,revok+ section #accb guidance4,sec4 #aji4 ,requir+ ,m>ketplace outrea*1 educational activities1 & annual enrollm5t t>gets4,sec4 #aaj4 ,report on effects ( website ma9t5ance dur+ op5 enrollm5t4,sec4 #aaa4 ,promot+ consum] outrea* & education4,sec4 #aab4 ,improv+ transp>5cy & acc\ntability 9 ! ,m>ketplace4,sec4 #aac4 ,improv+ aw>5ess ( heal? cov]age options4,sec4 #aad4 ,promot+ ,/ate innovations to exp& cov]age4,sec4 #aae4 ,/r5g!n+ network adequacy4,sec4 #aaf4 ,protect+ consum]s f unreasonable rate hikes4,sec4 #aag4 ,eligibility ( ,,daca recipi5ts = qualifi$ heal? plans (f]$ ?r\gh ,ex*anges4,title ,,ii--,enc\rag+ ,m$icaid ,expansion & ,/r5g!n+ ! ,m$icaid ,program,sec4 #bja4 ,inc5tiviz+ ,m$icaid expansion4,sec4 #bjb4 ,provid+ #ab-mon?s ( cont9u\s eligibility = ,m$icaid & ,,*ip4,sec4 #bjc4 ,m&atory #ab-mon?s ( po/p>tum ,m$icaid eligibility4,sec4 #bjd4 ,r$uc+ ! adm9i/rative ,,fmap = nonexpansion ,/ates4,sec4 #bje4 ,enhanc$ report+ requirem5ts = nonexpansion /ates4,sec4 #bjf4 ,prim>y c>e pay increase4,sec4 #bjg4 ,p]man5t fund+ = ,,*ip4,sec4 #bjh4 ,p]man5t ext5sion ( ,,*ip enrollm5t & quality measures4,sec4 #bji4 ,/ate option to increase *ildr5's eligibility = ,m$icaid & ,,*ip4,sec4 #baj4 ,m$icaid cov]age = citiz5s ( ,freely ,associat$ ,/ates4,sec4 #baa4 ,ext5sion ( full ,f$]al m$ical assi/ance p]c5tage to ,indian heal? c>e provid]s4,title ,,iii--,l[]+ ,prices ,?r\gh ,fair ,drug ,price ,negotiation,sec4 #cja4 ,e/abli%+ a ,fair ,drug ,pric+ ,program4,sec4 #cjb4 ,drug manufactur] excise tax = noncompliance4,sec4 #cjc4 ,fair ,price ,negotiation ,implem5tation ,fund4,title ,,iv--,public ,heal? ,investments,sec4 #dja4 ,support+ increas$ innovation4 ,i ,l[]+ ,heal? ,c>e ,co/s & ,protect+ ,p ) ,preexi/+ ,conditions #aja4 ,improv+ af=dability by exp&+ premium assi/ance = consum]s 7a7 ,9 g5]al ,section #cf;,b7b77#c77;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 7,a7 ,applicable p]c5tage ,! applicable p]c5tage = any taxable ye> %all be ! p]c5tage su* t ! applicable p]c5tage = any taxpay] ^: h\sehold income is )9 an income ti] specifi$ 9 ! foll[+ table %all increase1 on a slid+ scale 9 a l9e> mann]1 f ! initial premium p]c5tage to ! f9al premium p]c5tage specifi$ 9 su* table = su* income ti]3 ,9 ! case ( h\sehold income 7express$ z a p]c5t ( pov]ty l9e7 )9 ! foll[+ income ti]3,! initial premiump]c5tage is--,! f9al premium p]c5tage is--,up to #aej4j p]c5t#j4jj4jaej4j p]c5t up to #bjj4j p]c5t#j4jc4jbjj4j p]c5t up to #bej4j p]c5t#c4jd4jbej4j p]c5t up to #cjj4j p]c5t#d4jf4jcjj4j p]c5t up to #djj4j p]c5t#f4jh4edjj4j p]c5t & high]#h4eh4e 4 7b7 ,con=m+ am5dm5t ,section #cf;,b7c77#a77;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ b does n exce$ #djj p]c5t4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 #ajb4 ,improv+ af=dability by r$uc+ out-(-pocket & premium co/s = consum]s ,section #acjb7;c77#d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;c77#d77 is am5d$ by /rik+ cal5d> ye>7 & ins]t+ cal5d> ye>1 bas$ on e/imates & projections = ! applicable cal5d> ye> ( ! p]c5tage 7if any7 by :i* ! av]age p] enrollee premium = eligible employ]-sponsor$ heal? plans 7z def9$ 9 section #ejjj;,a7f77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 exce$s su* av]age p] enrollee premium = ! prec$+ cal5d> ye>1 z publi%$ 9 ! ,national ,heal? ,exp5diture ,acc\nts74 #ajc4 ,exp&+ af=dability = work+ families to fix ! family glit* 7a7 ,9 g5]al ,clause 7i7 ( section #cf;,b7c77#b77;,c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 7i7 ,cov]age mu/ be af=dable 7,i7 ,employees ,an employee %all n be treat$ z eligible = m9imum ess5tial cov]age if su* cov]age consi/s ( an eligible employ]-sponsor$ plan 7z def9$ 9 section #ejjj;,a7f77#b77 & ! employee's requir$ contribution 7)9 ! mean+ ( section #ejjj;,a7e77#a77;,b77 ) respect to ! plan exce$s #i4e p]c5t ( ! employee's h\sehold income4 7,,ii7 ,family memb]s ,an individual :o is eligible to enroll 9 an eligible employ]-sponsor$ plan 7z def9$ 9 section #ejjj;,a7f77#b77 by reason ( a relation%ip ! individual be>s to ! employee %all n be treat$ z eligible = m9imum ess5tial cov]age by reason ( su* eligibility to enroll if ! employee's requir$ contribution 7)9 ! mean+ ( section #ejjj;,a7e77#a77;,b71 det]m9$ by sub/itut+ family = self-only7 ) respect to ! plan exce$s #i4e p]c5t ( ! employee's h\sehold income4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,clause 7ii7 ( section #cf;,b7c77#b77;,c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,except z provid$ 9 clause 7iii71 an employee & ins]t+ ,an individual4 7#b7 ,clause 7iii7 ( section #cf;,b7c77#b77;,c7 ( su* ,code is am5d$ by /rik+ ! la/ s5t5ce ( clause 7i7 & ins]t+ clause 7i77,,ii74 7#c7 ,clause 7iv7 ( section #cf;,b7c77#b77;,c7 ( su* ,code is am5d$ by /rik+ ! #i4e p]c5t "u clause 7i77,,ii7 & ins]t+ ! #i4e p]c5t "u clauses 7i77,i7 & 7i77,,ii74 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjba4 #ajd4 ,tax cr$it reconciliation protections = individuals receiv+ social security lump-sum paym5ts 7a7 ,9 g5]al ,section #cf;,b7d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,exclusion ( portion ( lump-sum social security b5efits 7i7 ,9 g5]al ,! t]m modifi$ adju/$ gross income %all n include s mu* ( any lump-sum social security b5efit paym5t z is attributable to mon?s end+ be=e ! beg9n+ ( ! taxable ye>4 7ii7 ,lump-sum social security b5efit paym5t ,= purposes ( ?is subp>agraph1 ! t]m lump-sum social security b5efit paym5t means any paym5t ( social security b5efits 7z def9$ 9 section #hf7;d77#a77 :i* con/itutes m ?an #a mon? ( su* b5efits4 7iii7 ,election to include excludable am\nt ,a taxpay] may elect 7at su* "t & 9 su* mann] z ! ,secret>y may provide7 to h ?is subp>agraph n apply = any taxable ye>4 4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 #aje4 ,pres]v+ ,/ate option to implem5t heal? c>e ,m>ketplaces 7a7 ,9 g5]al ,section #acaa ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#d77;,b71 by /rik+ "u ?is subsection & ins]t+ "u ?is p>agraph or p>agraph 7#a72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,additional plann+ & e/abli%m5t grants 7,a7 ,9 g5]al ,!re %all be appropriat$ to ! ,secret>y1 out ( any moneys 9 ! ,treasury n o!rwise appropriat$1 #bjj million to aw>d grants to eligible ,/ates = ! uses describ$ 9 p>agraph 7#c74 7,b7 ,duration & r5ewability ,a grant aw>d$ "u subp>agraph 7,a7 %all be = a p]iod ( #b ye>s & may n be r5ew$4 7,c7 ,limitation ,a grant may n be aw>d$ "u subp>agraph 7,a7 aft] ,decemb] #ca1 #bjbc4 7,d7 ,eligible ,/ate def9$ ,= purposes ( ?is p>agraph1 ! t]m eligible ,/ate means a ,/ate t1 z ( ! date ( ! enactm5t ( ?is p>agraph1 is n op]at+ an ,ex*ange 7o!r ?an an ,ex*ange describ$ 9 section #aee4bjj7;f7 ( title #de1 ,code ( ,f$]al ,regulations74 2 & 7#b7 9 subsection 7d77#e77;,a7-- 7,a7 by /rik+ op]ations4--,9 e/abli%+ an ,ex*ange "u ?is section & ins]t+ op]ations4-- 7i7 ,9 g5]al ,9 e/abli%+ an ,ex*ange "u ?is section 7o!r ?an 9 e/abli%+ an ,ex*ange pursuant to a grant aw>d$ "u subsection 7a77#f77 2 & 7,b7 by add+ at ! end ! foll[+3 7ii7 ,additional plann+ & e/abli%m5t grants ,9 e/abli%+ an ,ex*ange pursuant to a grant aw>d$ "u subsection 7a77#f71 ! ,/ate %all ensure t su* ,ex*ange is self-su/a9+ beg9n+ on ,janu>y #a1 #bjbe1 includ+ all[+ ! ,ex*ange to *>ge assessm5ts or us] fees to p>ticipat+ heal? insurance issu]s1 or to o!rwise g5]ate fund+1 to support its op]ations4 4 7b7 ,cl>ification reg>d+ failure to e/abli% ,ex*ange or implem5t requirem5ts ,section #acba7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjda7;c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ ,if & ins]t+ ,subject to p>agraph 7#c71 if2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,cl>ification ,?is subsection %all n apply 9 ! case ( a ,/ate t elects to apply ! requirem5ts describ$ 9 subsection 7a7 & satisfies ! requirem5t describ$ 9 subsection 7b7 on or aft] ,janu>y #a1 #bjad4 4 #ajf4 ,e/abli%+ a ,heal? ,insurance ,af=dability ,fund ,subtitle ,d ( title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act is am5d$ by ins]t+ aft] "p #e 7#db ,u4,s4,c4 #ahjfa et seq47 ! foll[+ new "p3 #f ,improve ,heal? ,insurance ,af=dability ,fund #acea4 ,e/abli%m5t ( program ,!re is h]eby e/abli%$ ! ,improve ,heal? ,insurance ,af=dability ,fund to be adm9i/]$ by ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 79 ?is section ref]r$ to z ! ,adm9i/rator71 to provide fund+1 9 accordance ) ?is "p1 to ! #ej ,/ates & ! ,di/rict ( ,columbia 7ea* ref]r$ to 9 ?is section z a ,/ate7 beg9n+ on ,janu>y #a1 #bjbb1 = ! purposes describ$ 9 section #aceb4 #aceb4 ,use ( funds 7a7 ,9 g5]al ,a ,/ate %all use ! funds allocat$ to ! ,/ate "u ?is "p = "o ( ! foll[+ purposes3 7#a7 ,to provide re9surance paym5ts to heal? insurance issu]s ) respect to individuals enroll$ "u individual heal? insurance cov]age 7o!r ?an ?r\gh a plan describ$ 9 subsection 7b77 (f]$ by su* issu]s4 7#b7 ,to provide assi/ance 7o!r ?an ?r\gh paym5ts describ$ 9 p>agraph 7#a77 to r$uce out-(-pocket co/s1 su* z copaym5ts1 co9surance1 premiums1 & d$uctibles1 ( individuals enroll$ "u qualifi$ heal? plans (f]$ on ! individual m>ket ?r\gh an ,ex*ange4 7b7 ,exclusion ( c]ta9 gr&fa!r$ & transitional plans ,= purposes ( subsection 7a71 a plan describ$ 9 ?is subsection is ! foll[+3 7#a7 ,a gr&fa!r$ heal? plan 7z def9$ 9 section #abea74 7#b7 ,a plan 7commonly ref]r$ to z a transitional plan7 cont9u$ "u ! lett] issu$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices on ,novemb] #ad1 #bjac1 to ! ,/ate ,insurance ,commission]s outl9+ a transitional policy = cov]age 9 ! individual & small gr\p m>kets to :i* section #abea does n apply1 & "u ! ext5sion ( ! transitional policy = su* cov]age set =? 9 ! ,insurance ,/&>ds ,bullet9 ,s]ies guidance issu$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices on ,m>* #e1 #bjad1 ,febru>y #bi1 #bjaf1 ,febru>y #ac1 #bjag1 ,april #i1 #bjah1 ,m>* #be1 #bjai1 & ,janu>y #ca1 #bjbj1 or "u any subsequ5t ext5sions !re(4 7#c7 ,/ud5t heal? insurance cov]age 7z def9$ 9 section #adg4ade ( title #de1 ,code ( ,f$]al ,regulations74 #acec4 ,/ate eligibility & approval2 ,default safegu>d 7a7 ,enc\rag+ ,/ate options = allocations 7#a7 ,9 g5]al ,to be eligible = an allocation ( funds "u ?is "p = a ye> 7beg9n+ ) #bjbb71 a ,/ate %all submit to ! ,adm9i/rator an application at su* "t 7b1 9 ! case ( allocations = #bjbb1 n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is "p &1 9 ! case ( allocations = a subsequ5t ye>1 n lat] ?an ,m>* #a ( ! previ\s ye>7 & 9 su* =m & mann] z specifi$ by ! ,adm9i/rator conta9+-- 7,a7 a description ( h[ ! funds w be us$2 & 7,b7 su* o!r in=mation z ! ,adm9i/rator may require4 7#b7 ,automatic approval ,an application s submitt$ is approv$ unless ! ,adm9i/rator notifies ! ,/ate submitt+ ! application1 n lat] ?an #fj days aft] ! date ( ! submission ( su* application1 t ! application has be5 d5i$ = n be+ 9 compliance ) any requirem5t ( ?is "p & ( ! reason = su* d5ial4 7#c7 #e-ye> application approval ,if an application ( a ,/ate is approv$ = a purpose describ$ 9 section #aceb = a ye>1 su* application %all be treat$ z approv$ = su* purpose = ea* ( ! subsequ5t #d ye>s4 7#d7 ,revocation ( approval ,! approval ( an application ( a ,/ate1 ) respect to a purpose describ$ 9 section #aceb1 may be revok$ if ! ,/ate fails to use funds provid$ to ! ,/ate "u ?is section = su* purpose or o!rwise fails to comply ) ! requirem5ts ( ?is section4 7b7 ,default ,f$]al safegu>d 7#a7 #bjbb ,= #bjbb1 9 ! case ( a ,/ate t does n submit an application "u subsection 7a7 by ! #ij-;day submission date applicable to su* ye> "u subsection 7a77#a7 & 9 ! case ( a ,/ate t does submit su* an application by su* date t is n approv$1 ! ,adm9i/rator1 9 consultation ) ! ,/ate insurance commission]1 %all1 f ! am\nt calculat$ "u p>agraph 7#d7 = su* ye>1 c>ry out ! purpose describ$ 9 p>agraph 7#c7 9 su* ,/ate = su* ye>4 7#b7 #bjbc & subsequ5t ye>s ,= #bjbc or a subsequ5t ye>1 9 ! case ( a ,/ate t does n h 9 effect an approv$ application "u ?is section = su* ye>1 ! ,adm9i/rator1 9 consultation ) ! ,/ate insurance commission]1 %all1 f ! am\nt calculat$ "u p>agraph 7#d7 = su* ye>1 c>ry out ! purpose describ$ 9 p>agraph 7#c7 9 su* ,/ate = su* ye>4 7#c7 ,specifi$ use ,! am\nt describ$ 9 p>agraph 7#d71 ) respect to #bjbb or a subsequ5t ye>1 %all be us$ to c>ry out ! purpose describ$ 9 section #aceb7;a77#a7 9 ea* ,/ate describ$ 9 p>agraph 7#a7 or 7#b7 = su* ye>1 z applicable1 by provid+ re9surance paym5ts to heal? insurance issu]s ) respect to atta*m5t range claims 7z def9$ 9 section #aced7;b77#b771 us+ ! doll> am\nts specifi$ 9 subp>agraph 7,b7 ( su* section = su* ye>7 9 an am\nt equal to1 subject to p>agraph 7#e71 ! p]c5tage 7specifi$ = su* ye> by ! ,secret>y "u su* subp>agraph7 ( ! am\nt ( su* claims4 7#d7 ,am\nt describ$ ,! am\nt describ$ 9 ?is p>agraph1 ) respect to #bjbb or a subsequ5t ye>1 is ! am\nt equal to ! total sum ( am\nts t ! ,secret>y w\ld o!rwise e/imate "u section #aced7;b77#b77;,a77i7 = su* ye> = ea* ,/ate describ$ 9 p>agraph 7#a7 or 7#b7 = su* ye>1 z applicable1 if ea* su* ,/ate 7 n s describ$ = su* ye>4 7#e7 ,adju/m5t ,= purposes ( ?is subsection1 ! ,secret>y may apply a p]c5tage "u p>agraph 7#c7 ) respect to a ye> t is less ?an ! p]c5tage o!rwise specifi$ 9 section #aced7;b77#b77;,b7 = su* ye>1 if ! co/ ( pay+ ! total eligible atta*m5t range claims = ,/ates describ$ 9 ?is subsection = su* ye> at su* p]c5tage o!rwise specifi$ w\ld exce$ ! am\nt calculat$ "u p>agraph 7#d7 = su* ye>4 #aced4 ,allocations 7a7 ,appropriation ,= ! purpose ( provid+ allocations = ,/ates "u subsection 7b7 & paym5ts "u section #acec7;b7 !re is appropriat$1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #aj1jjj1jjj1jjj = #bjbb & ea* subsequ5t ye>4 7b7 ,allocations 7#a7 ,paym5t 7,a7 ,9 g5]al ,f am\nts appropriat$ "u subsection 7a7 = a ye>1 ! ,secret>y %all1 ) respect to a ,/ate n describ$ 9 section #acec7;b7 = su* ye> & n lat] ?an ! date specifi$ "u subp>agraph 7,b7 = su* ye>1 allocate = su* ,/ate ! am\nt det]m9$ = su* ,/ate & ye> "u p>agraph 7#b74 7,b7 ,specifi$ date ,= purposes ( subp>agraph 7,a71 ! date specifi$ 9 ?is subp>agraph is-- 7i7 = #bjbb1 ! date t is #de days aft] ! date ( ! enactm5t ( ?is "p2 & 7ii7 = #bjbc or a subsequ5t ye>1 ,janu>y #a ( ! respective ye>4 7,c7 ,notifications ( allocation am\nts ,= #bjbc & ea* subsequ5t ye>1 ! ,secret>y %all notify ea* ,/ate ( ! am\nt det]m9$ = su* ,/ate "u p>agraph 7#b7 = su* ye> by n lat] ?an ,janu>y #a ( ! previ\s ye>4 7#b7 ,allocation am\nt det]m9ations 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! am\nt det]m9$ "u ?is p>agraph = a ye> = a ,/ate describ$ 9 p>agraph 7#a77;,a7 = su* ye> is ! am\nt equal to-- 7i7 ! am\nt t ! ,secret>y e/imates w\ld be exp5d$ "u ?is "p = su* ye> on atta*m5t range claims ( individuals resid+ 9 su* ,/ate if su* ,/ate us$ su* funds only = ! purpose describ$ 9 p>agraph 7#a7 ( section #aceb7;a7 at ! doll> am\nts & p]c5tage specifi$ "u subp>agraph 7,b7 = su* ye>2 m9us 7ii7 ! am\nt1 if any1 by :i* ! ,secret>y det]m9es-- 7,i7 ! e/imat$ am\nt ( premium tax cr$its "u section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf t w\ld be attributable to individuals resid+ 9 su* ,/ate = su* ye> )\t application ( ?is "p2 exce$s 7,,ii7 ! e/imat$ am\nt ( premium tax cr$its "u section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf t w\ld be attributable to individuals resid+ 9 su* ,/ate = su* ye> if su* ,/ate 7 a ,/ate describ$ 9 section #acec7;b7 = su* ye>4 ,= purposes ( ! previ\s s5t5ce & section #acec7;b77#c71 ! t]m atta*m5t range claims means1 ) respect to an individual1 ! claims = su* individual t exce$ a doll> am\nt specifi$ by ! ,secret>y = a ye>1 b d n exce$ a ceil+ doll> am\nt specifi$ by ! ,secret>y = su* ye>1 "u subp>agraph 7,b74 7,b7 ,specifications ,= purposes ( subp>agraph 7,a7 & section #acec7;b77#c71 ! ,secret>y %all det]m9e ! doll> am\nts & ! p]c5tage to be specifi$ "u ?is subp>agraph = a ye> 9 a mann] to ensure t ! total am\nt ( exp5ditures "u ?is "p = su* ye> is e/imat$ to equal ! total am\nt appropriat$ = su* ye> "u subsection 7a7 if su* exp5ditures 7 us$ solely = ! purpose describ$ 9 p>agraph 7#a7 ( section #aceb7;a7 = atta*m5t range claims at ! doll> am\nts & p]c5tage s specifi$ = su* ye>4 7#c7 ,availability ,funds allocat$ to a ,/ate "u ?is subsection = a ye> %all rema9 available ?r\gh ! end ( ! subsequ5t ye>4 4 #ajg4 ,resc9d+ ! %ort-t]m limit$ duration insurance regulation 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,on ,augu/ #c1 #bjah1 ! ,adm9i/ration issu$ a f9al rule entitl$ ,%ort-,t]m1 ,limit$-,duration ,insurance 7#hc ,f$4 ,reg4 #chbab74 7#b7 ,! f9al rule dramatically exp&s ! sale & m>ket+ ( insurance t-- 7,a7 may discrim9ate aga9/ individuals liv+ ) preexi/+ heal? conditions1 includ+ *ildr5 ) complex m$ical ne$s & disabilities & _! families2 7,b7 lacks important f9ancial protections provid$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh71 includ+ ! prohibition ( annual & lifetime cov]age limits & annual out-(-pocket limits1 t may increase ! co/ ( treatm5t & cause f9ancial h>d%ip to ^? requir+ m$ical c>e1 includ+ *ildr5 ) complex m$ical ne$s & disabilities & _! families2 & 7,c7 excludes cov]age ( ess5tial heal? b5efits includ+ hospitalization1 prescription drugs1 & o!r lifesav+ c>e4 7#c7 ,! implem5tation & en=cem5t ( ! f9al rule weak5s critical protections = up to #acj million ,am]icans liv+ ) preexi/+ heal? conditions & may place a l>ge f9ancial burd5 on ^? :o enroll 9 %ort-t]m limit$-duration insurance1 :i* jeop>dizes ,am]icans' access to quality1 af=dable heal? insurance4 7b7 ,prohibition ,! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ! ,treasury1 & ! ,secret>y ( ,labor-- 7#a7 may n take any action to implem5t1 en=ce1 or o!rwise give effect to ! rule entitl$ ,%ort-,t]m1 ,limit$ ,duration ,insurance 7#hc ,f$4 ,reg4 #chbab 7,augu/ #c1 #bjah772 7#b7 %all apply any regulation revis$ by su* rule z if su* rule _h n be5 issu$2 & 7#c7 may n promulgate any sub/antially simil> rule4 #ajh4 ,revok+ section #accb guidance 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,on ,octob] #bd1 #bjah1 ! adm9i/ration publi%$ new guidance to c>ry out section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7 entitl$ 8,/ate ,relief & ,emp[]m5t ,waiv]s0 7#hc ,f$4 ,reg4 #ecege74 7#b7 ,! new guidance enc\rages ,/ates to provide heal? insurance cov]age ?r\gh insurance plans t may discrim9ate aga9/ individuals ) preexi/+ heal? conditions1 includ+ ! "o 9 f\r ,am]icans liv+ ) a disability4 7#c7 ,! implem5tation & en=cem5t ( ! new guidance weak5s protections = ! millions ( ,am]icans liv+ ) preexi/+ heal? conditions & jeop>dizes ,am]icans' access to quality1 af=dable heal? insurance cov]age4 7b7 ,provid+ t c]ta9 guidance relat$ to waiv]s = ,/ate innovation "u ! ,pati5t ,protection & ,af=dable ,c>e ,act %all h no =ce or effect ,beg9n+ ,july #a1 #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury may n take any action to implem5t1 en=ce1 or o!rwise give effect to ! guidance entitl$ ,/ate ,relief & ,emp[]m5t ,waiv]s 7#hc ,f$4 ,reg4 #ecege 7,octob] #bd1 #bjah771 includ+ any su* action t w\ld result 9 individuals los+ heal? insurance cov]age t includes ! ess5tial heal? b5efits package 7z def9$ 9 subsection 7a7 ( section #acjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;a77 )\t reg>d to any waiv] ( any provision ( su* package "u a waiv] "u su* section #accb71 includ+ ! mat]nity & newborn c>e ess5tial heal? b5efit describ$ 9 subsection 7b77#a77;,d7 ( su* section1 includ+ any su* action t w\ld result 9 a decrease 9 ! numb] ( su* individuals enroll$ 9 cov]age t is at lea/ z compreh5sive z ! cov]age def9$ 9 section #acjb7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;a77 comp>$ to ! numb] ( su* individuals :o w\ld h be5 s enroll$ 9 su* cov]age _h su* action n be5 tak51 includ+ any su* action t w\ld1 ) respect to individuals ) sub/ance use disord]s1 includ+ opioid use disord]s1 r$uce ! availability or af=dability ( cov]age t is at lea/ z compreh5sive z ! cov]age def9$ 9 section #acjb7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;a77 comp>$ to ! availability or af=dability1 respectively1 ( su* cov]age _h su* action n be5 tak51 includ+ any su* action t w\ld result1 ) respect to vuln]able populations 7includ+ l[-income individuals1 eld]ly individuals1 & individuals ) s]i\s heal? issues or :o h a great] risk ( develop+ s]i\s heal? issues71 9 a decrease 9 ! availability ( cov]age t is at lea/ z compreh5sive z ! cov]age def9$ 9 section #acjb7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;a77 ) cov]age & co/ %>+ protections requir$ "u section #accb7;b77#a77;,b7 ( su* ,act 7#db ,u4,s4,c4 #ahjeb7;b77#a77;,b771 includ+ any su* action t w\ld1 ) respect to individuals ) preexi/+ conditions1 r$uce ! af=dability ( cov]age t is at lea/ z compreh5sive z ! cov]age def9$ 9 section #acjb7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;a77 comp>$ to ! af=dability ( su* cov]age _h su* action n be5 tak51 includ+ any su* action t w\ld result 9 high] heal? insurance premiums = individuals enroll$ 9 heal? insurance cov]age t is at lea/ z compreh5sive z ! cov]age def9$ 9 section #acjb7;b7 ( su* ,act 7#db ,u4,s4,c4 #ahjbb7;b771 & ! ,secret>ies may n promulgate any sub/antially simil> guidance or rule4 ,no?+ 9 ! previ\s s5t5ce %all be con/ru$ to affect ! approval ( waiv]s "u section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7 t e/abli% re9surance programs t are consi/5t ) ! requirem5ts "u subsection 7b77#a7 ( su* section 7#db ,u4,s4,c4 #ahjeb7;b77#a771 l[] heal? insurance premiums1 & protect heal? insurance cov]age = p ) preexi/+ conditions4 7c7 ,,gao report on affect ( ,/ate innovation waiv]s on cov]age ( individuals & on m5tal heal? heal? c>e treatm5t ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! numb] ( individuals expect$ to lose access to heal? insurance cov]age 7z def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia77 if subsection 7b7 7 n enact$ & waiv]s "u section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7 7 approv$ "u ! guidance describ$ 9 su* subsection 7b74 ,su* report %all include an analysis ( ! expect$ effect su* waiv]s approv$ "u su* guidance w\ld h on m5tal heal? c>e treatm5t4 #aji4 ,requir+ ,m>ketplace outrea*1 educational activities1 & annual enrollm5t t>gets 7a7 ,9 g5]al ,section #acba7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjda7;c771 z am5d$ by section #aje7;b71 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraphs3 7#d7 ,outrea* & educational activities 7,a7 ,9 g5]al ,9 ! case ( an ,ex*ange e/abli%$ or op]at$ by ! ,secret>y )9 a ,/ate pursuant to ?is subsection1 ! ,secret>y %all c>ry out outrea* & educational activities = purposes ( in=m+ individuals ab\t qualifi$ heal? plans (f]$ ?r\gh ! ,ex*ange1 includ+ by in=m+ su* individuals ( ! availability ( cov]age "u su* plans & f9ancial assi/ance = cov]age "u su* plans4 ,su* outrea* & educational activities %all be provid$ 9 a mann] t is culturally & l+ui/ically appropriate to ! ne$s ( ! populations be+ s]v$ by ! ,ex*ange 7includ+ h>d-to-rea* populations1 su* z racial & sexual m9orities1 limit$ ,engli% pr(ici5t populations1 individuals 9 rural areas1 vet]ans1 & "y adults7 & %all be provid$ to populations resid+ 9 high heal? disp>ity areas 7z def9$ 9 subp>agraph 7,e77 s]v$ by ! ,ex*ange1 9 addition to o!r populations s]v$ by ! ,ex*ange4 7,b7 ,limitation on use ( funds ,no funds appropriat$ "u ?is p>agraph %all be us$ = exp5ditures = promot+ non-,,aca compliant heal? insurance cov]age4 7,c7 ,non-aca compliant heal? insurance cov]age ,= purposes ( subp>agraph 7,b73 7i7 ,! t]m non-,,aca compliant heal? insurance cov]age means heal? insurance cov]age1 or a gr\p heal? plan1 t is n a qualifi$ heal? plan4 7ii7 ,su* t]m includes ! foll[+3 7,i7 ,an association heal? plan4 7,,ii7 ,%ort-t]m limit$ duration insurance4 7,d7 ,fund+ ,out ( any funds 9 ! ,treasury n o!rwise appropriat$1 !re are h]eby appropriat$ = fiscal ye> #bjbb & ea* subsequ5t fiscal ye>1 #ajj1jjj1jjj to c>ry out ?is p>agraph4 ,funds appropriat$ "u ?is subp>agraph %all rema9 available until exp5d$4 7,e7 ,high heal? disp>ity area def9$ ,= purposes ( subp>agraph 7,a71 ! t]m high heal? disp>ity area means a contigu\s geographic area t-- 7i7 is locat$ 9 "o c5sus tract or ,,zip code2 7ii7 has measurable & docum5t$ racial1 e?nic1 or geographic heal? disp>ities2 7iii7 has a l[-income population1 z demon/rat$ by-- 7,i7 av]age income bel[ #ach p]c5t ( ! ,f$]al pov]ty l9e2 or 7,,ii7 a rate ( p>ticipation 9 ! special supplem5tal nutrition program "u section #ag ( ! ,*ild ,nutrition ,act ( #aiff 7#db ,u4,s4,c4 #aghf7 t is high] ?an ! national av]age rate ( p>ticipation 9 su* program2 7iv7 has poor heal? outcomes1 z demon/rat$ by-- 7,i7 l[] life expectancy ?an ! national av]age2 or 7,,ii7 a high] p]c5tage ( in/ances ( l[ bir? weight ?an ! national av]age2 & 7v7 is "p ( a ,metropolitan ,/ati/ical ,area id5tifi$ by ! ,(fice ( ,managem5t & ,budget4 7#e7 ,annual enrollm5t t>gets ,= plan ye> #bjba & ea* subsequ5t plan ye>1 9 ! case ( an ,ex*ange e/abli%$ or op]at$ by ! ,secret>y )9 a ,/ate pursuant to ?is subsection1 ! ,secret>y %all e/abli% annual enrollm5t t>gets = su* ,ex*ange = su* ye>4 4 7b7 ,/udy & report ,n lat] ?an #cj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all release to ,congress all aggregat$ docum5ts relat+ to /udies & data sets t 7 creat$ on or aft] ,janu>y #a1 #bjad1 & relat$ to m>ket+ & outrea* ) respect to qualifi$ heal? plans (f]$ ?r\gh ,ex*anges "u title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjja et seq474 #aaj4 ,report on effects ( website ma9t5ance dur+ op5 enrollm5t ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report exam9+ :e!r ! ,dep>tm5t ( ,heal? & ,human ,s]vices has be5 conduct+ ma9t5ance on ! website commonly ref]r$ to z ,heal?c>e4gov dur+ annual op5 enrollm5t p]iods 7z describ$ 9 section #acaa7;c77#f77;,b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c77#f77;,b77 9 su* a mann] s z to m9imize any disruption to ! use ( su* website result+ f su* ma9t5ance4 #aaa4 ,promot+ consum] outrea* & education 7a7 ,9 g5]al ,section #acaa7;i7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;i77 is am5d$-- 7#a7 9 p>agraph 7#b71 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,selection ( recipi5ts ,9 ! case ( an ,ex*ange e/abli%$ & op]at$ by ! ,secret>y )9 a ,/ate pursuant to section #acba7;c71 9 aw>d+ grants "u p>agraph 7#a71 ! ,ex*ange %all-- 7i7 select entities to receive su* grants bas$ on an entity's demon/rat$ capacity to c>ry out ea* ( ! duties specifi$ 9 p>agraph 7#c72 7ii7 n take into acc\nt :e!r or n ! entity has demon/rat$ h[ ! entity w provide in=mation to individuals relat+ to gr\p heal? plans (f]$ by a gr\p or association ( employ]s describ$ 9 section #beaj4c-e7;b7 ( title #bi1 ,code ( ,f$]al ,regulations 7or any successor regulation71 or %ort-t]m limit$ duration insurance 7z def9$ by ! ,secret>y = purposes ( section #bgia7;b77#e7 ( ! ,public ,heal? ,s]vice ,act72 & 7iii7 ensure t1 ea* ye>1 ! ,ex*ange aw>ds su* a grant to-- 7,i7 at lea/ "o entity describ$ 9 ?is p>agraph t is a community & consum]-focus$ nonpr(it gr\p2 & 7,,ii7 at lea/ "o entity describ$ 9 subp>agraph 7,b71 :i* may include ano!r community & consum]-focus$ nonpr(it gr\p 9 addition to any su* gr\p aw>d$ a grant pursuant to subclause 7,i74 ,9 aw>d+ su* grants1 an ,ex*ange may consid] an entity's record ) respect to wa/e1 fraud1 & abuse = purposes ( ma9ta9+ ! integrity ( su* ,ex*ange4 2 7#b7 9 p>agraph 7#c7-- 7,a7 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 facilitate enrollm5t1 includ+ ) respect to individuals ) limit$ ,engli% pr(ici5cy & individuals ) *ronic illnesses1 9 qualifi$ heal? plans1 ,/ate m$icaid plans "u title ,,xix ( ! ,social ,security ,act1 & ,/ate *ild heal? plans "u title ,,xxi ( su* ,act2 2 7,b7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7,c7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 7,d7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 provide ref]rals to community-bas$ organizations t address social ne$s relat$ to heal? outcomes4 2 & 7,e7 by add+ at ! end ! foll[+ flu% left s5t5ce3 ,! duties specifi$ 9 ! prec$+ s5t5ce may be c>ri$ out by su* a navigator at any "t dur+ a ye>4 2 7#c7 9 p>agraph 7#d77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ n2 7,b7 9 clause 7i7-- 7i7 by ins]t+ n be=e be2 & 7ii7 by /rik+ 2 or & ins]t+ a semicolon2 7,c7 9 clause 7ii7-- 7i7 by ins]t+ n be=e receive2 & 7ii7 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,d7 by add+ at ! end ! foll[+ new clauses3 7iii7 ma9ta9 physical pres5ce 9 ! ,/ate ( ! ,ex*ange s z to all[ 9-p]son assi/ance to consum]s2 & 7iv7 receive opioid specific education & tra9+ t ensures ! navigator c be/ educate individuals on qualifi$ heal? plans (f]$ ?r\gh an ,ex*ange1 specifically cov]age "u su* plans = opioid heal? c>e treatm5t4 2 & 7#d7 9 p>agraph 7#f7-- 7,a7 by /rik+ ,fund+4--,grants "u & ins]t+ ,fund+4-- 7,a7 ,/ate ,ex*anges ,grants "u 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,f$]al ,ex*anges ,= purposes ( c>ry+ out ?is subsection1 ) respect to an ,ex*ange e/abli%$ & op]at$ by ! ,secret>y )9 a ,/ate pursuant to section #acba7;c71 ! ,secret>y %all obligate #ajj1jjj1jjj out ( am\nts collect$ ?r\gh ! us] fees on p>ticipat+ heal? insurance issu]s pursuant to section #aef4ej ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 = fiscal ye> #bjbb & ea* subsequ5t fiscal ye>4 ,su* am\nt = a fiscal ye> %all rema9 available until exp5d$4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 #aab4 ,improv+ transp>5cy & acc\ntability 9 ! ,m>ketplace 7a7 ,op5 enrollm5t reports ,= plan ye> #bjba & ea* subsequ5t ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 coord9ation ) ! ,secret>y ( ! ,treasury & ! ,secret>y ( ,labor1 %all issue biweekly public reports dur+ ! annual op5 enrollm5t p]iod on ! p]=mance ( ! f$]ally facilitat$ ,ex*ange op]at$ pursuant to section #acba7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjda7;c774 ,ea* su* report %all include a summ>y1 includ+ in=mation on a ,/ate-by-,/ate basis :]e available1 (-- 7#a7 ! numb] ( unique website visits2 7#b7 ! numb] ( individuals :o create an acc\nt2 7#c7 ! numb] ( calls to ! call c5t]2 7#d7 ! av]age wait "t = call]s contact+ ! call c5t]2 7#e7 ! numb] ( individuals :o enroll 9 a qualifi$ heal? plan2 & 7#f7 ! p]c5tage ( individuals :o enroll 9 a qualifi$ heal? plan ?r\gh ea* (-- 7,a7 ! website2 7,b7 ! call c5t]2 7,c7 navigators2 7,d7 ag5ts & brok]s2 7,e7 ! enrollm5t assi/ant program2 7,f7 directly f issu]s or web brok]s2 & 7,g7 o!r means4 7b7 ,op5 ,enrollm5t ,aft] ,action ,report ,= plan ye> #bjba & ea* subsequ5t ye>1 ! ,secret>y1 9 coord9ation ) ! ,secret>y ( ! ,treasury & ! ,secret>y ( ,labor1 %all publi% an aft] action report n lat] ?an #c mon?s aft] ! completion ( ! annual op5 enrollm5t p]iod reg>d+ ! p]=mance ( ! ,ex*ange describ$ 9 subsection 7a7 = ! applicable plan ye>4 ,ea* su* report %all include a summ>y1 includ+ in=mation on a ,/ate-by-,/ate basis :]e available1 (-- 7#a7 ! op5 enrollm5t data report$ "u subsection 7a7 = ! entirety ( ! enrollm5t p]iod2 & 7#b7 activities relat$ to pati5t navigators describ$ 9 section #acaa7;i7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;i771 includ+-- 7,a7 ! p]=mance objectives e/abli%$ by ! ,secret>y = su* pati5t navigators2 7,b7 ! numb] ( consum]s enroll$ by su* a pati5t navigator2 7,c7 an assessm5t ( h[ su* pati5t navigators h met e/abli%$ p]=mance metrics1 includ+ a detail$ li/ ( all pati5t navigators1 fund+ receiv$ by pati5t navigators1 & :e!r e/abli%$ p]=mance objectives ( pati5t navigators 7 met2 & 7,d7 ) respect to ! p]=mance objectives describ$ 9 subp>agraph 7,a7-- 7i7 :e!r su* objectives assess ! full scope ( pati5t navigator responsibilities1 includ+ g5]al education1 plan selection1 & det]m9ation ( eligibility = tax cr$its1 co/-%>+ r$uctions1 or o!r cov]age2 7ii7 h[ ! ,secret>y work$ ) pati5t navigators to e/abli% su* objectives2 & 7iii7 h[ ! ,secret>y adju/$ su* objectives = case complexity & o!r contextual factors4 7c7 ,report on adv]tis+ & consum] outrea* ,n lat] ?an #c mon?s aft] ! completion ( ! annual op5 enrollm5t p]iod = plan ye> #bjba1 ! ,secret>y %all issue a report on adv]tis+ & outrea* to consum]s = ! op5 enrollm5t p]iod = plan ye> #bjba4 ,su* report %all include a description (-- 7#a7 ! division ( sp5d+ on individual adv]tis+ plat=ms1 includ+ television & radio adv]tisem5ts & digital m$ia1 to raise consum] aw>5ess ( op5 enrollm5t2 7#b7 ! division ( sp5d+ on individual outrea* plat=ms1 includ+ email & text messages1 to raise consum] aw>5ess ( op5 enrollm5t2 & 7#c7 :e!r ! ,secret>y conduct$ t>get$ outrea* to specific demographic gr\ps & geographic areas4 7b7 ,promot+ transp>5cy & acc\ntability 9 ! adm9i/ration's exp5ditures ( ex*ange us] fees ,= plan ye> #bjba & ea* subsequ5t plan ye>1 n lat] ?an ! date t is #c mon?s aft] ! end ( su* plan ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! appropriate committees ( ,congress & make available to ! public an annual report on ! exp5ditures by ! ,dep>tm5t ( ,heal? & ,human ,s]vices ( us] fees collect$ pursuant to section #aef4ej ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 ,ea* su* report = a plan ye> %all include a detail$ acc\nt+ ( ! am\nt ( su* us] fees collect$ dur+ su* plan ye> & ( ! am\nt ( su* exp5ditures us$ dur+ su* plan ye> = ! f$]ally facilitat$ ,ex*ange op]at$ pursuant to section #acba7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjda7;c77 on outrea* & enrollm5t activities1 navigators1 ma9t5ance ( ,heal?c>e4gov1 & op]ation ( call c5t]s4 #aac4 ,improv+ aw>5ess ( heal? cov]age options 7a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,labor1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all update1 & make publicly available 9 a prom95t location on ! website ( ! ,dep>tm5t ( ,labor1 ! model ,consolidat$ ,omnibus ,budget ,reconciliation ,act ( #aihe 7ref]r$ to 9 ?is section z ,,cobra7 cont9uation cov]age g5]al notice & ! model ,,cobra cont9uation cov]age election notice develop$ by ! ,secret>y ( ,labor = purposes ( facilitat+ compliance ( gr\p heal? plans ) ! notification requirem5ts "u section #fjf ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaff74 ,9 updat+ ea* su* notice1 ! ,secret>y ( ,labor %all include in=mation reg>d+ any ,ex*ange e/abli%$ "u title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjja et seq47 ?r\gh :i* a qualifi$ b5efici>y may be eligible to enroll 9 a qualifi$ heal? plan1 includ+-- 7#a7 ! publicly accessible ,int]net website address = su* ,ex*ange2 7#b7 ! publicly accessible ,int]net website address = ! ,f9d ,local ,help directory ma9ta9$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices on ! heal?c>e4gov ,int]net website 7or a successor website72 7#c7 a cle> explanation t-- 7,a7 an individual :o is eligible = cont9uation cov]age may also be eligible to enroll1 ) f9ancial assi/ance1 9 a qualifi$ heal? plan (f]$ ?r\gh su* ,ex*ange1 b1 9 ! case t su* individual elects to enroll 9 su* cont9uation cov]age & subsequ5tly elects to t]m9ate su* cont9uation cov]age be=e ! p]iod ( su* cont9uation cov]age expires1 su* individual w n be eligible to enroll 9 a qualifi$ heal? plan (f]$ ?r\gh su* ,ex*ange dur+ a special enrollm5t p]iod2 & 7,b7 an individual :o elects to enroll 9 cont9uation cov]age w rema9 eligible to enroll 9 a qualifi$ heal? plan (f]$ ?r\gh su* ,ex*ange dur+ an op5 enrollm5t p]iod & may be eligible = f9ancial assi/ance ) respect to enroll+ 9 su* a qualifi$ heal? plan2 7#d7 in=mation on consum] protections ) respect to enroll+ 9 a qualifi$ heal? plan (f]$ ?r\gh su* ,ex*ange1 includ+ ! requirem5t = su* a qualifi$ heal? plan to provide cov]age = ess5tial heal? b5efits 7z def9$ 9 section #acjb7;b7 ( su* ,act 7#db ,u4,s4,c4 #ahjbb7;b77 & ! requirem5ts applicable to su* a qualifi$ heal? plan "u "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq472 & 7#e7 in=mation on ! availability ( f9ancial assi/ance ) respect to enroll+ 9 a qualifi$ heal? plan1 includ+ ! maximum income limit = eligibility = a premium tax cr$it "u section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf4 7b7 ,"n ( notices ,9 addition to updat+ ! model ,,cobra cont9uation cov]age g5]al notice & ! model ,,cobra cont9uation cov]age election notice "u p>agraph 7#a71 ! ,secret>y ( ,labor %all r5ame ea* su* notice z ! model ,,cobra cont9uation cov]age & ,af=dable ,c>e ,act cov]age g5]al notice & ! model ,,cobra cont9uation cov]age & ,af=dable ,c>e ,act cov]age election notice1 respectively4 7c7 ,consum] te/+ ,prior to mak+ publicly available ! model ,,cobra cont9uation cov]age g5]al notice & ! model ,,cobra cont9uation cov]age election notice updat$ "u p>agraph 7#a71 ! ,secret>y ( ,labor %all provide an opportunity = consum] te/+ ( ea* su* notice1 z s updat$1 to ensure t ea* su* notice is cle> & und]/&able to ! av]age p>ticipant or b5efici>y ( a gr\p heal? plan4 7d7 ,def9itions ,9 ?is subsection3 7#a7 ,cont9uation cov]age ,! t]m cont9uation cov]age1 ) respect to a gr\p heal? plan1 has ! mean+ giv5 su* t]m 9 section #fjb ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aafb74 7#b7 ,gr\p heal? plan ,! t]m gr\p heal? plan has ! mean+ giv5 su* t]m 9 section #fjg ( su* ,act 7#bi ,u4,s4,c4 #aafg74 7#c7 ,qualifi$ b5efici>y ,! t]m qualifi$ b5efici>y has ! mean+ giv5 su* t]m 9 su* section #fjg4 7#d7 ,qualifi$ heal? plan ,! t]m qualifi$ heal? plan has ! mean+ giv5 su* t]m 9 section #acja ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjba74 #aad4 ,promot+ ,/ate innovations to exp& cov]age 7a7 ,9 g5]al ,subject to subsection 7d71 ! ,secret>y ( ,heal? & ,human ,s]vices %all aw>d grants to eligible ,/ate ag5cies to enable su* ,/ates to explore innovative solutions to promote great] enrollm5t 9 heal? insurance cov]age 9 ! individual & small gr\p m>kets1 includ+ activities describ$ 9 subsection 7c74 7b7 ,eligibility ,= purposes ( subsection 7a71 eligible ,/ate ag5cies are ,ex*anges e/abli%$ by a ,/ate "u title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjja et seq47 & ,/ate ag5cies ) prim>y responsibility ov] heal? & human s]vices = ! ,/ate involv$4 7c7 ,use ( funds ,= purposes ( subsection 7a71 ! activities describ$ 9 ?is subsection are ! foll[+3 7#a7 ,/ate ef=ts to /reaml9e heal? insurance enrollm5t proc$ures 9 ord] to r$uce burd5s on consum]s & facilitate great] enrollm5t 9 heal? insurance cov]age 9 ! individual & small gr\p m>kets1 includ+ automatic enrollm5t & re5rollm5t (1 or pre-populat$ applications =1 individuals )\t heal? insurance :o are eligible = tax cr$its "u section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf1 ) ! ability to opt out ( su* enrollm5t4 7#b7 ,/ate inve/m5t 9 te*nology to improve data %>+ & collection = ! purposes ( facilitat+ great] enrollm5t 9 heal? insurance cov]age 9 su* m>kets4 7#c7 ,implem5tation ( a ,/ate v]sion ( an individual m&ate to be enroll$ 9 heal? insurance cov]age4 7#d7 ,feasibility /udies to develop compreh5sive & coh]5t ,/ate plan = increas+ enrollm5t 9 ! individual & small gr\p m>ket4 7d7 ,fund+ ,= purposes ( c>ry+ out ?is section1 !re is h]eby appropriat$1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 #bjj1jjj1jjj = ea* ( ! fiscal ye>s #bjbb ?r\gh #bjbd4 ,su* am\nt %all rema9 available until exp5d$4 #aae4 ,/r5g!n+ network adequacy 7a7 ,9 g5]al ,section #acaa7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;d77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,network adequacy /&>ds 7,a7 ,c]ta9 ,ex*anges ,9 ! case ( an ,ex*ange op]at$ by ! ,secret>y pursuant section #acba7;c77#a7 or an ,ex*ange describ$ 9 section #aee4bjj7;f7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 ! ,ex*ange %all require ea* qualifi$ heal? plan (f]$ ?r\gh su* ,ex*ange to meet su* quantitative network adequacy /&>ds z ! ,secret>y may prescribe = purposes ( ?is subp>agraph4 7,b7 ,/ate ,ex*anges ,9 ! case ( an ,ex*ange n describ$ 9 subp>agraph 7,a71 ! ,ex*ange %all e/abli% quantitative network adequacy /&>ds ) respect to qualifi$ heal? plans (f]$ ?r\gh su* ,ex*ange & require su* plans to meet su* /&>ds4 4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb4 #aaf4 ,protect+ consum]s f unreasonable rate hikes 7a7 ,protection f excessive1 unju/ifi$1 or unfairly discrim9atory rates ,! fir/ section #bgid ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#id71 z add$ by section #ajjc ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh71 is am5d$ by add+ at ! end ! foll[+ new subsection3 7e7 ,protection f excessive1 unju/ifi$1 or unfairly discrim9atory rates 7#a7 ,au?ority ( ,/ates ,no?+ 9 ?is section %all be con/ru$ to prohibit a ,/ate f impos+ requirem5ts 7includ+ requirem5ts relat+ to rate review /&>ds & proc$ures & in=mation report+7 on heal? insurance issu]s ) respect to rates t are 9 addition to ! requirem5ts ( ?is section & are m protective ( consum]s ?an su* requirem5ts4 7#b7 ,consultation 9 rate review process ,9 c>ry+ out ?is section1 ! ,secret>y %all consult ) ! ,national ,association ( ,insurance ,commission]s & consum] gr\ps4 7#c7 ,det]m9ation ( :o conducts reviews = ea* ,/ate ,! ,secret>y %all det]m9e1 aft] ! date ( enactm5t ( ?is section & p]iodically !reaft]1 ! foll[+3 7,a7 ,9 :i* m>kets 9 ea* ,/ate ! ,/ate insurance commission] or relevant ,/ate regulator %all und]take ! corrective actions "u p>agraph 7#d71 bas$ on ! ,secret>y's det]m9ation t ! ,/ate regulator is adequately und]tak+ & utiliz+ su* actions 9 t m>ket4 7,b7 ,9 :i* m>kets 9 ea* ,/ate ! ,secret>y %all und]take ! corrective actions "u p>agraph 7#d71 9 coop]ation ) ! relevant ,/ate insurance commission] or ,/ate regulator1 bas$ on ! ,secret>y's det]m9ation t ! ,/ate is n adequately und]tak+ & utiliz+ su* actions 9 t m>ket4 7#d7 ,corrective action = excessive1 unju/ifi$1 or unfairly discrim9atory rates ,9 accordance ) ! process e/abli%$ "u ?is section1 ! ,secret>y or ! relevant ,/ate insurance commission] or ,/ate regulator %all take corrective actions to ensure t any excessive1 unju/ifi$1 or unfairly discrim9atory rates are correct$ prior to implem5tation1 or z soon z possible !reaft]1 ?r\gh me*anisms su* z-- 7,a7 d5y+ rates2 7,b7 modify+ rates2 or 7,c7 requir+ rebates to consum]s4 7#e7 ,noncompliance ,failure to comply ) any corrective action tak5 by ! ,secret>y "u ?is subsection may result 9 ! application ( civil monet>y p5alties "u section #bgbc &1 if ! ,secret>y det]m9es appropriate1 make ! plan involv$ ineligible = classification z a qualifi$ heal? plan4 4 7b7 ,cl>ification ( ,regulatory ,au?ority ,su* section is fur!r am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! head+1 by /rik+ premium & ins]t+ rate2 7,b7 9 p>agraph 7#a71 by /rik+ unreasonable increases 9 premiums & ins]t+ pot5tially excessive1 unju/ifi$1 or unfairly discrim9atory rates1 includ+ premiums12 & 7,c7 9 p>agraph 7#b7-- 7i7 by /rik+ an unreasonable premium increase & ins]t+ a pot5tially excessive1 unju/ifi$1 or unfairly discrim9atory rate2 7ii7 by /rik+ ! increase & ins]t+ ! rate2 & 7iii7 by /rik+ su* increases & ins]t+ su* rates2 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ premium increases ea* place x appe>s & ins]t+ rates2 & 7,b7 9 p>agraph 7#b77;,b71 by /rik+ premium & ins]t+ rate4 7c7 ,con=m+ am5dm5ts ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$-- 7#a7 9 section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb71 z r$esignat$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by ins]t+ & section #bgid aft] ?is "p2 & 7ii7 9 p>agraph 7#b71 by ins]t+ or section #bgid aft] ?is "p2 & 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by ins]t+ & section #bgid aft] ?is "p2 & 7ii7 9 p>agraph 7#b7-- 7,i7 9 subp>agraph 7,a71 by ins]t+ or section #bgid t is aft] ?is "p2 & 7,,ii7 9 subp>agraph 7,c77ii71 by ins]t+ or section #bgid aft] ?is "p2 & 7#b7 9 section #bgfa 7#db ,u4,s4,c4 #cjj;gg-#fa7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by ins]t+ & section #bgid aft] ?is "p2 & 7ii7 9 p>agraph 7#b7-- 7,i7 by ins]t+ or section #bgid aft] set =? 9 ?is "p2 & 7,,ii7 by ins]t+ & section #bgid aft] ! requirem5ts ( ?is "p2 & 7,b7 9 subsection 7b7-- 7i7 by ins]t+ & section #bgid aft] ?is "p2 & 7ii7 by ins]t+ & section #bgid aft] "p ,a4 7d7 ,applicability to gr&fa!r$ plans ,section #abea7;a77#d77;,a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh71 z add$ by section #bcja ( ! ,heal? ,c>e & ,education ,reconciliation ,act ( #bjaj 7,public ,law #aaa-aeb71 is am5d$ by add+ at ! end ! foll[+3 7v7 ,section #bgid 7relat+ to reasonabl5ess ( rates ) respect to heal? insurance cov]age74 4 7e7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is ,act su* sums z may be necess>y4 7f7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date ( enactm5t ( ?is ,act & %all be implem5t$ ) respect to heal? plans beg9n+ n lat] ?an ,janu>y #a1 #bjbb4 #aag4 ,eligibility ( ,,daca recipi5ts = qualifi$ heal? plans (f]$ ?r\gh ,ex*anges 7a7 ,9 g5]al ,section #acab7;f77#c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb7;f77#c77 is am5d$-- 7#a7 by /rik+ or an ali5 lawfully pres5t 9 ! ,unit$ ,/ates & ins]t+ 1 an ali5 lawfully pres5t 9 ! ,unit$ ,/ates1 or a ,,daca recipi5t2 & 7#b7 by add+ at ! end ! foll[+3 ,= purposes ( ! previ\s s5t5ce1 ! t]m ,,daca recipi5t means an individual :o 0 grant$ def]r$ action pursuant to ! ,def]r$ ,action = ,*ildhood ,arrivals ,program ann\nc$ 9 ! memor&um ( ! ,secret>y ( ,homel& ,security dat$ ,june #ae1 #bjab1 & = :om su* grant rema9s valid44 7b7 ,application ( r$uc$ co/-,%>+ ,section #adjb7;e77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjga7;e77#b77 is am5d$ by add+ at ! end ! foll[+3 ,a ,,daca recipi5t 7z def9$ 9 section #acab7;f77#c77 %all be treat$ z lawfully pres5t = purposes ( ?is section44 7c7 ,eligibility = advance paym5ts ,section #adab7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjhb7;d77 is am5d$ by add+ at ! end ! foll[+3 ,= purposes ( ! previ\s s5t5ce1 a ,,daca recipi5t 7z def9$ 9 section #acab7;f77#c77 %all be treat$ z lawfully pres5t 9 ! ,unit$ ,/ates44 7d7 ,v]ification ( eligibility ,section #adaa7;c77#b77;,b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjha7;c77#b77;,b77 is am5d$-- 7#a7 9 clause 7i77,i71 by ins]t+ or a ,,daca recipi5t 7z def9$ 9 section #acab7;f77#c77 aft] an ali5 lawfully pres5t 9 ! ,unit$ ,/ates2 & 7#b7 9 clause 7ii71 by ins]t+ or a ,,daca recipi5t 7z def9$ 9 section #acab7;f77#c77 aft] an ali5 lawfully pres5t 9 ! ,unit$ ,/ates4 7e7 ,application ( tax cr$it = cov]age "u a qualifi$ heal? plan ,section #cf;,b7e77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+3 ,a ,,daca recipi5t 7z def9$ 9 section #acab7;f77#c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act7 %all be treat$ z lawfully pres5t = purposes ( ?is section44 7f7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ,janu>y #a1 #bjba4 ,,ii ,enc\rag+ ,m$icaid ,expansion & ,/r5g!n+ ! ,m$icaid ,program #bja4 ,inc5tiviz+ ,m$icaid expansion 7a7 ,9 g5]al ,section #aije7y77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7y77#a77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ #bjad1 #bjae1 & #bjaf & ins]t+ ea* ( ! fir/ #c consecutive #ab-mon? p]iods 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 7#b7 9 subp>agraph 7,b71 by /rik+ #bjag & ins]t+ ! f\r? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 7#c7 9 subp>agraph 7,c71 by /rik+ #bjah & ins]t+ ! fif? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 7#d7 9 subp>agraph 7,d71 by /rik+ #bjai & ins]t+ ! six? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 & 7#e7 9 subp>agraph 7,e71 by /rik+ #bjbj & ea* ye> !reaft] & ins]t+ ! sev5? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals & ea* su* p]iod !reaft]4 7b7 ,effective date ,beg9n+ on ,janu>y #a1 #bjbb1 ! am5dm5ts made by subsection 7a7 %all take effect z if includ$ 9 ! enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh74 #bjb4 ,provid+ #ab-mon?s ( cont9u\s eligibility = ,m$icaid & ,,*ip 7a7 ,requirem5t ( #ab-,mon? cont9u\s enrollm5t "u ,m$icaid ,section #aijb7;e77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7e77#ab77 is am5d$ to read z foll[s3 7#ab7 #ab-mon? cont9u\s enrollm5t ,not)/&+ any o!r provision ( ?is title1 a ,/ate plan approv$ "u ?is title 7or "u any waiv] ( su* plan approv$ pursuant to section #aaae or section #aiae71 %all provide t an individual :o is det]m9$ to be eligible = b5efits "u su* plan 7or waiv]7 %all rema9 eligible & enroll$ = su* b5efits ?r\gh ! end ( ! mon? 9 :i* ! #ab-mon? p]iod 7beg9n+ on ! date ( det]m9ation ( eligibility7 ends4 4 7b7 ,requirem5t ( #ab-,mon? cont9u\s enrollm5t "u ,,*ip 7#a7 ,9 g5]al ,section #bajb7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;bb7b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,requirem5t = #ab-mon? cont9u\s enrollm5t ,not)/&+ any o!r provision ( ?is title1 a ,/ate *ild heal? plan t provides *ild heal? assi/ance "u ?is title ?r\gh a means o!r ?an describ$ 9 section #baja7;a77#b71 %all provide t an individual :o is det]m9$ to be eligible = b5efits "u su* plan %all rema9 eligible & enroll$ = su* b5efits ?r\gh ! end ( ! mon? 9 :i* ! #ab-mon? p]iod 7beg9n+ on ! date ( det]m9ation ( eligibility7 ends4 4 7#b7 ,con=m+ am5dm5t ,section #baje7;a77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;ee7a77#d77;,a77 is am5d$-- 7,a7 by /rik+ has elect$ ! option ( & ins]t+ is 9 compliance ) ! requirem5t =2 & 7,b7 by /rik+ apply+ su* policy "u its ,/ate *ild heal? plan "u ?is title & ins]t+ 9 compliance ) section #bajb7;b74 7c7 ,effective date 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b7 or 7#c71 ! am5dm5ts made by subsections 7a7 & 7b7 %all apply to det]m9ations 7& r$et]m9ations7 ( eligibility made on or aft] ! date t is #ab mon?s aft] ! la/ day ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 7#b7 ,ext5sion ( effective date = ,/ate law am5dm5t ,9 ! case ( a ,/ate plan "u title ,,xix or ,/ate *ild heal? plan "u title ,,xxi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 7o!r ?an legislation appropriat+ funds7 9 ord] = ! respective plan to meet ! additional requirem5t impos$ by ! am5dm5t made by subsection 7a7 or 7b71 respectively1 ! respective plan %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( su* title solely on ! basis ( its failure to meet su* applicable additional requirem5t be=e ! fir/ day ( ! fir/ cal5d> qu>t] beg9n+ aft] ! close ( ! fir/ regul> session ( ! ,/ate legislature t beg9s aft] ! date ( enactm5t ( ?is ,act4 ,= purposes ( ! previ\s s5t5ce1 9 ! case ( a ,/ate t has a #b-ye> legislative session1 ea* ye> ( ! session is consid]$ to be a sep>ate regul> session ( ! ,/ate legislature4 7#c7 ,option to implem5t #ab-mon? cont9u\s eligibility prior to effective date ,a ,/ate may elect ?r\gh a ,/ate plan am5dm5t "u title ,,xix or ,,xxi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 to apply ! am5dm5t made by subsection 7a7 or 7b71 respectively1 on any date prior to ! date specifi$ 9 p>agraph 7#a71 b n soon] ?an ! date ( ! enactm5t ( ?is ,act4 #bjc4 ,m&atory #ab-mon?s ( po/p>tum ,m$icaid eligibility 7a7 ,ext5d+ cont9u\s ,m$icaid & ,,*ip cov]age = pregnant & po/p>tum wom5 7#a7 ,m$icaid ,title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is am5d$-- 7,a7 9 section #aijb7l77#a77;,a71 by /rik+ #fj-;day p]iod & ins]t+ #cfe-;day p]iod2 7,b7 9 section #aijb7;e77#f71 by /rik+ #fj-;day p]iod & ins]t+ #cfe-;day p]iod2 7,c7 9 section #aijc7v77#d77;,a77i71 by /rik+ #fj-;day p]iod & ins]t+ #cfe-;day p]iod2 & 7,d7 9 section #aije7;a71 9 ! #d? s5t5ce 9 ! matt] foll[+ p>agraph 7#cj71 by /rik+ #fj-;day p]iod & ins]t+ #cfe-;day p]iod4 7#b7 ,,*ip ,section #baab ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acigll7 is am5d$ by /rik+ #fj-;day p]iod ea* place x appe>s & ins]t+ #cfe-;day p]iod4 7b7 ,requir+ full b5efits = pregnant & po/p>tum wom5 7#a7 ,m$icaid 7,a7 ,9 g5]al ,p>agraph 7#e7 ( section #aijb7;e7 ( ! ,social ,security ,act 7#bd ,u4,s4,c4 #acif;a7e77 is am5d$ to read z foll[s3 7#e7 ,any woman :o is eligible = m$ical assi/ance "u ! ,/ate plan or a waiv] ( su* plan & :o is1 or :o :ile s eligible becomes1 pregnant1 %all cont9ue to be eligible "u ! plan or waiv] = m$ical assi/ance ?r\gh ! end ( ! mon? 9 :i* ! #cfe-;day p]iod 7beg9n+ on ! la/ day ( h] pregnancy7 ends1 reg>dless ( ! basis = ! woman's eligibility = m$ical assi/ance1 includ+ if ! woman's eligibility = m$ical assi/ance is on ! basis ( be+ pregnant4 4 7,b7 ,con=m+ am5dm5t ,section #aijb7;a77#aj7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77 is am5d$ 9 ! matt] foll[+ subp>agraph 7,g7 by /rik+ 7,,vii7 ! m$ical assi/ance & all t foll[s ?r\gh complicate pregnancy14 7#b7 ,,*ip ,section #bajg7;e77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77 is am5d$-- 7,a7 by r$esignat+ subp>agraphs 7,h7 ?r\gh 7,s7 z subp>agraphs 7,i7 ?r\gh 7,t71 respectively2 & 7,b7 by ins]t+ aft] subp>agraph 7,g71 ! foll[+3 7,h7 ,section #aijb7;e77#e7 7requir+ #cfe-;day cont9u\s cov]age = pregnant & po/p>tum wom574 4 7c7 ,ma9t5ance ( ef=t 7#a7 ,m$icaid ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is am5d$-- 7,a7 9 p>agraph 7#gd71 by /rik+ subsection 7gg72 & & ins]t+ subsections 7gg7 & 7qq722 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7qq7 ,ma9t5ance ( ef=t relat$ to l[-,income pregnant wom5 ,= cal5d> qu>t]s beg9n+ on or aft] ! effective date describ$ 9 section #bjc7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,enhancem5t ,act1 & be=e ,janu>y #a1 #bjbc1 no ,f$]al paym5t %all be made to a ,/ate "u section #aijc7;a7 = am\nts exp5d$ "u a ,/ate plan "u ?is title or a waiv] ( su* plan if ! ,/ate-- 7#a7 has 9 effect "u su* plan eligibility /&>ds1 me?odologies1 or proc$ures = individuals describ$ 9 subsection 7l77#a7 :o are eligible = m$ical assi/ance "u ! ,/ate plan or waiv] "u subsection 7a77#aj77;,a77ii77,,ix7 t are m re/rictive ?an ! eligibility /&>ds1 me?odologies1 or proc$ures1 respectively1 = su* individuals "u su* plan or waiv] t are 9 effect on ! date ( ! enactm5t ( ?is subsection2 or 7#b7 provides m$ical assi/ance to individuals describ$ 9 subsection 7l77#a7 :o are eligible = m$ical assi/ance "u su* plan or waiv] "u subsection 7a77#aj77;,a77ii77,,ix7 at a level t is less ?an ! level at :i* ! ,/ate provides su* assi/ance to su* individuals "u su* plan or waiv] on ! date ( ! enactm5t ( ?is subsection4 4 7#b7 ,,*ip ,section #baab ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acigll71 z am5d$ by subsection 7b71 is fur!r am5d$ by add+ at ! end ! foll[+ subsection3 7g7 ,ma9t5ance ( ef=t ,= cal5d> qu>t]s beg9n+ on or aft] ! effective date describ$ 9 section #bjc7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,enhancem5t ,act1 & be=e ,janu>y #a1 #bjbc1 no paym5t may be made "u section #baje7;a7 ) respect to a ,/ate *ild heal? plan if ! ,/ate-- 7#a7 has 9 effect "u su* plan eligibility /&>ds1 me?odologies1 or proc$ures = t>get$ l[-income pregnant wom5 t are m re/rictive ?an ! eligibility /&>ds1 me?odologies1 or proc$ures1 respectively1 "u su* plan t are 9 effect on ! date ( ! enactm5t ( ?is subsection2 or 7#b7 provides pregnancy-relat$ assi/ance to t>get$ l[-income pregnant wom5 "u su* plan at a level t is less ?an ! level at :i* ! ,/ate provides su* assi/ance to su* wom5 "u su* plan on ! date ( ! enactm5t ( ?is subsection4 4 7d7 ,effective date 7#a7 ,9 g5]al ,except z provid$ "u p>agraph 7#b71 ! am5dm5ts made by subsections 7a7 & 7b7 %all take effect on 7& ! effective date describ$ 9 ?is subsection %all be7 ! fir/ day ( ! cal5d> qu>t] dur+ :i* ! la/ day ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b77 occurs4 7#b7 ,ext5sion ( effective date = ,/ate law am5dm5t ,9 ! case ( a ,/ate plan "u title ,,xix or ,/ate *ild heal? plan "u title ,,xxi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 7o!r ?an legislation appropriat+ funds7 9 ord] = ! respective plan to meet ! additional requirem5t impos$ by ! am5dm5ts made by subsection 7a7 or 7b71 respectively1 ! respective plan %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( su* title solely on ! basis ( its failure to meet su* applicable additional requirem5t be=e ! fir/ day ( ! fir/ cal5d> qu>t] beg9n+ aft] ! close ( ! fir/ regul> session ( ! ,/ate legislature t beg9s aft] ! date ( enactm5t ( ?is ,act4 ,= purposes ( ! previ\s s5t5ce1 9 ! case ( a ,/ate t has a #b-ye> legislative session1 ea* ye> ( ! session is consid]$ to be a sep>ate regul> session ( ! ,/ate legislature4 #bjd4 ,r$uc+ ! adm9i/rative ,,fmap = nonexpansion ,/ates ,section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is am5d$-- 7#a7 9 subsection 7a77#g71 by ins]t+ subsection 7bb7 & be=e section #aiai7;g77#c77;,b72 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7bb7 ,r$uction ( ,f$]al paym5ts = c]ta9 adm9i/rative co/s ( nonexpansion ,/ates 7#a7 ,9 g5]al ,9 ! case ( a ,/ate t does n provide "u ! ,/ate plan ( su* ,/ate 7or waiv] ( su* plan7 = mak+ m$ical assi/ance available 9 accordance ) section #aijb7k77#a7 to all individuals describ$ 9 section #aijb7;a77#aj77;i77,,viii7 = a cal5d> qu>t] beg9n+ on or aft] ,octob] #a1 #bjbb1 ! ,secret>y may r$uce ! p]c5tage specifi$ 9 subsection 7a77#g7 = am\nts describ$ 9 su* subsection exp5d$ dur+ su* qu>t] by su* ,/ate by ! numb] ( p]c5tage po9ts specifi$ 9 p>agraph 7#b7 = su* qu>t]4 7#b7 ,am\nt ( r$uction ,= purposes ( p>agraph 7#a71 ! numb] ( p]c5tage po9ts specifi$ 9 ?is p>agraph = a cal5d> qu>t] is ! foll[+3 7,a7 ,= ! cal5d> qu>t] beg9n+ on ,octob] #a1 #bjbb1 #j4e4 7,b7 ,= a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbc1 & end+ be=e ,july #a1 #bjbg1 ! numb] ( p]c5tage po9ts specifi$ "u ?is p>agraph = ! previ\s qu>t]1 plus #j4e4 7,c7 ,= a cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjbg1 #aj4 7#c7 ,def9ition ,= purposes ( ?is subsection1 ! t]m ,/ate means a ,/ate t is "o ( ! #ej ,/ates or ! ,di/rict ( ,columbia4 4 #bje4 ,enhanc$ report+ requirem5ts = nonexpansion /ates ,section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 z am5d$ by section #bjd1 is fur!r am5d$-- 7#a7 9 subsection 7a77#g71 by /rik+ subsection 7bb7 & ins]t+ subsections 7bb7 & 7cc72 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7cc7 ,r$uction ( ,f$]al paym5ts = c]ta9 adm9i/rative co/s ( nonexpansion ,/ates t d n satisfy report+ requirem5ts 7#a7 ,9 g5]al 7,a7 ,r$uction ,9 ! case ( a nonexpansion ,/ate1 ) respect to a fiscal ye> 7beg9n+ ) fiscal ye> #bjbc7 t does n satisfy ! report+ requirem5t "u p>agraph 7#b7 = su* fiscal ye>1 ! p]c5tage specifi$ 9 subsection 7a77#g7 = am\nts describ$ 9 su* subsection exp5d$ by su* ,/ate dur+ a cal5d> qu>t] describ$ 9 p>agraph 7#d7 ) respect to su* fiscal ye>1 subject to subp>agraph 7,b71 %all be r$uc$ by ! numb] ( p]c5tage po9ts specifi$ 9 p>agraph 7#d7 = ! respective cal5d> qu>t]4 7,b7 ,exception ,9 ! case ( a nonexpansion ,/ate t is subject to a r$uction "u subp>agraph 7,a7 = ! cal5d> qu>t] describ$ 9 p>agraph 7#d77;,a7 ) respect to a fiscal ye>1 if ! ,/ate satisfies ! crit]ia describ$ 9 subp>agraphs 7,a71 7,b71 & 7,c7 ( p>agraph 7#b7 7)\t reg>d to ! dates specifi$ 9 su* subp>agraph 7,a7 & 7,c77 be=e ! beg9n+ ( a subsequ5t cal5d> qu>t] describ$ 9 p>agraph 7#d7 ) respect to su* fiscal ye>1 !n su* ,/ate %all n be subject to a r$uction "u subp>agraph 7,a7 = su* subsequ5t cal5d> qu>t]4 7#b7 ,report+ requirem5t ,= purposes ( p>agraph 7#a71 a nonexpansion ,/ate satisfies ! report+ requirem5t "u ?is p>agraph = a fiscal ye>1 if ! nonexpansion ,/ate-- 7,a7 by n lat] ?an ,janu>y #a ( su* ye>1 po/s on ! public website ( ! ,/ate ag5cy adm9i/]+ ! ,/ate plan1 ! in=mation describ$ 9 p>agraph 7#c7 ) respect to su* ,/ate = ! previ\s ye>2 7,b7 provides = at lea/ a #cj-;day p]iod = notice & comm5t on su* in=mation2 & 7,c7 by n lat] ?an ,m>* #a ( su* ye>1 submits to ! ,secret>y a complete report includ+ su* in=mation1 comm5ts submitt$ pursuant to subp>agraph 7,b71 & a response by ! ,/ate to ea* su* comm5t4 7#c7 ,in=mation describ$ ,! in=mation describ$ 9 ?is p>agraph1 ) respect to a ,/ate & ye>1 is ! foll[+3 7,a7 ,! ! e/imat$ numb] ( individuals :o 7 un9sur$ = at lea/ #f mon?s1 %[n by age-gr\ps ( #j to #ah ye>s ( age & ( #ai ye>s ( age to #fd ye>s ( age1 z well z a detail$ description ( ! basis = ! e/imates4 7,b7 ,! e/imat$ numb] ( ! individuals e/imat$ "u subp>agraph 7,a7 9 ! ,/ate :o w\ld be eligible = m$ical assi/ance "u ! ,/ate plan if ! ,/ate 7 to make m$ical assi/ance "u ! ,/ate plan available 9 accordance ) section #aijb7k77#a7 to all individuals describ$ 9 section #aijb7;a77#aj77;i77,,viii71 & a detail$ description ( ! basis = ! e/imates4 7,c7 ,a compreh5sive li/+ ( ,/ate income eligibility crit]ia = all m&atory & optional ,m$icaid eligibility gr\ps = :i* ! ,/ate plan provides m$ical assi/ance 7o!r ?an ) respect to individuals describ$ 9 clause 7i77,,ii71 7ii77,,vi71 or 7ii77,,xxii7 ( section #aijb7;a77#aj77;,a774 7,d7 ,! total am\nt ( hospital uncomp5sat$-c>e co/s & a breakd[n ( ! s\rce ( su* co/s1 z well z a breakd[n = rural & non-rural hospitals4 7#d7 ,p]c5tage describ$ ,= purposes ( p>agraph 7#a71 a cal5d> qu>t] describ$ 9 ?is p>agraph1 ) respect to a fiscal ye>1 & ! p]c5tage po9ts describ$ 9 ?is p>agraph = su* qu>t]1 ) respect to a ,/ate1 are-- 7,a7 = ! cal5d> qu>t] beg9n+ on ! ,april #a occurr+ dur+ su* fiscal ye>1 #j4e p]c5tage po9ts2 7,b7 = ! cal5d> qu>t] beg9n+ on ! ,july #a occurr+ dur+ su* fiscal ye>1 #a4j p]c5tage po9t2 & 7,c7 = ! cal5d> qu>t] beg9n+ on ! ,octob] #a occurr+ dur+ ! subsequ5t fiscal ye>1 #a4e p]c5tage po9ts4 7#e7 ,paym5t 9 case ( report+ ,/ate ,! exp5ses incurr$ by a non-expansion ,/ate1 ) respect to any cal5d> qu>t] ) respect to a fiscal ye> 7beg9n+ ) #bjba71 = c>ry+ out subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b7 %all1 = purposes ( section #aijc7;a77#g71 be consid]$ to be exp5ses necess>y = ! prop] & effici5t adm9i/ration ( ! ,/ate plan "u ?is title4 7#f7 ,nonexpanion ,/ate def9$ ,= purposes ( ?is subsection1 ! t]m nonexpansion ,/ate means1 ) respect to a fiscal ye>1 a ,/ate t z ( ! fir/ qu>t] ( su* fiscal ye> does n provide "u ! ,/ate plan ( su* ,/ate 7or waiv] ( su* plan7 = mak+ m$ical assi/ance available 9 accordance ) section #aijb7k77#a7 to all individuals describ$ 9 section #aijb7;a77#aj77;i77,,viii74 4 #bjf4 ,prim>y c>e pay increase 7a7 ,r5ewal ( paym5t floor2 additional provid]s 7#a7 ,9 g5]al ,section #aijb7;a77#ac7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#ac77 is am5d$ by /rik+ subp>agraph 7,c7 & ins]t+ ! foll[+3 7,c7 paym5t = prim>y c>e s]vices 7z def9$ 9 subsection 7jj77 at a rate t is n less ?an #ajj p]c5t ( ! paym5t rate t applies to su* s]vices & physician "u "p ,b ( title ,,xviii 7or1 if great]1 ! paym5t rate t w\ld be applicable "u su* "p if ! conv]sion factor "u section #ahdh7;d7 = ! ye> involv$ 7 ! conv]sion factor "u su* section = #bjji71 & t is n less ?an ! rate t w\ld o!rwise apply to su* s]vices "u ?is title if ! rate 7 det]m9$ )\t reg>d to ?is subp>agraph1 & t are-- 7i7 furni%$ dur+ #bjac & #bjad1 by a physician ) a prim>y specialty designation ( family m$ic9e1 g5]al int]nal m$ic9e1 or p$iatric m$ic9e2 or 7ii7 furni%$ dur+ ! p]iod t beg9s on ! fir/ day ( ! fir/ mon? t beg9s "o ye> aft] ! date ( enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,enhancem5t ,act & ends ,septemb] #cj1 #bjbd-- 7,i7 by a physician ) a prim>y specialty designation ( family m$ic9e1 g5]al int]nal m$ic9e1 or p$iatric m$ic9e1 b only if ! physician self-atte/s t ! physician is ,bo>d c]tifi$ 9 family m$ic9e1 g5]al int]nal m$ic9e1 or p$iatric m$ic9e2 7,,ii7 by a physician ) a prim>y specialty designation ( ob/etrics & gynecology1 b only if ! physician self-atte/s t ! physician is ,bo>d c]tifi$ 9 ob/etrics & gynecology2 7,,iii7 by an advanc$ practice cl9ician1 z def9$ by ! ,secret>y1 t works "u ! sup]vision (-- 7aa7 a physician t satisfies ! crit]ia specifi$ 9 subclause 7,i7 or 7,,ii72 or 7bb7 a nurse practition] or a physician assi/ant 7z su* t]ms are def9$ 9 section #ahfa7;aa77#e77;,a77 :o is work+ 9 accordance ) ,/ate law1 or a c]tifi$ nurse-midwife 7z def9$ 9 section #ahfa7;gg77 :o is work+ 9 accordance ) ,/ate law2 7,,iv7 by a rural heal? cl9ic1 ,f$]ally-qualifi$ heal? c5t]1 or o!r heal? cl9ic t receives reimbursem5t on a fee s*$ule applicable to a physician1 a nurse practition] or a physician assi/ant 7z su* t]ms are def9$ 9 section #ahfa7;aa77#e77;,a77 :o is work+ 9 accordance ) ,/ate law1 or a c]tifi$ nurse-midwife 7z def9$ 9 section #ahfa7;gg77 :o is work+ 9 accordance ) ,/ate law1 = s]vices furni%$ by a physician1 nurse practition]1 physician assi/ant1 or c]tifi$ nurse-midwife1 or s]vices furni%$ by an advanc$ practice cl9ician sup]vis$ by a physician describ$ 9 subclause 7,i77aa7 or 7,,ii77aa71 ano!r advanc$ practice cl9ician1 or a c]tifi$ nurse-midwife2 or 7,v7 by a nurse practition] or a physician assi/ant 7z su* t]ms are def9$ 9 section #ahfa7;aa77#e77;,a77 :o is work+ 9 accordance ) ,/ate law1 or a c]tifi$ nurse-midwife 7z def9$ 9 section #ahfa7;gg77 :o is work+ 9 accordance ) ,/ate law1 9 accordance ) proc$ures t ensure t ! portion ( ! paym5t = su* s]vices t ! nurse practition]1 physician assi/ant1 or c]tifi$ nurse-midwife is paid is n less ?an ! am\nt t ! nurse practition]1 physician assi/ant1 or c]tifi$ nurse-midwife w\ld be paid if ! s]vices 7 provid$ "u "p ,b ( title ,,xviii2 4 7#b7 ,con=m+ am5dm5ts ,section #aije7;dd7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7dd77 is am5d$-- 7,a7 by /rik+ ,not)/&+ & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,not)/&+ 2 7,b7 by ins]t+ or furni%$ dur+ ! additional p]iod specifi$ 9 p>agraph 7#b71 aft] #bjae12 & 7,c7 by add+ at ! end ! foll[+3 7#b7 ,additional p]iod ,= purposes ( p>agraph 7#a71 ! additional p]iod specifi$ 9 ?is p>agraph is ! p]iod t beg9s on ! fir/ day ( ! fir/ mon? t beg9s "o ye> aft] ! date ( enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,enhancem5t ,act4 4 7b7 ,improv$ t>get+ ( prim>y c>e ,section #aijb7;jj7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7jj77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z subp>agraphs 7,a7 & 7,b71 respectively & realign+ ! left m>g9s accord+ly2 7#b7 by /rik+ ,= purposes ( & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,= purposes ( 2 & 7#c7 by add+ at ! end ! foll[+3 7#b7 ,exclusions ,su* t]m does n include any s]vices describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 if su* s]vices are provid$ 9 an em]g5cy dep>tm5t ( a hospital4 4 7c7 ,ensur+ paym5t by manag$ c>e entities 7#a7 ,9 g5]al ,section #aijc7m77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is am5d$-- 7,a7 9 clause 7xii71 by /rik+ & aft] ! semicolon2 7,b7 by realign+ ! left m>g9 ( clause 7xiii7 s z to align ) ! left m>g9 ( clause 7xii7 & by /rik+ ! p]iod at ! end ( clause 7xiii7 & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] clause 7xiii7 ! foll[+3 7xiv7 su* contract provides t 7,i7 paym5ts to provid]s specifi$ 9 section #aijb7;a77#ac77;,c7 = prim>y c>e s]vices def9$ 9 section #aijb7;jj7 t are furni%$ dur+ a ye> or p]iod specifi$ 9 section #aijb7;a77#ac77;,c7 & section #aije7;dd7 are at lea/ equal to ! am\nts set =? & requir$ by ! ,secret>y by regulation1 7,,ii7 ! entity %all1 ^u reque/1 provide docum5tation to ! ,/ate1 suffici5t to enable ! ,/ate & ! ,secret>y to ensure compliance ) subclause 7,i71 & 7,,iii7 ! ,secret>y %all approve paym5ts describ$ 9 subclause 7,i7 t are furni%$ ?r\gh an agre$ ^u capitation1 p>tial capitation1 or o!r value-bas$ paym5t arrangem5t if ! capitation1 p>tial capitation1 or o!r value-bas$ paym5t arrangem5t is bas$ on a reasonable me?odology & ! entity provides docum5tation to ! ,/ate suffici5t to enable ! ,/ate & ! ,secret>y to ensure compliance ) subclause 7,i74 4 7#b7 ,con=m+ am5dm5t ,section #aicb7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;f77 is am5d$ by ins]t+ & clause 7xiv7 ( section #aijc7m77#b77;,a7 be=e ! p]iod4 #bjg4 ,p]man5t fund+ = ,,*ip 7a7 ,9 g5]al ,section #bajd7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7a77 is am5d$-- 7#a7 9 p>agraph 7#bf71 by ins]t+ at ! end &2 7#b7 by am5d+ p>agraph 7#bg7 to read z foll[s3 7#bg7 = ea* fiscal ye> beg9n+ ) fiscal ye> #bjbd1 su* sums z are necess>y to fund allotm5ts to ,/ates "u subsections 7c7 & 7m74 2 & 7#c7 by /rik+ p>agraph 7#bh74 7b7 ,9 g5]al ,section #bajd7;a77#bh7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7a77#bh77 is am5d$ to read z foll[s3 7#bh7 = fiscal ye> #bjbg & ea* subsequ5t ye>1 su* sums z are necess>y to fund allotm5ts to ,/ates "u subsections 7c7 & 7m74 4 7c7 ,allotm5ts 7#a7 ,9 g5]al ,section #bajd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7m77 is am5d$-- 7,a7 9 p>agraph 7#b77;,b77i71 by /rik+ 11 #bjbc1 & #bjbg & ins]t+ & #bjbc2 7,b7 9 p>agraph 7#g7-- 7i7 9 subp>agraph 7,a71 by /rik+ & end+ ) fiscal ye> #bjbg12 & 7ii7 9 ! flu% left matt] at ! end1 by /rik+ or fiscal ye> #bjbf & ins]t+ fiscal ye> #bjbf1 or a subsequ5t ev5-numb]$ fiscal ye>2 7,c7 9 p>agraph 7#i7-- 7i7 by /rik+ 7#aj71 or 7#aa7 & ins]t+ or 7#aj72 & 7ii7 by /rik+ #bjbc1 or #bjbg1 & ins]t+ or #bjbc2 & 7,d7 by /rik+ p>agraph 7#aa74 7#b7 ,con=m+ am5dm5t ,section #ejaja7;b77#b7 ( ! ,bip>tisan ,budget ,act ( #bjah 7,public ,law #aae-abc7 is repeal$4 #bjh4 ,p]man5t ext5sion ( ,,*ip enrollm5t & quality measures 7a7 ,p$iatric quality measures program ,section #aaci;,a7i77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#i;a7i77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ at ! end &2 7#b7 9 subp>agraph 7,d71 by /rik+ ! p]iod at ! end & ins]t a semicolon2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraphs3 7,e7 = fiscal ye> #bjbh1 #ae1jjj1jjj = ! purpose ( c>ry+ out ?is section 7o!r ?an subsections 7e71 7f71 & 7g772 & 7,f7 = a subsequ5t fiscal ye>1 ! am\nt appropriat$ "u ?is p>agraph = ! previ\s fiscal ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 ov] su* previ\s fiscal ye>1 = ! purpose ( c>ry+ out ?is section 7o!r ?an subsections 7e71 7f71 & 7g774 4 7b7 ,express lane eligibility option ,section #aijb7;e77#ac7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7e77#ac77 is am5d$ by /rik+ subp>agraph 7,i74 7c7 ,assurance ( af=dability /&>d = *ildr5 & families 7#a7 ,9 g5]al ,section #baje7;d77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;ee7d77#c77 is am5d$-- 7,a7 9 ! p>agraph head+1 by /rik+ ?r\gh ,septemb] #cj1 #bjbg2 & 7,b7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i7-- 7i7 by /rik+ ,dur+ ! p]iod t beg9s on ! date ( enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,act & ends on ,septemb] #cj1 #bjbg & ins]t+ ,beg9n+ on ! date ( ! enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,act2 7ii7 by /rik+ ,dur+ ! p]iod t beg9s on ,octob] #a1 #bjai1 & ends on ,septemb] #cj1 #bjbg & ins]t+ ,beg9n+ on ,octob] #a1 #bjai2 & 7iii7 by /rik+ ,! prec$+ s5t5ces %all n be con/ru$ z prev5t+ a ,/ate dur+ any su* p]iods f & ins]t+ ,! prec$+ s5t5ces %all n be con/ru$ z prev5t+ a ,/ate f4 7#b7 ,con=m+ am5dm5ts ,section #aijb7;gg77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7gg77#b77 is am5d$-- 7,a7 9 ! p>agraph head+1 by /rik+ ?r\gh ,septemb] #cj1 #bjbg2 & 7,b7 by /rik+ ?r\gh ,septemb] #cj & all t foll[s ?r\gh ends on ,septemb] #cj1 #bjbg & ins]t+ 7b beg9n+ on ,octob] #a1 #bjai14 7d7 ,qualify+ /ates option ,section #baje7;g77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;ee7g77#d77 is am5d$-- 7#a7 9 ! p>agraph head+1 by /rik+ = fiscal ye>s #bjji ?r\gh #bjbg & ins]t+ aft] fiscal ye> #bjjh2 & 7#b7 9 subp>agraph 7,a71 by /rik+ = any ( fiscal ye>s #bjji ?r\gh #bjbg & ins]t+ = any fiscal ye> aft] fiscal ye> #bjjh4 7e7 ,outrea* & enrollm5t program ,section #baac ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acigmm7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by /rik+ dur+ ! p]iod ( fiscal ye>s #bjji ?r\gh #bjbg & ins]t+ 1 beg9n+ ) fiscal ye> #bjji12 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ #aj p]c5t ( su* am\nts & ins]t+ #aj p]c5t ( su* am\nts = ! p]iod or ! fiscal ye> = :i* su* am\nts are appropriat$2 & 7ii7 by /rik+ dur+ su* p]iod & ins]t+ 1 dur+ su* p]iod or su* fiscal ye>12 & 7,c7 9 p>agraph 7#c71 by /rik+ ,= ! p]iod ( fiscal ye>s #bjbd ?r\gh #bjbg1 an am\nt equal to #aj p]c5t ( su* am\nts & ins]t+ ,beg9n+ ) fiscal ye> #bjbd1 an am\nt equal to #aj p]c5t ( su* am\nts = ! p]iod or ! fiscal ye> = :i* su* am\nts are appropriat$2 & 7#b7 9 subsection 7g7-- 7,a7 by /rik+ #bjag11 & ins]t+ #bjag12 7,b7 by /rik+ & #dh1jjj1jjj & ins]t+ #dh1jjj1jjj2 & 7,c7 by ins]t+ aft] ?r\gh #bjbg ! foll[+3 1 #ab1jjj1jjj = fiscal ye> #bjbh1 &1 = ea* fiscal ye> aft] fiscal ye> #bjbh1 ! am\nt appropriat$ "u ?is subsection = ! previ\s fiscal ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 ov] su* previ\s fiscal ye>4 7f7 ,*ild enrollm5t cont+5cy fund ,section #bajd7n7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7n77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a77ii7-- 7i7 by /rik+ & #bjbd ?r\gh #bjbf & ins]t+ beg9n+ ) fiscal ye> #bjbd2 & 7ii7 by /rik+ #bjbc1 & #bjbg & ins]t+ 1 & #bjbc2 & 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ #bjbd ?r\gh #bjbf & ins]t+ beg9n+ ) fiscal ye> #bjbd2 & 7ii7 by /rik+ #bjbc1 & #bjbg & ins]t+ 1 & #bjbc2 & 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 by /rik+ fiscal ye>s #bjbd ?r\gh #bjbf & ins]t+ beg9n+ ) fiscal ye> #bjbd2 & 7,b7 by /rik+ #bjbc1 or #bjbg & ins]t+ 1 or #bjbc4 #bji4 ,/ate option to increase *ildr5's eligibility = ,m$icaid & ,,*ip ,section #baaj7;b77#a77;,b77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;jj7b77#a77;,b77ii77 is am5d$-- 7#a7 9 subclause 7,,ii71 by /rik+ or at ! end2 7#b7 9 subclause 7,,iii71 by /rik+ & at ! end & ins]t+ or2 & 7#c7 by ins]t+ aft] subclause 7,,iii7 ! foll[+ new subclause3 7,,iv7 at ! option ( ! ,/ate1 ^: family income exce$s ! maximum income level o!rwise e/abli%$ = *ildr5 "u ! ,/ate *ild heal? plan z ( ! date ( ! enactm5t ( ?is subclause2 & 4 #baj4 ,m$icaid cov]age = citiz5s ( ,freely ,associat$ ,/ates 7a7 ,9 g5]al ,section #djb7;b77#b7 ( ! ,p]sonal ,responsibility & ,"w ,opportunity ,reconciliation ,act ( #aiif 7#h ,u4,s4,c4 #afab7;b77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,m$icaid exception = citiz5s ( ,freely ,associat$ ,/ates ,) respect to eligibility = b5efits = ! designat$ ,f$]al program def9$ 9 p>agraph 7#c77;,c7 7relat+ to ! ,m$icaid program71 section #dja7;a7 & p>agraph 7#a7 %all n apply to any individual :o lawfully resides 9 #a ( ! #ej ,/ates or ! ,di/rict ( ,columbia 9 accordance ) ! ,compacts ( ,free ,association betwe5 ! ,gov]nm5t ( ! ,unit$ ,/ates & ! ,gov]nm5ts ( ! ,f$]at$ ,/ates ( ,micronesia1 ! ,republic ( ! ,m>%all ,isl&s1 & ! ,republic ( ,palau & %all n apply1 at ! option ( ! ,gov]nor ( ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 or ,am]ican ,samoa z communicat$ to ! ,secret>y ( ,heal? & ,human ,s]vices 9 writ+1 to any individual :o lawfully resides 9 ! respective t]ritory 9 accordance ) su* ,compacts4 4 7b7 ,exception to #e-,ye> limit$ eligibility ,section #djc7;d7 ( su* ,act 7#h ,u4,s4,c4 #afac7;d77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ or at ! end2 7#b7 9 p>agraph 7#b71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 an individual describ$ 9 section #djb7;b77#b77;,g71 b only ) respect to ! designat$ ,f$]al program def9$ 9 section #djb7;b77#c77;,c74 4 7c7 ,def9ition ( qualifi$ ali5 ,section #dca7;b7 ( su* ,act 7#h ,u4,s4,c4 #afda7;b77 is am5d$-- 7#a7 9 p>agraph 7#f71 by /rik+ 2 or at ! end & ins]t+ a comma2 7#b7 9 p>agraph 7#g71 by /rik+ ! p]iod at ! end & ins]t+ 1 or2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 an individual :o lawfully resides 9 ! ,unit$ ,/ates 9 accordance ) a ,compact ( ,free ,association ref]r$ to 9 section #djb7;b77#b77;,g71 b only ) respect to ! designat$ ,f$]al program def9$ 9 section #djb7;b77#c77;,c7 7relat+ to ! ,m$icaid program74 4 7d7 ,application to ,/ate plans ,section #aijb7;a77#aj77;,a77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77 is am5d$ by ins]t+ aft] subclause 7,,ix7 ! foll[+3 7,x7 :o are describ$ 9 section #djb7;b77#b77;,g7 ( ! ,p]sonal ,responsibility & ,"w ,opportunity ,reconciliation ,act ( #aiif & eligible = b5efits "u ?is title by reason ( application ( su* section2 4 7e7 ,con=m+ am5dm5ts ,section #aajh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acjh7 is am5d$-- 7#a7 9 subsection 7f71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ subsections 7g7 & 7h7 & section #aice7;e77#a77;,b7 & ins]t+ subsections 7g71 7h71 & 7i7 & section #aice7;e77#a77;,b72 & 7#b7 by add+ at ! end ! foll[+3 7i7 ,exclusion ( m$ical assi/ance exp5ditures = citiz5s ( ,freely ,associat$ ,/ates ,exp5ditures = m$ical assi/ance provid$ to an individual describ$ 9 section #dca7;b77#h7 ( ! ,p]sonal ,responsibility & ,"w ,opportunity ,reconciliation ,act ( #aiif 7#h ,u4,s4,c4 #afda7;b77#h77 %all n be tak5 into acc\nt = purposes ( apply+ paym5t limits "u subsections 7f7 & 7g74 4 7f7 ,effective date ,! am5dm5ts made by ?is section %all apply to b5efits = items & s]vices furni%$ on or aft] ! date ( ! enactm5t ( ?is ,act4 #baa4 ,ext5sion ( full ,f$]al m$ical assi/ance p]c5tage to ,indian heal? c>e provid]s 7a7 ,9 g5]al ,section #aije ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is am5d$-- 7#a7 9 subsection 7a71 by am5d+ p>agraph 7#i7 to read z foll[s3 7#i7 cl9ic s]vices furni%$ by or "u ! direction ( a physician1 )\t reg>d to :e!r ! cl9ic itself is adm9i/]$ by a physician1 includ+-- 7,a7 su* s]vices furni%$ outside ! cl9ic by cl9ic p]sonnel to an eligible individual :o does n reside 9 a p]man5t dwell+ or does n h a fix$ home or mail+ address2 & 7,b7 su* s]vices provid$ outside ! cl9ic on ! basis ( a ref]ral f a cl9ic adm9i/]$ by an ,indian ,heal? ,program 7z def9$ 9 p>agraph 7#ab7 ( section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act1 or an ,urban ,indian ,organization z def9$ 9 p>agraph 7#bi7 ( section #d ( su* ,act t has a grant or contract ) ! ,indian ,heal? ,s]vice "u title ,v ( su* ,act2 4 7#b7 9 subsection 7b71 by ins]t+ aft] 7z def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act7 ! foll[+3 2 ! ,f$]al m$ical assi/ance p]c5tage %all also be #ajj p] c5tum ) respect to am\nts exp5d$ z m$ical assi/ance = s]vices :i* are receiv$ ?r\gh an ,urban ,indian organization 7z def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act7 t has a grant or contract ) ! ,indian ,heal? ,s]vice "u title ,v ( su* ,act4 7b7 ,ext5sion ( full ,f$]al m$ical assi/ance p]c5tage to s]vices furni%$ by ,native ,hawaiian ,heal? ,c>e sy/ems 7#a7 ,9 g5]al ,beg9n+ on ! date ( enactm5t ( ?is ,act-- 7,a7 = purposes ( section #aije7;a77#i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77#i771 s]vices describ$ 9 subsection 7b7 t are furni%$ 9 any location %all be deem$ to be cl9ic s]vices2 & 7,b7 not)/&+ section #aije7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7b771 ! ,f$]al m$ical assi/ance p]c5tage ) respect to am\nts exp5d$ z m$ical assi/ance = su* s]vices %all be #ajj p]c5t4 7#b7 ,s]vices describ$ ,! s]vices describ$ 9 ?is subsection are s]vices = :i* paym5t is available "u ! ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 ( ,hawaii 7or any waiv] ( su* plan7 t-- 7,a7 are furni%$ on or aft] ! date ( enactm5t ( ?is ,act2 7,b7 are furni%$ to an individual :o-- 7i7 is a ,native ,hawaiian2 & 7ii7 is eligible = m$ical assi/ance "u su* plan2 & 7,c7 are furni%$ by an ,indian heal? c>e provid] 7z su* t]m is def9$ 9 section #aicb7;h77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;h77#d77;,a77 or a ,native ,hawaiian heal? c>e sy/em 7)\t reg>d to :e!r su* s]vices are furni%$ ?r\gh an ,indian ,heal? ,s]vice facility74 ,,iii ,l[]+ ,prices ,?r\gh ,fair ,drug ,price ,negotiation #cja4 ,e/abli%+ a ,fair ,drug ,pric+ ,program 7a7 ,program ,to l[] prices = c]ta9 high-,pric$ s+le s\rce drugs ,title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by add+ at ! end ! foll[+ new "p3 ,e ,fair ,price ,negotiation ,program to ,l[] ,prices = ,c]ta9 ,high-,pric$ ,s+le ,s\rce ,drugs #aaia4 ,e/abli%m5t ( program 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a ,fair ,price ,negotiation ,program 79 ?is "p ref]r$ to z ! program74 ,"u ! program1 ) respect to ea* price applicability p]iod1 ! ,secret>y %all-- 7#a7 publi% a li/ ( select$ drugs 9 accordance ) section #aaib2 7#b7 ent] into agreem5ts ) manufactur]s ( select$ drugs ) respect to su* p]iod1 9 accordance ) section #aaic2 7#c7 negotiate &1 if applicable1 r5egotiate maximum fair prices = su* select$ drugs1 9 accordance ) section #aaid2 & 7#d7 c>ry out ! adm9i/rative duties describ$ 9 section #aaif4 7b7 ,def9itions relat+ to tim+ ,= purposes ( ?is "p3 7#a7 ,initial price applicability ye> ,! t]m initial price applicability ye> means a plan ye> 7beg9n+ ) plan ye> #bjbc7 or1 if agre$ to 9 an agreem5t "u section #aaic by ! ,secret>y & manufactur] involv$1 a p]iod ( m ?an "o plan ye> 7beg9n+ on or aft] ,janu>y #a1 #bjbc74 7#b7 ,price applicability p]iod ,! t]m price applicability p]iod means1 ) respect to a drug1 ! p]iod beg9n+ ) ! initial price applicability ye> ) respect to :i* su* drug is a select$ drug & end+ ) ! la/ plan ye> dur+ :i* ! drug is a select$ drug4 7#c7 ,select$ drug publication date ,! t]m select$ drug publication date means1 ) respect to ea* initial price applicability ye>1 ,april #ae ( ! plan ye> t beg9s #b ye>s prior to su* ye>4 7#d7 ,volunt>y negotiation p]iod ,! t]m volunt>y negotiation p]iod means1 ) respect to an initial price applicability ye> ) respect to a select$ drug1 ! p]iod-- 7,a7 beg9n+ on ! soon] (-- 7i7 ! date on :i* ! manufactur] ( ! drug & ! ,secret>y ent] into an agreem5t "u section #aaic ) respect to su* drug2 or 7ii7 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug2 & 7,b7 end+ on ,m>* #ca ( ! ye> t beg9s "o ye> prior to ! initial price applicability ye>4 7c7 ,o!r def9itions ,= purposes ( ?is "p3 7#a7 ,fair price eligible individual ,! t]m fair price eligible individual means1 ) respect to a select$ drug-- 7,a7 9 ! case su* drug is furni%$ or disp5s$ to ! individual at a ph>macy or by a mail ord] s]vice-- 7i7 an individual :o is enroll$ "u 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* select$ drug2 & 7ii7 an individual :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$2 & 7,b7 9 ! case su* drug is furni%$ or adm9i/]$ to ! individual by a hospital1 physician1 or o!r provid] ( s]vices or suppli]-- 7i7 an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title if su* select$ drug is cov]$ "u ! respective "p2 & 7ii7 an individual :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/]$4 7#b7 ,maximum fair price ,! t]m maximum fair price means1 ) respect to a plan ye> dur+ a price applicability p]iod & ) respect to a select$ drug 7z def9$ 9 section #aaib7;c77 ) respect to su* p]iod1 ! price publi%$ pursuant to section #aaie 9 ! ,f$]al ,regi/] = su* drug & ye>4 7#c7 ,av]age int]national m>ket price def9$ 7,a7 ,9 g5]al ,! t]ms av]age int]national m>ket price & ,,aim price mean1 ) respect to a drug1 ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit 7z def9$ 9 p>agraph 7#d77 ( ! drug = sales ( su* drug 7calculat$ across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type71 z comput$ 7z ( ! date ( publication ( su* drug z a select$ drug "u section #aaib7;a77 9 all c\ntries describ$ 9 clause 7ii7 ( subp>agraph 7,b7 t are applicable c\ntries 7z describ$ 9 clause 7i7 ( su* subp>agraph7 ) respect to su* drug4 7,b7 ,applicable c\ntries 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 a c\ntry describ$ 9 clause 7ii7 is an applicable c\ntry describ$ 9 ?is clause ) respect to a drug if !re is available an av]age price = any unit = ! drug = sales ( su* drug 9 su* c\ntry4 7ii7 ,c\ntries describ$ ,= purposes ( ?is p>agraph1 ! foll[+ are c\ntries describ$ 9 ?is clause3 7,i7 ,au/ralia4 7,,ii7 ,canada4 7,,iii7 ,france4 7,,iv7 ,g]many4 7,v7 ,japan4 7,,vi7 ,! ,unit$ ,k+dom4 7#d7 ,unit ,! t]m unit means1 ) respect to a drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! drug t is disp5s$4 #aaib4 ,selection ( negotiation-eligible drugs z select$ drugs 7a7 ,9 g5]al ,n lat] ?an ! select$ drug publication date ) respect to an initial price applicability ye>1 subject to subsection 7h71 ! ,secret>y %all select & publi% 9 ! ,f$]al ,regi/] a li/ (-- 7#a7 7,a7 ) respect to an initial price applicability ye> dur+ #bjbc1 at lea/ #be negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod beg9n+ aft] #bjbc1 ! maximum numb] 7if su* numb] is less ?an #be7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 & 7,b7 ) respect to an initial price applicability ye> dur+ #bjbd or a subsequ5t ye>1 at lea/ #ej negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #ej7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7#b7 all negotiation-eligible drugs describ$ 9 subp>agraph 7,c7 ( su* subsection ) respect to su* ye>2 & 7#c7 all new-entrant negotiation-eligible drugs 7z def9$ 9 subsection 7g77#a77 ) respect to su* ye>4 ,ea* drug publi%$ on ! li/ pursuant to ! previ\s s5t5ce %all be subject to ! negotiation process "u section #aaid = ! volunt>y negotiation p]iod ) respect to su* initial price applicability ye> 7& ! r5egotiation process "u su* section z applicable = any subsequ5t ye> dur+ ! applicable price applicability p]iod74 ,9 apply+ ?is subsection1 any negotiation-eligible drug t is select$ "u ?is subsection = an initial price applicability ye> %all n c\nt t[>d ! requir$ m9imum am\nt ( drugs to be select$ "u p>agraph 7#a7 = any subsequ5t ye>1 includ+ su* a drug s select$ t is subject to r5egotiation "u section #aaid4 7b7 ,selection ( drugs ,9 c>ry+ out subsection 7a77#a7 ! ,secret>y %all select = inclusion on ! publi%$ li/ describ$ 9 subsection 7a7 ) respect to a price applicability p]iod1 ! negotiation-eligible drugs t ! ,secret>y projects w result 9 ! greate/ sav+s to ! ,f$]al ,gov]nm5t or fair price eligible individuals dur+ ! price applicability p]iod4 ,9 mak+ ?is projection ( sav+s = drugs = :i* !re is an ,,aim price = a price applicability p]iod1 ! sav+s %all be project$ across diff]5t dosage =ms & /r5g?s ( ! drugs & n bas$ on ! specific =mulation or package size or package type ( ! drugs1 tak+ into consid]ation bo? ! volume ( drugs = :i* paym5t is made1 to ! ext5t su* data is available1 & ! am\nt by :i* ! net price = ! drugs exce$s ! ,,aim price = ! drugs4 7c7 ,select$ drug ,= purposes ( ?is "p1 ea* drug includ$ on ! li/ publi%$ "u subsection 7a7 ) respect to an initial price applicability ye> %all be ref]r$ to z a select$ drug ) respect to su* ye> & ea* subsequ5t plan ye> beg9n+ be=e ! fir/ plan ye> beg9n+ aft] ! date on :i* ! ,secret>y det]m9es two or m drug products-- 7#a7 are approv$ or lic5s$ 7z applicable7-- 7,a7 "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act us+ su* drug z ! li/$ drug2 or 7,b7 "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act us+ su* drug z ! ref]5ce product2 & 7#b7 cont9ue to be m>ket$4 7d7 ,negotiation-,eligible drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug1 z def9$ 9 subsection 7e71 t meets any ( ! foll[+ crit]ia3 7,a7 ,cov]$ "p ,d drugs ,! drug is among ! #abe cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e77 = :i* !re 0 an e/imat$ greate/ net sp5d+ "u p>ts ,c & ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,b7 ,o!r drugs ,! drug is among ! #abe drugs = :i* !re 0 an e/imat$ greate/ net sp5d+ 9 ! ,unit$ ,/ates 7includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates71 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,c7 ,insul9 ,! drug is a qualify+ s+le s\rce drug describ$ 9 subsection 7e77#c74 7#b7 ,cl>ification ,9 det]m9+ :e!r a qualify+ s+le s\rce drug satisfies any ( ! crit]ia describ$ 9 p>agraph 7#a71 ! ,secret>y %all1 to ! ext5t practicable1 use data t is aggregat$ across dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7#c7 ,publication ,n lat] ?an ! select$ drug publication date ) respect to an initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a li/ ( negotiation-eligible drugs ) respect to su* select$ drug publication date4 7e7 ,qualify+ s+le s\rce drug ,= purposes ( ?is "p1 ! t]m qualify+ s+le s\rce drug means any ( ! foll[+3 7#a7 ,drug products ,a drug t-- 7,a7 is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & cont9ues to be m>ket$ pursuant to su* approval2 & 7,b7 is n ! li/$ drug = any drug t is approv$ & cont9ues to be m>ket$ "u section #eje7;j7 ( su* ,act4 7#b7 ,biological products ,a biological product t-- 7,a7 is lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 includ+ any product t has be5 deem$ to be lic5s$ "u section #cea ( su* ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji1 & cont9ues to be m>ket$ "u section #cea ( su* ,act2 & 7,b7 is n ! ref]5ce product = any biological product t is lic5s$ & cont9ues to be m>ket$ "u section #cea7k7 ( su* ,act4 7#c7 ,insul9 product ,not)/&+ p>agraphs 7#a7 & 7#b71 any insul9 product t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act & cont9ues to be m>ket$ "u su* section #eje or #cea1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & cont9ues to be m>ket$ pursuant to su* lic5sure4 ,= purposes ( apply+ p>agraphs 7#a7 & 7#b71 a drug or biological product t is m>ket$ by ! same sponsor or manufactur] 7or an affiliate !re( or a cross-lic5s$ produc] or di/ributor7 z ! li/$ drug or ref]5ce product describ$ 9 su* respective p>agraph %all n be tak5 into consid]ation4 7f7 ,in=mation on int]national drug prices ,= purposes ( det]m9+ :i* negotiation-eligible drugs to select "u subsection 7a7 &1 9 ! case ( su* drugs t are select$ drugs1 to det]m9e ! maximum fair price = su* a drug & :e!r su* maximum fair price %\ld be r5egotiat$ "u section #aaid1 ! ,secret>y %all use data relat+ to ! ,,aim price ) respect to su* drug z available or provid$ to ! ,secret>y & %all on an ongo+ basis reque/ f manufactur]s ( select$ drugs in=mation on ! ,,aim price ( su* a drug4 7g7 ,new-,entrant negotiation-,eligible drugs 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m new-entrant negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug-- 7,a7 t is fir/ approv$ or lic5s$1 z describ$ 9 p>agraph 7#a71 7#b71 or 7#c7 ( subsection 7e71 z applicable1 dur+ ! ye> prec$+ su* select$ drug publication date2 & 7,b7 t ! ,secret>y det]m9es "u p>agraph 7#b7 is likely to be includ$ z a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date4 7#b7 ,det]m9ation ,9 ! case ( a qualify+ s+le s\rce drug t meets ! crit]ia describ$ 9 subp>agraph 7,a7 ( p>agraph 7#a71 ) respect to an initial price applicability ye>1 if ! :olesale acquisition co/ at :i* su* drug is fir/ m>ket$ 9 ! ,unit$ ,/ates is equal to or great] ?an ! m$ian h\sehold income 7z det]m9$ accord+ to ! mo/ rec5t data collect$ by ! ,unit$ ,/ates ,c5sus ,bureau71 ! ,secret>y %all det]m9e be=e ! select$ drug publication date ) respect to ! initial price applicability ye>1 if ! drug is likely to be includ$ z a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date1 bas$ on ! project$ sp5d+ "u title ,,xviii or 9 ! ,unit$ ,/ates on su* drug4 ,= purposes ( ?is p>agraph ! t]m ,unit$ ,/ates includes ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates4 7h7 ,conflict ( int]e/ 7#a7 ,9 g5]al ,9 ! case ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices det]m9es ! ,secret>y has a conflict1 ) respect to a matt] describ$ 9 p>agraph 7#b71 ! individual describ$ 9 p>agraph 7#c7 %all c>ry out ! duties ( ! ,secret>y "u ?is "p1 ) respect to a negotiation-eligible drug1 t w\ld o!rwise be su* a conflict4 7#b7 ,matt] describ$ ,a matt] describ$ 9 ?is p>agraph is-- 7,a7 a f9ancial int]e/ 7z describ$ 9 section #bfce4djb ( title #e1 ,code ( ,f$]al ,regulations 7except = an int]e/ describ$ 9 subsection 7b77#b77;iv7 ( su* section77 on ! date ( ! select$ drug publication date1 ) respect ! price applicability ye> 7z applicable72 7,b7 a p]sonal or bus9ess relation%ip 7z describ$ 9 section #bfce4ejb ( su* title7 on ! date ( ! select$ drug publication date1 ) respect ! price applicability ye>2 7,c7 employm5t by a manufactur] ( a negotiation-eligible drug dur+ ! prec$+ #aj-ye> p]iod beg9n+ on ! date ( ! select$ drug publication date1 ) respect to ea* price applicability ye>2 & 7,d7 any o!r matt] ! ,g5]al ,c\nsel det]m9es appropriate4 7#c7 ,individual describ$ ,an individual describ$ 9 ?is p>agraph is-- 7,a7 ! highe/-rank+ (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7z det]m9$ by ! organizational *>t ( ! ,dep>tm5t7 t does n h a conflict "u ?is subsection2 & 7,b7 is nom9at$ by ! ,presid5t & confirm$ by ! ,s5ate ) respect to ! position4 #aaic4 ,manufactur] agreem5ts 7a7 ,9 g5]al ,= purposes ( section #aaia7;a77#b71 ! ,secret>y %all ent] into agreem5ts ) manufactur]s ( select$ drugs ) respect to a price applicability p]iod1 by n lat] ?an ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug1 "u :i*-- 7#a7 dur+ ! volunt>y negotiation p]iod = ! initial price applicability ye> = ! select$ drug1 ! ,secret>y & manufactur]1 9 accordance ) section #aaid1 negotiate to det]m9e 7&1 by n lat] ?an ! la/ date ( su* p]iod & 9 accordance ) subsection 7c71 agree to7 a maximum fair price = su* select$ drug ( ! manufactur] 9 ord] to provide access to su* price-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug dur+1 subject to subp>agraph 7#b71 ! price applicability p]iod2 & 7,b7 to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s ) respect to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( su* section & are furni%$ or adm9i/]$ su* drug dur+1 subject to subp>agraph 7#b71 ! price applicability p]iod2 7#b7 ! ,secret>y & ! manufactur] %all1 9 accordance ) a process & dur+ a p]iod specifi$ by ! ,secret>y pursuant to rulemak+1 r5egotiate 7&1 by n lat] ?an ! la/ date ( su* p]iod & 9 accordance ) subsection 7c71 agree to7 ! maximum fair price = su* drug if ! ,secret>y det]m9es t !re is a mat]ial *ange 9 any ( ! factors describ$ 9 section #aaid7;d7 relat+ to ! drug1 includ+ *anges 9 ! ,,aim price = su* drug1 9 ord] to provide access to su* maximum fair price 7z s r5egotiat$7-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug dur+ any ye> dur+ ! price applicability p]iod 7beg9n+ aft] su* r5egotiation7 ) respect to su* select$ drug2 & 7,b7 to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s ) respect to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( su* section & are furni%$ or adm9i/]$ su* drug dur+ any ye> describ$ 9 subp>agraph 7,a72 7#c7 ! maximum fair price 7includ+ z r5egotiat$ pursuant to p>agraph 7#b771 ) respect to su* a select$ drug1 %all be provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ! ph>macy or by a mail ord] s]vice at ! po9t-(-sale ( su* drug2 7#d7 ! manufactur]1 subject to subsection 7d71 submits to ! ,secret>y1 9 a =m & mann] specifi$ by ! ,secret>y-- 7,a7 = ! volunt>y negotiation p]iod = ! price applicability p]iod 7&1 if applicable1 be=e any p]iod ( r5egotiation specifi$ pursuant to p>agraph 7#b77 ) respect to su* drug all in=mation t ! ,secret>y requires to c>ry out ! negotiation 7or r5egotiation process7 "u ?is "p1 includ+ in=mation describ$ 9 section #aaib7;f7 & section #aaid7;d77#a72 & 7,b7 on an ongo+ basis1 in=mation on *anges 9 prices = su* drug t w\ld affect ! ,,aim price = su* drug or o!rwise provide a basis = r5egotiation ( ! maximum fair price = su* drug pursuant to p>agraph 7#b72 7#e7 ! manufactur] agrees t 9 ! case ! select$ drug ( a manufactur] is a drug describ$ 9 subsection 7c71 ! manufactur] w1 9 accordance ) su* subsection1 make any paym5t requir$ "u su* subsection ) respect to su* drug2 & 7#f7 ! manufactur] complies ) requirem5ts impos$ by ! ,secret>y = purposes ( adm9i/]+ ! program1 includ+ ) respect to ! duties describ$ 9 section #aaif4 7b7 ,agreem5t 9 effect until drug is no long] a select$ drug ,an agreem5t ent]$ into "u ?is section %all be effective1 ) respect to a drug1 until su* drug is no long] consid]$ a select$ drug "u section #aaib7;c74 7c7 ,special rule = c]ta9 select$ drugs )\t ,,aim price 7#a7 ,9 g5]al ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug & = :i* an ,,aim price becomes available beg9n+ ) respect to a subsequ5t plan ye> dur+ ! price applicability p]iod = su* drug1 if ! ,secret>y det]m9es t ! am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug is great] ?an ! am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug1 !n by n lat] ?an "o ye> aft] ! date ( su* det]m9ation1 ! manufactur] ( su* select$ drug %all pay to ! ,treasury an am\nt equal to ! product (-- 7,a7 ! diff]5ce betwe5 su* am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug & su* am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug2 & 7,b7 ! numb] ( units ( su* drug sold 9 ! ,unit$ ,/ates1 includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates1 dur+ ! p]iod describ$ 9 p>agraph 7#b77;,b74 7#b7 ,am\nts describ$ 7,a7 ,weight$ av]age price be=e ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to ! weight$ av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* dosage /r5g? & =m = ! drug dur+ ! p]iod beg9n+ ) ! fir/ plan ye> = :i* ! drug is includ$ on ! li/ ( negotiation-eligible drugs publi%$ "u section #aaib7;d7 & end+ ) ! la/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is no ,,aim price available = su* drug4 7,b7 ,am\nt multipli] aft] ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to #bjj p]c5t ( ! ,,aim price = su* drug ) respect to ! fir/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is an ,,aim price available = su* drug4 7d7 ,confid5tiality ( in=mation ,in=mation submitt$ to ! ,secret>y "u ?is "p by a manufactur] ( a select$ drug t is propriet>y in=mation ( su* manufactur] 7z det]m9$ by ! ,secret>y7 may be us$ only by ! ,secret>y or disclos$ to & us$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates or ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( c>ry+ out ?is "p4 7e7 ,regulations 7#a7 ,9 g5]al ,! ,secret>y %all1 pursuant to rulemak+1 specify1 9 accordance ) p>agraph 7#b71 ! in=mation t mu/ be submitt$ "u subsection 7a77#d74 7#b7 ,in=mation specifi$ ,in=mation describ$ 9 p>agraph 7#a71 ) respect to a select$ drug1 %all include in=mation on sales ( ! drug 7by ! manufactur] ( ! drug or by ano!r entity "u lic5se or o!r agreem5t ) ! manufactur]1 ) respect to ! sales ( su* drug1 reg>dless ( ! "n "u :i* ! drug is sold7 9 any =eign c\ntry t is "p ( ! ,,aim price4 ,! ,secret>y %all v]ify1 to ! ext5t practicable1 su* sales f appropriate (ficials ( ! gov]nm5t ( ! =eign c\ntry involv$4 7f7 ,compliance ) requirem5ts = adm9i/ration ( program ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all comply ) requirem5ts impos$ by ! ,secret>y or a ?ird p>ty ) a contract "u section #aaif7;c77#a71 z applicable1 = purposes ( adm9i/]+ ! program4 #aaid4 ,negotiation & r5egotiation process 7a7 ,9 g5]al ,= purposes ( ?is "p1 "u an agreem5t "u section #aaic betwe5 ! ,secret>y & a manufactur] ( a select$ drug1 ) respect to ! p]iod = :i* su* agreem5t is 9 effect & 9 accordance ) subsections 7b7 & 7c71 ! ,secret>y & ! manufactur]-- 7#a7 %all dur+ ! volunt>y negotiation p]iod ) respect to ! initial price applicability ye> = su* drug1 9 accordance ) ?is section1 negotiate a maximum fair price = su* drug = ! purpose describ$ 9 section #aaic7;a77#a72 & 7#b7 z applicable pursuant to section #aaic7;a77#b7 & 9 accordance ) ! process specifi$ pursuant to su* section1 r5egotiate su* maximum fair price = su* drug = ! purpose describ$ 9 su* section4 7b7 ,negotiat+ me?odology & objective 7#a7 ,9 g5]al ,! ,secret>y %all develop & use a consi/5t me?odology = negotiations "u subsection 7a7 t1 9 accordance ) p>agraph 7#b7 & subject to p>agraph 7#c71 a*ieves ! l[e/ maximum fair price = ea* select$ drug :ile appropriately rew>d+ innovation4 7#b7 ,prioritiz+ factors ,9 consid]+ ! factors describ$ 9 subsection 7d7 9 negotiat+ 7&1 z applicable1 r5egotiat+7 ! maximum fair price = a select$ drug1 ! ,secret>y %all1 to ! ext5t practicable1 consid] all ( ! available factors li/$ b %all prioritize ! foll[+ factors3 7,a7 ,rese>* & developm5t co/s ,! factor describ$ 9 p>agraph 7#a77;,a7 ( subsection 7d74 7,b7 ,m>ket data ,! factor describ$ 9 p>agraph 7#a77;,b7 ( su* subsection4 7,c7 ,unit co/s ( production & di/ribution ,! factor describ$ 9 p>agraph 7#a77;,c7 ( su* subsection4 7,d7 ,comp>ison to exi/+ !rapeutic alt]natives ,! factor describ$ 9 p>agraph 7#b77;,a7 ( su* subsection4 7#c7 ,requirem5t 7,a7 ,9 g5]al ,9 negotiat+ ! maximum fair price ( a select$ drug1 ) respect to an initial price applicability ye> = ! select$ drug1 &1 z applicable1 9 r5egotiat+ ! maximum fair price = su* drug1 ) respect to a subsequ5t ye> dur+ ! price applicability p]iod = su* drug1 9 ! case t ! manufactur] ( ! select$ drug (f]s "u ! negotiation or r5egotiation1 z applicable1 a price = su* drug t is n m ?an ! t>get price describ$ 9 subp>agraph 7,b7 = su* drug = ! respective ye>1 ! ,secret>y %all agree "u su* negotiation or r5egotiation1 respectively1 to su* (f]$ price z ! maximum fair price4 7,b7 ,t>get price 7i7 ,9 g5]al ,subject to clause 7ii71 ! t>get price describ$ 9 ?is subp>agraph = a select$ drug ) respect to a ye>1 is ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit ( su* drug = sales ( su* drug1 z comput$ 7across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug7 9 ! applicable c\ntry describ$ 9 section #aaia7;c77#c77;,b7 ) respect to su* drug t1 ) respect to su* ye>1 has ! l[e/ av]age price = su* drug z comp>$ to ! av]age prices 7z s comput$7 ( su* drug ) respect to su* ye> 9 ! o!r applicable c\ntries describ$ 9 su* section ) respect to su* drug4 7ii7 ,select$ drugs )\t ,,aim price ,9 apply+ ?is p>agraph 9 ! case ( negotiat+ ! maximum fair price ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 or1 z applicable1 r5egotiat+ ! maximum fair price = su* drug ) respect to a subsequ5t ye> dur+ ! price applicability p]iod = su* drug be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! t>get price describ$ 9 ?is subp>agraph = su* drug & respective ye> is ! am\nt t is #hj p]c5t ( ! av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* drug & ye>4 7#d7 ,annual report ,aft] ! completion ( ea* volunt>y negotiation p]iod1 ! ,secret>y %all submit to ,congress a report on ! maximum fair prices negotiat$ 7or1 z applicable1 r5egotiat$7 = su* p]iod4 ,su* report %all include in=mation on h[ su* prices s negotiat$ 7or r5egotiat$7 meet ! requirem5ts ( ?is "p1 includ+ ! requirem5ts ( ?is subsection4 7c7 ,limitation 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = a select$ drug1 ) respect to ea* plan ye> dur+ a price applicability p]iod = su* drug1 %all n exce$ #abj p]c5t ( ! ,,aim price applicable to su* drug ) respect to su* ye>4 7#b7 ,select$ drugs )\t ,,aim price ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 = ea* plan ye> dur+ ! price applicability p]iod be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = ! select$ drug %all n exce$ ! am\nt equal to #he p]c5t ( ! av]age manufactur] price = ! drug ) respect to su* ye>4 7d7 ,consid]ations ,= purposes ( negotiat+ &1 z applicable1 r5egotiat+ 7includ+ = purposes ( det]m9+ :e!r to r5egotiate7 ! maximum fair price ( a select$ drug "u ?is "p ) ! manufactur] ( ! drug1 ! ,secret>y1 consi/5t ) subsection 7b77#b71 %all take into consid]ation ! factors describ$ 9 p>agraphs 7#a71 7#b71 7#c71 & 7#e71 & may take into consid]ation ! factor describ$ 9 p>agraph 7#d73 7#a7 ,manufactur]-specific in=mation ,! foll[+ in=mation1 includ+ z submitt$ by ! manufactur]3 7,a7 ,rese>* & developm5t co/s ( ! manufactur] = ! drug & ! ext5t to :i* ! manufactur] has rec\p$ rese>* & developm5t co/s4 7,b7 ,m>ket data = ! drug1 includ+ ! di/ribution ( sales across diff]5t programs & pur*as]s & project$ future rev5ues = ! drug4 7,c7 ,unit co/s ( production & di/ribution ( ! drug4 7,d7 ,prior ,f$]al f9ancial support = novel !rapeutic discov]y & developm5t ) respect to ! drug4 7,e7 ,data on pat5ts & on exi/+ & p5d+ exclusivity = ! drug4 7,f7 ,national sales data = ! drug4 7,g7 ,in=mation on cl9ical trials = ! drug 9 ! ,unit$ ,/ates or 9 applicable c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#b7 ,in=mation on alt]native products ,! foll[+ in=mation3 7,a7 ,! ext5t to :i* ! drug repres5ts a !rapeutic advance z comp>$ to exi/+ !rapeutic alt]natives &1 to ! ext5t su* in=mation is available1 ! co/s ( su* exi/+ !rapeutic alt]natives4 7,b7 ,in=mation on approval by ! ,food & ,drug ,adm9i/ration ( alt]native drug products4 7,c7 ,in=mation on comp>ative effectiv5ess analysis = su* products1 tak+ into consid]ation ! effects ( su* products on specific populations1 su* z individuals ) disabilities1 ! eld]ly1 t]m9ally ill1 *ildr51 & o!r pati5t populations4 ,9 consid]+ in=mation describ$ 9 subp>agraph 7,c71 ! ,secret>y %all n use evid5ce or f9d+s f comp>ative cl9ical effectiv5ess rese>* 9 a mann] t treats ext5d+ ! life ( an eld]ly1 disabl$1 or t]m9ally ill individual z ( l[] value ?an ext5d+ ! life ( an individual :o is y\ng]1 nondisabl$1 or n t]m9ally ill4 ,no?+ 9 ! previ\s s5t5ce %all affect ! application or consid]ation ( an ,,aim price = a select$ drug4 7#c7 ,=eign sales in=mation ,to ! ext5t available on a timely basis1 includ+ z provid$ by a manufactur] ( ! select$ drug or o!rwise1 in=mation on sales ( ! select$ drug 9 ea* ( ! c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#d7 ,,va drug pric+ in=mation ,in=mation disclos$ to ! ,secret>y pursuant to subsection 7f74 7#e7 ,additional in=mation ,in=mation submitt$ to ! ,secret>y1 9 accordance ) a process specifi$ by ! ,secret>y1 by o!r p>ties t are affect$ by ! e/abli%m5t ( a maximum fair price = ! select$ drug4 7e7 ,reque/ = in=mation ,= purposes ( negotiat+ &1 z applicable1 r5egotiat+ 7includ+ = purposes ( det]m9+ :e!r to r5egotiate7 ! maximum fair price ( a select$ drug "u ?is "p ) ! manufactur] ( ! drug1 ) respect to a price applicability p]iod1 & o!r relevant data = purposes ( ?is section-- 7#a7 ! ,secret>y %all1 n lat] ?an ! select$ drug publication date ) respect to ! initial price applicability ye> ( su* p]iod1 reque/ drug pric+ in=mation f ! manufactur] ( su* select$ drug1 includ+ in=mation describ$ 9 subsection 7d77#a72 & 7#b7 by n lat] ?an ,octob] #a foll[+ ! select$ drug publication date1 ! manufactur] ( su* select$ drug %all submit to ! ,secret>y su* reque/$ in=mation 9 su* =m & mann] z ! ,secret>y may require4 ,! ,secret>y %all reque/1 f ! manufactur] or o!rs1 su* additional in=mation z may be ne$$ to c>ry out ! negotiation & r5egotiation process "u ?is section4 7f7 ,disclosure ( in=mation ,= purposes ( ?is "p1 ! ,secret>y ( ,vet]ans ,affairs may disclose to ! ,secret>y ( ,heal? & ,human ,s]vices ! price ( any negotiation-eligible drug t is pur*as$ pursuant to section #habf ( title #ch1 ,unit$ ,/ates ,code4 #aaie4 ,publication ( maximum fair prices 7a7 ,9 g5]al ,) respect to an initial price applicability ye> & select$ drug ) respect to su* ye>1 n lat] ?an ,april #a ( ! plan ye> prior to su* initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! maximum fair price = su* drug negotiat$ "u ?is "p ) ! manufactur] ( su* drug4 7b7 ,updates 7#a7 ,subsequ5t ye> maximum fair prices ,= a select$ drug1 = ea* plan ye> subsequ5t to ! initial price applicability ye> = su* drug ) respect to :i* an agreem5t = su* drug is 9 effect "u section #aaic1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/]-- 7,a7 subject to subp>agraph 7,b71 ! am\nt equal to ! maximum fair price publi%$ = su* drug = ! previ\s ye>1 increas$ by ! annual p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,u4,s4 city av]age7 z ( ,septemb] ( su* previ\s ye>2 or 7,b7 9 ! case ! maximum fair price = su* drug 0 r5egotiat$1 = ! fir/ ye> = :i* su* price z s r5egotiat$ applies1 su* r5egotiat$ maximum fair price4 7#b7 ,prices negotiat$ aft] deadl9e ,9 ! case ( a select$ drug ) respect to an initial price applicability ye> = :i* ! maximum fair price is det]m9$ "u ?is "p aft] ! date ( publication "u ?is section1 ! ,secret>y %all publi% su* maximum fair price 9 ! ,f$]al ,regi/] by n lat] ?an #cj days aft] ! date su* maximum price is s det]m9$4 #aaif4 ,adm9i/rative duties2 coord9ation provisions 7a7 ,adm9i/rative duties 7#a7 ,9 g5]al ,= purposes ( section #aaia1 ! adm9i/rative duties describ$ 9 ?is section are ! foll[+3 7,a7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p1 contracts ) prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title1 & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i* ! maximum fair price = a select$ drug is provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( ! drug = ! applicable price p]iod = su* drug & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u su* plans or cov]age = ! select$ drug4 7,b7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p & contracts ) hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i*1 9 ! case ( a select$ drug furni%$ or adm9i/]$ by su* a hospital1 physician1 or o!r provid] ( s]vices or suppli] to fair price eligible individuals 7:o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( section #aaia7;c77#a771 ! maximum fair price = ! select$ drug is provid$ to su* hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s 7z applicable7 ) respect to su* individuals & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u ! respective "p1 plan1 or cov]age = ! select$ drug4 7,c7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts & contracts describ$ 9 subp>agraphs 7,a7 & 7,b77 to ensure t1 n lat] ?an #ij days aft] ! disp5s+ ( a select$ drug to a fair price eligible individual by a ph>macy or mail ord] s]vice1 ! ph>macy or mail ord] s]vice is reimburs$ = an am\nt equal to ! diff]5ce betwe5-- 7i7 ! less] (-- 7,i7 ! :olesale acquisition co/ ( ! drug2 7,,ii7 ! national av]age drug acquisition co/ ( ! drug2 & 7,,iii7 any o!r simil> det]m9ation ( ph>macy acquisition co/s ( ! drug1 z det]m9$ by ! ,secret>y2 & 7ii7 ! maximum fair price = ! drug4 7,d7 ,! e/abli%m5t ( proc$ures to ensure t ! maximum fair price = a select$ drug is appli$ be=e-- 7i7 any cov]age or f9ancial assi/ance "u o!r heal? b5efit plans or programs t provide cov]age or f9ancial assi/ance = ! pur*ase or provision ( prescription drug cov]age on behalf ( fair price eligible individuals z ! ,secret>y may specify2 & 7ii7 any o!r disc\nts4 7,e7 ,! e/abli%m5t ( proc$ures to ent] into appropriate agreem5ts & protocols = ! ongo+ computation ( ,,aim prices = select$ drugs1 includ+1 to ! ext5t possible1 to compute ! ,,aim price = select$ drugs & includ+ by provid+ t ! manufactur] ( su* a select$ drug %\ld provide in=mation = su* computation n lat] ?an #c mon?s aft] ! fir/ date ( ! volunt>y negotiation p]iod = su* select$ drug4 7,f7 ,! e/abli%m5t ( proc$ures to compute & apply ! maximum fair price across diff]5t /r5g?s & dosage =ms ( a select$ drug & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7,g7 ,! e/abli%m5t ( proc$ures to negotiate & apply ! maximum fair price 9 a mann] t does n include any disp5s+ or simil> fee4 7,h7 ,! e/abli%m5t ( proc$ures to c>ry out ! provisions ( ?is "p1 z applicable1 ) respect to-- 7i7 fair price eligible individuals :o are enroll$ "u a prescription drug plan "u "p ,d ( title ,,xviii or an ,,ma-,,pd plan "u "p ,c ( su* title2 7ii7 fair price eligible individuals :o are enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ by a heal? insurance issu] 9 ! individual or gr\p m>ket ) respect to :i* !re is an agreem5t 9 effect "u section #aaig2 & 7iii7 fair price eligible individuals :o are entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title4 7,i7 ,! e/abli%m5t ( a negotiation process & r5egotiation process 9 accordance ) section #aaid1 includ+ a process = acquir+ in=mation describ$ 9 subsection 7d7 ( su* section & det]m9+ am\nts describ$ 9 subsection 7b7 ( su* section4 7,j7 ,! provision ( a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 fair price eligible individuals1 & ! ?ird p>ty ) a contract "u subsection 7c77#a74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,secret>y %all monitor compliance by a manufactur] ) ! t]ms ( an agreem5t "u section #aaic1 includ+ by e/abli%+ a me*anism ?r\gh :i* violations ( su* t]ms may be report$4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7c77#a7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf or section #aaih1 z applicable4 7b7 ,collection ( data 7#a7 ,f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7#b7 ,f heal? plans ,! ,secret>y may collect appropriate data f gr\p heal? plans or heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7#c7 ,coord9ation ( data collection ,to ! ext5t feasible1 z det]m9$ by ! ,secret>y1 ! ,secret>y %all ensure t data collect$ pursuant to ?is subsection is coord9at$ )1 & n duplicative (1 o!r ,f$]al data collection ef=ts4 7c7 ,contract ) ?ird p>ties 7#a7 ,9 g5]al ,! ,secret>y may ent] into a contract ) #a or m ?ird p>ties to adm9i/] ! requirem5ts e/abli%$ by ! ,secret>y 9 ord] to c>ry out ?is "p4 ,at a m9imum1 ! contract ) a ?ird p>ty "u ! prec$+ s5t5ce %all require t ! ?ird p>ty-- 7,a7 receive & transmit in=mation betwe5 ! ,secret>y1 manufactur]s1 & o!r individuals or entities ! ,secret>y det]m9es appropriate2 7,b7 receive1 di/ribute1 or facilitate ! di/ribution ( funds ( manufactur]s to appropriate individuals or entities 9 ord] to meet ! obligations ( manufactur]s "u agreem5ts "u ?is "p2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is "p1 z necess>y = ! manufactur] to fulfill its obligations "u ?is "p2 & 7,d7 p]mit manufactur]s to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ by ! ?ird p>ty to det]m9e disc\nts = applicable drugs ( ! manufactur] "u ! program4 7#b7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#a7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is "p4 #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 ) respect to 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$2 & 7,b7 ) respect to su* select$ 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 #aaih4 ,civil monet>y p5alty 7a7 ,violations relat+ ,to (f]+ ( maximum fair price ,any manufactur] ( a select$ drug t has ent]$ into an agreem5t "u section #aaic1 ) respect to a plan ye> dur+ ! price applicability p]iod = su* drug1 t does n provide access to a price t is n m ?an ! maximum fair price 7or a less] price7 = su* drug = su* ye>-- 7#a7 to a fair price eligible individual :o ) respect to su* drug is describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & :o is furni%$ or disp5s$ su* drug dur+ su* ye>2 or 7#b7 to a hospital1 physician1 or o!r provid] ( s]vices or suppli] ) respect to fair price eligible individuals :o ) respect to su* drug is describ$ 9 subp>agraph 7,b7 ( su* section & is furni%$ or adm9i/]$ su* drug by su* hospital1 physician1 or provid] or suppli] dur+ su* ye>2 %all be subject to a civil monet>y p5alty equal to t5 times ! am\nt equal to ! diff]5ce betwe5 ! price = su* drug made available = su* ye> by su* manufactur] ) respect to su* individual or hospital1 physician1 provid]1 or suppli] & ! maximum fair price = su* drug = su* ye>4 7b7 ,violations ( c]ta9 t]ms ( agreem5t ,any manufactur] ( a select$ drug t has ent]$ into an agreem5t "u section #aaic1 ) respect to a plan ye> dur+ ! price applicability p]iod = su* drug1 t is 9 violation ( a requirem5t impos$ pursuant to section #aaic7;a77#f7 %all be subject to a civil monet>y p5alty ( n m ?an #a1jjj1jjj = ea* su* violation4 7c7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is section 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 #aaii4 ,miscellane\s provisions 7a7 ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to data collect$ "u ?is "p4 7b7 ,national ,academy ( ,m$ic9e /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,national ,academy ( ,m$ic9e %all conduct a /udy1 & submit to ,congress a report1 on recomm5dations = improvem5ts to ! program "u ?is "p1 includ+ ! det]m9ation ( ! limits appli$ "u section #aaid7;c74 7c7 ,med,p,a,c /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy1 & submit to ,congress a report1 on ! program "u ?is "p ) respect to ! ,m$ic>e program "u title ,,xviii1 includ+ ) respect to ! effect ( ! program on individuals entitl$ to b5efits or enroll$ "u su* title4 7d7 ,limitation on judicial review ,! foll[+ %all n be subject to judicial review3 7#a7 ,! selection ( drugs = publication "u section #aaib7;a74 7#b7 ,! det]m9ation ( :e!r a drug is a negotiation-eligible drug "u section #aaib7;d74 7#c7 ,! det]m9ation ( ! maximum fair price ( a select$ drug "u section #aaid4 7#d7 ,! det]m9ation ( units ( a drug = purposes ( section #aaia7;c77#c74 7e7 ,coord9ation ,9 c>ry+ out ?is "p ) respect to gr\p heal? plans or heal? insurance cov]age (f]$ 9 ! gr\p m>ket t are subject to ov]sight by ! ,secret>y ( ,labor or ! ,secret>y ( ! ,treasury1 ! ,secret>y ( ,heal? & ,human ,s]vices %all coord9ate ) su* respective ,secret>y4 7f7 ,data %>+ ,! ,secret>y %all %>e ) ! ,secret>y ( ! ,treasury su* in=mation z is necess>y to det]m9e ! tax impos$ by section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 7g7 ,,gao /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy (1 & submit to ,congress a report on1 ! implem5tation ( ! ,fair ,price ,negotiation ,program "u ?is "p4 4 7b7 ,application ( maximum fair prices & con=m+ am5dm5ts 7#a7 ,"u ,m$ic>e 7,a7 ,application to paym5ts "u "p ,b ,section #ahdg;,a7b77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#a77;,b77 is am5d$ by ins]t+ or 9 ! case ( su* a drug or biological t is a select$ drug 7z def9$ 9 section #aaib7;c771 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 #ajf p]c5t ( ! maximum fair price 7z def9$ 9 section #aaia7;c77#b7 applicable = su* drug & a plan ye> dur+ su* p]iod aft] p>agraph 7#d74 7,b7 ,exception to "p ,d non-int]f]5ce ,section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i77 is am5d$ by ins]t+ 1 except z provid$ "u "p ,e ( title ,,xi aft] ! ,secret>y4 7,c7 ,application z negotiat$ price "u "p ,d ,section #ahfj;,d-#b7;d77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;d77#a77 is am5d$-- 7i7 9 subp>agraph 7,b71 by ins]t+ 1 subject to subp>agraph 7,d71 aft] negotiat$ prices2 & 7ii7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,application ( maximum fair price = select$ drugs ,9 apply+ ?is section1 9 ! case ( a cov]$ "p ,d drug t is a select$ drug 7z def9$ 9 section #aaib7;c771 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 ! negotiat$ prices us$ = paym5t 7z describ$ 9 ?is subsection7 %all be ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug & = ea* plan ye> dur+ su* p]iod4 4 7,d7 ,in=mation f prescription drug plans & ,,ma-,,pd plans requir$ 7i7 ,prescription drug plans ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,provision ( in=mation relat$ to maximum fair prices ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all require ! sponsor to provide in=mation to ! ,secret>y z reque/$ by ! ,secret>y 9 accordance ) section #aaif7;b74 4 7ii7 ,,ma-,,pd plans ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,provision ( in=mation relat$ to maximum fair prices ,section #ahfj;,d-#ab7;b77#h74 4 7#b7 ,"u gr\p heal? plans & heal? insurance cov]age 7,a7 ,,phsa ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgbi ! foll[+ new section3 #bgbi;,a4 ,fair ,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 ! ,fair ,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 ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan or cov]age if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans 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 individuals 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 or cov]age if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plans or cov]age (f]$ by su* plan or issu]s1 to ! individuals 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>y1 to individuals 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* individuals 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 ,fair ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual 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 ! ,fair ,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 7i7 ,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 #gaf4 ,fair ,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 "u ! ,fair ,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 ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan or cov]age if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans 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 individuals 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 or cov]age if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plans or cov]age (f]$ by su* plan or issu]s1 to ! individuals 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>y1 to individuals 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* individuals s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,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 ! ,fair ,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 7ii7 ,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 & #gaf4 7iii7 ,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 #gaf4 ,fair ,price ,negotiation ,program & application ( maximum fair prices4 4 7,c7 ,,irc 7i7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihaf4 ,fair ,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 "u ! ,fair ,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 ) respect to :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 ! individuals 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 individuals 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 ! individuals 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>y1 to individuals 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* individuals s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,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 ! ,fair ,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 7ii7 ,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 #ihaf1 be=e any gr\p heal? plan4 7iii7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihaf4 ,fair ,price ,negotiation ,program & application ( maximum fair prices4 4 7#c7 ,fair price negotiation program prices includ$ 9 be/ price & ,,amp ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7,a7 9 subsection 7c77#a77;,c77ii7-- 7i7 9 subclause 7,,iii71 by /rik+ at ! end 2 &2 7ii7 9 subclause 7,,iv71 by /rik+ at ! end ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subclause3 7,v7 9 ! case ( a rebate p]iod & a cov]$ outpati5t drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 dur+ su* rebate p]iod1 %all be inclusive ( ! price = su* drug made available f ! manufactur] dur+ ! rebate p]iod by reason ( application ( "p ,e ( title ,,xi to any :olesal]1 retail]1 provid]1 heal? ma9t5ance organization1 nonpr(it entity1 or gov]nm5tal entity )9 ! ,unit$ ,/ates4 2 & 7,b7 9 subsection 7k77#a77;,b71 by add+ at ! end ! foll[+ new clause3 7iii7 ,cl>ification ,not)/&+ clause 7i71 9 ! case ( a rebate p]iod & a cov]$ outpati5t drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 dur+ su* rebate p]iod1 any r$uction 9 price paid dur+ ! rebate p]iod to ! manufactur] = ! drug by a :olesal] or retail community ph>macy describ$ 9 subp>agraph 7,a7 by reason ( application ( "p ,e ( title ,,xi %all be includ$ 9 ! av]age manufactur] price = ! cov]$ outpati5t drug4 4 7#d7 ,,fehbp ,section #hijb ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7p7 ,a contract may n be made or a plan approv$ "u ?is *apt] ) any c>ri] t has affirmatively elect$1 pursuant to section #aaig ( ! ,social ,security ,act1 n to p>ticipate 9 ! ,fair ,price ,negotiation ,program e/abli%$ "u section #aaia ( su* ,act = any select$ drug 7z t t]m is def9$ 9 section #aaib7;c7 ( su* ,act74 4 7#e7 ,option ( ,secret>y ( ,vet]ans ,affairs to pur*ase cov]$ drugs at maximum fair prices ,section #habf ( title #ch1 ,unit$ ,/ates ,code1 is am5d$-- 7,a7 9 subsection 7a77#b71 by ins]t+ 1 subject to subsection 7j71 aft] may n exce$2 7,b7 9 subsection 7d71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 1 subject to subsection 7j7 aft] = ! procurem5t ( ! drug2 & 7,c7 by add+ at ! end ! foll[+ new subsection3 7j7 7#a7 ,9 ! case ( a cov]$ drug t is a select$ drug1 = any ye> dur+ ! price applicability p]iod = su* drug1 if ! ,secret>y det]m9es t ! maximum fair price ( su* drug = su* ye> is less ?an ! price = su* drug o!rwise 9 effect pursuant to ?is section 7includ+ aft] application ( any r$uction "u subsection 7a77#b7 & any disc\nt "u subsection 7c771 at ! option ( ! ,secret>y1 9 lieu ( ! maximum price 7det]m9$ aft] application ( ! r$uction "u subsection 7a77#b7 & any disc\nt "u subsection 7c71 z applicable7 t w\ld be p]mitt$ to be *>g$ dur+ su* ye> = su* drug pursuant to ?is section )\t application ( ?is subsection1 ! maximum price p]mitt$ to be *>g$ dur+ su* ye> = su* drug pursuant to ?is section %all be su* maximum fair price = su* drug & ye>4 7#b7 ,= purposes ( ?is subsection3 7,a7 ,! t]m maximum fair price means1 ) respect to a select$ drug & ye> dur+ ! price applicability p]iod = su* drug1 ! maximum fair price 7z def9$ 9 section #aaia7;c77#b7 ( ! ,social ,security ,act7 = su* drug & ye>4 7,b7 ,! t]m negotiation eligible drug has ! mean+ giv5 su* t]m 9 section #aaib7;d77#a7 ( ! ,social ,security ,act4 7,c7 ,! t]m price applicability p]iod has1 ) respect to a select$ drug1 ! mean+ giv5 su* t]m 9 section #aaia7;b77#b7 ( su* ,act4 7,d7 ,! t]m select$ drug means1 ) respect to a ye>1 a drug t is a select$ drug "u section #aaib7;c7 ( su* ,act = su* ye>4 4 #cjb4 ,drug manufactur] excise tax = noncompliance 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #daib4 ,select$ drugs dur+ noncompliance p]iods 7a7 ,9 g5]al ,!re is h]eby impos$ on ! sale by ! manufactur]1 produc]1 or import] ( any select$ drug dur+ a day describ$ 9 subsection 7b7 a tax 9 an am\nt su* t ! applicable p]c5tage is equal to ! ratio (-- 7#a7 su* tax1 divid$ by 7#b7 ! sum ( su* tax & ! price = :i* s sold4 7b7 ,noncompliance p]iods ,a day is describ$ 9 ?is subsection ) respect to a select$ drug if x is a day dur+ "o ( ! foll[+ p]iods3 7#a7 ,! p]iod beg9n+ on ! ,june #af? imm$iately foll[+ ! select$ drug publication date & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has 9 place an agreem5t describ$ 9 subsection 7a7 ( section #aaic ( ! ,social ,security ,act ) respect to su* drug4 7#b7 ,! p]iod beg9n+ on ! ,april #a/ imm$iately foll[+ ! ,june #af? describ$ 9 p>agraph 7#a7 & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has agre$ to a maximum fair price "u su* agreem5t4 7#c7 ,9 ! case ( a select$ drug ) respect to :i* ! ,secret>y ( ,heal? & ,human ,s]vices has specifi$ a r5egotiation p]iod "u su* agreem5t1 ! p]iod beg9n+ on ! fir/ date aft] ! la/ date ( su* r5egotiation p]iod & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has agre$ to a r5egotiat$ maximum fair price "u su* agreem5t4 7#d7 ,) respect to in=mation t is requir$ to be submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices "u su* agreem5t1 ! p]iod beg9n+ on ! date on :i* su* ,secret>y c]tifies t su* in=mation is ov]due & end+ on ! date t su* in=mation is s submitt$4 7#e7 ,9 ! case ( a select$ drug ) respect to :i* a paym5t is due "u subsection 7c7 ( su* section #aaic1 ! p]iod beg9n+ on ! date on :i* ! ,secret>y ( ,heal? & ,human ,s]vices c]tifies t su* paym5t is ov]due & end+ on ! date t su* paym5t is made 9 full4 7c7 ,applicable p]c5tage ,= purposes ( ?is section1 ! t]m applicable p]c5tage means-- 7#a7 9 ! case ( sales ( a select$ drug dur+ ! fir/ #ij days describ$ 9 subsection 7b7 ) respect to su* drug1 #fe p]c5t1 7#b7 9 ! case ( sales ( su* drug dur+ ! #ia/ day ?r\gh ! #ahj? day describ$ 9 subsection 7b7 ) respect to su* drug1 #ge p]c5t1 7#c7 9 ! case ( sales ( su* drug dur+ ! #aha/ day ?r\gh ! #bgj? day describ$ 9 subsection 7b7 ) respect to su* drug1 #he p]c5t1 & 7#d7 9 ! case ( sales ( su* drug dur+ any subsequ5t day1 #ie p]c5t4 7d7 ,select$ drug ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,! t]m select$ drug means any select$ drug 7)9 ! mean+ ( section #aaib ( ! ,social ,security ,act7 :i* is manufactur$ or produc$ 9 ! ,unit$ ,/ates or ent]$ into ! ,unit$ ,/ates = consumption1 use1 or w>eh\s+4 7#b7 ,unit$ ,/ates ,! t]m ,unit$ ,/ates has ! mean+ giv5 su* t]m by section #dfab7;a77#d74 7#c7 ,coord9ation ) rules = possessions ( ! ,unit$ ,/ates ,rules simil> to ! rules ( p>agraphs 7#b7 & 7#d7 ( section #dacb7;c7 %all apply = purposes ( ?is section4 7e7 ,o!r def9itions ,= purposes ( ?is section1 ! t]ms select$ drug publication date & maximum fair price h ! mean+ giv5 su* t]ms 9 section #aaia ( ! ,social ,security ,act4 7f7 ,anti-,abuse rule ,9 ! case ( a sale :i* 0 tim$ = ! purpose ( avoid+ ! tax impos$ by ?is section1 ! ,secret>y may treat su* sale z occurr+ dur+ a day describ$ 9 subsection 7b74 4 7b7 ,no d$uction = excise tax paym5ts ,section #bge ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ or by section #daib be=e ! p]iod at ! end ( subsection 7a77#f74 7c7 ,con=m+ am5dm5ts 7#a7 ,section #dbba7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or #daib aft] section #daia4 7#b7 ,section #fdaf7;b77#b7 ( su* ,code is am5d$ by ins]t+ or #daib aft] section #daia4 7d7 ,cl]ical am5dm5ts 7#a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,o!r m$ical products4 7#b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,o!r m$ical products 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,select$ drugs dur+ noncompliance p]iods4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 #cjc4 ,fair ,price ,negotiation ,implem5tation ,fund 7a7 ,9 g5]al ,!re is h]eby e/abli%$ a ,fair ,price ,negotiation ,implem5tation ,fund 7ref]r$ to 9 ?is section z ! ,fund74 ,! ,secret>y ( ,heal? & ,human ,s]vices may obligate & exp5d am\nts 9 ! ,fund to c>ry out ?is title 7& ! am5dm5ts made by su* title74 7b7 ,fund+ ,!re is au?oriz$ to be appropriat$1 & !re is h]eby appropriat$1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to ! ,fund #c1jjj1jjj1jjj1 to rema9 available until exp5d$1 ( :i*-- 7#a7 #fjj1jjj1jjj %all become available on ! date ( ! enactm5t ( ?is ,act2 7#b7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbj2 7#c7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjba2 7#d7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbb2 & 7#e7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbc4 7c7 ,supplem5t n supplant ,any am\nts appropriat$ pursuant to ?is section %all be 9 addition to any o!r am\nts o!rwise appropriat$ pursuant to any o!r provision ( law4 ,,iv ,public ,heal? ,inve/m5ts #dja4 ,support+ increas$ innovation 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all cont9ue to support & to exp&1 z applicable1 biom$ical rese>* c>ri$ out ?r\gh ! ,national ,in/itutes ( ,heal? innovation projects describ$ 9 section #ajja7;b77#d7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee74 ,! ,secret>y %all ensure t any su* rese>* 7& relat$ activities7 is conduct$ 9 compliance ) section #dib;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7 7relat+ to ! inclusion ( wom5 & memb]s ( m9ority gr\ps 9 rese>*74 7b7 ,au?orization ( appropriations ,to c>ry out ?is subsection1 9 addition to funds made available "u p>agraph 7#b7 ( section #ajja7;b7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee71 !re is au?oriz$ to be appropriat$1 & !re is appropriat$ to ! ,,nih ,innovation ,acc\nt e/abli%$ "u su* section #ajja7;b71 out ( any moneys 9 ! ,treasury n o!rwise obligat$1 #b1jjj1jjj1jjj = fiscal ye> #bjba1 to rema9 available until exp5d$4 ,pass$ ! ,h\se ( ,repres5tatives ,june #bi1 #bjbj4;,*]yl ,l4 ,johnson1,cl]k4 ,septemb] #h1 #bjbj,read ! second "t & plac$ on ! cal5d>