#aaf? ,,congress #a/ ,session ,h4 ,r4 #c ,,an ,,act ,to e/abli% a fair price negotiation program1 protect ! ,m$ic>e program f excessive price increases1 & e/abli% an out-(-pocket maximum = ,m$ic>e "p ,d enrollees1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,l[]+ ,prices ,?r\gh ,fair ,drug ,price ,negotiation ,sec4 #aja4 ,provid+ = l[] prices = c]ta9 high-pric$ s+le s\rce drugs4 ,sec4 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods4 ,sec4 #ajc4 ,fair ,price ,negotiation ,implem5tation ,fund4 ,title ,,ii--,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates ,sec4 #bja4 ,m$ic>e "p ,b rebate by manufactur]s4 ,sec4 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s4 ,sec4 #bjc4 ,provision reg>d+ inflation rebates = gr\p heal? plans & gr\p heal? insurance cov]age4 ,sec4 #bjd4 ,annual report on drug co/s 9 gr\p heal? plans & gr\p heal? insurance cov]age4 ,sec4 #bje4 ,collection ( data4 ,title ,,iii--,"p ,d ,improvem5ts & ,maximum ,out-(-,pocket ,cap = ,m$ic>e ,b5efici>ies ,sec4 #cja4 ,m$ic>e "p ,d b5efit r$esign4 ,sec4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4 ,sec4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4 ,title ,,iv--,drug ,price ,transp>5cy ,sec4 #dja4 ,drug price transp>5cy4 ,title ,v--,program improvem5ts = ,m$ic>e l[-income b5efici>ies ,sec4 #eja4 ,dissem9ation to ,m$ic>e "p ,d subsidy eligible individuals ( in=mation comp>+ premiums ( c]ta9 prescription drug plans4 ,sec4 #ejb4 ,provid+ = intellig5t assignm5t ( c]ta9 subsidy eligible individuals auto-enroll$ "u ,m$ic>e prescription drug plans & ,,ma-,,pd plans4 ,sec4 #ejc4 ,exp&+ eligibility = l[-income subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #ejd4 ,automatic eligibility ( c]ta9 l[-income t]ritorial resid5ts = premium & co/-%>+ subsidies "u ! ,m$ic>e program2 ,sunset ( enhanc$ allotm5t program4 ,sec4 #eje4 ,automatic qualification ( c]ta9 ,m$icaid b5efici>ies = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #ejf4 ,provid+ = c]ta9 rules reg>d+ ! treatm5t ( eligible retirem5t plans 9 det]m9+ ! eligibility ( individuals = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #ejg4 ,r$uc+ co/-%>+ & o!r program improvem5ts = l[-income b5efici>ies4 ,title ,,vi--,provid+ = ,d5tal1 ,vision1 & ,he>+ ,cov]age "u ! ,m$ic>e program ,sec4 #fja4 ,d5tal & oral heal? c>e4 ,sec4 #fjb4 ,provid+ cov]age = he>+ c>e "u ! ,m$ic>e program4 ,sec4 #fjc4 ,provid+ cov]age = vision c>e "u ! ,m$ic>e program4 ,title ,,vii--,,nih1 ,,fda1 & ,opioids ,fund+ ,subtitle ,a--,biom$ical ,innovation ,expansion ,sec4 #gja4 ,,nih ,innovation ,initiatives4 ,sec4 #gjb4 ,,nih cl9ical trial4 ,sec4 #gjc4 ,innovation ,network4 ,subtitle ,b--,inve/+ 9 ,safety & ,innovation ,sec4 #gaa4 ,food & ,drug ,adm9i/ration4 ,sec4 #gab4 ,/udy on high-risk1 high-rew>d drugs4 ,subtitle ,c--,opioid ,epidemic ,response ,sec4 #gba4 ,opioid ,epidemic ,response ,fund4 ,sec4 #gbb4 ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration4 ,sec4 #gbc4 ,c5t]s = ,disease ,control & ,prev5tion4 ,sec4 #gbd4 ,food & ,drug ,adm9i/ration4 ,sec4 #gbe4 ,national ,in/itutes ( ,heal?4 ,sec4 #gbf4 ,heal? ,res\rces & ,s]vices ,adm9i/ration4 ,sec4 #gbg4 ,adm9i/ration = ,*ildr5 & ,families4 ,subtitle ,d--,r$uc+ ,adm9i/rative ,co/s & ,burd5s 9 ,heal? ,c>e ,sec4 #gca4 ,r$uc+ adm9i/rative co/s & burd5s 9 heal? c>e4 ,title ,,viii--,miscellane\s ,sec4 #hja4 ,gu>ante$ issue ( c]ta9 ,m$igap policies4 ,sec4 #hjb4 ,report+ requirem5ts = ,,pdp sponsors reg>d+ po9t-(-sale rejections "u ,m$ic>e "p ,d4 ,sec4 #hjc4 ,provid+ access to annual ,m$ic>e notifications 9 multiple languages4 ,sec4 #hjd4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = c]ta9 biosimil> biological products4 ,sec4 #hje4 ,waiv+ m$ic>e co9surance = colorectal canc] scre5+ te/s4 ,sec4 #hjf4 ,m$ic>e cov]age ( c]ta9 lymph$ema compression treatm5t items4 ,sec4 #hjg4 ,physician fee update4 ,sec4 #hjh4 ,additional community heal? c5t] fund+4 ,sec4 #hji4 ,grants to improve trauma support s]vices & m5tal heal? c>e = *ildr5 & y\? 9 educational sett+s4 ,sec4 #haj4 ,pa?way to ,heal? ,c>e]s ,act4 ,sec4 #haa4 ,home ,visit+ to ,r$uce ,mat]nal ,mortality & ,morbidity ,act4 ,sec4 #hab4 ,addition ( new measures bas$ on access to biosimil> biological products to ! #e-/> rat+ sy/em "u m$ic>e advantage4 ,sec4 #hac4 ,s5se ( ,congress reg>d+ ! impact ( ! high co/ ( prescription drugs on communities ( color & p]sons liv+ 9 rural or sp>sely populat$ areas ( ! ,unit$ ,/ates4 ,sec4 #had4 ,regulations requir+ direct-to-consum] adv]tisem5ts = prescription drugs & biological products to include tru?ful & n mislead+ pric+ in=mation4 ,sec4 #hae4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid4 ,sec4 #haf4 ,graduate m$ical education improvem5ts 9 rural & und]s]v$ communities4 ,i ,l[]+ ,prices ,?r\gh ,fair ,drug ,price ,negotiation #aja4 ,provid+ = l[] prices = c]ta9 high-pric$ s+le s\rce drugs 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 et4 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 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods 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 #ajc4 ,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 & titles ,,ii & ,,iii 7& ! am5dm5ts made by su* titles74 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 ,,ii ,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates #bja4 ,m$ic>e "p ,b rebate by manufactur]s 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,rebate by manufactur]s = s+le s\rce drugs ) prices increas+ fa/] ?an inflation 7#a7 ,requirem5ts 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #f mon?s aft] ! end ( ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjba1 ! ,secret>y %all1 = ea* "p ,b rebatable drug1 report to ea* manufactur] ( su* "p ,b rebatable drug ! foll[+ = su* cal5d> qu>t]3 7i7 ,in=mation on ! total numb] ( units ( ! bill+ & paym5t code describ$ 9 subp>agraph 7,a77i7 ( p>agraph 7#c7 ) respect to su* drug & cal5d> qu>t]4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age sales price increase describ$ 9 subp>agraph 7,a77ii7 ( su* p>agraph = su* drug & cal5d> qu>t]4 7iii7 ,! rebate am\nt specifi$ "u su* p>agraph = su* "p ,b rebatable drug & cal5d> qu>t]4 7,b7 ,manufactur] requirem5t ,= ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjba1 ! manufactur] ( a "p ,b rebatable drug %all1 = su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation describ$ 9 subp>agraph 7,a7 = su* cal5d> qu>t]1 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* cal5d> qu>t]4 7#b7 ,"p ,b rebatable drug def9$ 7,a7 ,9 g5]al ,9 ?is subsection1 ! t]m "p ,b rebatable drug means a s+le s\rce drug or biological 7z def9$ 9 subp>agraph 7,d7 ( section #ahdg;,a7c77#f771 includ+ a biosimil> biological product 7z def9$ 9 subp>agraph 7,h7 ( su* section71 paid = "u ?is "p1 except su* t]m %all n include su* a drug or biological-- 7i7 if ! av]age total all[$ *>ges = a ye> p] individual t uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 are less ?an1 subject to subp>agraph 7,b71 #ajj2 or 7ii7 t is a vacc9e describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #ahfa7s77#aj74 7,b7 ,increase ,! doll> am\nt appli$ "u subp>agraph 7,a77i7-- 7i7 = #bjbb1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjba1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab mon? p]iod end+ ) ,june ( ! previ\s ye>2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is clause 7or clause 7i77 = ! previ\s ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab mon? p]iod end+ ) ,june ( ! previ\s ye>4 ,any doll> am\nt specifi$ "u ?is subp>agraph t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 7#c7 ,rebate am\nt 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! am\nt specifi$ 9 ?is p>agraph = a "p ,b rebatable drug assign$ to a bill+ & paym5t code = a cal5d> qu>t] is1 subject to p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraphs 7,b7 & 7,g71 ! total numb] ( units ( ! bill+ & paym5t code = su* "p ,b rebatable drug furni%$ "u ?is "p dur+ ! cal5d> qu>t]2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! paym5t am\nt "u subp>agraph 7,b7 or 7,c7 ( section #ahdg;,a7b77#a71 z applicable1 = su* "p ,b rebatable drug dur+ ! cal5d> qu>t]2 exce$s 7,,ii7 ! inflation-adju/$ paym5t am\nt det]m9$ "u subp>agraph 7,c7 = su* "p ,b rebatable drug dur+ ! cal5d> qu>t]4 7,b7 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( units ( ! bill+ & paym5t code = ea* "p ,b rebatable drug furni%$ dur+ a cal5d> qu>t] %all n include-- 7i7 units packag$ into ! paym5t = a proc$ure or s]vice "u section #ahcc7t7 or "u section #ahcc7;i7 7in/ead ( sep>ately payable "u su* respective section72 7ii7 units includ$ "u ! s+le paym5t sy/em = r5al dialysis s]vices "u section #ahha7;b77#ad72 or 7iii7 units ( a "p ,b rebatable drug ( a manufactur] furni%$ to an individual1 if su* manufactur]1 ) respect to ! furni%+ ( su* units ( su* drug1 provides = disc\nts "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or = rebates "u section #aibg4 7,c7 ,det]m9ation ( inflation-adju/$ paym5t am\nt ,! inflation-adju/$ paym5t am\nt det]m9$ "u ?is subp>agraph = a "p ,b rebatable drug = a cal5d> qu>t] is-- 7i7 ! paym5t am\nt = ! bill+ & paym5t code = su* drug 9 ! paym5t am\nt b5*m>k qu>t] 7z def9$ 9 subp>agraph 7,d772 increas$ by 7ii7 ! p]c5tage by :i* ! rebate p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,f77 = ! cal5d> qu>t] exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,e774 7,d7 ,paym5t am\nt b5*m>k qu>t] ,! t]m paym5t am\nt b5*m>k qu>t] means ! cal5d> qu>t] beg9n+ ,janu>y #a1 #bjaf4 7,e7 ,b5*m>k p]iod ,,cpi-,u ,! t]m b5*m>k p]iod ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,july #bjae4 7,f7 ,rebate p]iod ,,cpi-,u ,! t]m rebate p]iod ,,cpi-,u means1 ) respect to a cal5d> qu>t] describ$ 9 subp>agraph 7,c71 ! great] ( ! b5*m>k p]iod ,,cpi-,u & ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! fir/ mon? ( ! cal5d> qu>t] t is two cal5d> qu>t]s prior to su* describ$ cal5d> qu>t]4 7,g7 ,c\nt+ units 7i7 ,cut-(f p]iod to c\nt units ,= purposes ( subp>agraph 7,a77i71 subject to clause 7ii71 to c\nt ! total numb] ( bill+ units = a "p ,b rebatable drug = a qu>t]1 ! ,secret>y may use a cut-(f p]iod 9 ord] to exclude f su* total numb] ( bill+ units = su* qu>t] claims = s]vices furni%$ dur+ su* qu>t] t 7 n process$ at an appropriate "t prior to ! end ( ! cut-(f p]iod4 7ii7 ,c\nt+ units = claims process$ aft] cut-(f p]iod ,if ! ,secret>y uses a cut-(f p]iod pursuant to clause 7i71 9 ! case ( units ( a "p ,b rebatable drug furni%$ dur+ a qu>t] b pursuant to application ( su* cut-(f p]iod exclud$ = purposes ( subp>agraph 7,a77i7 f ! total numb] ( bill+ units = ! drug = su* qu>t]1 ! ,secret>y %all c\nt su* units ( su* drug s furni%$ 9 ! total numb] ( bill+ units = su* drug = a subsequ5t qu>t]1 z ! ,secret>y det]m9es appropriate4 7#d7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,subject to subp>agraph 7,b71 9 ! case ( a "p ,b rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjae1 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! ?ird full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$ & clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#c77;,e7 z if ! ref]5ce to ,july #bjae "u su* p>agraph 7 a ref]5ce to ! fir/ mon? ( ! fir/ full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$4 7,b7 ,timel9e = provision ( rebates = subsequ5tly approv$ drugs ,9 ! case ( a "p ,b rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjae1 p>agraph 7#a77;,b7 %all be appli$ z if ! ref]5ce to ,july #a1 #bjba "u su* p>agraph 7 a ref]5ce to ! lat] ( ! #f? full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$ or ,july #a1 #bjba4 7,c7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate am\nt "u p>agraph 7#a77;,b7 ) respect to a "p ,b rebatable drug t is describ$ z curr5tly 9 %ortage on ! %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,d7 ,select$ drugs ,9 ! case ( a "p ,b rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 = a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b77-- 7i7 = cal5d> qu>t]s dur+ su* p]iod = :i* a maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug has be5 det]m9$ & is appli$ "u "p ,e ( title ,,xi1 ! rebate am\nt "u p>agraph 7#a77;,b7 %all be waiv$2 & 7ii7 9 ! case su* drug is det]m9$ 7pursuant to su* section #aaib7;c77 to no long] be a select$ drug1 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod ) respect to su* drug1 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! cal5d> qu>t] beg9n+ ,janu>y #a ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* select$ drug & clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#c77;,e7 z if ! ref]5ce to ,july #bjae "u su* p>agraph 7 a ref]5ce to ! ,july ( ! ye> prec$+ su* la/ ye>4 7#e7 ,application to b5efici>y co9surance ,9 ! case ( a "p ,b rebatable drug1 if ! paym5t am\nt = a qu>t] exce$s ! inflation adju/$ paym5t = su* qu>t]-- 7,a7 9 comput+ ! am\nt ( any co9surance applicable "u ?is title to an individual ) respect to su* drug1 ! computation ( su* co9surance %all be bas$ on ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c77;,c7 = su* "p ,b rebatable drug2 & 7,b7 ! am\nt ( su* co9surance is equal to #bj p]c5t ( su* inflation-adju/$ paym5t am\nt s det]m9$4 7#f7 ,rebate deposits ,am\nts paid z rebates "u p>agraph 7#a77;,b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#g7 ,civil money p5alty ,if a manufactur] ( a "p ,b rebatable drug has fail$ to comply ) ! requirem5ts "u p>agraph 7#a77;,b7 = su* drug = a cal5d> qu>t]1 ! manufactur] %all be subject to1 9 accordance ) a process e/abli%$ by ! ,secret>y pursuant to regulations1 a civil money p5alty 9 an am\nt equal to at lea/ #abe p]c5t ( ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* cal5d> qu>t]4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7#h7 ,/udy & report 7,a7 ,/udy ,! ,secret>y %all conduct a /udy ( ! feasibility ( & op]ational issues involv$ ) ! foll[+3 7i7 ,includ+ multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c77 9 ! rebate sy/em "u ?is subsection4 7ii7 ,includ+ drugs & biologicals paid = "u ,,ma plans "u "p ,c 9 ! rebate sy/em "u ?is subsection4 7iii7 ,includ+ drugs exclud$ "u p>agraph 7#b77;,a7 & units ( ! bill+ & paym5t code ( ! drugs exclud$ "u p>agraph 7#c77;,b7 9 ! rebate sy/em "u ?is subsection4 7,b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a74 7#i7 ,application to multiple s\rce drugs ,! ,secret>y may1 bas$ on ! report submitt$ "u p>agraph 7#h7 & pursuant to rulemak+1 apply ! provisions ( ?is subsection to multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c771 includ+1 = purposes ( det]m9+ ! rebate am\nt "u p>agraph 7#c71 by calculat+ manufactur]-specific av]age sales prices = ! b5*m>k p]iod & ! rebate p]iod4 4 7b7 ,am\nts payable2 co/-,%>+ ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,s71 by /rik+ ) respect to & ins]t+ subject to subp>agraph 7,,dd71 ) respect to2 7ii7 by /rik+ & 7,,cc7 & ins]t+ 7,,cc72 & 7iii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,dd7 ) respect to a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* ! paym5t am\nt = a cal5d> qu>t] "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* qu>t] exce$s ! inflation-adju/$ paym5t "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* qu>t]1 ! am\nts paid %all be ! diff]5ce betwe5 7i7 ! paym5t am\nt "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* drug1 & 7ii7 #bj p]c5t ( ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* drug2 7,b7 by add+ at ! end ( ! flu% left matt] foll[+ p>agraph 7#i71 ! foll[+3 ,= purposes ( apply+ p>agraph 7#a77;,,dd71 subsections 7i77#i7 & 7t77#h77;,f71 & section #ahcd7x77#e71 ! ,secret>y %all make su* e/imates & use su* data z ! ,secret>y det]m9es appropriate1 & not)/&+ any o!r provision ( law1 may d s by program in/ruction or o!rwise4 2 7#b7 9 subsection 7i71 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,9 ! case ( a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* paym5t "u ?is subsection is n packag$ into a paym5t = a cov]$ ,,opd s]vice 7z def9$ 9 subsection 7t77#a77;,b77 7or gr\p ( s]vices7 furni%$ on or aft] ,july #a1 #bjba1 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahcd7x77#e71 p>agraph 7#a77;,,dd7 ( subsection 7a71 & ! flu% left matt] foll[+ p>agraph 7#i7 ( subsection 7a71 %all1 z det]m9$ appropriate by ! ,secret>y1 apply "u ?is subsection 9 ! same mann] z su* provisions ( section #ahcd7x77#e7 & subsection 7a7 apply "u su* section & subsection4 2 & 7#c7 9 subsection 7t77#h71 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,"p ,b rebatable drugs ,9 ! case ( a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* paym5t "u ?is "p is n packag$ into a paym5t = a s]vice furni%$ on or aft] ,july #a1 #bjba1 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahcd7x77#e71 p>agraph 7#a77;,,dd7 ( subsection 7a71 & ! flu% left matt] foll[+ p>agraph 7#i7 ( subsection 7a71 %all1 z det]m9$ appropriate by ! ,secret>y1 apply "u ?is subsection 9 ! same mann] z su* provisions ( section #ahcd7x77#e7 & subsection 7a7 apply "u su* section & subsection4 4 7c7 ,con=m+ am5dm5ts 7#a7 ,to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is am5d$ by ins]t+ or section #ahcd7x7 aft] section #aibg4 7#b7 ,exclud+ p>ts ,b drug inflation rebate f be/ price ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is am5d$ by ins]t+ or section #ahcd7x7 aft] ?is section4 7#c7 ,coord9ation ) ,m$icaid rebate in=mation disclosure ,section #aibg7;b77#c77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i77 is am5d$ by /rik+ or to c>ry out section #ahdg;,b & ins]t+ to c>ry out section #ahdg;,b or section #ahcd7x74 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s 7a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,a 7#db ,u4,s4,c4 #aciew-#aad;a7 ! foll[+ new section3 #ahfj;,d-#ad;,b4 ,manufactur] rebate = c]ta9 drugs ) prices increas+ fa/] ?an inflation 7a7 ,9 g5]al 7#a7 ,9 g5]al ,subject to ! provisions ( ?is section1 9 ord] = cov]age to be available "u ?is "p = a "p ,d rebatable drug 7z def9$ 9 subsection 7h77#a77 ( a manufactur] 7z def9$ 9 section #aibg7k77#e77 disp5s$ dur+ an applicable ye>1 ! manufactur] mu/ h ent]$ into & h 9 effect an agreem5t describ$ 9 subsection 7b74 7#b7 ,au?oriz+ ,cov]age = ,drugs ,n ,cov]$ ,"u ,agreem5ts ,p>agraph 7#a7 %all n apply to ! disp5s+ ( a cov]$ "p ,d drug if-- 7,a7 ! ,secret>y has made a det]m9ation t ! availability ( ! drug is ess5tial to ! heal? ( b5efici>ies "u ?is "p2 or 7,b7 ! ,secret>y det]m9es t 9 ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ on ,decemb] #ca1 #bjbb1 !re 7 ext5uat+ circum/ances4 7#c7 ,applicable ye> ,= purposes ( ?is section ! t]m applicable ye> means a ye> beg9n+ ) #bjbb4 7b7 ,agreem5ts 7#a7 ,t]ms ( agreem5t ,an agreem5t describ$ 9 ?is subsection1 ) respect to a manufactur] ( a "p ,d rebatable drug1 is an agreem5t "u :i* ! foll[+ %all apply3 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #i mon?s aft] ! end ( ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! ,secret>y1 = ea* "p ,d rebatable drug ( ! manufactur]1 %all report to ! manufactur] ! foll[+ = su* ye>3 7i7 ,in=mation on ! total numb] ( units 7z def9$ 9 subsection 7h77#b77 = ea* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age manufactur] price increase describ$ 9 subsection 7c77#a77;,b7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7iii7 ,! rebate am\nt specifi$ "u subsection 7c7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7,b7 ,manufactur] requirem5ts ,= ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! manufactur] ( ! "p ,d rebatable drug1 = ea* dosage =m & /r5g? ) respect to su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation describ$ 9 subp>agraph 7,a7 = su* ye>1 %all provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 subsection 7c7 = su* dosage =m & /r5g? ) respect to su* drug = su* ye>4 7#b7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section1 ) respect to a "p ,d rebatable drug1 %all be effective = an initial p]iod ( n less ?an "o ye> & %all be automatically r5ew$ = a p]iod ( n less ?an "o ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 b su* he>+ %all n delay ! effective date ( ! t]m9ation4 7ii7 ,by a manufactur] ,a manufactur] may t]m9ate an agreem5t "u ?is section = any reason4 ,any su* t]m9ation %all be effective1 ) respect to a plan ye>-- 7,i7 if ! t]m9ation occurs be=e ,janu>y #cj ( ! plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( ! plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7,c7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is p>agraph %all n affect rebates due "u ! agreem5t "u ?is section be=e ! effective date ( its t]m9ation4 7,d7 ,delay be=e re5try ,9 ! case ( any agreem5t "u ?is section ) a manufactur] t is t]m9at$ 9 a plan ye>1 ! ,secret>y may n ent] into ano!r su* agreem5t ) ! manufactur] 7or a successor manufactur]7 be=e ! subsequ5t plan ye>1 unless ! ,secret>y f9ds good cause = an e>li] re9/atem5t ( su* an agreem5t4 7c7 ,rebate am\nt 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! am\nt specifi$ 9 ?is subsection = a dosage =m & /r5g? ) respect to a "p ,d rebatable drug & applicable ye> is1 subject to subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#e71 ! am\nt equal to ! product (-- 7,a7 ! total numb] ( units ( su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>2 & 7,b7 ! am\nt 7if any7 by :i*-- 7i7 ! annual manufactur] price 7z det]m9$ 9 p>agraph 7#b77 paid = su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug = ! ye>2 exce$s 7ii7 ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c7 = su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug = ! ye>4 7#b7 ,det]m9ation ( annual manufactur] price ,! annual manufactur] price det]m9$ "u ?is p>agraph = a dosage =m & /r5g?1 ) respect to a "p ,d rebatable drug & an applicable ye>1 is ! sum ( ! products (-- 7,a7 ! av]age manufactur] price 7z def9$ 9 subsection 7h77#f77 ( su* dosage =m & /r5g?1 z calculat$ = a unit ( su* drug1 ) respect to ea* ( ! cal5d> qu>t]s ( su* ye>2 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ ea* su* cal5d> qu>t] ( su* ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* ye>4 7#c7 ,det]m9ation ( inflation-adju/$ paym5t am\nt ,! inflation-adju/$ paym5t am\nt det]m9$ "u ?is p>agraph = a dosage =m & /r5g? ) respect to a "p ,d rebatable drug = an applicable ye>1 subject to subp>agraphs 7,a7 & 7,d7 ( p>agraph 7#e71 is-- 7,a7 ! b5*m>k ye> manufactur] price det]m9$ "u p>agraph 7#d7 = su* dosage =m & /r5g? ) respect to su* drug & an applicable ye>2 increas$ by 7,b7 ! p]c5tage by :i* ! applicable ye> ,,cpi-,u 7z def9$ 9 subsection 7h77#e77 = ! applicable ye> exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subsection 7h77#d774 7#d7 ,det]m9ation ( b5*m>k ye> manufactur] price ,! b5*m>k ye> manufactur] price det]m9$ "u ?is p>agraph = a dosage =m & /r5g?1 ) respect to a "p ,d rebatable drug & an applicable ye>1 is ! sum ( ! products (-- 7,a7 ! av]age manufactur] price 7z def9$ 9 subsection 7h77#f77 ( su* dosage =m & /r5g?1 z calculat$ = a unit ( su* drug1 ) respect to ea* ( ! cal5d> qu>t]s ( ! paym5t am\nt b5*m>k ye> 7z def9$ 9 subsection 7h77#c772 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ ea* su* cal5d> qu>t] ( su* paym5t am\nt b5*m>k ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* paym5t am\nt b5*m>k ye>4 7#e7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,9 ! case ( a "p ,d rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,janu>y #a1 #bjaf1 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#d7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k ye> 7 def9$ "u subsection 7h77#c7 z ! fir/ cal5d> ye> beg9n+ aft] ! day on :i* ! drug 0 fir/ m>ket$ by any manufactur] & subp>agraph 7,b7 ( p>agraph 7#c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u subsection 7h77#d7 z if ! ref]5ce to ,janu>y #bjaf "u su* subsection 7 a ref]5ce to ,janu>y ( ! fir/ ye> beg9n+ aft] ! date on :i* ! drug 0 fir/ m>ket$ by any manufactur]4 7,b7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u p>agraph 7#a7 ) respect to a "p ,d rebatable drug t is describ$ z curr5tly 9 %ortage on ! %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,c7 ,treatm5t ( new =mulations 7i7 ,9 g5]al ,9 ! case ( a "p ,d rebatable drug t is a l9e ext5sion ( a "p ,d rebatable drug t is an oral solid dosage =m1 ! ,secret>y %all e/abli% a =mula = det]m9+ ! am\nt specifi$ 9 ?is subsection ) respect to su* "p ,d rebatable drug & an applicable ye> ) consid]ation ( ! orig9al "p ,d rebatable drug4 7ii7 ,l9e ext5sion def9$ ,9 ?is subp>agraph1 ! t]m l9e ext5sion means1 ) respect to a "p ,d rebatable drug1 a new =mulation ( ! drug 7z det]m9$ by ! ,secret>y71 su* z an ext5d$ release =mulation1 b does n include an abuse-det]r5t =mulation ( ! drug 7z det]m9$ by ! ,secret>y71 reg>dless ( :e!r su* abuse-det]r5t =mulation is an ext5d$ release =mulation4 7,d7 ,select$ drugs ,9 ! case ( a "p ,d rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 = a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b77-- 7i7 = plan ye>s dur+ su* p]iod = :i* a maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug has be5 det]m9$ & is appli$ "u "p ,e ( title ,,xi1 ! rebate "u subsection 7b77#a77;,b7 %all be waiv$2 & 7ii7 9 ! case su* drug is det]m9$ 7pursuant to su* section #aaib7;c77 to no long] be a select$ drug1 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod ) respect to su* drug1 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#d7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k ye> 7 def9$ "u subsection 7h77#c7 z ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* select$ drug & subp>agraph 7,b7 ( p>agraph 7#c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u subsection 7h77#d7 z if ! ref]5ce to ,janu>y #bjaf "u su* subsection 7 a ref]5ce to ,janu>y ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* drug4 7d7 ,rebate deposits ,am\nts paid z rebates "u subsection 7c7 %all be deposit$ into ! ,m$ic>e ,prescription ,drug ,acc\nt 9 ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7e7 ,in=mation ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all use in=mation submitt$ by manufactur]s "u section #aibg7;b77#c74 7f7 ,civil money p5alty ,9 ! case ( a manufactur] ( a "p ,d rebatable drug ) an agreem5t 9 effect "u ?is section :o has fail$ to comply ) ! t]ms ( ! agreem5t "u subsection 7b77#a77;,b7 ) respect to su* drug = an applicable ye>1 ! ,secret>y may impose a civil money p5alty on su* manufactur] 9 an am\nt equal to #abe p]c5t ( ! am\nt specifi$ 9 subsection 7c7 = su* drug = su* ye>4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7g7 ,judicial review ,!re %all be no judicial review ( ! foll[+3 7#a7 ,! det]m9ation ( units "u ?is section4 7#b7 ,! det]m9ation ( :e!r a drug is a "p ,d rebatable drug "u ?is section4 7#c7 ,! calculation ( ! rebate am\nt "u ?is section4 7h7 ,def9itions ,9 ?is section3 7#a7 ,"p ,d rebatable drug def9$ 7,a7 ,9 g5]al ,! t]m "p ,d rebatable drug means a drug or biological t w\ld 7)\t application ( ?is section7 be a cov]$ "p ,d drug1 except su* t]m %all1 ) respect to an applicable ye>1 n include su* a drug or biological if ! av]age annual total co/ "u ?is "p = su* ye> p] individual :o uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 is less ?an1 subject to subp>agraph 7,b71 #ajj1 z det]m9$ by ! ,secret>y us+ ! mo/ rec5t data available or1 if data is n available1 z e/imat$ by ! ,secret>y4 7,b7 ,increase ,! doll> am\nt appli$ "u subp>agraph 7,a7-- 7i7 = #bjbc1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbb1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod beg9n+ ) ,janu>y ( #bjbb2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod beg9n+ ) ,janu>y ( ! previ\s ye>4 ,any doll> am\nt specifi$ "u ?is subp>agraph t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 7#b7 ,unit def9$ ,! t]m unit means1 ) respect to a "p ,d rebatable drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! "p ,d rebatable drug t is disp5s$ to individuals "u ?is "p4 7#c7 ,paym5t am\nt b5*m>k ye> ,! t]m paym5t am\nt b5*m>k ye> means ! ye> beg9n+ ,janu>y #a1 #bjaf4 7#d7 ,b5*m>k p]iod ,,cpi-,u ,! t]m b5*m>k p]iod ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,janu>y #bjaf4 7#e7 ,applicable ye> ,,cpi-,u ,! t]m applicable ye> ,,cpi-,u means1 ) respect to an applicable ye>1 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,janu>y ( su* ye>4 7#f7 ,av]age manufactur] price ,! t]m av]age manufactur] price has ! mean+1 ) respect to a "p ,d rebatable drug ( a manufactur]1 giv5 su* t]m 9 section #aibg7k77#a71 ) respect to a cov]$ outpati5t drug ( a manufactur] = a rebate p]iod "u section #aibg4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c771 z am5d$ by section #bja7;c77#a71 is fur!r am5d$ by /rik+ section #aibg or section #ahcd7x7 & ins]t+ section #aibg1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 7#b7 ,exclud+ "p ,d drug inflation rebate f be/ price ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i771 z am5d$ by section #bja7;c77#b71 is fur!r am5d$ by /rik+ or section #ahcd7x7 & ins]t+ 1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 7#c7 ,coord9ation ) ,m$icaid rebate in=mation disclosure ,section #aibg7;b77#c77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i771 z am5d$ by section #bja7;c77#c71 is fur!r am5d$ by /rik+ or section #ahcd7x7 & ins]t+ 1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 #bjc4 ,provision reg>d+ inflation rebates = gr\p heal? plans & gr\p heal? insurance cov]age 7a7 ,9 g5]al ,n lat] ?an ,decemb] #ca1 #bjba1 ! ,secret>y ( ,labor1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 %all submit to ,congress a report on-- 7#a7 pot5tial models = an agreem5t process ) manufactur]s ( prescription drugs "u :i* su* manufactur]s provide = inflation rebates ) respect to su* drugs t are furni%$ or disp5s$ to p>ticipants & b5efici>ies ( gr\p heal? plans & heal? insurance cov]age (f]$ 9 ! gr\p m>ket 9 a mann] simil> to h[ manufactur]s provide = rebates "u section #ahcd7x7 ( ! ,social ,security ,act1 z add$ by section #bja1 & section #ahfj;,d-#ad;,b ( su* ,act1 z add$ by section #bjb1 ) respect to prescription drugs t are furni%$ or disp5s$ "u "p ,b ( title ,,xviii ( su* ,act & "p ,d ( su* title1 respectively2 & 7#b7 pot5tial models = en=cem5t me*anisms ) respect to su* an agreem5t process t ensure t su* inflation rebates are proportionally di/ribut$1 ) respect to co/s1 to gr\p heal? plans & heal? insurance issu]s (f]+ heal? insurance cov]age 9 ! gr\p m>ket1 to p>ticipants & b5efici>ies ( su* plans & cov]age1 or to bo?4 7b7 ,regulations ,n lat] ?an ,decemb] #ca1 #bjbb1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 promulgate regulations to implem5t a model describ$ 9 subsection 7a77#a7 & a model describ$ 9 subsection 7a77#b71 if ! ,secret>y det]m9es t-- 7#a7 ! prices ( a suffici5t numb] 7z det]m9$ by ! ,secret>y7 ( drugs describ$ 9 subsection 7a77#a7 h increas$ ov] a p]iod ( "t 7z det]m9$ by ! ,secret>y7 at a p]c5tage t exce$s ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 has increas$ ov] su* p]iod2 & 7#b7 su* model describ$ 9 subsection 7a77#a7 & su* model describ$ 9 subsection 7a77#b7 are feasible4 #bjd4 ,annual report on drug co/s 9 gr\p heal? plans & gr\p heal? insurance cov]age 7a7 ,initial report ,n lat] ?an ,decemb] #ca1 #bjba1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 submit to ,congress a report1 ) respect to a p]iod 7z det]m9$ by ! ,secret>y ( ,labor71 on-- 7#a7 :e!r ! prices ( prescription drugs t are furni%$ or disp5s$ to p>ticipants & b5efici>ies ( gr\p heal? plans & heal? insurance cov]age (f]$ 9 ! gr\p m>ket dur+ su* p]iod h increas$ at a p]c5tage t exce$s ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 increas$ = su* p]iod2 & 7#b7 :e!r !re are me*anisms by :i* manufactur]s ( prescription drugs h attempt$ to recov] rebate paym5ts requir$ ( su* manufactur]s "u section #ahcd7x7 ( ! ,social ,security ,act1 z add$ by section #bja1 & section #ahfj;,d-#ad;,b ( su* ,act1 z add$ by section #bjb1 ) respect to prescription drugs t are furni%$ or disp5s$ "u "p ,b ( title ,,xviii ( su* ,act & "p ,d ( su* title1 respectively1 ?r\gh increas$ prices *>g$ ) respect to drugs t are furni%$ or disp5s$ to p>ticipants & b5efici>ies ( gr\p heal? plans & heal? insurance cov]age (f]$ 9 ! gr\p m>ket dur+ su* p]iod4 7b7 ,annual report ,n lat] ?an ,decemb] #ca ( ea* ye> foll[+ #bjba1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 submit to ,congress a report updat+ ! in=mation & analysis includ$ 9 ! report requir$ "u subsection 7a71 reflect+1 9 "p1 new price & co/ in=mation & data = ! #ab-mon? p]iod aft] ! p]iod on :i* ! prior ye>'s report 0 bas$4 #bje4 ,collection ( data 7a7 ,manufactur]s ( prescription drugs ,manufactur]s ( prescription drugs %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices1 ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury appropriate data z necess>y = ! ,secret>ies to obta9 in=mation ne$$ to provide ! reports "u sections #bjc & #bjd4 7b7 ,gr\p heal? plans & heal? insurance issu]s (f]+ heal? insurance cov]age 9 ! gr\p m>ket ,gr\p heal? plans & heal? insurance issu]s (f]+ heal? insurance cov]age 9 ! gr\p m>ket %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices1 ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury appropriate data z necess>y = ! ,secret>ies to obta9 in=mation ne$$ to provide ! reports "u sections #bjc & #bjd4 ,,iii ,"p ,d ,improvem5ts & ,maximum ,out-(-,pocket ,cap = ,m$ic>e ,b5efici>ies #cja4 ,m$ic>e "p ,d b5efit r$esign 7a7 ,b5efit /ructure r$esign ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbb & ea* subsequ5t ye> aft] p>agraph 7#c72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ & #bjba2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjba2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjba2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjba2 & 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i7-- 7,i7 by r$esignat+ subclauses 7,i7 & 7,,ii7 z items 7aa7 & 7bb71 respectively1 & mov+ ! m>g9 ( ea* su* r$esignat$ item #b ems to ! "r2 7,,ii7 9 ! matt] prec$+ item 7aa71 z r$esignat$ by subclause 7,i71 by /rik+ is equal to ! great] (-- & ins]t+ 8is equal to-- 7,i7 = a ye> prec$+ #bjbb1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 9 subclause 7,v71 by /rik+ or at ! end2 7,,ii7 9 subclause 7,,vi7-- 7aa7 by /rik+ = a subsequ5t ye> & ins]t+ = #bjba2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbb1 is equal to #b1jjj2 or 7,,viii7 = a subsequ5t ye>1 is equal to ! am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = ! ye> involv$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ &1 = a ye> prec$+ #bjbb1 = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( ye>s #bjaa ?r\gh #bjba1 9 apply+4 7b7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is am5d$ by ins]t+ aft] #hj p]c5t ! foll[+3 7or1 ) respect to a cov]age ye> aft] #bjba1 #bj p]c5t74 7c7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq471 z am5d$ by section #bjb1 is fur!r am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,b ! foll[+ new section3 #ahfj;,d-#ad;,c4 ,manufactur] disc\nt program 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a manufactur] disc\nt program 79 ?is section ref]r$ to z ! program74 ,"u ! program1 ! ,secret>y %all ent] into agreem5ts describ$ 9 subsection 7b7 ) manufactur]s & provide = ! p]=mance ( ! duties describ$ 9 subsection 7c74 ,! ,secret>y %all e/abli% a model agreem5t = use "u ! program by n lat] ?an ,janu>y #a1 #bjba1 9 consultation ) manufactur]s1 & all[ = comm5t on su* model agreem5t4 7b7 ,t]ms ( agreem5t 7#a7 ,9 g5]al 7,a7 ,agreem5t ,an agreem5t "u ?is section %all require ! manufactur] to provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbb4 7,b7 ,provision ( disc\nt$ prices at ! po9t-(-sale ,! disc\nt$ prices describ$ 9 subp>agraph 7,a7 %all be provid$ to ! applicable b5efici>y at ! ph>macy or by ! mail ord] s]vice at ! po9t-(-sale ( an applicable drug4 7,c7 ,tim+ ( agreem5t 7i7 ,special rule = #bjbb ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ on ,decemb] #ca1 #bjbb1 ! manufactur] %all ent] into su* agreem5t n lat] ?an #cj days aft] ! date ( ! e/abli%m5t ( a model agreem5t "u subsection 7a74 7ii7 #bjbc & subsequ5t ye>s ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to plan ye> #bjbc or a subsequ5t plan ye>1 ! manufactur] %all ent] into su* agreem5t 7or su* agreem5t %all be r5ew$ "u p>agraph 7#d77;,a77 n lat] ?an ,janu>y #cj ( ! prec$+ ye>4 7#b7 ,provision ( appropriate data ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all collect & h available appropriate data1 z det]m9$ by ! ,secret>y1 to ensure t x c demon/rate to ! ,secret>y compliance ) ! requirem5ts "u ! program4 7#c7 ,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 subsection 7d77#c71 z applicable1 = purposes ( adm9i/]+ ! program1 includ+ any det]m9ation "u subp>agraph 7,a7 ( subsection 7c77#a7 or proc$ures e/abli%$ "u su* subsection 7c77#a74 7#d7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section %all be effective = an initial p]iod ( n less ?an #ab mon?s & %all be automatically r5ew$ = a p]iod ( n less ?an #a ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ! ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = a kn[+ & willful violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice to ! manufactur] ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 & su* he>+ %all take place prior to ! effective date ( ! t]m9ation ) suffici5t "t = su* effective date to be repeal$ if ! ,secret>y det]m9es appropriate4 7ii7 ,by a manufactur] ,a manufactur] may t]m9ate an agreem5t "u ?is section = any reason4 ,any su* t]m9ation %all be effective1 ) respect to a plan ye>-- 7,i7 if ! t]m9ation occurs be=e ,janu>y #cj ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( a plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7iii7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is subp>agraph %all n affect disc\nts = applicable drugs ( ! manufactur] t are due "u ! agreem5t be=e ! effective date ( its t]m9ation4 7iv7 ,notice to ?ird p>ty ,! ,secret>y %all provide notice ( su* t]m9ation to a ?ird p>ty ) a contract "u subsection 7d77#c7 )9 n less ?an #cj days be=e ! effective date ( su* t]m9ation4 7c7 ,duties describ$ ,! duties describ$ 9 ?is subsection are ! foll[+3 7#a7 ,adm9i/ration ( program ,adm9i/]+ ! program1 includ+-- 7,a7 ! det]m9ation ( ! am\nt ( ! disc\nt$ price ( an applicable drug ( a manufactur]2 7,b7 ! e/abli%m5t ( proc$ures "u :i* disc\nt$ prices are provid$ to applicable b5efici>ies at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( an applicable drug2 7,c7 ! e/abli%m5t ( proc$ures to ensure t1 n lat] ?an ! applicable numb] ( cal5d> days aft] ! disp5s+ ( an applicable drug 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 ! negotiat$ price ( ! applicable drug2 & 7ii7 ! disc\nt$ price ( ! applicable drug2 7,d7 ! e/abli%m5t ( proc$ures to ensure t ! disc\nt$ price = an applicable drug "u ?is section is appli$ be=e 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 ( applicable b5efici>ies z ! ,secret>y may specify2 & 7,e7 provid+ a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 applicable b5efici>ies1 & ! ?ird p>ty ) a contract "u subsection 7d77#c74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,secret>y %all monitor compliance by a manufactur] ) ! t]ms ( an agreem5t "u ?is section4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7d77#c7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u subsection 7e74 7#c7 ,collection ( data f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans & ,,ma-,,pd plans 9 a timeframe t all[s = disc\nt$ prices to be provid$ = applicable drugs "u ?is section4 7d7 ,adm9i/ration 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y %all provide = ! implem5tation ( ?is section1 includ+ ! p]=mance ( ! duties describ$ 9 subsection 7c74 7#b7 ,limitation ,9 provid+ = ! implem5tation ( ?is section1 ! ,secret>y %all n receive or di/ribute any funds ( a manufactur] "u ! program4 7#c7 ,contract ) ?ird p>ties ,! ,secret>y %all 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 section4 ,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 section2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is section1 z necess>y = ! manufactur] to fulfill its obligations "u ?is section2 & 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#d7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#c7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is section4 7#e7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ! program "u ?is section by program in/ruction or o!rwise4 7#f7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 7e7 ,en=cem5t 7#a7 ,audits ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all be subject to p]iodic audit by ! ,secret>y4 7#b7 ,civil money p5alty 7,a7 ,9 g5]al ,! ,secret>y may impose a civil money p5alty on a manufactur] t fails to provide applicable b5efici>ies disc\nts = applicable drugs ( ! manufactur] 9 accordance ) su* agreem5t = ea* su* failure 9 an am\nt ! ,secret>y det]m9es is equal to ! sum (-- 7i7 ! am\nt t ! manufactur] w\ld h paid ) respect to su* disc\nts "u ! agreem5t1 :i* w !n be us$ to pay ! disc\nts :i* ! manufactur] _h fail$ to provide2 & 7ii7 #be p]c5t ( su* am\nt4 7,b7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7f7 ,cl>ification reg>d+ availability ( o!r cov]$ "p ,d drugs ,no?+ 9 ?is section %all prev5t an applicable b5efici>y f pur*as+ a cov]$ "p ,d drug t is n an applicable drug 7includ+ a g5]ic drug or a drug t is n on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 974 7g7 ,def9itions ,9 ?is section3 7#a7 ,applicable b5efici>y ,! t]m applicable b5efici>y means an individual :o1 on ! date ( disp5s+ a cov]$ "p ,d drug-- 7,a7 is enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is n enroll$ 9 a qualifi$ retiree prescription drug plan2 & 7,c7 has incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t exce$ ! annual d$uctible ) respect to su* individual = su* ye>1 z specifi$ 9 section #ahfj;,d-#b7;b77#a71 section #ahfj;,d-#ad7;a77#a77;,b71 or section #ahfj;,d-#ad7;a77#b77;,b71 z applicable4 7#b7 ,applicable drug ,! t]m applicable drug1 ) respect to an applicable b5efici>y-- 7,a7 means a cov]$ "p ,d drug-- 7i7 approv$ "u a new drug application "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or1 9 ! case ( a biologic product1 lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 7,i7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan uses a =mul>y1 :i* is on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 7,,ii7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan does n use a =mul>y1 = :i* b5efits are available "u ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 or 7,,iii7 is provid$ ?r\gh an exception or appeal2 & 7,b7 does n include a select$ drug 7z def9$ 9 section #aaib7;c77 dur+ a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b77 ) respect to su* drug4 7#c7 ,applicable numb] ( cal5d> days ,! t]m applicable numb] ( cal5d> days means-- 7,a7 ) respect to claims = reimbursem5t submitt$ electronically1 #ad days2 & 7,b7 ) respect to claims = reimbursem5t submitt$ o!rwise1 #cj days4 7#d7 ,disc\nt$ price 7,a7 ,9 g5]al ,! t]m disc\nt$ price means1 ) respect to an applicable drug ( a manufactur] disp5s$ dur+ a ye> to an applicable b5efici>y-- 7i7 :o has n incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>1 #ij p]c5t ( ! negotiat$ price ( su* drug2 & 7ii7 :o has incurr$ su* co/s1 z s det]m9$1 9 ! ye> t are equal to or exce$ su* ?re%old = ! ye>1 #gj p]c5t ( ! negotiat$ price ( su* drug4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+ ! responsibility ( an applicable b5efici>y = paym5t ( a disp5s+ fee = an applicable drug4 7,c7 ,special case = c]ta9 claims 7i7 ,claims spann+ d$uctible ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall above ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price "u ?is section on only ! portion ( ! negotiat$ price ( ! applicable drug t falls above su* annual d$uctible4 7ii7 ,claims spann+ out-(-pocket ?re%old ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall entirely bel[ or entirely above ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price-- 7,i7 9 accordance ) subp>agraph 7,a77i7 on ! portion ( ! negotiat$ price ( ! applicable drug t falls bel[ su* ?re%old2 & 7,,ii7 9 accordance ) subp>agraph 7,a77ii7 on ! portion ( su* price ( su* drug t falls at or above su* ?re%old4 7#e7 ,manufactur] ,! t]m manufactur] means any entity :i* is engag$ 9 ! production1 prep>ation1 propagation1 comp\nd+1 conv]sion1 or process+ ( prescription drug products1 ei!r directly or indirectly by extraction f sub/ances ( natural orig91 or indep5d5tly by means ( *emical syn!sis1 or by a comb9ation ( extraction & *emical syn!sis4 ,su* t]m does n include a :olesale di/ributor ( drugs or a retail ph>macy lic5s$ "u ,/ate law4 7#f7 ,negotiat$ price ,! t]m negotiat$ price has ! mean+ giv5 su* t]m 9 section #dbc4ajj ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 except t1 ) respect to an applicable drug1 su* negotiat$ price %all n include any disp5s+ fee = ! applicable drug4 7#g7 ,qualifi$ retiree prescription drug plan ,! t]m qualifi$ retiree prescription drug plan has ! mean+ giv5 su* t]m 9 section #ahfj;,d-#bb7;a77#b74 4 7#b7 ,sunset ( ,m$ic>e cov]age gap disc\nt program ,section #ahfj;,d-#ad;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is am5d$-- 7,a7 9 subsection 7a71 9 ! fir/ s5t5ce1 by /rik+ ,! ,secret>y & ins]t+ ,subject to subsection 7h71 ! ,secret>y2 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7h7 ,sunset ( program 7#a7 ,9 g5]al ,! program %all n apply ) respect to applicable drugs disp5s$ on or aft] ,janu>y #a1 #bjbb1 &1 subject to p>agraph 7#b71 agreem5ts "u ?is section %all be t]m9at$ z ( su* date4 7#b7 ,cont9u$ application = applicable drugs disp5s$ prior to sunset ,! provisions ( ?is section 7includ+ all responsibilities & duties7 %all cont9ue to apply aft] ,janu>y #a1 #bjbb1 ) respect to applicable drugs disp5s$ prior to su* date4 4 7#c7 ,inclusion ( actu>ial value ( manufactur] disc\nts 9 bids ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ 8assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c subtract$ f ! actu>ial value to produce su* bid2 & 2 & 7,b7 9 subsection 7c77#a77;,c7-- 7i7 by /rik+ an actu>ial valuation ( ! re9surance & ins]t+ 8an actu>ial valuation (-- 7i7 ! re9surance 2 7ii7 9 clause 7i71 z ins]t$ by clause 7i7 ( ?is subp>agraph1 by add+ & at ! end2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c2 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or1 = a ye> prec$+ #bjbb1 an increase 9 ! initial2 7,b7 9 subsection 7c77#a77;,c7-- 7i7 9 ! subp>agraph head+1 by /rik+ at initial cov]age limit2 & 7ii7 by ins]t+ = a ye> prec$+ #bjbb or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbb & ea* subsequ5t ye> aft] subsection 7b77#c7 = ! ye> ea* place x appe>s2 & 7,c7 9 subsection 7d77#a77;,a71 by /rik+ or an initial & ins]t+ or1 = a ye> prec$+ #bjbb1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbb1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbb1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is am5d$ by /rik+ section #ahfj;,d-#b7;b77#d77;,b77i7 & ins]t+ section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is am5d$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbb1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ by subp>agraph 7,a7 ( ?is p>agraph1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7ii7 = #bjbb & ea* subsequ5t ye>1 any disc\nt provid$ pursuant to section #ahfj;,d-#ad;,c4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is am5d$-- 7,a7 by ins]t+ = a ye> be=e #bjbb aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7#g7 ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is am5d$-- 7,a7 9 subsection 7a7-- 7i7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 p>ticipate 9-- 7,a7 = #bjaa ?r\gh #bjba1 ! ,m$ic>e cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 2 7ii7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 h ent]$ into & h 9 effect-- 7,a7 = #bjaa ?r\gh #bjba1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,a ) ! ,secret>y2 & 7,b7 = #bjbb & ea* subsequ5t ye>1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,c ) ! ,secret>y2 & 2 & 7iii7 by /rik+ p>agraph 7#c7 & ins]t+ ! foll[+3 7#c7 h ent]$ into & h 9 effect1 "u t]ms & conditions specifi$ by ! ,secret>y-- 7,a7 = #bjaa ?r\gh #bjba1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbb & ea* subsequ5t ye>1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( section #ahfj;,d-#ad;,c4 2 & 7,b7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,effective date ,p>agraphs 7#a77;,a71 7#b77;,a71 & 7#c77;,a7 ( subsection 7a7 %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjaa1 & be=e ,janu>y #a1 #bjbb1 & p>agraphs 7#a77;,b71 7#b77;,b71 & 7#c77;,b7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjbb4 4 7#h7 ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7,a7 9 subsection 7c77#a77;,c77i77,,vi71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or "u ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 & 7,b7 9 subsection 7k77#a77;,b77i77,v71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or "u section #ahfj;,d-#ad;,c4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye> #bjbb & subsequ5t plan ye>s4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances ,section #ahfj;,d-#b7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 z am5d$ by section #cja1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,subject to subp>agraphs 7,c7 & 7,d7 & ins]t+ ,subject to subp>agraphs 7,c71 7,d71 & 7,e72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,enrollee option reg>d+ spread+ co/-%>+ ,! ,secret>y %all e/abli% by regulation a process "u :i*1 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 a prescription drug plan or an ,,ma-,,pd plan %all1 9 ! case ( a "p ,d eligible individual enroll$ ) su* plan = su* plan ye> :o is n a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77 & ) respect to :om ! plan projects t ! disp5s+ ( ! fir/ fill ( a cov]$ "p ,d drug to su* individual w result 9 ! individual incurr+ co/s t are equal to or above ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = su* plan ye>1 provide su* individual ) ! option to make ! co9surance paym5t requir$ "u subp>agraph 7,a7 7= ! portion ( su* co/s t are n above su* annual out-(-pocket ?re%old7 9 ! =m ( p]iodic in/allm5ts ov] ! rema9d] ( su* plan ye>4 4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$-- 7#a7 by r$esignat+ ! p>agraph 7#f71 z add$ by section #ejced ( division ,e ( ! ,bip>tisan ,budget ,act ( #bjah 7,public ,law #aae-abc71 z p>agraph 7#g72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ( ph>macy quality measures 7,a7 ,9 g5]al ,a ,,pdp sponsor t implem5ts inc5tive paym5ts to a ph>macy or price concessions paid by a ph>macy bas$ on quality measures %all use measures e/abli%$ or approv$ by ! ,secret>y "u subp>agraph 7,b7 ) respect to paym5t = cov]$ "p ,d drugs disp5s$ by su* ph>macy4 7,b7 ,/&>d ph>macy quality measures ,! ,secret>y %all e/abli% or approve /&>d quality measures f a cons5sus & evid5ce-bas$ organization = paym5ts describ$ 9 subp>agraph 7,a74 ,su* measures %all focus on pati5t heal? outcomes & be bas$ on prov5 crit]ia measur+ ph>macy p]=mance4 7,c7 ,effective date ,! requirem5t "u subp>agraph 7,a7 %all take effect = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 or su* e>li] date specifi$ by ! ,secret>y if ! ,secret>y det]m9es !re are suffici5t measures e/abli%$ or approv$ "u subp>agraph 7,b7 to meet ! requirem5t "u subp>agraph 7,a74 4 ,,iv ,drug ,price ,transp>5cy #dja4 ,drug price transp>5cy ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new sections3 #aaej;,c4 ,report+ on drug prices 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 :o is responsible = sett+ ! :olesale acquisition co/ = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug 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-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m1 adju/$ = inflation occurr+ aft] ! date ( enactm5t ( ?is section1 = a mon?'s supply or a typical c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7ii7 n a prev5tative vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii or "u a ,/ate ,m$icaid plan "u title ,,xix or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b74 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y if1 ) respect to ! qualify+ drug-- 7,a7 !re is an increase 9 ! price ( ! qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a #ab-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjai2 7,b7 ! e/imat$ price ( ! qualify+ drug or sp5d+ p] individual or p] us] ( su* drug 7z e/imat$ by ! ,secret>y7 = ! applicable ye> 7or p] c\rse ( treatm5t 9 su* applicable ye> z det]m9$ by ! ,secret>y7 is at lea/ #bf1jjj beg9n+ on or aft] ,janu>y #a1 #bjba2 or 7,c7 !re 0 an increase 9 ! price ( ! qualify+ drug t result$ 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a #ab-mon? p]iod t beg9s & ends dur+ ! #e-ye> p]iod prec$+ ,janu>y #a1 #bjba2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod t beg9s & ends dur+ ! #e-ye> p]iod prec$+ ,janu>y #a1 #bjba4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y-- 7,a7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjai1 & end+ on ! day t is #fj days aft] ! date ( ! enactm5t ( ?is section1 n lat] ?an #ij days aft] su* date ( enactm5t2 7,b7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs aft] ! p]iod describ$ 9 subp>agraph 7,a71 n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase = su* qualify+ drug2 7,c7 9 ! case ( a report ) respect to a qualify+ drug t meets ! crit]ia "u p>agraph 7#a77;,b71 n lat] ?an #cj days aft] su* drug meets su* crit]ia2 & 7,d7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ a #ab-mon? or #cf-mon? p]iod describ$ 9 p>agraph 7#a77;,c71 n lat] ?an ,april #a1 #bjba4 7c7 ,cont5ts ,a report "u subsection 7b71 consi/5t ) ! /&>d = disclosures describ$ 9 section #bac4c7;d7 ( title #ab1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is section71 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug )9 ! #ab-mon? p]iod or #cf-mon? p]iod z describ$ 9 subsection 7b77#a77;,a77i71 7b77#a77;,a77ii71 7b77#a77;,c77i71 or 7b77#a77;,c77ii71 z applicable1 & ! effective date ( su* price increase or ! co/ associat$ ) a qualify+ drug if su* drug meets ! crit]ia "u subsection 7b77#a77;,b7 & ! effective date at :i* su* drug meets su* crit]ia2 7,b7 an explanation =1 & description (1 ea* price increase = su* drug t w occur dur+ ! #ab-mon? p]iod or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77i71 7b77#a77;,a77ii71 7b77#a77;,c77i71 or 7b77#a77;,c77ii71 z applicable2 7,c7 an explanation =1 & description (1 ! co/ associat$ ) a qualify+ drug if su* drug meets ! crit]ia "u subsection 7b77#a77;,b71 z applicable2 7,d7 if kn[n & diff]5t f ! manufactur] ( ! qualify+ drug1 ! id5tity (-- 7i7 ! sponsor or sponsors ( any inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = cl9ical inve/igations ) respect to su* drug1 = :i* ! full reports are submitt$ z "p ( ! application-- 7,i7 = approval ( ! drug "u section #eje ( su* ,act2 or 7,,ii7 = lic5sure ( ! drug "u section #cea ( ! ,pubic ,heal? ,s]vice ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7,e7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 if applicable2 7,f7 ! curr5t :olesale acquisition co/ ( ! drug2 7,g7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 & 7iii7 pur*as+ or acquir+ su* drug f ano!r manufactur]1 if applicable2 7,h7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,i7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is necess>y to demon/rate t x meets applicable /atutory /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable2 7,j7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7,k7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,l7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,m7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #ab-mon? p]iod describ$ 9 subsection 7b77#a77;,a77i7 or 7b77#a77;,c77i7 or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77ii7 or 7b77#a77;,c77ii71 z applicable2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #ab-mon? p]iods describ$ 9 subsection 7b77#a77;,a77i7 or 7b77#a77;,c77i7 or ! #cf-mon? p]iods describ$ 9 subsection 7b77#a77;,a77ii7 or 7b77#a77;,c77ii71 z applicable2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials1 includ+ on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate & z specifi$ by ! ,secret>y4 7d7 ,in=mation provid$ ,! manufactur] ( a qualify+ drug t is requir$ to submit a report "u subsection 7b71 %all ensure t su* report & any explanation =1 & description (1 ea* price increase describ$ 9 subsection 7c77#a7 %all be tru?ful1 n mislead+1 & accurate4 7e7 ,civil monet>y p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 foll[+ notification by ! ,secret>y to ! manufactur] t ! manufactur] is n 9 compliance ) ?is section1 %all be subject to a civil monet>y p5alty ( #ge1jjj = ea* day on :i* ! violation cont9ues4 7f7 ,false in=mation ,any manufactur] t submits a report = a drug z requir$ by ?is section t kn[+ly provides false in=mation 9 su* report is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7g7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#d71 ! ,secret>y %all po/ ea* report submitt$ "u subsection 7b7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! day ! price increase ( a qualify+ drug is s*$ul$ to g into effect4 7#b7 ,=mat ,9 develop+ ! =mat 9 :i* reports w be publicly po/$ "u p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back f consum] advocates & readability exp]ts on ! =mat & pres5tation ( ! cont5t ( su* reports to ensure t su* reports are-- 7,a7 us]-fri5dly to ! public2 & 7,b7 writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,li/ ,9 addition to ! reports submitt$ "u subsection 7b71 ! ,secret>y %all also po/ a li/ ( ea* qualify+ drug ) respect to :i* ! manufactur] 0 requir$ to submit su* a report 9 ! prec$+ ye> & :e!r su* manufactur] 0 requir$ to submit su* report bas$ on a qualify+ price increase or :e!r su* drug meets ! crit]ia "u subsection 7b77#a77;,b74 7#d7 ,protect$ in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 #aaej;,d4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ! ,committees on ,en]gy & ,comm]ce & ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committees on ,heal?1 ,education1 ,labor1 & ,p5sions & ,f9ance ( ! ,s5ate1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is us]-fri5dly to ! public & writt5 9 pla9 language t consum]s c readily und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #aaej;,c2 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section2 7#c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out section #aaej;,c2 & 7#d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7b7 ,protect$ in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 4 ,v ,program improvem5ts = ,m$ic>e l[-income b5efici>ies #eja4 ,dissem9ation to ,m$ic>e "p ,d subsidy eligible individuals ( in=mation comp>+ premiums ( c]ta9 prescription drug plans ,section #ahfj;,d-#a7;c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;c77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,in=mation on premiums = subsidy eligible individuals 7i7 ,9 g5]al ,= plan ye> #bjbb & ea* subsequ5t plan ye>1 ! ,secret>y %all dissem9ate to ea* subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77 in=mation "u ?is p>agraph comp>+ premiums t w\ld apply to su* individual = prescription drug cov]age "u ,,lis b5*m>k plans1 includ+1 9 ! case ( an individual enroll$ 9 a prescription drug plan "u ?is "p1 in=mation t comp>es ! premium t w\ld apply if su* individual 7 to rema9 enroll$ 9 su* plan to premiums t w\ld apply if ! individual 7 to enroll 9 o!r ,,lis b5*m>k plans4 7ii7 ,,lis b5*m>k plan ,= purposes ( clause 7i71 ! t]m ,,lis b5*m>k plan means1 ) respect to an individual1 a prescription drug plan "u ?is "p t is (f]$ 9 ! region 9 :i* ! individual resides &-- 7,i7 t provides = a premium t is n m ?an ! l[-income b5*m>k premium am\nt 7z def9$ 9 section #ahfj;,d-#ad7;b77#b77 = su* region2 or 7,,ii7 ) respect to :i* ! premium w\ld be waiv$ z de m9imis pursuant to section #ahfj;,d-#ad7;a77#e7 = su* individual4 4 #ejb4 ,provid+ = intellig5t assignm5t ( c]ta9 subsidy eligible individuals auto-enroll$ "u ,m$ic>e prescription drug plans & ,,ma-,,pd plans 7a7 ,9 g5]al ,section #ahfj;,d-#a7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;b77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c7-- 7,a7 by ins]t+ aft] ,,pdp region ! foll[+3 or ?r\gh use ( an intellig5t assignm5t process t is design$ to maximize ! access ( su* individual to necess>y prescription drugs :ile m9imiz+ co/s to su* individual & to ! program "u ?is "p to ! greate/ ext5t possible4 ,9 ! case ! ,secret>y enrolls su* individuals ?r\gh use ( an intellig5t assignm5t process1 su* process %all take into acc\nt ! ext5t to :i* prescription drugs necess>y = ! individual are cov]$ 9 ! case ( a ,,pdp sponsor ( a prescription drug plan t uses a =mul>y1 ! use ( prior au?orization or o!r re/rictions on access to cov]age ( su* prescription drugs by su* a sponsor1 & ! ov]all quality ( a prescription drug plan z measur$ by quality rat+s e/abli%$ by ! ,secret>y2 & 7,b7 by /rik+ ,no?+ 9 ! previ\s s5t5ce & ins]t+ ,no?+ 9 ?is subp>agraph2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 by ins]t+ aft] ,,pdp region ! foll[+3 or ?r\gh use ( an intellig5t assignm5t process t is design$ to maximize ! access ( su* individual to necess>y prescription drugs :ile m9imiz+ co/s to su* individual & to ! program "u ?is "p to ! greate/ ext5t possible4 ,9 ! case ! ,secret>y enrolls su* individuals ?r\gh use ( an intellig5t assignm5t process1 su* process %all take into acc\nt ! ext5t to :i* prescription drugs necess>y = ! individual are cov]$ 9 ! case ( a ,,pdp sponsor ( a prescription drug plan t uses a =mul>y1 ! use ( prior au?orization or o!r re/rictions on access to cov]age ( su* prescription drugs by su* a sponsor1 & ! ov]all quality ( a prescription drug plan z measur$ by quality rat+s e/abli%$ by ! ,secret>y2 & 7,b7 by /rik+ ,no?+ 9 ! previ\s s5t5ce & ins]t+ ,no?+ 9 ?is subp>agraph4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply ) respect to plan ye>s beg9n+ ) plan ye> #bjbb4 #ejc4 ,exp&+ eligibility = l[-income subsidies "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 z am5d$ by section #cja7;d71 is fur!r am5d$-- 7#a7 9 ! subsection head+1 by /rik+ individuals & all t foll[s ?r\gh l9e & ins]t+ c]ta9 individuals2 7#b7 9 p>agraph 7#a7-- 7,a7 by /rik+ ! p>agraph head+ & ins]t+ ,individuals ) c]ta9 l[ incomes2 & 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #aej p]c5t7 aft] #ace p]c5t2 & 7#c7 9 p>agraph 7#b7-- 7,a7 by /rik+ ! p>agraph head+ & ins]t+ ,o!r l[-income individuals2 & 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,9 ! case ( a subsidy & ins]t+ ,) respect to a plan ye> beg9n+ be=e ,janu>y #a1 #bjbb1 9 ! case ( a subsidy4 #ejd4 ,automatic eligibility ( c]ta9 l[-income t]ritorial resid5ts = premium & co/-%>+ subsidies "u ! ,m$ic>e program2 ,sunset ( enhanc$ allotm5t program 7a7 ,automatic eligibility ( c]ta9 l[-,income t]ritorial resid5ts = premium & co/-,%>+ subsidies "u ! ,m$ic>e program 7#a7 ,9 g5]al ,section #ahfj;,d-#ad7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77 is am5d$-- 7,a7 9 subp>agraph 7,b77v7-- 7i7 9 subclause 7,i71 by /rik+ & at ! end2 7ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by ins]t+ aft] subclause 7,,ii7 ! foll[+ new subclause3 7,,iii7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbd1 %all provide t any "p ,d eligible individual :o is enroll$ = m$ical assi/ance "u ! ,/ate ,m$icaid plan ( a t]ritory 7z def9$ 9 section #aice7;f77 "u title ,,xix 7or a waiv] ( su* a plan7 %all be treat$ z a subsidy eligible individual describ$ 9 p>agraph 7#a74 2 & 7,b7 9 subp>agraph 7,f71 by add+ at ! end ! foll[+ new s5t5ce3 ,! previ\s s5t5ce %all n apply ) respect to eligibility det]m9ations = premium & co/-%>+ subsidies "u ?is section made on or aft] ,janu>y #a1 #bjbd44 7#b7 ,con=m+ am5dm5t ,section #ahfj;,d-#ca7;j77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ada7;j77#b77;,d77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,! previ\s s5t5ce %all n apply ) respect to am\nts made available to a ,/ate "u ?is p>agraph on or aft] ,janu>y #a1 #bjbd44 7b7 ,sunset ( enhanc$ allotm5t program 7#a7 ,9 g5]al ,section #aice7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7;e77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a71 by ins]t+ aft] su* ,/ate ! foll[+3 be=e ,janu>y #a1 #bjba2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ aft] a ye> ! foll[+3 7be=e #bjbd72 & 7ii7 9 subp>agraph 7,b77iii71 by /rik+ a subsequ5t ye> & ins]t+ ea* ( fiscal ye>s #bjjh ?r\gh #bjbc4 7#b7 ,t]ritory def9$ ,section #aice ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,t]ritory def9$ ,9 ?is section1 ! t]m t]ritory means ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa4 4 #eje4 ,automatic qualification ( c]ta9 ,m$icaid b5efici>ies = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program ,clause 7v7 ( section #ahfj;,d-#ad7;a77#c77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,b771 z am5d$ by section #ejd1 is fur!r am5d$-- 7#a7 9 subclause 7,,ii71 by /rik+ & at ! end2 7#b7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] subclause 7,,iii7 ! foll[+ new subclause3 7,,iv7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbd1 %all1 not)/&+ ! prec$+ clauses ( ?is subp>agraph1 provide t any "p ,d eligible individual n describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 :o is enroll$1 z ( ! day be=e ! date on :i* su* individual atta9s ! age ( #fe1 = m$ical assi/ance "u a ,/ate plan "u title ,,xix 7or a waiv] ( su* plan7 pursuant to clause 7i77,,viii7 or 7ii77,,xx7 ( section #aijb7;a77#aj77;,a71 & :o has income bel[ #bjj p]c5t ( ! pov]ty l9e applicable to a family ( ! size involv$1 %all be treat$ z a subsidy eligible individual describ$ 9 p>agraph 7#a7 = a limit$ p]iod ( "t1 z specifi$ by ! ,secret>y4 4 #ejf4 ,provid+ = c]ta9 rules reg>d+ ! treatm5t ( eligible retirem5t plans 9 det]m9+ ! eligibility ( individuals = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a77#c77;,c77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,c77i77 is am5d$1 by /rik+ except t support & ma9t5ance furni%$ 9 k9d %all n be c\nt$ z income2 & & ins]t+ except t-- 7,i7 support & ma9t5ance furni%$ 9 k9d %all n be c\nt$ z income2 & 7,,ii7 = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbd1 any di/ribution or )drawal f an eligible retirem5t plan 7z def9$ 9 subp>agraph 7,b7 ( section #djb7;c77#h7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 b exclud+ any def9$ b5efit plan describ$ 9 clause 7iv7 or 7v7 ( su* subp>agraph & any qualifi$ tru/ 7z def9$ 9 subp>agraph 7,a7 ( su* section7 :i* is "p ( su* a def9$ b5efit plan7 %all be c\nt$ z income2 & 4 #ejg4 ,r$uc+ co/-%>+ & o!r program improvem5ts = l[-income b5efici>ies 7a7 ,increase 9 income eligibility to #aej p]c5t ( ,,fpl = qualifi$ ,m$ic>e b5efici>ies 7#a7 ,9 g5]al ,section #aije7p77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7p77#b77;,a77 is am5d$ by /rik+ %all be at lea/ ! p]c5t provid$ "u subp>agraph 7,b7 7b n m ?an #ajj p]c5t7 ( ! (ficial pov]ty l9e & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 %all be-- 7i7 be=e ,janu>y #a1 #bjbb1 at lea/ ! p]c5t provid$ "u subp>agraph 7,b7 7b n m ?an #ajj p]c5t7 ( ! (ficial pov]ty l9e 7z def9$ by ! ,(fice ( ,managem5t & ,budget1 & revis$ annually 9 accordance ) section #fgc7b7 ( ! ,omnibus ,budget ,reconciliation ,act ( #aiha7 applicable to a family ( ! size involv$2 & 7ii7 on or aft] ,janu>y #a1 #bjbb1 equal to #aej p]c5t ( ! (ficial pov]ty l9e 7z s def9$ & revis$7 applicable to a family ( ! size involv$4 4 7#b7 ,n c\nt+ 9-k9d support & ma9t5ance z income ,section #aije7p77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7p77#b77;,d77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,9 det]m9+ income "u ?is subsection1 support & ma9t5ance furni%$ 9 k9d1 z describ$ 9 section #afab7;a77#b77;,a71 %all n be c\nt$ z income4 4 7#c7 ,con=m+ am5dm5ts 7,a7 ,section #aijb7;a77#aj77;,e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,e77 is am5d$-- 7i7 9 clause 7iii71 by /rik+ = mak+ m$ical & ins]t+ be=e ,janu>y #a1 #bjbb1 = mak+ m$ical2 & 7ii7 9 clause 7iv71 by /rik+ subject to sections & ins]t+ be=e ,janu>y #a1 #bjbb1 subject to sections4 7,b7 ,section #aicc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#c7 is am5d$-- 7i7 9 subsection 7a71 by /rik+ ,a ,/ate plan & ins]t+ ,subject to subsection 7h71 a ,/ate plan2 & 7ii7 by add+ at ! end ! foll[+ new subsection3 7h7 ,sunset ,! provisions ( ?is section %all h no =ce or effect aft] ,decemb] #ca1 #bjba4 4 7b7 #ajj p]c5t ,,fmap ,section #aije ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7gg7 ,increas$ ,,fmap = exp&$ m$ic>e co/-,%>+ populations 7#a7 ,9 g5]al ,not)/&+ subsection 7b71 ) respect to exp5ditures describ$ 9 p>agraph 7#b7 ! ,f$]al m$ical assi/ance p]c5tage %all be equal to #ajj p]c5t4 7#b7 ,exp5ditures describ$ ,! exp5ditures describ$ 9 ?is p>agraph are exp5ditures made on or aft] ,janu>y #a1 #bjbb1 = m$ical assi/ance = m$ic>e co/-%>+ provid$ to any individual "u clause 7i7 or 7ii7 ( section #aijb7;a77#aj77;,e7 :o w\ld n h be5 eligible = m$ic>e co/-%>+ "u any su* clause "u ! income or res\rce eligibility /&>ds 9 effect on ,octob] #a1 #bjah4 4 ,,vi ,provid+ = ,d5tal1 ,vision1 & ,he>+ ,cov]age "u ! ,m$ic>e program #fja4 ,d5tal & oral heal? c>e 7a7 ,cov]age ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$-- 7#a7 9 subp>agraph 7,,gg71 by /rik+ & aft] ! semicolon at ! end2 7#b7 9 subp>agraph 7,,hh71 by /rik+ ! p]iod at ! end & add+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,,ii7 d5tal & oral heal? s]vices 7z def9$ 9 subsection 7kkk772 4 7b7 ,d5tal & oral heal? s]vices def9$ ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7kkk7 ,d5tal & oral heal? s]vices 7#a7 ,9 g5]al ,! t]m d5tal & oral heal? s]vices means items & s]vices 7o!r ?an su* items & s]vices = :i* paym5t may be made "u "p ,a z inpati5t hospital s]vices7 t are furni%$ dur+ #bjbe or a subsequ5t ye>1 = :i* cov]age 0 n provid$ "u "p ,b z ( ! date ( ! enactm5t ( ?is subsection1 & t are-- 7,a7 ! prev5tive & scre5+ s]vices describ$ 9 p>agraph 7#b7 furni%$ by a doctor ( d5tal surg]y or ( d5tal m$ic9e 7z describ$ 9 subsection 7r77#b77 or an oral heal? pr(essional 7z def9$ 9 p>agraph 7#d772 or 7,b7 ! basic treatm5ts specifi$ = su* ye> by ! ,secret>y pursuant to p>agraph 7#c77;,a7 & ! major treatm5ts specifi$ = su* ye> by ! ,secret>y pursuant to p>agraph 7#c77;,b7 furni%$ by su* a doctor or su* a pr(essional4 7#b7 ,prev5tive & scre5+ s]vices ,! prev5tive & scre5+ s]vices describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,oral exams4 7,b7 ,d5tal clean+s4 7,c7 ,d5tal x-rays p]=m$ 9 ! (fice ( a doctor or pr(essional describ$ 9 p>agraph 7#a77;,a74 7,d7 ,fluoride treatm5ts4 7#c7 ,basic & major treatm5ts ,= #bjbe & ea* subsequ5t ye>1 ! ,secret>y %all specify-- 7,a7 basic treatm5ts 7:i* may include basic too? re/orations1 basic p]iodontic s]vices1 too? extractions1 & oral disease managem5t s]vices72 & 7,b7 major treatm5ts 7:i* may include major too? re/orations1 major p]iodontic s]vices1 bridges1 cr[ns1 & root canals72 t %all be includ$ z d5tal & oral heal? s]vices = su* ye>4 7#d7 ,oral heal? pr(essional ,! t]m oral heal? pr(essional means1 ) respect to d5tal & oral heal? s]vices1 a heal? pr(essional :o is lic5s$ to furni% su* s]vices1 act+ )9 ! scope ( su* lic5se1 by ! ,/ate 9 :i* su* s]vices are furni%$4 4 7c7 ,paym5t2 co9surance2 & limitations 7#a7 ,9 g5]al ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7 9 subp>agraph 7,n71 by ins]t+ & d5tal & oral heal? s]vices 7z def9$ 9 section #ahfa7kkk77 aft] section #ahfa7;hhh77#a772 7,b7 by /rik+ & be=e 7,,cc72 & 7,c7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,dd7 ) respect to d5tal & oral heal? s]vices 7z def9$ 9 section #ahfa7kkk771 ! am\nt paid %all be ! paym5t am\nt specifi$ "u section #ahcd7x74 7#b7 ,paym5t & limits specifi$ ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,paym5t & limits = d5tal & oral heal? s]vices 7#a7 ,9 g5]al ,! paym5t am\nt "u ?is "p = d5tal & oral heal? s]vices 7z def9$ 9 section #ahfa7kkk77 %all be1 subject to p>agraph 7#c71 ! applicable p]c5t 7specifi$ 9 p>agraph 7#b77 ( ! less] ( ! actual *>ge = ! s]vices or ! am\nt det]m9$ "u ! paym5t basis det]m9$ "u section #ahdh4 ,9 det]m9+ su* am\nts det]m9$ "u su* paym5t basis1 ! ,secret>y %all consid] paym5t rates paid to d5ti/s = comp>able s]vices "u ,/ate plans "u title ,,xix1 "u ! ,,tric>e program "u *apt] #ee ( title #aj ( ! ,unit$ ,/ates ,code1 & by o!r heal? c>e pay]s1 su* z ,m$ic>e ,advantage plans "u "p ,c4 7#b7 ,applicable p]c5t ,= purposes ( p>agraph 7#a71 ! applicable p]c5t specifi$ 9 ?is p>agraph is1 ) respect to d5tal & oral heal? s]vices 7z def9$ 9 section #ahfa7kkk77 furni%$ 9 a ye>-- 7,a7 t are prev5tive & scre5+ s]vices describ$ 9 p>agraph 7#b7 or basic treatm5ts specifi$ = su* ye> pursuant to p>agraph 7#c77;,a7 ( su* section1 #hj p]c5t2 & 7,b7 t are major treatm5ts specifi$ = su* ye> pursuant to p>agraph 7#c77;,b7 ( su* section-- 7i7 9 ! case su* s]vices are furni%$ dur+ #bjbe1 #aj p]c5t2 7ii7 9 ! case su* s]vices are furni%$ dur+ #bjbf or a subsequ5t ye> be=e #bjbi1 ! applicable p]c5t specifi$ "u ?is subp>agraph = ! previ\s ye>1 increas$ by #aj p]c5tage po9ts2 & 7iii7 9 ! case su* s]vices are furni%$ dur+ #bjbi or a subsequ5t ye>1 #ej p]c5t4 7#c7 ,limitations ,) respect to d5tal & oral heal? s]vices t are-- 7,a7 prev5tive & scre5+ oral exams1 paym5t may be made "u ?is "p = n m ?an two su* exams dur+ a #ab-mon? p]iod2 7,b7 d5tal clean+s1 paym5t may be made "u ?is "p = n m ?an two su* clean+s dur+ a #ab-mon? p]iod2 & 7,c7 n describ$ 9 subp>agraph 7,a7 or 7,b71 paym5t may be made "u ?is "p only at su* frequ5cies & "u su* circum/ances det]m9$ appropriate by ! ,secret>y4 4 7d7 ,paym5t "u physician fee s*$ule 7#a7 ,9 g5]al ,section #ahdh7;j77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;j77#c77 is am5d$ by ins]t+ 7#b77;,,ii71 be=e 7#c74 7#b7 ,exclusion f ,,mips ,section #ahdh7q77#a77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#a77;,c77ii77 is am5d$-- 7,a7 9 subclause 7,,ii71 by /rik+ or at ! end2 7,b7 9 subclause 7,,iii71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+ new subclause3 7,,iv7 ) respect to #bjbe & ea* subsequ5t ye>1 is a doctor ( d5tal surg]y or ( d5tal m$ic9e 7z describ$ 9 section #ahfa7r77#b77 or is an oral heal? pr(essional 7z def9$ 9 section #ahfa7kkk77#d774 4 7#c7 ,inclusion ( oral heal? pr(essionals z c]ta9 practition]s ,section #ahdb7;b77#ah77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#ah77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7vii7 ,) respect to #bjbe & ea* subsequ5t ye>1 an oral heal? pr(essional 7z def9$ 9 section #ahfa7kkk77#d774 4 7e7 ,d5tures 7#a7 ,9 g5]al ,section #ahfa7s77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h77 is am5d$-- 7,a7 by /rik+ 7o!r ?an d5tal72 & 7,b7 by ins]t+ & exclud+ d5tal1 except = a full or p>tial set ( d5tures furni%$ on or aft] ,janu>y #a1 #bjbe aft] colo/omy c>e4 7#b7 ,special paym5t rules 7,a7 ,limitations ,section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,special paym5t rule = d5tures ,paym5t may be made "u ?is "p ) respect to an individual = d5tures-- 7,a7 n m ?an once dur+ any #e-ye> p]iod 7except 9 ! case t a doctor or pr(essional describ$ 9 section #ahfa7kkk77#a77;,a7 det]m9es su* d5tures d n fit ! individual72 & 7,b7 only to ! ext5t t su* d5tures are furni%$ pursuant to a writt5 ord] ( su* a doctor or pr(essional4 4 7,b7 ,application ( competitive acquisition 7i7 ,9 g5]al ,section #ahcd7;h77#a77;,h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h77 is am5d$-- 7,i7 9 ! subp>agraph head+1 by ins]t+ 1 d5tures aft] or?otics2 7,,ii7 by ins]t+ 1 ( d5tures describ$ 9 p>agraph 7#b77;,d7 ( su* section1 aft] #bjaa12 & 7,,iii7 9 clause 7i71 by ins]t+ 1 su* d5tures aft] or?otics4 7ii7 ,con=m+ am5dm5t ,section #ahdg7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,d5tures ,d5tures describ$ 9 section #ahfa7s77#h7 = :i* paym5t w\ld o!rwise be made "u section #ahcd7;h74 4 7iii7 ,exemption ( c]ta9 items f competitive acquisition ,section #ahdg7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,c]ta9 d5tures ,^? items & s]vices describ$ 9 p>agraph 7#b77;,d7 if furni%$ by a physician or o!r practition] 7z def9$ by ! ,secret>y7 to ! physician's or practition]'s own pati5ts z "p ( ! physician's or practition]'s pr(essional s]vice4 4 7f7 ,exclusion modifications ,section #ahfb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,o71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,p71 by /rik+ ! semicolon at ! end & ins]t+ 1 &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,q7 9 ! case ( d5tal & oral heal? s]vices 7z def9$ 9 section #ahfa7kkk77 t are prev5tive & scre5+ s]vices describ$ 9 p>agraph 7#b7 ( su* section1 :i* are furni%$ m frequ5tly ?an provid$ "u section #ahcd7x77#c7 & "u circum/ances o!r ?an circum/ances det]m9$ appropriate "u su* section2 2 & 7#b7 9 p>agraph 7#ab71 by ins]t+ be=e ! semicolon at ! end ! foll[+3 & except t paym5t may be made "u "p ,b = d5tal & oral heal? s]vices t are cov]$ "u section #ahfa7s77#b77;,,ii74 7g7 ,c]ta9 non-application 7#a7 ,9 g5]al ,p>agraphs 7#a7 & 7#d7 ( section #ahci7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acier7a77 are am5d$ by add+ at ! end ( ea* su* p>agraphs ! foll[+3 ,9 apply+ ?is p>agraph !re %all n be tak5 into acc\nt b5efits & adm9i/rative co/s attributable to ! am5dm5ts made by section #fja 7o!r ?an subsection 7g77 ( ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act & ! ,gov]nm5t contribution "u section #ahdd7;a77#d74 7#b7 ,paym5t ,section #ahdd7;a7 ( su* ,act 7#db ,u4,s4,c4 #aciew7a77 is am5d$-- 7,a7 9 p>agraph 7#c71 by /rik+ ! p]iod at ! end & ins]t+ 2 plus2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 a ,gov]nm5t contribution equal to ! am\nt t is e/imat$ to be payable = b5efits & relat$ adm9i/rative co/s incurr$ t are attributable to ! am5dm5ts made by section #fja 7o!r ?an subsection 7g77 ( ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act4 4 7h7 ,implem5tation fund+ 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all provide = ! transf] f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt (-- 7,a7 #bj1jjj1jjj = ea* ( fiscal ye>s #bjbj ?r\gh #bjbe = purposes ( implem5t+ ! am5dm5ts made by ?is section2 & 7,b7 su* sums z det]m9$ appropriate by ! ,secret>y = ea* subsequ5t fiscal ye> = purposes ( adm9i/]+ ! provisions ( su* am5dm5ts4 7#b7 ,availability & additional use ( funds ,funds transf]r$ pursuant to p>agraph 7#a7 %all rema9 available until exp5d$ & may be us$1 9 addition to ! purpose specifi$ 9 p>agraph 7#a77;,a71 to implem5t ! am5dm5ts made by sections #fjb & #fjc4 #fjb4 ,provid+ cov]age = he>+ c>e "u ! ,m$ic>e program 7a7 ,provision ( aural rehabilitation & treatm5t s]vices by qualifi$ audiologi/s ,section #ahfa7ll77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ll77#c77 is am5d$ by ins]t+ 7&1 beg9n+ ,janu>y #a1 #bjbc1 su* aural rehabilitation & treatm5t s]vices7 aft] assessm5t s]vices4 7b7 ,cov]age ( he>+ aids 7#a7 ,inclusion ( he>+ aids z pro/hetic devices ,section #ahfa7s77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h77 is am5d$ by ins]t+ 1 & includ+ he>+ aids furni%$ on or aft] ,janu>y #a1 #bjbc1 to individuals diagnos$ ) pr(\nd or sev]e he>+ loss be=e ! semicolon at ! end4 7#b7 ,paym5t limitations = he>+ aids ,section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 z am5d$ by section #fja7;e77#b77;,a71 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,limitations = he>+ aids ,paym5t may be made "u ?is "p ) respect to an individual1 ) respect to he>+ aids furni%$ on or aft] ,janu>y #a1 #bjbc-- 7,a7 n m ?an once dur+ a #e-ye> p]iod2 7,b7 only = types ( su* he>+ aids t are n ov]-!-c\nt] he>+ aids 7z def9$ 9 section #ebj7q77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 & t are det]m9$ appropriate by ! ,secret>y2 & 7,c7 only if furni%$ pursuant to a writt5 ord] ( a physician or qualifi$ audiologi/ 7z def9$ 9 section #ahfa7ll77#d77;,b774 4 7#c7 ,application ( competitive acquisition 7,a7 ,9 g5]al ,section #ahcd7;h77#a77;,h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h771 z am5d$ by section #fja7;e77#b77;,b77i71 is fur!r am5d$-- 7i7 9 ! head]1 by ins]t+ 1 he>+ aids aft] d5tures2 7ii7 by ins]t+ 1 ( he>+ aids describ$ 9 p>agraph 7#b77;,e7 ( su* section1 aft] p>agraph 7#b77;,d7 ( su* section2 & 7iii7 9 clause 7i71 by ins]t+ 1 su* he>+ aids aft] su* d5tures4 7,b7 ,con=m+ am5dm5t 7i7 ,9 g5]al ,section #ahdg7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b771 z am5d$ by section #fja7;e77#b77;,b77ii71 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,he>+ aids ,he>+ aids describ$ 9 section #ahfa7s77#h7 = :i* paym5t w\ld o!rwise be made "u section #ahcd7;h74 4 7ii7 ,exemption ( c]ta9 items f competitive acquisition ,section #ahdg7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g771 z am5d$ by section #fja7;e77#b77;,b77iii71 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,c]ta9 he>+ aids ,^? items & s]vices describ$ 9 p>agraph 7#b77;,e7 if furni%$ by a physician or o!r practition] 7z def9$ by ! ,secret>y7 to ! physician's or practition]'s own pati5ts z "p ( ! physician's or practition]'s pr(essional s]vice4 4 7#d7 ,inclusion ( audiologi/s z c]ta9 practition]s to receive paym5t on an assignm5t-relat$ basis ,section #ahdb7;b77#ah77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#ah77;,c771 z am5d$ by section #fja7;d77#d71 is fur!r am5d$ by add+ at ! end ! foll[+ new clause3 7viii7 ,) respect to #bjbc & ea* subsequ5t ye>1 a qualifi$ audiologi/ 7z def9$ 9 section #ahfa7ll77#d77;,b774 4 7c7 ,exclusion modification ,section #ahfb7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#g77 is am5d$ by ins]t+ 7except su* he>+ aids or exam9ations !re= z describ$ 9 & o!rwise all[$ "u section #ahfa7s77#h77 aft] he>+ aids or exam9ations !re=4 7d7 ,c]ta9 non-application 7#a7 ,9 g5]al ,! la/ s5t5ce ( section #ahci7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acier7a77#a771 z add$ by section #fja7;g77#a71 is am5d$ by /rik+ section #fja 7o!r ?an subsection 7g77 & ins]t+ sections #fja 7o!r ?an subsection 7g771 #fjb 7o!r ?an subsection 7d774 7#b7 ,paym5t ,p>agraph 7#d7 ( section #ahdd7;a7 ( su* ,act 7#db ,u4,s4,c4 #aciew7a771 z add$ by section #fja7;g77#b71 is am5d$ by /rik+ section #fja 7o!r ?an subsection 7g77 & ins]t+ sections #fja 7o!r ?an subsection 7g771 #fjb 7o!r ?an subsection 7d774 7e7 ,report2 regulations 7#a7 ,report ,n lat] ?an ! date t is #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct a /udy to assess 7& submit to ! ,secret>y ( ,heal? & ,human ,s]vices a report on7 any program integrity or ov]utilization risks ) respect to all[+ qualifi$ audiologi/s 7z def9$ 9 p>agraph 7#d77;,b7 ( #ahfa7ll7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ll777 to furni% audiology s]vices 7z def9$ 9 p>agraph 7#c7 ( su* section7 to individuals entitl$ to b5efits "u "p ,a ( title ,,xviii ( su* ,act 7#db ,u4,s4,c4 #acie;c et seq47 & enroll$ = b5efits "u "p ,b ( su* title 7#db ,u4,s4,c4#acie;j et seq47 )\t su* individuals be+ ref]r$ by a physician 7z def9$ 9 section #ahfa7r7 ( su* ,act 7#db ,u4,s4,c4 #aciex7r777 or practition] 7z describ$ 9 section #fjb4cb ( title #db1 ,code ( ,f$]al ,regulations7 to su* qualifi$ audiologi/s4 ,9 conduct+ su* /udy1 ! ,inspector ,g5]al may take into acc\nt exp]i5ces ) audiologi/s furni%+ audiology s]vices to enrollees 9 o!r ,f$]al programs1 includ+ 9 a heal? b5efit plan "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code or 9 heal? c>e b5efits "u ! ,,tric>e program "u *apt] #ee ( title #aj ( ! ,unit$ ,/ates ,code or "u *apt] #ag ( title #ch ( su* ,code4 7#b7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices may promulgate regulations to all[ qualifi$ audiologi/s 7z s def9$7 to furni% audiology s]vices 7z s def9$7 )\t a ref]ral f a physician or practition]1 consi/5t ) ! f9d+s submitt$ to ! ,secret>y pursuant to p>agraph 7#a77;,b74 7f7 ,implem5tation fund+ 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all provide = ! transf] f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt (-- 7,a7 #bj1jjj1jjj = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd = purposes ( implem5t+ ! am5dm5ts made by ?is section2 & 7,b7 su* sums z det]m9$ appropriate by ! ,secret>y = ea* subsequ5t fiscal ye> = purposes ( adm9i/]+ ! provisions ( su* am5dm5ts4 7#b7 ,availability & additional use ( funds ,funds transf]r$ pursuant to p>agraph 7#a7 %all rema9 available until exp5d$ & may be us$1 9 addition to ! purpose specifi$ 9 p>agraph 7#a77;,a71 to implem5t ! am5dm5ts made by sections #fja & #fjc4 #fjc4 ,provid+ cov]age = vision c>e "u ! ,m$ic>e program 7a7 ,cov]age ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b771 z am5d$ by section #fja7;a71 is fur!r am5d$-- 7#a7 9 subp>agraph 7,,hh71 by /rik+ & aft] ! semicolon at ! end2 7#b7 9 subp>agraph 7,,ii71 by /rik+ ! p]iod at ! end & add+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,,jj7 vision s]vices 7z def9$ 9 subsection 7lll772 4 7b7 ,vision s]vices def9$ ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex71 z am5d$ by section #fja7;b71 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7lll7 ,vision s]vices ,! t]m vision s]vices means-- 7#a7 r\t9e eye exam9ations to det]m9e ! refractive /ate ( ! eyes1 includ+ proc$ures p]=m$ dur+ ! c\rse ( su* exam9ation2 & 7#b7 contact l5s fitt+ s]vices2 furni%$ on or aft] ,janu>y #a1 #bjbc1 by or "u ! direct sup]vision ( an optometri/ or oph?almologi/ :o is legally au?oriz$ to furni% su* exam9ations1 proc$ures1 or fitt+ s]vices 7z applicable7 "u ,/ate law 7or ! ,/ate regulatory me*anism provid$ by ,/ate law7 ( ! ,/ate 9 :i* ! exam9ations1 proc$ures1 or fitt+ s]vices are furni%$4 4 7c7 ,paym5t limitations ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 z am5d$ by section #fja7;c77#b71 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7y7 ,limitation = vision s]vices ,) respect to vision s]vices 7z def9$ 9 section #ahfa7lll77 & an individual1 paym5t may be made "u ?is "p = only #a r\t9e eye exam9ation describ$ 9 p>agraph 7#a7 ( su* section & #a contact l5s fitt+ s]vice describ$ 9 p>agraph 7#b7 ( su* section dur+ a #b-ye> p]iod4 4 7d7 ,paym5t "u physician fee s*$ule ,section #ahdh7;j77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;j77#c771 z am5d$ by section #fja7;d77#a71 is fur!r am5d$ by ins]t+ 7#b77;,,jj71 be=e 7#c74 7e7 ,cov]age ( conv5tional eyeglasses & contact l5ses ,section #ahfa7s77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h771 z am5d$ by section #fjb7;b77#a71 is fur!r am5d$ by /rik+ 1 & includ+ "o pair ( conv5tional eyeglasses or contact l5ses furni%$ subsequ5t to ea* cat>act surg]y ) ins]tion ( an intraocul> l5s & ins]t+ 1 includ+ "o pair ( conv5tional eyeglasses or contact l5ses furni%$ subsequ5t to ea* cat>act surg]y ) ins]tion ( an intraocul> l5s1 if furni%$ be=e ,janu>y #a1 #bjbc1 includ+ conv5tional eyeglasses or contact l5ses1 :e!r or n furni%$ subsequ5t to su* a surg]y1 if furni%$ on or aft] ,janu>y #a1 #bjbd4 7f7 ,special paym5t rules = eyeglasses & contact l5ses 7#a7 ,limitations ,section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 z am5d$ by section #fja7;e77#b77;,a7 & section #fjb7;b77#b71 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,paym5t limitations = eyeglasses & contact l5ses 7,a7 ,9 g5]al ,) respect to eyeglasses & contact l5ses furni%$ to an individual on or aft] ,janu>y #a1 #bjbc1 subject to subp>agraph 7,b71 paym5t may be made "u ?is "p only-- 7i7 dur+ a #b-ye> p]iod1 = ei!r #a pair ( eyeglasses 7includ+ l5ses & frames7 or n m ?an a #b-ye> supply ( contact l5ses t is provid$ 9 n m ?an #ahj-;day increm5ts2 7ii7 ) respect to am\nts attributable to ! l5ses & frames ( su* a pair ( eyeglasses or am\nts attributable to su* a #b-ye> supply ( contact l5ses1 9 an am\nt n great] ?an-- 7,i7 = a pair ( eyeglasses furni%$ 91 or a #b-ye> supply ( contact l5ses beg9n+ 91 #bjbc-- 7aa7 #he = ! l5ses ( su* pair ( eyeglasses & #he = ! frames ( su* pair ( eyeglasses2 or 7bb7 #he = su* #b-ye> supply ( contact l5ses2 & 7,,ii7 = ! l5ses & frames ( a pair ( eyeglasses furni%$ 91 or a #b-ye> supply ( contact l5ses beg9n+ 91 a subsequ5t ye>1 ! doll> am\nts specifi$ "u ?is subp>agraph = ! previ\s ye>1 increas$ by ! p]c5tage *ange 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>2 7iii7 = types ( eyeglass l5ses1 & = types ( contact l5ses1 z det]m9$ appropriate by ! ,secret>y2 7iv7 if furni%$ pursuant to a writt5 ord] ( a physician describ$ 9 section #ahfa7lll72 & 7v7 if dur+ ! #b-ye> p]iod describ$ 9 clause 7i71 ! individual did n already receive 7z describ$ 9 subp>agraph 7,b77 "o pair ( conv5tional eyeglasses or contact l5ses subsequ5t to a cat>act surg]y ) ins]tion ( an intraocul> l5s furni%$ dur+ su* p]iod4 7,b7 ,exception ,) respect to a #b-ye> p]iod describ$ 9 subp>agraph 7,a77i71 9 ! case ( an individual :o receives cat>act surg]y ) ins]tion ( an intraocul> l5s1 not)/&+ subp>agraph 7,a71 paym5t may be made "u ?is "p = "o pair ( conv5tional eyeglasses or contact l5ses furni%$ subsequ5t to su* cat>act surg]y dur+ su* p]iod4 4 7#b7 ,application ( competitive acquisition 7,a7 ,9 g5]al ,section #ahcd7;h77#a77;,h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h771 z am5d$ by section #fja7;e77#b77;,b77i7 & section #fjb7;b77#c77;,a71 is fur!r am5d$-- 7i7 9 ! head] by ins]t+ 1 eyeglasses1 & contact l5ses aft] he>+ aids2 7ii7 by ins]t+ & ( eyeglasses & contact l5ses describ$ 9 p>agraph 7#b77;,f7 ( su* section1 aft] p>agraph 7#b77;,e7 ( su* section12 & 7iii7 9 clause 7i71 by ins]t+ 1 or su* eyeglasses & contact l5ses aft] su* he>+ aids4 7,b7 ,con=m+ am5dm5t 7i7 ,9 g5]al ,section #ahdg7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b771 z am5d$ by section #fja7;e77#b77;,b77ii7 & section #fjb7;b77#c77;,b77i71 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,eyeglasses & contact l5ses ,eyeglasses & contact l5ses describ$ 9 section #ahfa7s77#h7 = :i* paym5t w\ld o!rwise be made "u section #ahcd7;h74 4 7ii7 ,exemption ( c]ta9 items f competitive acquisition ,section #ahdg7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g771 z am5d$ by section #fja7;e77#b77;,b77iii7 & section #fjb7;b77#c77;,b77ii71 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,c]ta9 eyeglasses & contact l5ses ,^? items & s]vices describ$ 9 p>agraph 7#b77;,f7 if furni%$ by a physician or o!r practition] 7z def9$ by ! ,secret>y7 to ! physician's or practition]'s own pati5ts z "p ( ! physician's or practition]'s pr(essional s]vice4 4 7g7 ,exclusion modifications ,section #ahfb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a771 z am5d$ by section #fja7;f71 is fur!r am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,p71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,q71 by /rik+ ! semicolon at ! end & ins]t+ 1 &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,r7 9 ! case ( vision s]vices 7z def9$ 9 section #ahfa7lll77 t are r\t9e eye exam9ations & contact l5s fitt+ s]vices 7z describ$ 9 p>agraph 7#a7 or 7#b71 respectively1 ( su* section71 :i* are furni%$ m frequ5tly ?an once dur+ a #b-ye> p]iod2 2 & 7#b7 9 p>agraph 7#g7-- 7,a7 by ins]t+ 7o!r ?an su* an exam9ation t is a vision s]vice t is cov]$ "u section #ahfa7s77#b77;,,jj77 aft] eye exam9ations2 & 7,b7 by ins]t+ 7o!r ?an su* a proc$ure t is a vision s]vice t is cov]$ "u section #ahfa7s77#b77;,,jj77 aft] refractive /ate ( ! eyes4 7h7 ,c]ta9 non-application 7#a7 ,9 g5]al ,! la/ s5t5ce ( section #ahci7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acier7a77#a771 z add$ by section #fja7;g77#a7 & am5d$ by section #fjb7;d77#a71 is fur!r am5d$ by ins]t+ 1 & #fjc 7o!r ?an subsection 7h77 aft] #fjb 7o!r ?an subsection 7d774 7#b7 ,paym5t ,p>agraph 7#d7 ( section #ahdd7;a7 ( su* ,act 7#db ,u4,s4,c4 #aciew7a771 z add$ by section #fja7;g77#b7 & am5d$ by section #fjb7;d77#b71 is fur!r am5d$ by ins]t+ 1 & #fjc 7o!r ?an subsection 7h77 aft] #fjb 7o!r ?an subsection 7d774 7i7 ,implem5tation fund+ 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all provide = ! transf] f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt (-- 7,a7 #bj1jjj1jjj = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd = purposes ( implem5t+ ! am5dm5ts made by ?is section2 & 7,b7 su* sums z det]m9$ appropriate by ! ,secret>y = ea* subsequ5t fiscal ye> = purposes ( adm9i/]+ ! provisions ( su* am5dm5ts4 7#b7 ,availability & additional use ( funds ,funds transf]r$ pursuant to p>agraph 7#a7 %all rema9 available until exp5d$ & may be us$1 9 addition to ! purpose specifi$ 9 p>agraph 7#a77;,a71 to implem5t ! am5dm5ts made by sections #fja & #fjb4 ,,vii ,,nih1 ,,fda1 & ,opioids ,fund+ ,a ,biom$ical ,innovation ,expansion #gja4 ,,nih ,innovation ,initiatives 7a7 ,,nih ,innovation acc\nt 7#a7 ,9 g5]al ,section #ajja7;b7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,supplem5tal fund+ & additional activities 7,a7 ,9 g5]al ,9 addition to ! funds made available "u p>agraph 7#b71 !re are au?oriz$ to be appropriat$1 & are h]eby appropriat$1 to ! ,acc\nt1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to be available until exp5d$ )\t fur!r appropriation1 ! foll[+3 7i7 ,= fiscal ye> #bjba1 #bee1djj1jjj4 7ii7 ,= fiscal ye> #bjbb1 #bfj1djj1jjj4 7iii7 ,= fiscal ye> #bjbc1 #afc1djj1jjj4 7iv7 ,= fiscal ye> #bjbd1 #edg1jjj1jjj4 7v7 ,= fiscal ye> #bjbe1 #hdh1jjj1jjj4 7vi7 ,= fiscal ye> #bjbf1 #hdb1djj1jjj4 7vii7 ,= fiscal ye> #bjbg1 #a1jhi1fjj1jjj4 7viii7 ,= fiscal ye> #bjbh1 #a1aae1fjj1jjj4 7ix7 ,= fiscal ye> #bjbi1 #a1agj1fjj1jjj4 7x7 ,= fiscal ye> #bjcj1 #a1bjg1fjj1jjj4 7,b7 ,supplem5tal fund+ = c]ta9 projects ,( ! total am\nts made available "u subp>agraph 7,a7 = ea* ( fiscal ye>s #bjba ?r\gh #bjcj1 a total am\nt n to exce$ ! foll[+ %all be made available = ! foll[+ categories ( ,,nih ,innovation ,projects3 7i7 ,= projects describ$ 9 p>agraph 7#d77;,a71 an am\nt n to exce$ a total ( #b1jgj1fjj1jjj z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjba & #bjbb1 #ej1jjj1jjj4 7,,ii7 ,= fiscal ye> #bjbd1 #ajj1jjj1jjj4 7,,iii7 ,= ea* ( fiscal ye>s #bjbe & #bjbf1 #cjj1jjj1jjj4 7,,iv7 ,= ea* ( fiscal ye>s #bjbg ?r\gh #bjbi1 #cag1jjj1jjj4 7,v7 ,= fiscal ye> #bjcj1 #cai1fjj1jjj4 7ii7 ,= projects describ$ 9 p>agraph 7#d77;,b71 an am\nt n to exce$ a total ( #b1jda1ijj1jjj z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjba & #bjbb1 #ej1jjj1jjj4 7,,ii7 ,= fiscal ye> #bjbd1 #abh1jjj1jjj4 7,,iii7 ,= fiscal ye> #bjbe1 #bji1jjj1jjj4 7,,iv7 ,= fiscal ye> #bjbf1 #ajj1jjj1jjj4 7,v7 ,= fiscal ye> #bjbg1 #cbe1jjj1jjj4 7,,vi7 ,= fiscal ye> #bjbh1 #cej1jjj1jjj4 7,,vii7 ,= fiscal ye> #bjbi1 #djj1jjj1jjj4 7,,viii7 ,= fiscal ye> #bjcj1 #dbi1ijj1jjj4 7iii7 ,= projects describ$ 9 p>agraph 7#d77;,c71 an am\nt n to exce$ a total ( #a1eeh1djj1jjj z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjbd & #bjbe1 #aea1bjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbf ?r\gh #bjcj1 #bea1bjj1jjj4 7iv7 ,= projects describ$ 9 p>agraph 7#d77;,d71 an am\nt n to exce$ #ae1djj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjcj4 7,c7 ,additional ,,nih ,innovation ,projects ,9 addition to fund+ ,,nih ,innovation ,projects pursuant to subp>agraph 7,b71 ( ! total am\nts made available "u subp>agraph 7,a71 a total am\nt n to exce$ ! foll[+ %all be made available = ! foll[+ categories ( ,,nih ,innovation ,projects3 7i7 ,to support rese>* relat$ to combat+ antimicrobial resi/ance & antibiotic resi/ant bact]ia1 includ+ rese>* into new treatm5ts1 diagno/ics1 & vacc9es1 rese>*1 9 consultation ) ! ,c5t]s = ,disease ,control & ,prev5tion1 into /ew>d%ip1 & ! developm5t ( /rategies1 9 coord9ation ) ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority "u section #cai,l ( ! ,public ,heal? ,s]vice ,act1 to support comm]cialization ( new antibiotics1 n to exce$ a total ( #a1add1ejj1jjj1 z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjba ?r\gh #bjbd1 #ajj1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbe & #bjbf1 #abj1jjj1jjj4 7,,iii7 ,= ea* ( fiscal ye>s #bjbg ?r\gh #bjbi1 #abe1jjj1jjj4 7,,iv7 ,= fiscal ye> #bjcj1 #abi1ejj1jjj4 7ii7 ,to support rese>* & rese>* activities relat$ to r>e diseases or conditions1 includ+ /udies or analyses t help to bett] und]/& ! natural hi/ory ( a r>e disease or condition & translational /udies relat$ to r>e diseases or conditions1 n to exce$ a total ( #ecj1fjj1jjj1 z foll[s3 7,i7 ,= fiscal ye> #bjba1 #dj1jjj1jjj4 7,,ii7 ,= fiscal ye> #bjbb1 #de1jjj1jjj4 7,,iii7 ,= fiscal ye> #bjbc1 #dh1jjj1jjj4 7,,iv7 ,= ea* ( fiscal ye>s #bjbd & #bjbe1 #eb1djj1jjj4 7,v7 ,= fiscal ye> #bjbf1 #ee1hjj1jjj4 7,,vi7 ,= fiscal ye> #bjbg1 #ef1jjj1jjj4 7,,vii7 ,= fiscal ye> #bjbh1 #eg1jjj1jjj4 7,,viii7 ,= ea* ( fiscal ye>s #bjbi & #bjcj1 #fb1jjj1jjj4 4 7#b7 ,con=m+ am5dm5ts ,section #ajja ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7,a7 9 subsection 7a71 by /rik+ subsection 7b77#d7 & ins]t+ subsections 7b77#d7 & 7b77#e72 7,b7 9 subsection 7b77#a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraphs 7#d7 & 7#e72 & 7,c7 9 subsection 7c77#b77;,a77ii71 by ins]t+ or pursuant to subsection 7b77#e7 aft] subsection 7b77#c72 & 7,d7 9 subsection 7d71 by ins]t+ or pursuant to subsection 7b77#e7 aft] subsection 7b77#c74 7b7 ,workplan ,section #ajja7;c77#a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by add+ at ! end ! foll[+3 7,d7 ,updates ,! ,director ( ,,nih %all 1 aft] seek+ recomm5dations 9 accordance ) ! process describ$ 9 subp>agraph 7,c71 update ! "w plan submitt$ "u ?is subsection = ea* ( fiscal ye>s #bjba ?r\gh #bjcj to reflect ! am5dm5ts made to ?is section by ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act4 4 7c7 ,annual reports ,section #ajja7;c77#b77;,a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by /rik+ #bjbg & ins]t+ #bjcj4 7d7 ,sunset ,section #ajja7;e7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by /rik+ ,septemb] #cj1 #bjbf & ins]t+ ,septemb] #cj1 #bjcj4 #gjb4 ,,nih cl9ical trial ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+3 #djd,o4 ,cl9ical ,trial ,accel]ation ,pilot ,initiative 7a7 ,e/abli%m5t ( pilot program ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 e/abli% & implem5t a pilot program to aw>d multi-ye> contracts to eligible entities to support phase ,,ii cl9ical trials & phase ,,iii cl9ical trials-- 7#a7 to promote innovation 9 treatm5ts & te*nologies support+ ! advanc$ rese>* & developm5t & production ( high ne$ cures2 & 7#b7 to provide support = ! developm5t ( m$ical products & !rapies4 7b7 ,eligible entities ,to be eligible to receive assi/ance "u ! pilot program e/abli%$ "u subsection 7a71 an entity %all-- 7#a7 be seek+ to m>ket a m$ical product or !rapy t is ! subject ( cl9ical trial or trials to be support$ us+ su* assi/ance2 7#b7 be a public or private entity1 :i* may include a private or public rese>* in/itution1 a contract rese>* organization1 an in/itution ( high] education 7z def9$ 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja771 a m$ical c5t]1 a biote*nology company1 or an academic rese>* in/itution2 & 7#c7 comply ) requirem5ts ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act at all /ages ( developm5t1 manufactur+1 review1 approval1 & safety surveillance ( a m$ical product4 7c7 ,duties ,! ,secret>y1 act+ ?r\gh ! ,director ( ,national ,in/itutes ( ,heal?1 %all-- 7#a7 9 e/abli%+ ! pilot program "u subsection 7a71 consult )-- 7,a7 ! ,director ( ! ,national ,c5t] = ,advanc+ ,translational ,sci5ces & ! o!r national rese>* in/itutes 9 consid]+ _! reque/s = new or exp&$ cl9ical trial support ef=ts2 & 7,b7 ! ,commission] ( ,food & ,drugs & any o!r head ( a ,f$]al ag5cy z ! ,secret>y det]m9es to be appropriate to ensure coord9ation & effici5tly advance cl9ical trial activities2 7#b7 9 implem5t+ ! pilot program "u subsection 7a71 consid] consult+ ) pati5ts & pati5t advocates2 & 7#c7 9 aw>d+ contracts "u ! pilot program "u subsection 7a71 consid]-- 7,a7 ! expect$ heal? impacts ( ! cl9ical trial or trials to be support$ "u ! contract2 & 7,b7 ! degree to :i* ! m$ical product or !rapy t is ! subject ( su* cl9ical trial or trials is a high ne$ cure4 7d7 ,exclusion ,a contract may n be aw>d$ "u ! pilot program "u subsection 7a7 if ! drug t is ! subject ( ! cl9ical trial or trials to be support$ "u ! contract is a drug designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act z a drug = a r>e disease or condition4 7e7 ,,nih ,cl9ical ,trial ,accel]ator ,acc\nt 7#a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,,nih ,cl9ical ,trial ,accel]ator ,acc\nt 7ref]r$ to 9 ?is section z ! ,acc\nt71 = purposes ( c>ry+ out ?is section4 7#b7 ,transf] ( direct sp5d+ sav+s ,!re %all be transf]r$ to ! ,acc\nt f ! g5]al fund ( ! ,treasury1 #fhj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 to be available until exp5d$ )\t fur!r appropriation4 7#c7 ,"w plan ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate a "w plan t includes ! propos$ implem5tation ( ?is section & ! propos$ allocation ( funds 9 ! ,acc\nt4 7f7 ,reports to ,congress ,n lat] ?an ,octob] #a ( ea* fiscal ye>1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate a report on-- 7#a7 ! implem5tation ( ?is section2 7#b7 any available results on phase ,,ii cl9ical trials & phase ,,iii cl9ical trials support$ "u ?is section dur+ su* fiscal ye>2 & 7#c7 ! ext5t to :i* ,f$]al funds are obligat$ to support su* cl9ical trials1 includ+ ! specific am\nt ( su* support & aw>ds pursuant to an allocation f ! ,acc\nt "u subsection 7e74 7g7 ,def9itions ,9 ?is section3 7#a7 ,phase ,,ii cl9ical trial ,! t]m phase ,,ii cl9ical trial means a phase ,,ii cl9ical inve/igation1 z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#b7 ,phase ,,iii cl9ical trials ,! t]m phase ,,iii cl9ical trial means a phase ,,iii cl9ical inve/igation1 z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#c7 ,high ne$ cure ,! t]m high ne$ cure has ! mean+ giv5 su* t]m 9 section #dhj7;a77#c74 4 #gjc4 ,innovation ,network ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq471 z am5d$ by section #gjb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #djd,p4 ,innovation ,network 7a7 ,funds ,! ,director ( ,,nih %all aw>d grants or contracts to eligible entities to develop1 exp&1 & enhance ! comm]cialization ( biom$ical products4 7b7 ,eligible entity ,9 ?is section1 ! t]m eligible entity means an entity receiv+ fund+ "u-- 7#a7 ! ,small ,bus9ess ,innovation ,rese>* program ( ! ,national ,in/itutes ( ,heal?2 or 7#b7 ! ,small ,bus9ess ,te*nology ,transf] program ( ! ,national ,in/itutes ( ,heal?4 7c7 ,use ( funds ,an eligible entity %all use ! funds receiv$ ?r\gh su* grant or contract to support-- 7#a7 ! ,comm]cialization ,read9ess ,pilot program ( ! ,national ,in/itutes ( ,heal?2 7#b7 ! ,innovation ,corps program ( ! ,national ,in/itutes ( ,heal?2 7#c7 ! ,comm]cialization ,accel]ator program ( ! ,national ,in/itutes ( ,heal?2 7#d7 ! ,comm]cialization ,assi/ance program ( ! ,national ,in/itutes ( ,heal?2 & 7#e7 su* o!r programs & activities z ! ,director ( ,,nih det]m9es to be appropriate1 to support ! comm]cialization /age ( rese>*1 lat] /age rese>* & developm5t1 te*nology transf]1 & comm]cialization te*nical assi/ance4 7d7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #ajj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 to be available until exp5d$4 4 ,b ,inve/+ 9 ,safety & ,innovation #gaa4 ,food & ,drug ,adm9i/ration 7a7 ,,fda ,innovation acc\nt 7#a7 ,9 g5]al ,section #ajjb7;b7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7,a7 9 p>agraph 7#a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraphs 7#d7 & 7#e72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,supplem5tal fund+ & additional activities 7,a7 ,9 g5]al ,9 addition to ! funds made available "u p>agraph 7#b71 !re are au?oriz$ to be appropriat$1 & are h]eby appropriat$1 to ! ,acc\nt1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to be available until exp5d$ )\t fur!r appropriation1 ! foll[+3 7i7 ,= fiscal ye> #bjbj1 #dag1ejj1jjj4 7ii7 ,= ea* ( fiscal ye>s #bjba & #bjbb1 #aeg1ejj1jjj4 7iii7 ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbe1 #aeb1ejj1jjj4 7iv7 ,= ea* ( fiscal ye>s #bjbf ?r\gh #bjbi1 #bjb1ejj1jjj4 7,b7 ,supplem5tal fund+ = c]ta9 activities ,( ! total am\nts made available "u subp>agraph 7,a7 = ea* ( fiscal ye>s #bjbf ?r\gh #bjbi1 a total am\nt n to exce$ #ej1jjj1jjj = ea* su* fiscal ye>1 %all be made available = ! activities "u subtitles ,a ?r\gh ,f 7includ+ ! am5dm5ts made by su* subtitles7 ( title ,,iii ( ?is ,act & section #ajad ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #cjgc ( ?is ,act4 7,c7 ,additional ,,fda activities ,9 addition to fund+ activities pursuant to subp>agraph 7,b71 ( ! total am\nts made available "u subp>agraph 7,a71 a total am\nt n to exce$ ! foll[+ %all be made available = ! foll[+ categories ( activities3 7i7 ,= mod]nization ( ! te*nical infra/ructure ( ! ,food & ,drug ,adm9i/ration1 includ+ enhancem5ts su* z int]op]ability across ! ag5cy1 & additional capabilities to develop an advanc$ in=mation te*nology infra/ructure to support ! ag5cy's regulatory mission3 7,i7 ,= fiscal ye> #bjbj1 #ahj1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjba ?r\gh #bjbi1 #fj1jjj4 7ii7 ,= support = cont9u\s manufactur+ ( drugs & biological products1 includ+ complex biological products su* z reg5]ative m$ic9e !rapies1 ?r\gh grants to in/itutions ( high] education & nonpr(it organizations & o!r appropriate me*anisms1 = ea* ( fiscal ye>s #bjbj ?r\gh #bjbi1 #bj1jjj1jjj4 7iii7 ,= support = ! ,commission] ( ,food & ,drugs to engage exp]ts1 su* z ?r\gh ! =mation & op]ation ( public-private p>tn]%ips or o!r appropriate collaborative ef=ts1 to advance ! developm5t & deliv]y ( individualiz$ human g5e !rapy products3 7,i7 ,= fiscal ye> #bjbj1 #ej1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjba ?r\gh #bjbi1 #aj1jjj1jjj4 7iv7 ,= support = inspections1 en=cem5t1 & quality surveillance activities across ! ,food & ,drug ,adm9i/ration1 includ+ =eign & dome/ic inspections across products1 = ea* ( fiscal ye>s #bjbj ?r\gh #bjbi1 #bj1jjj1jjj4 7v7 ,= support = activities ( ! ,food & ,drug ,adm9i/ration relat$ to cu/oms & bord] protection to provide improvem5ts to te*nologies1 inspection capacity1 & sites ( import 7includ+ int]national mail facilities7 9 :i* ! ,food & ,drug ,adm9i/ration op]ates1 = ea* ( fiscal ye>s #bjbj ?r\gh #bjbi1 #aj1jjj1jjj4 7vi7 ,to fur!r advance ! developm5t ( a coord9at$ po/m>ket surveillance sy/em = all m$ical products1 includ+ drugs1 biological products1 & devices1 l9k$ to electronic heal? records 9 fur!rance ( ! ,food & ,drug ,adm9i/ration's po/m>ket surveillance capabilities3 7,i7 ,= fiscal ye> #bjbj1 #aab1ejj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjba ?r\gh #bjbi1 #ab1ejj1jjj4 7vii7 ,= support = ,food & ,drug ,adm9i/ration activities to keep pace ) ! project$ product developm5t ( reg5]ative !rapies1 includ+ cellul> & somatic cell g5e !rapy products3 7,i7 ,= ea* ( fiscal ye>s #bjbj ?r\gh #bjbb1 #aj1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbi1 #e1jjj1jjj4 7viii7 ,= c>ry+ out section #gad;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a2 relat+ to hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel71 = ea* ( fiscal ye>s #bjbj ?r\gh #bjbi1 #b1ejj1jjj4 7ix7 ,= ! ,food & ,drug ,adm9i/ration to support improvem5ts to ! te*nological infra/ructure = report+ & analysis ( adv]se ev5ts associat$ ) ! use ( drugs & biological products1 = ea* ( fiscal ye>s #bjbj ?r\gh #bjbi1 #ab1ejj1jjj4 4 7#b7 ,con=m+ am5dm5ts ,section #ajjb ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7,a7 9 subsection 7a71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or pursuant to subp>agraph 7,a7 ( subsection 7b77#e7 to c>ry out ! activities describ$ 9 subp>agraphs 7,b7 & 7,c7 ( su* subsection2 & 7,b7 9 subsection 7d7-- 7i7 by ins]t+ or pursuant to subp>agraph 7,a7 ( subsection 7b77#e7 aft] subsection 7b77#c72 & 7ii7 by /rik+ subsection 7b77#d7 & ins]t+ subsections 7b77#d7 & 7b77#e74 7b7 ,annual ,report ,section #ajjb7;c77#b77;,a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$1 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbf & ins]t+ #bjcj4 7c7 ,sunset ,section #ajjb7;e7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by /rik+ ,septemb] #cj1 #bjbe & ins]t+ ,septemb] #cj1 #bjcj4 #gab4 ,/udy on high-risk1 high-rew>d drugs 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conduct a /udy to id5tify-- 7#a7 diseases or conditions t lack a treatm5t approv$ by ! ,food & ,drug ,adm9i/ration & in/ances 9 :i* developm5t ( a treatm5t = su* diseases or conditions c\ld fill an unmet m$ical ne$ = ! treatm5t ( a s]i\s or life-?reat5+ disease or condition or a r>e disease or condition2 & 7#b7 appropriate inc5tives t w\ld lead to ! developm5t1 approval1 & m>ket+ ( su* treatm5ts4 7b7 ,report to ,congress2 recomm5dations ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,congress a report t includes-- 7#a7 f9d+s f ! /udy "u subsection 7a72 & 7#b7 recomm5dations reg>d+ legislation necess>y to create appropriate inc5tives id5tifi$ pursuant to subsection 7a77#b74 ,c ,opioid ,epidemic ,response #gba4 ,opioid ,epidemic ,response ,fund 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all use any funds made available pursuant to subsection 7b7 to c>ry out ! programs & activities describ$ 9 subsection 7c7 to address ! opioid & sub/ance use disord] epidemic4 ,su* funds %all be 9 addition to any funds :i* are o!rwise available to c>ry out su* programs & activities4 7b7 ,opioid ,epidemic ,response ,fund 7#a7 ,e/abli%m5t ( acc\nt ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,opioid ,epidemic ,response ,fund 7ref]r$ to 9 ?is section z ! ,fund71 = purposes ( fund+ ! programs & activities describ$ 9 subsection 7c74 7#b7 ,fund+ ,!re is au?oriz$ to be appropriat$1 & !re is appropriat$1 to ! ,fund1 out ( any monies 9 ! ,treasury n o!rwise appropriat$ #a1ihj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#c7 ,availability ,am\nts made available by p>agraph 7#b7 %all be made available to ! ag5cies specifi$ 9 subsection 7c7 9 accordance ) su* subsection4 ,am\nts made available to an ag5cy pursuant to ! prec$+ s5t5ce = a fiscal ye> %all rema9 available until exp5d$4 7c7 ,programs & activities ,( ! total am\nt 9 ! ,fund = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 su* am\nt %all be allocat$ z foll[s3 7#a7 ,,samhsa ,= ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration to c>ry out programs & activities pursuant to section #gbb1 #a1ejj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#b7 ,,cdc ,= ! ,c5t]s = ,disease ,control & ,prev5tion to c>ry out programs & activities pursuant to section #gbc1 #abj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#c7 ,,fda ,= ! ,food & ,drug ,adm9i/ration to c>ry out programs & activities pursuant to section #gbd1 #aj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#d7 ,,nih ,= ! ,national ,in/itutes ( ,heal? to c>ry out programs & activities pursuant to section #gbe1 #bdj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#e7 ,,hrsa ,= ! ,heal? ,res\rces & ,s]vices ,adm9i/ration to c>ry out programs & activities pursuant to section #gbf1 #ij1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#f7 ,,acf ,= ! ,adm9i/ration = ,*ildr5 & ,families to c>ry out programs & activities pursuant to section #gbg1 #bj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7d7 ,acc\ntability & ov]sight 7#a7 ,"w plan 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,appropriations1 & ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives1 a "w plan includ+ ! propos$ allocation ( funds made available pursuant to subsection 7b7 = ea* ( fiscal ye>s #bjba ?r\gh #bjbe & ! cont5ts describ$ 9 subp>agraph 7,b74 7,b7 ,cont5ts ,! "w plan submitt$ "u subp>agraph 7,a7 %all include-- 7i7 ! am\nt ( money to be obligat$ or exp5d$ out ( ! ,fund 9 ea* fiscal ye> = ea* program & activity describ$ 9 subsection 7c72 & 7ii7 a description & ju/ification ( ea* su* program & activity4 7#b7 ,annual reports ,n lat] ?an ,octob] #a ( ea* ( fiscal ye>s #bjbb ?r\gh #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,appropriations1 & ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives1 a report includ+-- 7,a7 ! am\nt ( money obligat$ or exp5d$ out ( ! ,fund 9 ! prior fiscal ye> = ea* program & activity describ$ 9 subsection 7c72 7,b7 a description ( all programs & activities us+ funds made available pursuant to subsection 7b72 & 7,c7 h[ ! programs & activities are respond+ to ! opioid & sub/ance use disord] epidemic4 7e7 ,limitations ,not)/&+ any au?ority 9 ?is subtitle or any appropriations ,act1 any funds made available pursuant to subsection 7b7 may n be us$ = any purpose o!r ?an ! programs & activities describ$ 9 subsection 7c74 #gbb4 ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration 7a7 ,9 g5]al ,! entirety ( ! funds made available pursuant to section #gba7;c77#a7 %all be = ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use to cont9ue to aw>d ! ,/ate ,opioid ,response ,grants fund$ by ! head+ ,sub/ance ,abuse ,& ,m5tal ,heal? ,s]vices ,adm9i/ration--,sub/ance ,abuse ,treatm5t 9 title ,,ii ( ! ,dep>tm5ts ( ,labor1 ,heal? & ,human ,s]vices1 & ,education1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 ,subject to subsections 7b7 & 7c71 su* grants %all be aw>d$ 9 ! same mann] & subject to ! same conditions z 7 applicable to su* grants = fiscal ye> #bjah4 7b7 ,requirem5t t treatm5t be evid5ce-bas$ ,z a condition on receipt ( a grant pursuant to subsection 7a71 a grantee %all agree t-- 7#a7 treatm5ts1 practices1 or int]v5tions fund$ ?r\gh ! grant w be evid5ce-bas$2 & 7#b7 su* treatm5ts1 practices1 & int]v5tions w include m$ication-assi/$ treatm5t = individuals diagnos$ ) opioid use disord]1 us+ drugs only if ! drugs h be5 approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7c7 ,res]vations ,( ! am\nt made available pursuant to section #gca7;c77#a7 = a fiscal ye>-- 7#a7 n less ?an #ge1jjj1jjj %all be res]v$ to make grants "u subsection 7a7 to ,indian ,tribes or ,tribal organizations2 & 7#b7 n less ?an #ej1jjj1jjj %all be res]v$ to make grants "u subsection 7a7 to political subdivisions ( ,/ates1 su* z c\nties1 cities1 or t[ns4 #gbc4 ,c5t]s = ,disease ,control & ,prev5tion 7a7 ,address+ opioid use disord] ,! entirety ( ! funds made available pursuant to section #gba7;c77#b7 %all be = ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 to cont9ue & exp& programs ( ! ,c5t]s = ,disease ,control & ,prev5tion to address opioid & sub/ance use disord]1 includ+ by-- 7#a7 improv+ ! timel9ess & quality ( data on ! opioid use disord] epidemic1 includ+ improvem5t (-- 7,a7 data on fatal & nonfatal ov]doses2 7,b7 syndromic surveillance2 7,c7 data on long-t]m sequelae 7includ+ neonatal ab/95ce syndrome72 & 7,d7 cause ( dea? report+ relat$ to sub/ance abuse or opioid ov]dose2 7#b7 exp&+ & /r5g!n+ evid5ce-bas$ prev5tion & education /rategies2 7#c7 support+ responsible prescrib+ practices1 includ+ ?r\gh developm5t & dissem9ation ( prescrib] guidel9es2 7#d7 improv+ access to & use ( effective prev5tion1 treatm5t1 & recov]y support1 includ+ ?r\gh grants & ! provision ( te*nical assi/ance to ,/ates & localities2 7#e7 /r5g!n+ p>tn]%ips ) fir/ respond]s1 includ+ to protect _! safety2 7#f7 consid]+ ! ne$s ( vuln]able populations2 7#g7 address+ infecti\s diseases l9k$ to ! opioid crisis2 7#h7 /r5g!n+ prescription drug monitor+ programs2 & 7#i7 provid+ f9ancial & te*nical assi/ance to ,/ate & local heal? dep>tm5t ef=ts to treat & prev5t sub/ance use disord]4 7b7 ,limitation ,( ! funds made available pursuant to section #gba7;c77#b7 = c>ry+ out ?is section1 n m ?an #bj p]c5t may be us$ = intramural purposes4 #gbd4 ,food & ,drug ,adm9i/ration ,! entirety ( ! funds made available pursuant to section #gba7;c77#c7 %all be = ! ,commission] ( ,food & ,drugs1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq47 or ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & o!r applicable law1 to support widespread innovation 9 non-opioid & non-addictive m$ical products = pa9 treatm5t1 access to opioid addiction treatm5ts1 appropriate use ( approv$ opioids1 & ef=ts to r$uce illicit importation ( opioids4 ,su* support may include ! foll[+3 7#a7 ,facilitat+ ! developm5t ( non-opioid & non-addictive pa9 treatm5ts4 7#b7 ,advanc+ guidance docum5ts = sponsors ( non-opioid pa9 products4 7#c7 ,develop+ evid5ce to in=m ! pot5tial = nonprescription ov]dose !rapies4 7#d7 ,exam9+ exp&$ label+ indications = m$ication-assi/$ treatm5t4 7#e7 ,conduct+ public education & outrea*1 includ+ public work%ops or public meet+s1 reg>d+ ! b5efits ( m$ication-assi/$ treatm5t1 includ+ all drugs approv$ by ! ,food & ,drug ,adm9i/ration1 & device treatm5t options approv$ or cle>$ by ! ,food & ,drug ,adm9i/ration4 7#f7 ,explor+ ! expansion & possible m&atory nature ( prescrib] education reg>d+ pa9 managem5t & appropriate opioid prescrib+ ?r\gh au?orities "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74 7#g7 ,exam9+ options to limit ! duration ( opioid prescriptions = acute pa91 includ+ ?r\gh packag+ options4 7#h7 ,increas+ /aff & infra/ructure capacity to inspect & analyze packages at int]national mail facilities & pursue crim9al inve/igations4 #gbe4 ,national ,in/itutes ( ,heal? ,! entirety ( ! funds made available pursuant to section #gba7;c77#d7 %all be = ! ,director ( ! ,national ,in/itutes ( ,heal?1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 to c>ry out activities relat$ to-- 7#a7 accel]at+ rese>* = address+ ! opioid use disord] epidemic1 includ+ develop+ non-opioid m$ications & int]v5tions1 includ+ non-addictive m$ications1 to manage pa91 z well z develop+ m$ications & int]v5tions to treat & to prev5t sub/ance use disord]s2 7#b7 conduct+ & support+ rese>* on :i* treatm5ts 79 t]ms ( pa9 managem5t z well z treat+ & prev5t+ sub/ance use disord]s7 are optimal = :i* pati5ts2 & 7#c7 conduct+ & support+ rese>* on creat+ long]-la/+ or fa/]-act+ antidotes = opioid ov]dose1 p>ticul>ly 9 response to ! preval5ce ( f5tanyl & c>f5tanyl ov]doses4 #gbf4 ,heal? ,res\rces & ,s]vices ,adm9i/ration ,! entirety ( ! funds made available pursuant to section #gba7;c77#e7 %all be = ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 pursuant to applicable au?orities 9 titles ,,iii1 ,,vii1 & ,,viii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq471 to c>ry out activities t increase ! availability & capacity ( ! behavioral heal? work=ce4 ,su* activities %all include provid+ loan repaym5t assi/ance = sub/ance use disord] treatm5t provid]s4 #gbg4 ,adm9i/ration = ,*ildr5 & ,families ,( ! funds made available pursuant to section #gba7;c77#f7 = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 #bj1jjj1jjj = ea* su* fiscal ye> %all be = ! ,secret>y ( ,heal? & ,human ,s]vices to c>ry out title ,i ( ! ,*ild ,abuse ,prev5tion & ,treatm5t ,act 7#db ,u4,s4,c4 #eaja et seq474 ,d ,r$uc+ ,adm9i/rative ,co/s & ,burd5s 9 ,heal? ,c>e #gca4 ,r$uc+ adm9i/rative co/s & burd5s 9 heal? c>e ,title ,,ii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bjb et seq47 is am5d$ by add+ at ! end ! foll[+3 ,e ,r$uc+ adm9i/rative co/s & burd5s 9 heal? c>e #bha4 ,elim9at+ unnecess>y adm9i/rative burd5s & co/s 7a7 ,r$uc+ adm9i/rative burd5s & co/s ,! ,secret>y1 9 consultation ) provid]s ( heal? s]vices1 heal? c>e suppli]s ( s]vices1 heal? c>e pay]s1 heal? pr(essional societies1 heal? v5dors & develop]s1 heal? c>e /&>d developm5t organizations & op]at+ rule entities1 heal? c>e quality organizations1 heal? c>e accr$itation organizations1 public heal? entities1 ,/ates1 pati5ts1 & o!r appropriate entities1 %all1 9 accordance ) subsection 7b7-- 7#a7 e/abli% a goal ( r$uc+ unnecess>y co/s & adm9i/rative burd5s across ! heal? c>e sy/em1 includ+ ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! ,m$icaid program "u title ,,xix ( su* ,act1 & ! private heal? insurance m>ket1 by at lea/ half ov] a p]iod ( #aj ye>s f ! date ( enactm5t ( ?is section2 7#b7 develop /rategies & b5*m>ks = meet+ ! goal e/abli%$ "u p>agraph 7#a72 7#c7 develop recomm5dations = meet+ ! goal e/abli%$ "u p>agraph 7#a72 & 7#d7 take action to r$uce unnecess>y co/s & adm9i/rative burd5s bas$ on recomm5dations id5tifi$ 9 ?is subsection4 7b7 ,/rategies1 recomm5dations1 & actions 7#a7 ,9 g5]al ,to a*ieve ! goal e/abli%$ "u subsection 7a77#a71 ! ,secret>y1 9 consultation ) ! entities describ$ 9 su* subsection1 %all n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 develop /rategies & recomm5dations & take actions to meet su* goal 9 accordance ) ?is subsection4 ,no /rategies1 recomm5dation1 or action %all und]m9e ! quality ( pati5t c>e or pati5t heal? outcomes4 7#b7 ,/rategies ,! /rategies develop$ "u p>agraph 7#a7 %all address unnecess>y co/s & adm9i/rative burd5s4 ,su* /rategies %all include broad public comm5t & %all prioritize-- 7,a7 recomm5dations id5tifi$ z a result ( ef=ts und]tak5 to implem5t section #cjja2 7,b7 recomm5dations & be/ practices id5tifi$ z a result ( ef=ts und]tak5 "u ?is "p2 7,c7 a review ( regulations1 rules1 & requirem5ts ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices t c\ld be modifi$ or elim9at$ to r$uce unnecess>y co/s & adm9i/rative burd5 impos$ on pati5ts1 provid]s1 pay]s1 & o!r /akehold]s across ! heal? c>e sy/em2 & 7,d7 fe$back f /akehold]s 9 rural or fronti] areas on h[ to r$uce unnecess>y co/s & adm9i/rative burd5s on ! heal? c>e sy/em 9 ^? areas4 7#c7 ,recomm5dations ,! recomm5dations develop$ "u p>agraph 7#a7 %all include-- 7,a7 actions t improve ! /&>dization & automation ( adm9i/rative transactions2 7,b7 actions t integrate cl9ical & adm9i/rative functions2 7,c7 actions t improve pati5t c>e & r$uce unnecess>y co/s & adm9i/rative burd5s borne by pati5ts1 _! families1 & o!r c>etak]s2 7,d7 actions t advance ! developm5t & adoption ( op5 application programm+ int]faces & o!r em]g+ te*nologies to increase transp>5cy & int]op]ability1 emp[] pati5ts1 & facilitate bett] integration ( cl9ical & adm9i/rative functions2 7,e7 actions to be tak5 by ! ,secret>y & actions t ne$ to be tak5 by o!r entities2 & 7,f7 o!r areas1 z ! ,secret>y det]m9es appropriate1 to r$uce unnecess>y co/s & adm9i/rative burd5s requir$ ( heal? c>e provid]s4 7#d7 ,consi/5cy ,any improvem5ts 9 electronic processes propos$ by ! ,secret>y "u ?is section %\ld lev]age exi/+ in=mation te*nology def9itions "u ,f$]al ,law4 ,specifically1 any electronic processes %\ld n be con/ru$ to include a facsimile1 a propriet>y pay] portal t does n meet /&>ds specifi$ by ! ,secret>y1 or an electronic =m image4 7#e7 ,actions ,! ,secret>y %all take action to a*ieve ! goal e/abli%$ "u subsection 7a77#a71 &1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 & bi5nially !reaft]1 submit to ,congress & make publically available1 a report describ+ ! actions tak5 by ! ,secret>y pursuant to goals1 /rategies1 & recomm5dations describ$ 9 ?is subsection4 7#f7 ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all n apply to ! developm5t ( ! goal1 /rategies1 recomm5dations1 or actions describ$ 9 ?is section4 7#g7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to au?orize1 or be us$ by1 ! ,f$]al ,gov]nm5t to inhibit or o!rwise re/ra9 ef=ts made to r$uce wa/e1 fraud1 & abuse across ! heal? c>e sy/em4 #bhb4 ,grants to ,/ates to develop & implem5t recomm5dations to accel]ate ,/ate innovation to r$uce heal? c>e adm9i/rative co/s 7a7 ,grants 7#a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all aw>d grants to at lea/ #ae ,/ates1 & "o coord9at+ entity designat$ z provid$ = "u subsection 7e71 to enable su* ,/ates to e/abli% & adm9i/] private-public multi-/akehold] commissions = ! purpose ( r$uc+ heal? c>e adm9i/rative co/s & burd5 )9 & across ,/ates4 ,n less ?an #c ( su* grants %all be aw>d$ to ,/ates t are prim>ily rural1 fronti]1 or a comb9ation !re(1 9 nature4 7#b7 ,entities ,= purposes ( ?is section1 ! t]m ,/ate means a ,/ate1 a ,/ate designat$ entity1 or a multi-,/ate collaborative 7z def9$ by ! ,secret>y74 7#c7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all give priority to applications submitt$ by ,/ates t propose to c>ry out a pilot program or support ! adoption ( electronic heal? c>e transactions & op]at+ rules4 7b7 ,application 7#a7 ,9 g5]al ,to be eligible to receive a grant "u subsection 7a7 a ,/ate %all submit to ! ,secret>y an application 9 su* a mann] & conta9+ su* in=mation z ! ,secret>y may reasonably require1 includ+ ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,requir$ in=mation ,9 addition to any additional in=mation requir$ by ! ,secret>y "u ?is subsection1 an application %all include a description (-- 7,a7 ! size & composition ( ! commission to be e/abli%$ "u ! grant1 includ+ ! /akehold]s repres5t$ & ! degree to :i* ! commission reflects important geographic & population *>act]i/ics ( ! ,/ate2 7,b7 ! relation%ip ( ! commission to ! ,/ate (ficial responsible = coord9at+ & implem5t+ ! recomm5dations result+ f ! commission1 & ! role & responsibilities ( ! ,/ate ) respect to ! commission1 includ+ any p>ticipation1 review1 ov]sight1 implem5tation or o!r relat$ functions2 7,c7 ! hi/ory & exp]i5ce ( ! ,/ate 9 address+ heal? c>e adm9i/rative co/s1 & any exp]i5ce simil> to ! purpose ( ! commission to improve heal? c>e adm9i/rative processes & ! ex*ange ( heal? c>e adm9i/rative data2 7,d7 ! res\rces & exp]tise t w be made available to ! commission by commission memb]s or o!r possible s\rces1 & h[ ,f$]al funds w be us$ to lev]age & complem5t ^! res\rces2 7,e7 ! gov]nance /ructure & proc$ures t ! commission w foll[ to make1 implem5t1 & pilot recomm5dations2 7,f7 ! propos$ objectives relat+ to ! simplification ( adm9i/rative transactions & op]at+ rules1 increas$ /&>dization1 & ! effici5cy & effectiv5ess ( ! transmission ( heal? in=mation2 7,g7 pot5tial co/ sav+s & o!r improvem5ts 9 meet+ ! objectives describ$ 9 subp>agraph 7,f72 & 7,h7 ! me?od or me?ods by :i* ! recomm5dations describ$ 9 subsection 7c7 w be review$1 te/$1 adopt$1 implem5t$1 & updat$ z ne$$4 7c7 ,multi-,/akehold] commission 7#a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date on :i* a grant is aw>d$ to a ,/ate "u ?is section1 ! ,/ate (ficial describ$ 9 subsection 7b77#b77;,b71 ! ,/ate insurance commission]1 or o!r appropriate ,/ate (ficial %all conv5e a multi-/akehold] commission1 9 accordance ) ?is subsection4 7#b7 ,memb]%ip ,! commission conv5$ "u p>agraph 7#a7 %all include repres5tatives f heal? plans1 heal? c>e provid]s1 heal? v5dors1 relevant ,/ate ag5cies1 heal? c>e /&>d developm5t organizations1 & op]at+ rule entities1 relevant pr(essional & trade associations1 pati5ts1 & o!r entities det]m9$ appropriate by ! ,/ate4 7#c7 ,recomm5dations ,n lat] ?an "o ye> aft] ! date on :i* a grant is aw>d$ to a ,/ate "u ?is section1 ! commission %all make recomm5dations & plans1 consi/5t ) ! application submitt$ by ! ,/ate "u subsection 7b71 & int5d$ to meet ! objectives def9$ 9 ! application4 ,su* recomm5dations %all comply )1 & build ^u1 all relevant ,f$]al requirem5ts & regulations1 & may include-- 7,a7 common1 uni=m specifications1 be/ practices1 & conv5tions1 = ! effici5t1 effective ex*ange ( adm9i/rative transactions adopt$ pursuant to ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia72 7,b7 ! developm5t ( /reaml9$ bus9ess processes = ! ex*ange & use ( heal? c>e adm9i/rative data2 & 7,c7 specifications1 inc5tives1 requirem5ts1 tools1 me*anisms1 & res\rces to improve-- 7i7 ! access1 ex*ange1 & use ( heal? c>e adm9i/rative in=mation ?r\gh electronic means2 7ii7 ! implem5tation ( utilization managem5t protocols2 & 7iii7 compliance ) ,f$]al & ,/ate laws4 7d7 ,use ( funds = implem5tation ,a ,/ate may use am\nts receiv$ "u a grant "u ?is section = "o or m ( ! foll[+3 7#a7 ,! developm5t1 implem5tation1 & be/ use ( %>$ data infra/ructure t supports ! electronic transmission ( adm9i/rative data4 7#b7 ,! developm5t & provision ( tra9+ & educational mat]ials1 =ums1 & activities z well z te*nical assi/ance to effectively implem5t1 use1 & b5efit f electronic heal? c>e transactions & op]at+ rules4 7#c7 ,to accel]ate ! e>ly adoption & implem5tation ( adm9i/rative transactions & op]at+ rules designat$ by ! ,secret>y & t h be5 adopt$ pursuant to ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia71 includ+ transactions & op]at+ rules describ$ 9 section #aagc7;a77#b7 ( ! ,social ,security ,act4 7#d7 ,to accel]ate ! e>ly adoption & implem5tation ( additional or updat$ adm9i/rative transactions1 op]at+ rules1 & relat$ data ex*ange /&>ds t are be+ consid]$ = adoption "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif or are adopt$ pursuant to su* ,act1 or z designat$ by ! ,secret>y1 includ+ ! electronic claim atta*m5t4 7#e7 ,to conduct pilot projects to te/ approa*es to implem5t & use ! electronic heal? c>e transactions & op]at+ rules 9 practice "u a v>iety ( diff]5t sett+s4 ,) respect to ! electronic atta*m5t transaction1 priority %all be giv5 to pilot projects t te/ & evaluate me?ods & me*anisms to mo/ effectively incorporate pati5t heal? data f electronic heal? records & o!r electronic s\rces ) ! electronic atta*m5t transaction4 7#f7 ,to assess b>ri]s to ! adoption1 implem5tation1 & effective use ( electronic heal? c>e transactions & op]at+ rules1 z well z to explore1 id5tify1 & plan options1 approa*es1 & res\rces to address b>ri]s & make improvem5ts4 7#g7 ,! facilitation ( public & private initiatives to r$uce adm9i/rative co/s & accel]ate ! adoption1 implem5tation1 & effective use ( electronic heal? c>e transactions & op]at+ rules = ,/ate programs4 7#h7 ,develop+1 te/+1 implem5t+1 & assess+ additional data ex*ange specifications1 op]at+ rules1 inc5tives1 requirem5ts1 tools1 me*anisms1 & res\rces to accel]ate ! adoption & effective use ( ! transactions & op]at+ rules4 7#i7 ,ongo+ ne$s assessm5ts & plann+ relat$ to ! developm5t & implem5tation ( adm9i/rative simplification initiatives4 7e7 ,coord9at+ entity 7#a7 ,functions ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all designate a coord9at+ entity "u ?is subsection = ! purpose (-- 7,a7 provid+ te*nical assi/ance to ,/ates relat+ to ! simplification ( adm9i/rative transactions & op]at+ rules1 increas$ /&>dization1 & ! effici5cy & effectiv5ess ( ! transmission ( heal? c>e in=mation2 7,b7 evaluat+ pilot projects & o!r ef=ts conduct$ "u ?is section = impact & be/ practices to in=m broad] national use2 7,c7 us+ consi/5t evaluation me?odologies to comp>e return on inve/m5t across ef=ts conduct$ "u ?is section2 7,d7 compil+1 syn!siz+1 dissem9at+1 & adopt+ lessons le>n$ to promote ! adoption ( electronic heal? c>e transactions & op]at+ rules across ! heal? c>e sy/em2 & 7,e7 mak+ recomm5dations to ! ,secret>y & ! ,national ,committee on ,vital & ,heal? ,/ati/ics reg>d+ ! national adoption ( ef=ts conduct$ "u ?is section4 7#b7 ,eligibility ,! entity designat$ "u p>agraph 7#a7 %all be a qualifi$ nonpr(it entity t-- 7,a7 focuses its mission on adm9i/rative simplification2 7,b7 has demon/rat$ exp]i5ce us+ a multi-/akehold] & cons5sus-bas$ process = ! developm5t ( common1 uni=m specifications1 op]at+ rules1 be/ practices1 & conv5tions1 = ! effici5t1 effective ex*ange ( adm9i/rative transactions t includes repres5tation by or p>ticipation f heal? plans1 heal? c>e provid]s1 v5dors1 ,/ates1 relevant ,f$]al ag5cies1 & o!r heal? c>e /&>d developm5t organizations2 7,c7 has demon/rat$ exp]i5ce provid+ te*nical assi/ance to heal? plans1 heal? c>e provid]s1 v5dors1 & ,/ates relat+ to ! simplification ( adm9i/rative transactions & op]at+ rules1 increas$ /&>dization1 & ! effici5cy & effectiv5ess ( ! transmission ( heal? c>e in=mation2 7,d7 has demon/rat$ exp]i5ce evaluat+ & measur+ ! adoption & return on inve/m5t ( adm9i/rative transactions & op]at+ rules2 7,e7 has demon/rat$ exp]i5ce ga!r+1 syn!siz+1 & adopt+ common1 uni=m specifications1 op]at+ rules1 be/ practices1 & conv5tions = national use bas$ on lessons le>n$ to promote ! adoption ( electronic heal? c>e transactions & op]at+ rules across ! heal? c>e sy/em2 7,f7 has a public set ( guid+ pr9ciples t ensure processes are op5 & transp>5t1 & supports nondiscrim9ation & conflict ( int]e/ policies t demon/rate a commitm5t to op51 fair1 & nondiscrim9atory practices2 7,g7 builds on ! transaction /&>ds issu$ "u ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif2 & 7,h7 all[s = public review & updates ( common1 uni=m specifications1 op]at+ rules1 be/ practices1 & conv5tions to support adm9i/rative simplification4 7f7 ,p]iod & am\nt ,a grant aw>d$ to a ,/ate "u ?is section %all be = a p]iod ( #e ye>s & %all n exce$ #ej1jjj1jjj = su* #e-ye> p]iod4 ,a grant aw>d$ to ! coord9at+ entity designat$ by ! ,secret>y "u subsection 7e7 %all be = a p]iod ( #e ye>s & %all n exce$ #ae1jjj1jjj = su* #e-ye> p]iod4 7g7 ,reports 7#a7 ,/ates ,n lat] ?an #a ye> aft] receiv+ a grant "u ?is section1 & bi5nially !reaft]1 a ,/ate %all submit to ! ,secret>y a report on ! outcomes exp]i5c$ by ! ,/ate "u ! grant4 7#b7 ,coord9at+ entity ,n lat] ?an #a ye> aft] receiv+ a grant "u ?is section1 & at lea/ bi5nially !reaft]1 ! coord9at+ entity %all submit to ! ,secret>y & ! ,national ,committee on ,vital & ,heal? ,/ati/ics a report ( evaluations conduct$ "u ! grant "u ?is section & recomm5dations reg>d+ ! national adoption ( ef=ts conduct$ "u ?is section4 7#c7 ,secret>y ,n lat] ?an #f mon?s aft] ! date on :i* ! ,/ates & coord9at+ entity submit ! report requir$ "u p>agraphs 7#a7 & 7#b71 ! ,secret>y1 9 consultation ) ,national ,committee on ,vital & ,heal? ,/ati/ics1 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on ! outcomes a*iev$ "u ! grants "u ?is section4 7#d7 ,,gao ,n lat] ?an #f mon?s aft] ! date on :i* ! ,secret>y submits ! f9al report "u p>agraph 7#c71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy1 & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on ! outcomes ( ! activities c>ri$ out "u ?is section :i* %all conta9 a li/ ( be/ practices & recomm5dations to ,/ates conc]n+ adm9i/rative simplification4 7h7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 #bej1jjj1jjj = ! #e-;fiscal-ye> p]iod beg9n+ ) fiscal ye> #bjbj4 4 ,,viii ,miscellane\s #hja4 ,gu>ante$ issue ( c]ta9 ,m$igap policies 7a7 ,gu>ante$ issue ( ,m$igap policies to all ,m$igap-,eligible ,m$ic>e b5efici>ies 7#a7 ,9 g5]al ,section #ahhb7s7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77 is am5d$-- 7,a7 9 p>agraph 7#b77;,a71 by /rik+ #fe ye>s ( age or old] & is enroll$ = b5efits "u "p ,b & ins]t+ entitl$ to1 or enroll$ =1 b5efits "u "p ,a & enroll$ = b5efits "u "p ,b2 7,b7 9 p>agraph 7#b77;,d71 by /rik+ :o is #fe ye>s ( age or old] z ( ! date ( issuance &2 7,c7 9 p>agraph 7#c77;,b77ii71 by /rik+ is #fe ye>s ( age or old] &2 & 7,d7 9 p>agraph 7#c77;,b77vi71 by /rik+ at age #fe4 7#b7 ,additional enrollm5t p]iod = c]ta9 individuals 7,a7 ,"o-"t enrollm5t p]iod 7i7 ,9 g5]al ,9 ! case ( a specifi$ individual1 ! ,secret>y %all e/abli% a "o-"t enrollm5t p]iod describ$ 9 clause 7iii7 dur+ :i* su* an individual may enroll 9 any m$ic>e supplem5tal policy ( ! individual's *oos+4 7ii7 ,application ,! provisions (-- 7,i7 p>agraph 7#b7 ( section #ahhb7s7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77 %all apply ) respect to a specifi$ individual :o is describ$ 9 subclause 7,i7 ( subp>agraph 7,b77iii7 z if ref]5ces 9 su* p>agraph 7#b7 to ! #f mon? p]iod describ$ 9 subp>agraph 7,a7 ( su* p>agraph 7 ref]5ces to ! "o-"t enrollm5t p]iod e/abli%$ "u clause 7i72 & 7,,ii7 p>agraph 7#c7 ( su* section %all apply ) respect to a specifi$ individual :o is describ$ 9 subclause 7,,ii7 ( subp>agraph 7,b77iii7 z if ref]5ces 9 su* p>agraph 7#c7 to ! p]iod specifi$ 9 subp>agraph 7,e7 ( su* p>agraph 7 ref]5ces to ! "o-"t enrollm5t p]iod e/abli%$ "u clause 7i74 7iii7 ,p]iod ,! enrollm5t p]iod e/abli%$ "u clause 7i7 %all be ! #f-mon? p]iod beg9n+ on ,janu>y #a1 #bjbd4 7,b7 ,specifi$ individual ,= purposes ( ?is p>agraph1 ! t]m specifi$ individual means an individual :o-- 7i7 is entitl$ to hospital insurance b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 pursuant to section #bbf7;b7 or section #bbf;,a ( su* ,act 7#db ,u4,s4,c4 #dbf7;b72 #dbf-a72 7ii7 is enroll$ = b5efits "u "p ,b ( su* ,act 7#db ,u4,s4,c4 #acie;j et seq472 & 7iii7 7,i7 w\ld n1 b = ! am5dm5ts made by subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 & ! provisions ( ?is p>agraph 7if su* provisions appli$ to su* individual71 be eligible = ! gu>ante$ issue ( a m$ic>e supplem5tal policy "u p>agraph 7#b7 ( section #ahhb7s7 ( su* ,act 7#db ,u4,s4,c4 #aciess7s772 or 7,,ii7 w\ld n1 b = ! am5dm5ts made by subp>agraphs 7,c7 & 7,d7 ( p>agraph 7#a7 & ! provisions ( ?is p>agraph 7if su* provisions appli$ to su* individual71 be eligible = ! gu>ante$ issue ( a m$ic>e supplem5tal policy "u p>agraph 7#c7 ( su* section4 7,c7 ,outrea* plan 7i7 ,9 g5]al ,! ,secret>y %all develop an outrea* plan to notify specifi$ individuals ( ! "o-"t enrollm5t p]iod e/abli%$ "u subp>agraph 7,a74 7ii7 ,consultation ,9 implem5t+ ! outrea* plan develop$ "u clause 7i71 ! ,secret>y %all consult ) consum] advocates1 brok]s1 insur]s1 ! ,national ,association ( ,insurance ,commission]s1 & ,/ate ,heal? ,insurance ,assi/ance ,programs4 7#c7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply to m$ic>e supplem5tal policies effective on or aft] ,janu>y #a1 #bjbd4 7b7 ,gu>ante$ issue ( ,m$igap policies = ,m$ic>e ,advantage enrollees 7#a7 ,9 g5]al ,section #ahhb7s77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77#c771 z am5d$ by subsection 7a71 is fur!r am5d$-- 7,a7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+ new clause3 7vii7 ,! individual-- 7,i7 0 enroll$ 9 a ,m$ic>e ,advantage plan "u "p ,c = n less ?an #ab mon?s2 7,,ii7 subsequ5tly dis5roll$ f su* plan2 7,,iii7 elects to receive b5efits "u ?is title ?r\gh ! orig9al ,m$ic>e fee-=-s]vice program "u p>ts ,a & ,b2 & 7,,iv7 has n previ\sly elect$ to receive b5efits "u ?is title ?r\gh ! orig9al ,m$ic>e fee-=-s]vice program pursuant to dis5rollm5t f a ,m$ic>e ,advantage plan "u "p ,c4 2 7,b7 by /rik+ subp>agraph 7,c77iii7 & ins]t+ ! foll[+3 7iii7 ,subject to subsection 7v77#a71 = purposes ( an individual describ$ 9 clause 7vi7 or 7vii7 ( subp>agraph 7,b71 a m$ic>e supplem5tal policy describ$ 9 ?is subp>agraph %all include any m$ic>e supplem5tal policy4 2 & 7,c7 9 subp>agraph 7,e7-- 7i7 9 clause 7iv71 by /rik+ & at ! end2 7ii7 9 clause 7v71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new clause-- 7vi7 9 ! case ( an individual describ$ 9 subp>agraph 7,b77vii71 ! annual1 coord9at$ election p]iod 7z def9$ 9 section #ahea7;e77#c77;,b77 or a cont9u\s op5 enrollm5t p]iod 7z def9$ 9 section #ahea7;e77#b77 dur+ :i* ! individual dis5rolls f a ,m$ic>e ,advantage plan "u "p ,c4 4 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply to m$ic>e supplem5tal policies effective on or aft] ,janu>y #a1 #bjbd4 #hjb4 ,report+ requirem5ts = ,,pdp sponsors reg>d+ po9t-(-sale rejections "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;g77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,report+ requirem5ts reg>d+ po9t-,(-,sale rejections 7,a7 ,9 g5]al ,) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbj1 a ,,pdp sponsor (f]+ a prescription drug plan %all submit to ! ,secret>y1 9 a =m & mann] specifi$ by ! ,secret>y1 in=mation on po9t-(-sale rejections made dur+ a p]iod ( "t occurr+ 9 su* plan ye> 7z specifi$ by ! ,secret>y71 includ+ ea* ( ! foll[+3 7i7 ,! reason = ea* po9t-(-sale rejection4 7ii7 ,id5tify+ in=mation = ea* drug ) respect to :i* a po9t-(-sale rejection 0 made4 7iii7 ,) respect to applicable types ( po9t-(-sale rejections 7z specifi$ by ! ,secret>y71 ea* ( ! foll[+3 7,i7 ,:e!r su* a rejection 0 consi/5t ) ! =mul>y ( ! plan 7z approv$ by ! ,secret>y74 7,,ii7 ,:e!r a cov]age det]m9ation or appeal ( a cov]age det]m9ation 0 reque/$ = ! drug ) respect to :i* su* a rejection 0 made4 7,,iii7 ,! outcome ( any su* cov]age det]m9ation or appeal ( a cov]age det]m9ation4 7,,iv7 ,! l5g? ( "t betwe5 :5 su* a rejection 0 made & :5 ! drug ) respect to :i* su* rejection 0 made is disp5s$1 z applicable4 7,b7 ,public availability ( in=mation ,! ,secret>y %all make publicly available on ! public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices in=mation submitt$ "u subp>agraph 7,a74 7,c7 ,use ( in=mation ,! ,secret>y may use in=mation submitt$ "u subp>agraph 7,a71 z det]m9$ appropriate1 9 develop+ measures = ! #e-/> rat+ sy/em "u section #ahec7o77#d74 7,d7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is p>agraph ?r\gh program in/ruction or o!rwise4 7,e7 ,fund+ ,! are au?oriz$ to be appropriat$ to ! ,secret>y f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda su* sums z may be necess>y to implem5t ?is p>agraph4 4 #hjc4 ,provid+ access to annual ,m$ic>e notifications 9 multiple languages 7a7 ,9 g5]al ,section #ahjd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7e7 ,! notice provid$ "u subsection 7a7 %all be translat$ into languages 9 addition to ,engli% & ,spani%4 ,9 c>ry+ out ! previ\s s5t5ce1 ! ,secret>y %all prioritize translation ( ! notice into languages 9 :i* docum5ts provid$ by ! ,commission] ( ,social ,security are translat$ & language t are ! mo/ frequ5tly reque/$ = translation = purposes ( apply+ = old-age insurance b5efits "u title ,,ii4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply to notices di/ribut$ prior to ea* ,m$ic>e op5 enrollm5t p]iod beg9n+ aft] ,janu>y #a1 #bjbj4 #hjd4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = c]ta9 biosimil> biological products ,section #ahdg;,a7b77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#h77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & mov+ ! m>g9 ( ea* su* r$esignat$ clause #b ems to ! "r2 7#b7 by /rik+ product4--,! am\nt & ins]t+ ! foll[+3 8product4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! am\nt 2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,tempor>y paym5t increase 7i7 ,9 g5]al ,9 ! case ( a qualify+ biosimil> biological product t is furni%$ dur+ ! applicable #e-ye> p]iod = su* product1 ! am\nt specifi$ 9 ?is p>agraph = su* product ) respect to su* p]iod is ! sum det]m9$ "u subp>agraph 7,a71 except t clause 7ii7 ( su* subp>agraph %all be appli$ by sub/itut+ #h p]c5t = #f p]c5t4 7ii7 ,applicable #e-ye> p]iod ,= purposes ( clause 7i71 ! applicable #e-ye> p]iod = a biosimil> biological product is-- 7,i7 9 ! case ( su* a product = :i* paym5t 0 made "u ?is p>agraph z ( ,decemb] #ca1 #bjai1 ! #e-ye> p]iod beg9n+ on ,janu>y #a1 #bjbj2 & 7,,ii7 9 ! case ( su* a product = :i* paym5t is fir/ made "u ?is p>agraph dur+ a cal5d> qu>t] dur+ ! p]iod beg9n+ ,janu>y #a1 #bjbj1 & end+ ,decemb] #ca1 #bjbd1 ! #e-ye> p]iod beg9n+ on ! fir/ day ( su* cal5d> qu>t] dur+ :i* su* paym5t is fir/ made4 7iii7 ,qualify+ biosimil> biological product def9$ ,= purposes ( ?is subp>agraph1 ! t]m qualify+ biosimil> biological product means a biosimil> biological product describ$ 9 p>agraph 7#a77;,c7 ) respect to :i*-- 7,i7 9 ! case ( a product describ$ 9 clause 7ii77,i71 ! av]age sales price is n m ?an ! av]age sales price = ! ref]5ce biological product2 & 7,,ii7 9 ! case ( a product describ$ 9 clause 7ii77,,ii71 ! :olesale acquisition co/ is n m ?an ! :olesale acquisition co/ = ! ref]5ce biological product4 4 #hje4 ,waiv+ m$ic>e co9surance = colorectal canc] scre5+ te/s ,section #ahcc7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is am5d$-- 7#a7 9 ! second s5t5ce1 by /rik+ section #ahcd7j7 & ins]t+ section #ahcd7o72 7#b7 by mov+ su* second s5t5ce #b ems to ! left2 & 7#c7 by ins]t+ ! foll[+ ?ird s5t5ce foll[+ su* second s5t5ce3 ,= s]vices furni%$ on or aft] ,janu>y #a1 #bjba1 p>agraph 7#a77,y7 %all apply ) respect to a colorectal canc] scre5+ te/ reg>dless ( ! code t is bill$ = ! e/abli%m5t ( a diagnosis z a result ( ! te/1 or = ! removal ( tissue or o!r matt] or o!r proc$ure t is furni%$ 9 connection )1 z a result (1 & 9 ! same cl9ical enc\nt] z ! scre5+ te/44 #hjf4 ,m$ic>e cov]age ( c]ta9 lymph$ema compression treatm5t items 7a7 ,cov]age 7#a7 ,9 g5]al ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex71 z am5d$ by section #fja & section #fjc1 is fur!r am5d$-- 7,a7 9 subsection 7s77#b7-- 7i7 9 subp>agraph 7,,ii71 by /rik+ & aft] ! semicolon at ! end2 7ii7 9 subp>agraph 7,,jj71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,,kk7 lymph$ema compression treatm5t items 7z def9$ 9 subsection 7mmm772 2 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7mmm7 ,lymph$ema compression treatm5t items ,! t]m lymph$ema compression treatm5t items means compression g>m5ts1 devices1 b&ag+ sy/ems1 compon5ts1 & supplies1 includ+ multilay] compression b&ag+ sy/ems1 /&>d fit gradi5t compression g>m5ts1 & o!r compression g>m5ts1 devices1 b&ag+ sy/ems1 compon5ts1 or supplies 7z det]m9$ by ! ,secret>y71 t are-- 7#a7 furni%$ on or aft] ,janu>y #a1 #bjbb1 to an individual ) a diagnosis ( lymph$ema = ! treatm5t ( su* condition2 7#b7 prim>ily & cu/om>ily us$ 9 ! m$ical treatm5t ( lymph$ema1 z det]m9$ by ! ,secret>y2 & 7#c7 prescrib$ by a physician 7or a physician assi/ant1 nurse practition]1 or a cl9ical nurse speciali/ 7z ^? t]ms are def9$ 9 section #ahfa7;aa77#e77 to ! ext5t au?oriz$ "u ,/ate law74 4 7#b7 ,paym5t 7,a7 ,9 g5]al ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a771 z am5d$ by section #fja7;c77#a71 is fur!r am5d$-- 7i7 by /rik+ & be=e 7,,dd72 & 7ii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,ee7 ) respect to lymph$ema compression treatm5t items 7z def9$ 9 section #ahfa7mmm771 ! am\nt paid %all be equal to #hj p]c5t ( ! less] ( ! actual *>ge or ! am\nt det]m9$ "u ! paym5t basis det]m9$ "u section #ahcd7z74 7,b7 ,paym5t basis & limitations ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 z am5d$ by sections #fja7;c77#b7 & #fjc7;c71 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7z7 ,paym5t = lymph$ema compression treatm5t items 7#a7 ,9 g5]al ,! ,secret>y %all det]m9e an appropriate paym5t basis = lymph$ema compression treatm5t items 7z def9$ 9 section #ahfa7mmm774 ,9 mak+ su* a det]m9ation1 ! ,secret>y may take into acc\nt paym5t rates = su* items "u ,/ate plans 7or waiv]s ( su* plans7 "u title ,,xix1 ! ,vet]ans ,heal? ,adm9i/ration1 & gr\p heal? plans & heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 & su* o!r in=mation z ! ,secret>y det]m9es appropriate4 7#b7 ,frequ5cy limitation ,no paym5t may be made "u ?is "p = lymph$ema compression treatm5t items furni%$ o!r ?an at su* frequ5cy z ! ,secret>y may e/abli%4 7#c7 ,application ( competitive acquisition ,9 ! case ( lymph$ema compression treatm5t items t are includ$ 9 a competitive acquisition program 9 a competitive acquisition area "u section #ahdg7;a7-- 7,a7 ! paym5t basis "u ?is subsection = su* items furni%$ 9 su* area %all be ! paym5t basis det]m9$ "u su* competitive acquisition program2 & 7,b7 ! ,secret>y may use in=mation on ! paym5t det]m9$ "u su* competitive acquisition programs to adju/ ! paym5t am\nt o!rwise det]m9$ "u ?is subsection = an area t is n a competitive acquisition area "u section #ahdg1 & 9 ! case ( su* adju/m5t1 p>agraphs 7#h7 & 7#i7 ( section #ahdb7;b7 %all n be appli$4 4 7#c7 ,con=m+ am5dm5ts 7,a7 ,exclusions ,section #ahfb7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a771 z am5d$ by section #fja7;f7 & section #fjc7;g71 is fur!r am5d$-- 7i7 9 subp>agraph 7,q71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,r71 by /rik+ ! semicolon & ins]t+ 1 &2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,s7 9 ! case ( lymph$ema compression treatm5t items 7z def9$ 9 section #ahfa7mmm771 :i* are furni%$ m frequ5tly ?an is e/abli%$ pursuant to section #ahcd7z77#b72 4 7,b7 ,application ( competitive acquisition 7i7 ,9 g5]al ,section #ahdg7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b771 z am5d$ by sections #fja7;e77#b77;,b77ii71 #fjb7;b77#c77;,b77i71 & #fjc7;f77#b77;,b71 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,lymph$ema compression treatm5t items ,lymph$ema compression treatm5t items 7z def9$ 9 section #ahfa7mmm77 = :i* paym5t w\ld o!rwise be made "u section #ahcd7z74 4 7b7 ,inclusion 9 requirem5ts = suppli]s ( m$ical equipm5t & supplies ,section #ahcd7;j77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7j77#e77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,e7 & 7,f7 z subp>agraphs 7,f7 & 7,g71 respectively2 & 7#b7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+ new subp>agraph3 7,e7 lymph$ema compression treatm5t items 7z def9$ 9 section #ahfa7mmm772 4 7c7 ,/udy & report on implem5tation 7#a7 ,/udy ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all conduct a /udy on ! implem5tation ( ,m$ic>e cov]age ( c]ta9 lymph$ema compression treatm5t items "u ! am5dm5ts made by ?is ,act4 ,su* /udy %all include an evaluation ( ! foll[+3 7,a7 ,m$ic>e b5efici>y utilization ( items & s]vices "u p>ts ,a & ,b ( title ,,xviii ( ! ,social ,security ,act z a result ( ! implem5tation ( su* am5dm5ts4 7,b7 ,:e!r ! ,secret>y has det]m9$1 pursuant to section #ahfa7mmm7 ( ! ,social ,security ,act1 z add$ by subsection 7a77#a71 t lymph$ema compression treatm5t items o!r ?an compression b&ag+ sy/ems & /&>d fit gradi5t compression g>m5ts are cov]$ "u su* section4 7#b7 ,report ,n lat] ?an ,janu>y #a1 #bjbd1 ! ,secret>y %all submit to ,congress & make available to ! public a report on ! /udy conduct$ "u p>agraph 7#a74 #hjg4 ,physician fee update ,section #ahdh7;d77#ai7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;d77#ai77 is am5d$ to read z foll[s3 7#ai7 ,update = #bjbj ?r\gh #bjbe ,! update to ! s+le conv]sion factor e/abli%$ 9 p>agraph 7#a77;,c7-- 7,a7 = ea* ( #bjbj ?r\gh #bjbb %all be #j4e p]c5t2 & 7,b7 = ea* ( #bjbc ?r\gh #bjbe %all be #j4j p]c5t4 4 #hjh4 ,additional community heal? c5t] fund+ ,section #ajejc ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7 is am5d$ by /rik+ subsection 7c7 & ins]t+ ! foll[+3 7c7 ,additional enhanc$ fund+2 capital projects ,!re is au?oriz$ to be appropriat$1 & !re is appropriat$1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to ! ,,*c ,fund-- 7#a7 to be transf]r$ to ! ,secret>y ( ,heal? & ,human ,s]vices to provide additional enhanc$ fund+ = ! community heal? c5t] program "u section #ccj ( ! ,public ,heal? ,s]vice ,act1 #a1jjj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe2 & 7#b7 to be transf]r$ to ! ,secret>y ( ,heal? & ,human ,s]vices = capital projects ( ! community heal? c5t] program "u section #ccj ( ! ,public ,heal? ,s]vice ,act1 #e1jjj1jjj1jjj = ! p]iod ( fiscal ye>s #bjba ?r\gh #bjbe4 4 #hji4 ,grants to improve trauma support s]vices & m5tal heal? c>e = *ildr5 & y\? 9 educational sett+s 7a7 ,grants1 contracts1 & coop]ative agreem5ts au?oriz$ ,! ,secret>y1 9 coord9ation ) ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 is au?oriz$ to aw>d grants to1 or ent] into contracts or coop]ative agreem5ts )1 ,/ate educational ag5cies1 local educational ag5cies1 ,indian ,tribes 7z def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act7 or _! tribal educational ag5cies1 a s*ool op]at$ by ! ,bureau ( ,indian ,education1 a ,regional ,corporation1 or a ,native ,hawaiian educational organization1 = ! purpose ( increas+ /ud5t access to evid5ce-bas$ trauma support s]vices & m5tal heal? c>e by develop+ innovative initiatives1 activities1 or programs to l9k local s*ool sy/ems ) local trauma-in=m$ support & m5tal heal? sy/ems1 includ+ ^? "u ! ,indian ,heal? ,s]vice4 7b7 ,duration ,) respect to a grant1 contract1 or coop]ative agreem5t aw>d$ or ent]$ into "u ?is section1 ! p]iod dur+ :i* paym5ts "u su* grant1 contract1 or agreem5t are made to ! recipi5t may n exce$ #d ye>s4 7c7 ,use ( funds ,an entity t receives a grant1 contract1 or coop]ative agreem5t "u ?is section %all use am\nts made available ?r\gh su* grant1 contract1 or coop]ative agreem5t = evid5ce-bas$ activities1 :i* %all include any ( ! foll[+3 7#a7 ,collaborative ef=ts betwe5 s*ool-bas$ s]vice sy/ems & trauma-in=m$ support & m5tal heal? s]vice sy/ems to provide1 develop1 or improve prev5tion1 scre5+1 ref]ral1 & treatm5t & support s]vices to /ud5ts1 su* z provid+ trauma scre5+s to id5tify /ud5ts 9 ne$ ( specializ$ support4 7#b7 ,to implem5t s*oolwide positive behavioral int]v5tions & supports1 or o!r trauma-in=m$ models ( support4 7#c7 ,to provide pr(essional developm5t to tea*]s1 tea*] assi/ants1 s*ool lead]s1 specializ$ in/ructional support p]sonnel1 & m5tal heal? pr(essionals t-- 7,a7 fo/]s safe & /able le>n+ environm5ts t prev5t & mitigate ! effects ( trauma1 includ+ ?r\gh social & emotional le>n+2 7,b7 improves s*ool capacity to id5tify1 ref]1 & provide s]vices to /ud5ts 9 ne$ ( trauma support or behavioral heal? s]vices2 or 7,c7 reflects ! be/ practices = trauma-in=m$ id5tification1 ref]ral1 & support develop$ by ! ,int]ag5cy ,task ,=ce on ,trauma-,in=m$ ,c>e4 7#d7 ,s]vices at a full-s]vice community s*ool t focuses on trauma-in=m$ supports1 :i* may include a full-"t site coord9ator1 or o!r activities consi/5t ) section #dfbe ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #gbge74 7#e7 ,engag+ families & communities 9 ef=ts to increase aw>5ess ( *ild & y\? trauma1 :i* may include %>+ be/ practices ) law en=cem5t reg>d+ trauma-in=m$ c>e & work+ ) m5tal heal? pr(essionals to provide int]v5tions1 z well z long] t]m coord9at$ c>e )9 ! community = *ildr5 & y\? :o h exp]i5c$ trauma & _! families4 7#f7 ,to provide te*nical assi/ance to s*ool sy/ems & m5tal heal? ag5cies4 7#g7 ,to evaluate ! effectiv5ess ( ! program c>ri$ out "u ?is section 9 increas+ /ud5t access to evid5ce-bas$ trauma support s]vices & m5tal heal? c>e4 7#h7 ,to e/abli% p>tn]%ips ) or provide subgrants to ,head ,/>t ag5cies 7includ+ ,e>ly ,head ,/>t ag5cies71 public & private pres*ool programs1 *ild c>e programs 7includ+ home-bas$ provid]s71 or o!r entities describ$ 9 subsection 7a71 to include su* entities describ$ 9 ?is p>agraph 9 ! evid5ce-bas$ trauma initiatives1 activities1 support s]vices1 & m5tal heal? sy/ems e/abli%$ "u ?is section 9 ord] to provide1 develop1 or improve prev5tion1 scre5+1 ref]ral1 & treatm5t & support s]vices to "y *ildr5 & _! families4 7d7 ,applications ,to be eligible to receive a grant1 contract1 or coop]ative agreem5t "u ?is section1 an entity describ$ 9 subsection 7a7 %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require1 :i* %all include ! foll[+3 7#a7 ,a description ( ! innovative initiatives1 activities1 or programs to be fund$ "u ! grant1 contract1 or coop]ative agreem5t1 includ+ h[ su* program w increase access to evid5ce-bas$ trauma support s]vices & m5tal heal? c>e = /ud5ts1 &1 z applicable1 ! families ( su* /ud5ts4 7#b7 ,a description ( h[ ! program w provide l+ui/ically appropriate & culturally compet5t s]vices4 7#c7 ,a description ( h[ ! program w support /ud5ts & ! s*ool 9 improv+ ! s*ool climate 9 ord] to support an environm5t conducive to le>n+4 7#d7 ,an assurance t-- 7,a7 p]sons provid+ s]vices "u ! grant1 contract1 or coop]ative agreem5t are adequately tra9$ to provide su* s]vices2 & 7,b7 tea*]s1 s*ool lead]s1 adm9i/rators1 specializ$ in/ructional support p]sonnel1 repres5tatives ( local ,indian ,tribes or tribal organizations z appropriate1 o!r s*ool p]sonnel1 & p>5ts or gu>dians ( /ud5ts p>ticipat+ 9 s]vices "u ?is section w be engag$ & involv$ 9 ! design & implem5tation ( ! s]vices4 7#e7 ,a description ( h[ ! applicant w support & integrate exi/+ s*ool-bas$ s]vices ) ! program 9 ord] to provide m5tal heal? s]vices = /ud5ts1 z appropriate4 7#f7 ,a description ( ! entities 9 ! community ) :i* ! applicant w p>tn] or to :i* ! applicant w provide subgrants 9 accordance ) subsection 7c77#h74 7e7 ,int]ag5cy agreem5ts 7#a7 ,local int]ag5cy agreem5ts ,to ensure ! provision ( ! s]vices describ$ 9 subsection 7c71 a recipi5t ( a grant1 contract1 or coop]ative agreem5t "u ?is section1 or _! designee1 %all e/abli% a local int]ag5cy agreem5t among local educational ag5cies1 ag5cies responsible = e>ly *ildhood education programs1 ,head ,/>t ag5cies 7includ+ ,e>ly ,head ,/>t ag5cies71 juv5ile ju/ice au?orities1 m5tal heal? ag5cies1 *ild welf>e ag5cies1 & o!r relevant ag5cies1 au?orities1 or entities 9 ! community t w be involv$ 9 ! provision ( su* s]vices4 7#b7 ,cont5ts ,9 ensur+ ! provision ( ! s]vices describ$ 9 subsection 7c71 ! local int]ag5cy agreem5t %all specify ) respect to ea* ag5cy1 au?ority1 or entity t is a p>ty to su* agreem5t-- 7,a7 ! f9ancial responsibility = ! s]vices2 7,b7 ! conditions & t]ms ( responsibility = ! s]vices1 includ+ quality1 acc\ntability1 & coord9ation ( ! s]vices2 & 7,c7 ! conditions & t]ms ( reimbursem5t among su* ag5cies1 au?orities1 or entities1 includ+ proc$ures = dispute resolution4 7f7 ,evaluation ,! ,secret>y %all res]ve n m ?an #c p]c5t ( ! funds made available "u subsection 7l7 = ea* fiscal ye> to-- 7#a7 conduct a rigor\s1 indep5d5t evaluation ( ! activities fund$ "u ?is section2 & 7#b7 dissem9ate & promote ! utilization ( evid5ce-bas$ practices reg>d+ trauma support s]vices & m5tal heal? c>e4 7g7 ,di/ribution ( aw>ds ,! ,secret>y %all ensure t grants1 contracts1 & coop]ative agreem5ts aw>d$ or ent]$ into "u ?is section are equitably di/ribut$ among ! geographical regions ( ! ,unit$ ,/ates & among tribal1 urban1 suburban1 & rural populations4 7h7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to prohibit an entity involv$ ) a program c>ri$ out "u ?is section f report+ a crime t is committ$ by a /ud5t to appropriate au?orities2 or 7#b7 to prev5t ,f$]al1 ,/ate1 & tribal law en=cem5t & judicial au?orities f ex]cis+ _! responsibilities ) reg>d to ! application ( ,f$]al1 tribal1 & ,/ate law to crimes committ$ by a /ud5t4 7i7 ,supplem5t1 n supplant ,any s]vices provid$ ?r\gh programs c>ri$ out "u ?is section %all supplem5t1 & n supplant1 exi/+ m5tal heal? s]vices1 includ+ any special education & relat$ s]vices provid$ "u ! ,individuals ) ,disabilities ,education ,act 7#bj ,u4,s4,c4 #adjj et seq474 7j7 ,consultation ) ,indian tribes ,9 c>ry+ out subsection 7a71 ! ,secret>y %all1 9 a timely mann]1 mean+fully consult ) ,indian ,tribes & _! repres5tatives to ensure notice ( eligibility4 7k7 ,def9itions ,9 ?is section3 7#a7 ,elem5t>y s*ool ,! t]m elem5t>y s*ool has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 7#b7 ,evid5ce-bas$ ,! t]m evid5ce-bas$ has ! mean+ giv5 su* t]m 9 section #haja7ba77;,a77i7 ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja7ba77;,a77i774 7#c7 ,native hawaiian educational organization ,! t]m ,native ,hawaiian educational organization has ! mean+ giv5 su* t]m 9 section #fbjg ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #geag74 7#d7 ,local educational ag5cy ,! t]m local educational ag5cy has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 7#e7 ,regional corporation ,! t]m ,regional ,corporation has ! mean+ giv5 ! t]m 9 section #c ( ! ,alaska ,native ,claims ,settlem5t ,act 7#dc ,u4,s4,c4 #afjb74 7#f7 ,s*ool ,! t]m s*ool means a public elem5t>y s*ool or public second>y s*ool4 7#g7 ,s*ool lead] ,! t]m s*ool lead] has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 7#h7 ,second>y s*ool ,! t]m second>y s*ool has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 7#i7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,education4 7#aj7 ,specializ$ in/ructional support p]sonnel ,! t]m specializ$ in/ructional support p]sonnel has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 7#aa7 ,/ate educational ag5cy ,! t]m ,/ate educational ag5cy has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 7l7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$1 & !re is appropriat$1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 to c>ry out ?is section1 #bj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 #haj4 ,pa?way to ,heal? ,c>e]s ,act 7a7 ,%ort title ,?is section may be cit$ z ! ,pa?ways to ,heal? ,c>e]s ,act4 7b7 ,ext5sion ?r\gh fiscal ye> #bjbj ( fund+ = demon/ration projects to address heal? pr(essions work=ce ne$s 7#a7 ,9 g5]al ,section #bjjh7;c77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;g7c77#a77 is am5d$ by /rik+ #bjai4 & ins]t+ #bjbj1 & to provide te*nical assi/ance & cov] adm9i/rative co/s associat$ ) implem5t+ ! successor to ?is section #ae1jjj1jjj = fiscal ye> #bjbj44 7#b7 ,availability ( o!r funds ,^u ! date ( ! enactm5t ( ?is section-- 7,a7 am\nts exp5d$ pursuant to section #aeja ( division ,b ( ,public ,law #aaf-ei1 or any o!r prior law mak+ am\nts available = fiscal ye> #bjbj = activities au?oriz$ by section #bjjh ( ! ,social ,security ,act1 %all be *>g$ to ! appropriation made by subsection 7c77#a7 ( su* section #bjjh = fiscal ye> #bjbj 7n includ+ ! am\nt = te*nical assi/ance & adm9i/rative co/s72 & 7,b7 if su* enactm5t occurs on or be=e ,novemb] #ba1 #bjai1 ! availability ( funds appropriat$ 91 & ! au?ority provid$ "u1 su* section #aeja %all t]m9ate4 7c7 ,c>e] pa?ways ?r\gh heal? pr(ession opportunity grants ,effective ,octob] #a1 #bjbj1 section #bjjh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;g7 is am5d$ to read z foll[s3 #bjjh4 ,c>e] pa?ways ?r\gh heal? pr(ession opportunity grants 7a7 ,application requirem5ts ,an eligible entity desir+ a grant "u ?is section = a project %all submit to ! ,secret>y an application = ! grant1 t includes ! foll[+3 7#a7 ,a description ( h[ ! applicant w use a c>e] pa?ways approa* to tra9 eligible individuals = heal? pr(essions t pay well or w put eligible individuals on a c>e] pa? to an occupation t pays well1 "u ! project4 7#b7 ,a description ( ! adult basic education & lit]acy activities1 "w read9ess activities1 tra9+ activities1 & case managem5t & c>e] coa*+ s]vices t ! applicant w use to assi/ eligible individuals to ga9 "w exp]i5ce1 connection to employ]s1 & job placem5t1 & a description ( ! plan = recruit+1 hir+1 & tra9+ /aff to provide ! case managem5t1 m5tor+1 & c>e] coa*+ s]vices1 "u ! project directly or ?r\gh local gov]nm5tal1 appr5tice%ip1 educational1 or *>itable in/itutions4 7#c7 ,9 ! case ( an application = a grant "u ?is section = a demon/ration project describ$ 9 subsection 7c77#b77;,b77i77,i7-- 7,a7 a demon/ration t ! ,/ate 9 :i* ! demon/ration project is to be conduct$ has 9 effect policies or laws t p]mit c]ta9 alli$ heal? & behavioral heal? c>e cr$5tials to be aw>d$ to p ) c]ta9 arre/ or conviction records 7:i* policies or laws %all include appeals processes1 waiv]s1 c]tificates1 & o!r opportunities to demon/rate rehabilitation to obta9 cr$5tials1 lic5sure1 & approval to "w 9 ! propos$ heal? c>e]s71 & a plan describ$ 9 ! application t w use a c>e] pa?way to assi/ p>ticipants ) su* a record 9 acquir+ cr$5tials1 lic5s+1 & employm5t 9 ! specifi$ c>e]s2 7,b7 a discussion ( h[ ! project or future /rategic hir+ decisions w demon/rate ! exp]i5ce & exp]tise ( ! project 9 work+ ) job seek]s :o h arre/ or conviction records or employ]s ) exp]i5ce work+ ) p ) arre/ or conviction records2 7,c7 an id5tification ( promis+ innovations or be/ practices t c be us$ to provide ! tra9+2 7,d7 a pro( ( concept or demon/ration t ! applicant has done suffici5t rese>* on work=ce %ortage or 9-dem& jobs = :i* p ) c]ta9 types ( arre/ or conviction records c be hir$2 7,e7 a plan = recruit+ /ud5ts :o are eligible individuals into ! project2 & 7,f7 a plan = provid+ po/-employm5t support & ongo+ tra9+ z "p ( a c>e] pa?way "u ! project4 7#d7 ,9 ! case ( an application = a grant "u ?is section = a demon/ration project describ$ 9 subsection 7c77#b77;,b77i77,,ii7-- 7,a7 a description ( ! p>tn]%ips1 /rategic /aff hir+ decisions1 tailor$ program activities1 or o!r programmatic elem5ts ( ! project1 su* z tra9+ plans = d\las & o!r community heal? work]s & tra9+ plans = midwives & o!r alli$ heal? pr(essions1 t are design$ to support a c>e] pa?way 9 pregnancy1 bir?1 or po/-p>tum s]vices2 & 7,b7 a demon/ration t ! ,/ate 9 :i* ! demon/ration project is to be conduct$ recognizes d\las or midwives1 z ! case may be4 7#e7 ,a demon/ration t ! applicant has exp]i5ce work+ ) l[-income populations1 or a description ( ! plan ( ! applicant to "w ) a p>tn] organization t has ! exp]i5ce4 7#f7 ,a plan = provid+ po/-employm5t support & ongo+ tra9+ z "p ( a c>e] pa?way "u ! project4 7#g7 ,a description ( ! support s]vices t ! applicant w provide "u ! project1 includ+ a plan = h[ *ild c>e & transportation support s]vices w be gu>ante$ &1 if ! applicant w provide a ca% /ip5d or wage supplem5t1 h[ ! /ip5d or supplem5t w\ld be calculat$ & di/ribut$4 7#h7 ,a c]tification by ! applicant t ! project developm5t includ$-- 7,a7 consultation ) a local work=ce developm5t bo>d e/abli%$ "u section #ajg ( ! ,work=ce ,innovation & ,opportunity ,act2 7,b7 consid]ation ( appr5tice%ip & pre-appr5tice%ip models regi/]$ "u ! ,act ( ,augu/ #af1 #aicg 7also kn[n z ! ,national ,appr5tice%ip ,act72 7,c7 consid]ation ( c>e] pa?way programs 9 ! ,/ate 9 :i* ! project is to be conduct$2 & 7,d7 a review ( ! ,/ate plan "u section #ajb or #ajc ( ! ,work=ce ,innovation & ,opportunity ,act4 7#i7 ,a description ( ! availability & relevance ( rec5t labor m>ket in=mation & o!r p]t95t evid5ce ( 9-dem& jobs or work] %ortages4 7#aj7 ,a c]tification t ! applicant w directly provide or contract = ! tra9+ s]vices describ$ 9 ! application4 7#aa7 ,a commitm5t by ! applicant t1 if ! grant is made to ! applicant1 ! applicant w-- 7,a7 dur+ ! plann+ p]iod = ! project1 provide ! ,secret>y ) any in=mation ne$$ by ! ,secret>y to e/abli% adequate data report+ & adm9i/rative /ructure = ! project2 7,b7 hire a p]son to direct ! project n lat] ?an ! end ( ! plann+ p]iod applicable to ! project2 7,c7 accept all te*nical assi/ance (f]$ by ! ,secret>y ) respect to ! grant2 7,d7 p>ticipate 9 su* 9-p]son grantee conf]5ces z are regul>ly s*$ul$ by ! ,secret>y2 7,e7 provide all data requir$ by ! ,secret>y "u subsection 7g72 & 7,f7 notify ! local disabl$ vet]ans' outrea* program speciali/s "u section #dajc;,a ( title #ch1 ,unit$ ,/ates ,code1 & ! local vet]ans' employm5t repres5tatives "u section #dajd ( su* title1 ( ! grantee's outrea* plan = adv]tis+ tra9+ opportunities to pot5tial p>ticipants 9 ! project4 7b7 ,pref]5ces 9 consid]+ applications ,9 consid]+ applications = a grant "u ?is section1 ! ,secret>y %all give pref]5ce to-- 7#a7 applications submitt$ by applicants to :om a grant 0 made "u ?is section or any pr$ecessor to ?is section2 7#b7 applications submitt$ by applicants :o h bus9ess & community p>tn]s 9 ea* ( ! foll[+ categories3 7,a7 ,/ate & local gov]nm5t ag5cies & social s]vice provid]s1 includ+ a ,/ate or local entity t adm9i/]s a ,/ate program fund$ "u "p ,a ( ?is title2 7,b7 in/itutions ( high] education1 appr5tice%ip programs1 & local work=ce developm5t bo>ds e/abli%$ "u section #ajg ( ! ,work=ce ,innovation & ,opportunity ,act2 & 7,c7 heal? c>e employ]s1 heal? c>e indu/ry or sector p>tn]%ips1 labor unions1 & labor-managem5t p>tn]%ips2 7#c7 applications t include opportunities = m5tor+ or pe] support1 & make c>e] coa*+ available1 z "p ( ! case managem5t plan2 7#d7 applications :i* describe a project t w s]ve a rural area 9 :i*-- 7,a7 ! community 9 :i* ! individuals to be enroll$ 9 ! project reside is locat$2 7,b7 ! project w be conduct$2 or 7,c7 an employ] p>tn]%ip t has committ$ to hir+ individuals :o successfully complete all activities "u ! project is locat$2 7#e7 applications t include a commitm5t to provid+ project p>ticipants ) a ca% /ip5d or wage supplem5t2 & 7#f7 applications :i* h an em]g5cy ca% fund to assi/ project p>ticipants f9ancially 9 em]g5cy situations4 7c7 ,grants 7#a7 ,competitive grants 7,a7 ,grant au?ority 7i7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor & ! ,secret>y ( ,education1 may make a grant 9 accordance ) ?is p>agraph to an eligible entity ^: application = ! grant is approv$ by ! ,secret>y1 to conduct a project design$ to tra9 l[-income individuals = alli$ heal? pr(essions1 heal? in=mation te*nology1 physicians assi/ants1 nurs+ assi/ants1 regi/]$ nurse1 advanc$ practice nurse1 & o!r pr(essions consid]$ "p ( a heal? c>e c>e] pa?way model4 7ii7 ,gu>antee ( grantees 9 ea* /ate & ! di/rict ( columbia ,= ea* grant cycle1 ! ,secret>y %all aw>d a grant "u ?is p>agraph to at lea/ #b eligible entities 9 ea* ,/ate t is n a t]ritory1 to ! ext5t !re are a suffici5t numb] ( applications submitt$ by ! entities t meet ! requirem5ts applicable ) respect to su* a grant4 ,if1 = a grant cycle1 !re are few] ?an #b su* eligible entities 9 a ,/ate1 ! ,secret>y %all include t in=mation 9 ! report requir$ by subsection 7g77#b7 t cov]s ! fiscal ye>4 7,b7 ,gu>antee ( grants = indian populations ,f ! am\nt res]v$ "u subsection 7i77#b77;,b7 = ea* fiscal ye>1 ! ,secret>y %all aw>d a grant "u ?is p>agraph to at lea/ #aj eligible entities t are an ,indian tribe1 a tribal organization1 or a tribal college or univ]sity1 to ! ext5t !re are a suffici5t numb] ( applications submitt$ by ! entities t meet ! requirem5ts applicable ) respect to su* a grant4 7,c7 ,gu>antee ( grantees 9 ! t]ritories ,f ! am\nt res]v$ "u subsection 7i77#b77;,c7 = ea* fiscal ye>1 ! ,secret>y %all aw>d a grant "u ?is p>agraph to at lea/ #b eligible entities t are locat$ 9 a t]ritory1 to ! ext5t !re are a suffici5t numb] ( applications submitt$ by ! entities t meet ! requirem5ts applicable ) respect to su* a grant4 7#b7 ,grants = demon/ration projects 7,a7 ,grant au?ority ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor & ! ,secret>y ( ,education 7&1 ) respect to demon/ration projects ( ! type describ$ 9 subp>agraph 7,b77i77,i71 ! ,attorney ,g5]al7 %all make a grant 9 accordance ) ?is subsection to an eligible entity ^: application = ! grant is approv$ by ! ,secret>y1 to conduct a demon/ration project t meets ! requirem5ts ( subp>agraph 7,b74 7,b7 ,requirem5ts ,! requirem5ts ( ?is subp>agraph are ! foll[+3 7i7 ,type ( project ,! demon/ration project %all be ( #a ( ! foll[+ types3 7,i7 ,individuals ) arre/ or conviction records demon/ration ,! demon/ration project %all be ( a type design$ to provide education & tra9+ = eligible individuals ) arre/ or conviction records to ent] & foll[ a c>e] pa?way 9 ! heal? pr(essions ?r\gh occupations t pay well & are expect$ to exp]i5ce a labor %ortage or be 9 high dem&4 7,,ii7 ,pregnancy & *ildbir? c>e] pa?way demon/ration ,! demon/ration project %all be ( a type design$ to provide education & tra9+ = eligible individuals to ent] & foll[ a c>e] pa?way 9 ! field ( pregnancy1 *ildbir?1 or po/-p>tum1 9 a ,/ate t recognizes d\las or midwives & t provides paym5t = s]vices provid$ by d\las or midwives1 z ! case may be1 "u private or public heal? insurance plans4 7ii7 ,duration ,! demon/ration project %all be conduct$ = n less ?an #e ye>s4 7,c7 ,m9imum allocation ( funds = ea* type ( demon/ration project 7i7 ,individuals ) arre/ or conviction records demon/rations ,n less ?an #be p]c5t ( ! am\nts made available = grants "u ?is p>agraph %all be us$ to make grants = demon/ration projects ( ! type describ$ 9 subp>agraph 7,b77i77,i74 7ii7 ,pregnancy & *ildbir? c>e] pa?way demon/rations ,n less ?an #be p]c5t ( ! am\nts made available = grants "u ?is p>agraph %all be us$ to make grants = demon/ration projects ( ! type describ$ 9 subp>agraph 7,b77i77,,ii74 7#c7 ,grant cycle ,! grant cycle "u ?is section %all be n less ?an #e ye>s1 ) a plann+ p]iod ( n m ?an ! #a/ #ab mon?s ( ! grant cycle4 ,dur+ ! plann+ p]iod1 ! am\nt ( ! grant %all be 9 su* less] am\nt z ! ,secret>y det]m9es appropriate4 7d7 ,use ( grant 7#a7 ,9 g5]al ,an entity to :i* a grant is made "u ?is section %all use ! grant 9 accordance ) ! approv$ application = ! grant4 7#b7 ,support to be provid$ 7,a7 ,requir$ support ,a project = :i* a grant is made "u ?is section %all include ! foll[+3 7i7 ,an assessm5t = adult basic skill compet5cy1 & provision ( adult basic skills education if necess>y = l[]-skill$ eligible individuals to enroll 9 ! project & g on to ent] & complete po/-second>y tra9+1 ?r\gh means includ+ ! foll[+3 7,i7 ,e/abli%+ a network ( p>tn]s t (f] pre-tra9+ activities = project p>ticipants :o ne$ to improve basic academic skills or ,engli% language pr(ici5cy be=e ent]+ a heal? occupational tra9+ c>e] pa?way program4 7,,ii7 ,(f]+ res\rces to enable project p>ticipants to cont9ue advanc+ adult basic skill pr(ici5cy :ile enroll$ 9 a c>e] pa?way program4 7,,iii7 ,emb$d+ adult basic skill ma9t5ance z "p ( ongo+ po/-graduation c>e] coa*+ & m5tor+4 7ii7 ,a gu>antee t *ild c>e is an available & af=dable support s]vice = project p>ticipants ?r\gh means su* z ! foll[+3 7,i7 ,ref]ral to1 & assi/ance )1 enrollm5t 9 a subsidiz$ *ild c>e program4 7,,ii7 ,direct paym5t to a *ild c>e provid] if a slot 9 a subsidiz$ *ild c>e program is n available or reasonably accessible4 7,,iii7 ,paym5t ( co-paym5ts or associat$ fees = *ild c>e4 7iii7 ,case managem5t plans t include c>e] coa*+ 7) ! option to (f] appropriate pe] support & m5tor+ opportunities to help develop s(t skills & social capital71 :i* may be (f]$ on an ongo+ basis be=e1 dur+1 & aft] initial tra9+ z "p ( a c>e] pa?way model4 7iv7 ,a plan to provide project p>ticipants ) transportation ?r\gh means su* z ! foll[+3 7,i7 ,ref]ral to1 & assi/ance ) enrollm5t 91 a subsidiz$ transportation program4 7,,ii7 ,if a subsidiz$ transportation program is n reasonably available1 direct paym5ts to subsidize transportation co/s4 ,= purposes ( ?is clause1 ! t]m transportation includes public transit1 or gasol9e = a p]sonal vehicle if public transit is n reasonably accessible or available4 7v7 ,9 ! case ( a demon/ration project ( ! type describ$ 9 subsection 7c77#b77;,b77i77,i71 access to legal assi/ance = project p>ticipants = ! purpose ( address+ arre/ or conviction records & associat$ work=ce b>ri]s4 7,b7 ,all[$ support ,! goods & s]vices provid$ "u a project = :i* a grant is made "u ?is section may include ! foll[+3 7i7 ,a ca% /ip5d t is at lea/ mon?ly4 7ii7 ,a res]ve fund = f9ancial assi/ance to project p>ticipants 9 em]g5cy situations4 7iii7 ,tuition1 & tra9+ mat]ials su* z books1 s(tw>e1 uni=ms1 %oes1 & hair nets4 7iv7 ,9-k9d res\rce donations su* z int]view clo?+ & conf]5ce att5dance fees4 7v7 ,assi/ance ) access+ & complet+ high s*ool equival5cy or adult basic education c\rses z necess>y to a*ieve success 9 ! project & make progress t[>d c>e] goals4 7vi7 ,assi/ance ) programs & activities1 includ+ legal assi/ance1 deem$ necess>y to address arre/ or conviction records z an employm5t b>ri]4 7vii7 ,o!r support s]vices z deem$ necess>y = family well-be+1 success 9 ! project1 & progress t[>d c>e] goals4 7,c7 ,treatm5t ( support = purposes ( means-te/$ programs ,any goods or s]vices provid$ to an eligible individual p>ticipat+ 9 a project = :i* a grant is made "u ?is section %all n be consid]$ income1 & %all n be tak5 into acc\nt = purposes ( det]m9+ ! eligibility ( ! individual =1 or am\nt ( b5efits to be provid$ to ! individual1 "u any means-te/$ program4 7#c7 ,tra9+ ,! numb] ( h\rs ( tra9+ provid$ to an eligible individual "u a project = :i* a grant is made "u ?is section1 = a recogniz$ po/second>y cr$5tial1 includ+ an indu/ry-recogniz$ cr$5tial1 :i* is aw>d$ 9 recognition ( atta9m5t ( measurable te*nical or occupational skills necess>y to ga9 employm5t or advance )9 an occupation 7includ+ a c]tificate aw>d$ by a local work=ce developm5t bo>d e/abli%$ "u section #ajg ( ! ,work=ce ,innovation & ,opportunity ,act71 %all be-- 7,a7 n less ?an ! numb] ( h\rs ( tra9+ requir$ = c]tification 9 t level ( skill by ! ,/ate 9 :i* ! project is conduct$2 or 7,b7 if !re is no su* requirem5t1 su* numb] ( h\rs ( tra9+ z ! ,secret>y f9ds is necess>y to a*ieve t skill level4 7#d7 ,income limitation ,an entity to :i* a grant is made "u ?is section %all n use ! grant to provide support to a p]son :o is n an eligible individual4 7#e7 ,inclusion ( ,,tanf recipi5ts ,9 ! case ( a project = :i* a grant is made "u ?is section t is conduct$ 9 a ,/ate t has a program fund$ "u "p ,a ( title ,,iv1 at lea/ #aj p]c5t ( ! eligible individuals to :om support is provid$ "u ! project %all meet ! income eligibility requirem5ts "u t ,/ate program1 )\t reg>d to :e!r ! individuals receive b5efits or s]vices directly "u t ,/ate program4 7#f7 ,prohibition ,an entity to :i* a grant is made "u ?is section %all n use ! grant = purposes ( ent]ta9m5t1 except t case managem5t & c>e] coa*+ s]vices may include celebrations ( specific c>e]-bas$ mile/ones su* z complet+ a seme/]1 graduation1 or job placem5t4 7e7 ,te*nical assi/ance 7#a7 ,9 g5]al ,! ,secret>y %all provide te*nical assi/ance-- 7,a7 to assi/ eligible entities 9 apply+ = grants "u ?is section2 7,b7 t is tailor$ to meet ! ne$s ( grantees at ea* /age ( ! adm9i/ration ( projects = :i* grants are made "u ?is section2 7,c7 t is tailor$ to meet ! specific ne$s ( ,indian tribes1 tribal organizations1 & tribal colleges & univ]sities2 7,d7 t is tailor$ to meet ! specific ne$s ( ! t]ritories2 7,e7 t is tailor$ to meet ! specific ne$s ( eligible entities 9 c>ry+ out demon/ration projects = :i* a grant is made "u ?is section2 & 7,f7 to facilitate ! ex*ange ( in=mation among eligible entities reg>d+ be/ practices & promis+ practices us$ 9 ! projects4 7#b7 ,cont9uation ( pe] te*nical assi/ance conf]5ces ,! ,secret>y %all cont9ue to hold pe] te*nical assi/ance conf]5ces = entities to :i* a grant is made "u ?is section or 0 made "u ! imm$iate pr$ecessor ( ?is section4 7f7 ,evaluation ( demon/ration projects 7#a7 ,9 g5]al ,! ,secret>y %all1 by grant1 contract1 or int]ag5cy agreem5t1 conduct rigor\s & well-design$ evaluations ( ! demon/ration projects = :i* a grant is made "u ?is section4 7#b7 ,requirem5t applicable to individuals ) arre/ or conviction records demon/ration ,9 ! case ( a project ( ! type describ$ 9 subsection 7c77#b77;,b77i77,i71 ! evaluation %all include id5tification ( successful activities = creat+ opportunities = develop+ & su/a9+1 p>ticul>ly ) respect to l[-income individuals ) arre/ or conviction records1 a heal? pr(essions work=ce t has accessible entry po9ts1 t meets high /&>ds = education1 tra9+1 c]tification1 & pr(essional developm5t1 & t provides increas$ wages & af=dable b5efits1 includ+ heal? c>e cov]age1 t are responsive to ! ne$s ( ! work=ce4 7#c7 ,requirem5t applicable to pregnancy & *ildbir? c>e] pa?way demon/ration ,9 ! case ( a project ( ! type describ$ 9 subsection 7c77#b77;,b77i77,,ii71 ! evaluation %all include id5tification ( successful activities = creat+ opportunities = develop+ & su/a9+1 p>ticul>ly ) respect to l[-income individuals & o!r entry-level work]s1 a c>e] pa?way t has accessible entry po9ts1 t meets high /&>ds = education1 tra9+1 c]tification1 & pr(essional developm5t1 & t provides increas$ wages & af=dable b5efits1 includ+ heal? c>e cov]age1 t are responsive to ! ne$s ( ! bir?1 pregnancy1 & po/-p>tum work=ce4 7#d7 ,rule ( int]pretation ,evaluations conduct$ pursuant to ?is subsection may include a r&omiz$ controll$ trial1 b ?is subsection %all n be int]pret$ to require an evaluation to include su* a trial4 7g7 ,reports 7#a7 ,to ! ,secret>y ,an eligible entity aw>d$ a grant to conduct a project "u ?is section %all submit int]im reports to ! ,secret>y on ! activities c>ri$ out "u ! project1 &1 on ! conclusion ( ! project1 a f9al report on ! activities4 ,ea* su* report %all include data on p>ticipant outcomes relat$ to e>n+s1 employm5t 9 heal? pr(essions1 graduation rate1 graduation timel9ess1 cr$5tial atta9m5t1 p>ticipant demographics1 & o!r data specifi$ by ! ,secret>y4 7#b7 ,to ! ,congress ,dur+ ea* ,congress1 ! ,secret>y %all submit to ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate a report-- 7,a7 on ! demographics ( ! p>ticipants 9 ! projects = :i* a grant is made "u ?is section2 7,b7 on ! rate ( :i* project p>ticipants complet$ all activities "u ! projects2 7,c7 on ! employm5t cr$5tials acquir$ by project p>ticipants2 7,d7 on ! employm5t ( project p>ticipants on completion ( activities "u ! projects1 & ! e>n+s ( project p>ticipants at entry into employm5t2 7,e7 on be/ practices & promis+ practices us$ 9 ! projects2 7,f7 on ! nature ( any te*nical assi/ance provid$ to grantees "u ?is section2 7,g7 on1 ) respect to ! p]iod s9ce ! p]iod cov]$ 9 ! mo/ rec5t prior report submitt$ "u ?is p>agraph-- 7i7 ! numb] ( applications submitt$ "u ?is section1 ) a sep>ate /atem5t ( ! numb] ( applications ref]r$ to 9 subsection 7b77#e72 7ii7 ! numb] ( applications t 7 approv$1 ) a sep>ate /atem5t ( ! numb] ( su* applications ref]r$ to 9 subsection 7b77#e72 & 7iii7 a description ( h[ grants 7 made 9 any case describ$ 9 ! la/ s5t5ce ( subsection 7c77#a77;,a77ii72 & 7,h7 t includes an assessm5t ( ! effectiv5ess ( ! projects ) respect to address+ heal? pr(essions work=ce %ortages or 9-dem& jobs4 7h7 ,def9itions ,9 ?is section3 7#a7 ,alli$ heal? pr(ession ,! t]m alli$ heal? pr(ession has ! mean+ giv5 9 section #gii;,b7#e7 ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,c>e] pa?way ,! t]m c>e] pa?way has ! mean+ giv5 t t]m 9 section #c7g7 ( ! ,work=ce ,innovation & ,opportunity ,act4 7#c7 ,d\la ,! t]m d\la means an individual :o-- 7,a7 is c]tifi$ by an organization t has be5 e/abli%$ = n less ?an #e ye>s & t requires ! completion ( cont9u+ education to ma9ta9 ! c]tification1 to provide non-m$ical advice1 in=mation1 emotional support1 & physical com=t to an individual dur+ ! individual's pregnancy1 *ildbir?1 & po/-p>tum p]iod2 & 7,b7 ma9ta9s ! c]tification by complet+ ! requir$ cont9u+ education4 7#d7 ,eligible entity ,! t]m eligible entity means any ( ! foll[+ entities t demon/rates 9 an application submitt$ "u ?is section t ! entity has ! capacity to fully develop & adm9i/] ! project describ$ 9 ! application3 7,a7 ,a local work=ce developm5t bo>d e/abli%$ "u section #ajg ( ! ,work=ce ,innovation & ,opportunity ,act4 7,b7 ,a ,/ate or t]ritory1 a political subdivision ( a ,/ate or t]ritory1 or an ag5cy ( a ,/ate1 t]ritory1 or su* a political subdivision1 includ+ a ,/ate or local entity t adm9i/]s a ,/ate program fund$ "u "p ,a ( ?is title4 7,c7 ,an ,indian tribe1 a tribal organization1 or a tribal college or univ]sity4 7,d7 ,an in/itution ( high] education 7z def9$ 9 ! ,high] ,education ,act ( #aife74 7,e7 ,a hospital 7z def9$ 9 section #ahfa7;e774 7,f7 ,a high-quality skill$ nurs+ facility4 7,g7 ,a ,f$]ally qualifi$ heal? c5t] 7z def9$ 9 section #ahfa7;aa77#d774 7,h7 ,a nonpr(it organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 a labor organization1 or an entity ) %>$ labor-managem5t ov]sight1 t has a demon/rat$ hi/ory ( provid+ heal? pr(ession tra9+ to eligible individuals4 7,i7 ,9 ! case ( a demon/ration project ( ! type provid$ = 9 subsection 7c77#b77;,b77i77,,ii7 ( ?is section1 an entity recogniz$ by a ,/ate1 ,indian tribe1 or tribal organization z qualifi$ to tra9 d\las or midwives1 if midwives or d\las1 z ! case may be1 are p]mitt$ to practice 9 ! ,/ate involv$4 7,j7 ,an opioid treatm5t program 7z def9$ 9 section #ahfa7;jjj77#b771 & o!r high quality compreh5sive addiction c>e provid]s4 7#e7 ,eligible individual ,! t]m eligible individual means an individual ^: family income does n exce$ #bjj p]c5t ( ! ,f$]al pov]ty level4 7#f7 ,f$]al pov]ty level ,! t]m ,f$]al pov]ty level means ! pov]ty l9e 7z def9$ 9 section #fgc7b7 ( ! ,omnibus ,budget ,reconciliation ,act ( #aiha1 includ+ any revision requir$ by su* section applicable to a family ( ! size involv$74 7#g7 ,indian tribe2 tribal organization ,! t]ms ,indian tribe & tribal organization h ! mean+ giv5 ! t]ms 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #dej;b74 7#h7 ,in/itution ( high] education ,! t]m in/itution ( high] education has ! mean+ giv5 ! t]m 9 section #aja or #ajb7;a77#a77;,b7 ( ! ,high] ,education ,act ( #aife4 7#i7 ,t]ritory ,! t]m t]ritory means ! ,commonweal? ( ,pu]to ,rico1 ! ,unit$ ,/ates ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa4 7#aj7 ,tribal college or univ]sity ,! t]m tribal college or univ]sity has ! mean+ giv5 ! t]m 9 section #caf7;b7 ( ! ,high] ,education ,act ( #aife4 7i7 ,fund+ 7#a7 ,9 g5]al ,out ( any funds 9 ! ,treasury ( ! ,unit$ ,/ates n o!rwise appropriat$1 !re are appropriat$ to ! ,secret>y to c>ry out ?is section #dbe1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe4 7#b7 ,allocation ( funds ,( ! am\nt appropriat$ = a fiscal ye> "u p>agraph 7#a7 ( ?is subsection-- 7,a7 #ge p]c5t %all be available = grants "u subsection 7c77#a77;,a72 7,b7 #d p]c5t %all be res]v$ = grants "u subsection 7c77#a77;,b72 7,c7 #e p]c5t %all be res]v$ = grants "u subsection 7c77#a77;,c72 7,d7 #f p]c5t %all be available = demon/ration project grants "u subsection 7c77#b72 7,e7 #f p]c5t1 plus all am\nts ref]r$ to 9 subp>agraphs 7,a7 ?r\gh 7,d7 ( ?is p>agraph t rema9 unus$ aft] all grant aw>ds are made = ! fiscal ye>1 %all be available = ! provision ( te*nical assi/ance & associat$ /aff+2 & 7,f7 #d p]c5t %all be available = /udy+ ! effects ( ! demon/ration & non-demon/ration projects = :i* a grant is made "u ?is section1 & = associat$ /aff+1 = ! purpose ( support+ ! rigor\s evaluation ( ! demon/ration projects1 & support+ ! cont9u$ /udy ( ! %ort-1 m$ium-1 & long-t]m effects ( all su* projects1 includ+ ! effectiv5ess ( new or add$ elem5ts ( ! non-demon/ration projects4 7j7 ,nonapplicability ( prec$+ sections ( ?is subtitle 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! prec$+ sections ( ?is subtitle %all n apply to a grant aw>d$ "u ?is section4 7#b7 ,exception = c]ta9 limitations on use ( grants ,section #bjje7;a7 7o!r ?an p>agraphs 7#b71 7#c71 7#e71 7#f71 & 7#h77 %all apply to a grant aw>d$ "u ?is section to ! same ext5t & 9 ! same mann] z su* section applies to paym5ts to ,/ates "u ?is subtitle4 4 #haa4 ,home ,visit+ to ,r$uce ,mat]nal ,mortality & ,morbidity ,act 7a7 ,%ort title ,?is section may be cit$ z ! ,home ,visit+ to ,r$uce ,mat]nal ,mortality & ,morbidity ,act4 7b7 ,increase 9 tribal set-aside p]c5tage 7#a7 ,9 g5]al ,section #eaa7;j77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #gaa7;j77#b77;,a77 is am5d$ by /rik+ #c & ins]t+ #f4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect on ,octob] #a1 #bjbj4 7c7 ,increase 9 fund+ ,section #eaa7;j77#a7 ( su* ,act 7#db ,u4,s4,c4 #gaa7;j77#a77 is am5d$-- 7#a7 by /rik+ & at ! end ( subp>agraph 7,g72 & 7#b7 by /rik+ subp>agraph 7,h7 & ins]t+ ! foll[+3 7,h7 #djj1jjj1jjj = ea* ( fiscal ye>s #bjag ?r\gh #bjbj2 7,i7 #fjj1jjj1jjj = fiscal ye> #bjba2 & 7,j7 #hjj1jjj1jjj = fiscal ye> #bjbb4 4 7d7 ,use ( additional funds ,section #eaa7;c7 ( su* ,act 7#db ,u4,s4,c4 #gaa7;c77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,use ( c]ta9 funds to provide additional res\rces to address high rates ( mat]nal mortality & morbidity1 support unmet ne$s id5tifi$ by ! ne$s assessm5t1 or increase allocations to ,/ates & t]ritories bas$ on relative population or pov]ty ,! ,secret>y %all ensure t any am\nts exce$+ #djj1jjj1jjj t are us$ = grants "u ?is subsection = a fiscal ye> are us$ to-- 7,a7 provide additional fund+ priority to ,/ates1 tribes1 & t]ritories to address high rates ( mat]nal mortality & morbidity2 7,b7 address unmet ne$s id5tifi$ by a ne$s assessm5t conduct$ "u subsection 7b72 or 7,c7 increase ! am\nts allocat$ "u ?is section to ,/ates & to ,pu]to ,rico1 ,guam1 ! ,virg9 ,isl&s1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa1 bas$ on ! proportion ( *ildr5 :o h n atta9$ #e ye>s ( age & are liv+ 9 pov]ty4 4 #hab4 ,addition ( new measures bas$ on access to biosimil> biological products to ! #e-/> rat+ sy/em "u m$ic>e advantage 7a7 ,9 g5]al ,section #ahec7o77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,addition ( new measures bas$ on access to biosimil> biological products 7i7 ,9 g5]al ,= #bjba & subsequ5t ye>s1 ! ,secret>y %all add a new set ( measures to ! #e-/> rat+ sy/em bas$ on access to biosimil> biological products cov]$ "u "p ,b &1 9 ! case ( ,,ma-,,pd plans1 su* products t are cov]$ "p ,d drugs4 ,su* measures %all assess ! impact a plan's b5efit /ructure may h on enrollees' utilization ( or ability to access biosimil> biological products1 includ+ 9 comp>ison to ! ref]5ce biological product1 & %all include measures1 z applicable1 ) respect to ! foll[+3 7,i7 ,cov]age ,assess+ :e!r a biosimil> biological product is on ! plan =mul>y 9 lieu ( or 9 addition to ! ref]5ce biological product4 7,,ii7 ,pref]5c+ ,assess+ ti] placem5t or co/-%>+ = a biosimil> biological product relative to ! ref]5ce biological product4 7,,iii7 ,utilization managem5t tools ,assess+ :e!r & h[ utilization managem5t tools are us$ ) respect to a biosimil> biological product relative to ! ref]5ce biological product4 7,,iv7 ,utilization ,assess+ ! p]c5tage ( enrollees prescrib$ ! biosimil> biological product :5 ! ref]5ce biological product is also available4 7ii7 ,def9itions ,9 ?is subp>agraph1 ! t]ms biosimil> biological product & ref]5ce biological product h ! mean+ giv5 ^? t]ms 9 section #ahdg;,a7c77#f74 7iii7 ,protect+ pati5t int]e/s ,9 develop+ su* measures1 ! ,secret>y %all ensure t ea* measure develop$ to address cov]age1 pref]5c+1 or utilization managem5t is con/ruct$ su* t pati5ts reta9 equal access to appropriate !rapeutic options )\t undue adm9i/rative burd54 4 7b7 ,cl>ification reg>d+ application to prescription drug plans ,to ! ext5t ! ,secret>y ( ,heal? & ,human ,s]vices applies ! #e-/> rat+ sy/em "u section #ahec7o77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77#d771 or a simil> sy/em1 to prescription drug plans "u "p ,d ( title ,,xviii ( su* ,act1 ! provisions ( subp>agraph 7,e7 ( su* section1 z add$ by subsection 7a7 ( ?is section1 %all apply "u ! sy/em ) respect to su* plans 9 ! same mann] z su* provisions apply to ! #e-/> rat+ sy/em "u su* section #ahec7o77#d74 #hac4 ,s5se ( ,congress reg>d+ ! impact ( ! high co/ ( prescription drugs on communities ( color & p]sons liv+ 9 rural or sp>sely populat$ areas ( ! ,unit$ ,/ates ,x is ! s5se ( ! ,congress t-- 7#a7 ! ,unit$ ,/ates has ! highe/ drug prices 9 ! _w & = millions ( ,am]icans ! co/ ( prescription drugs is increas+ z a b>ri] to prop] disease treatm5t1 especially = communities ( color & = p]sons liv+ 9 rural or sp>sely populat$ areas ( ! nation2 7#b7 ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh7 sub/antially r$uc$ ! numb] ( un9sur$ ,am]icans1 b ov] #bh million ,am]icans rema9 )\t insurance & approximately #ee p]c5t ( un9sur$ ,am]icans "u ! age ( #fe are p]sons ( color2 7#c7 )\t heal? insurance1 pay+ retail prices = m$ications is inv>iably burd5some or f9ancially impossible2 7#d7 ! m$ian net wor? ( ,caucasian h\seholds 9 #bjaf 0 #i4g times high] ?an ,african-,am]ican h\seholds & #h4c times high] ?an ,hispanic h\seholds1 :i* contributes to disp>ities 9 negative heal? consequ5ces1 includ+ = example ! und]use ( insul9 among insur$ adults ) diabetes2 & 7#e7 due to ! high co/ ( prescription drugs to communities ( color & = p]sons liv+ 9 rural or sp>sely populat$ areas ( ! nation1 ?is ,act %\ld positively impact su* communities & p]sons 7& ! ,secret>ies ( ,heal? & ,human ,s]vices1 ,labor1 & ,treasury %\ld monitor su* impact74 #had4 ,regulations requir+ direct-to-consum] adv]tisem5ts = prescription drugs & biological products to include tru?ful & n mislead+ pric+ in=mation 7a7 ,9 g5]al ,n lat] ?an ! date t is "o ye> aft] ! date ( ! enactm5t ( ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7ref]r$ to 9 ?is section z ! ,adm9i/rator71 %all promulgate f9al regulations requir+ ea* direct-to-consum] adv]tisem5t on television 7includ+ broadca/1 cable1 /ream+1 & satellite television7 = a prescription drug or biological product = :i* paym5t is available "u title ,,xviii or ,,xix ( ! ,social ,security ,act to include a textual /atem5t1 :i* %all be tru?ful & n mislead+1 indicat+ ! li/ price1 z det]m9$ on ! fir/ day ( ! qu>t] dur+ :i* ! adv]tisem5t is be+ air$ or o!rwise broadca/1 = a typical #cj-;day regim5 or typical c\rse ( treatm5t 7:i*ev] is mo/ appropriate74 7b7 ,det]m9ations ,9 promulgat+ f9al regulations "u subsection 7a71 ! ,adm9i/rator %all det]m9e-- 7#a7 :e!r su* regulations %\ld apply ) respect to additional =ms ( adv]tis+2 7#b7 ! mann] & =mat ( textual /atem5ts describ$ 9 su* subsection2 7#c7 appropriate en=cem5t me*anisms2 & 7#d7 :e!r su* textual /atem5ts %\ld include any o!r price in=mation1 z appropriate4 #hae4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid 7a7 ,pass-?r\gh pric+ requir$ 7#a7 ,9 g5]al ,section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,pass-?r\gh pric+ requir$ ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm71 or a contract betwe5 ! ,/ate & a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d77 t includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs disp5s$ to individuals enroll$ ) ! entity1 %all require t paym5t = su* drugs & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or entity1 is bas$ on a pass-?r\gh pric+ model "u :i*-- 7,a7 any paym5t made by ! entity or ! ,,pbm 7z applicable7 = su* a drug-- 7i7 is limit$ to-- 7,i7 +r$i5t co/2 & 7,,ii7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate plan or waiv] w\ld pay if ! plan or waiv] 0 mak+ ! paym5t directly2 7ii7 is pass$ ?r\gh 9 its entirety by ! entity or ,,pbm to ! ph>macy t disp5ses ! drug2 & 7iii7 is made 9 a mann] t is consi/5t ) section #aijb7;a77#cj77;,a7 & sections #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 z if su* requirem5ts appli$ directly to ! entity or ! ,,pbm2 7,b7 paym5t to ! entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! entity or ,,pbm is limit$ to a reasonable adm9i/rative fee t cov]s ! reasonable co/ ( provid+ su* s]vices2 7,c7 ! entity or ! ,,pbm 7z applicable7 %all make available to ! ,/ate1 & ! ,secret>y ^u reque/1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices incurr$1 receiv$1 or made by ! entity or ! ,,pbm1 includ+ +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees1 po/-sale & po/-9-voice fees4 ,disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all remun]ation2 & 7,d7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! entity or ! ,,pbm 7z applicable7 t is 9 excess ( ! am\nt paid to ! ph>macies on behalf ( ! entity1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts 7aft] all[+ = a reasonable adm9i/rative fee z describ$ 9 subp>agraph 7,b771 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 4 7#b7 ,con=m+ am5dm5t ,clause 7xiii7 ( section #aijc7m77#b77;,a7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is am5d$-- 7,a7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,,iv7 ph>macy b5efit managem5t s]vices provid$ by ! entity1 or provid$ by a ph>macy b5efit manag] on behalf ( ! entity "u a contract or o!r arrangem5t betwe5 ! entity & ! ph>macy b5efit manag]1 %all comply ) ! requirem5ts ( section #aibg7;e77#f74 7#c7 ,effective date ,! am5dm5ts made by ?is subsection apply to contracts betwe5 ,/ates & manag$ c>e entities1 o!r specifi$ entities1 or ph>macy b5efits manag]s t are ent]$ into or r5ew$ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7b7 ,survey ( retail prices 7#a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7,a7 by /rik+ & aft] ! semicolon at ! end ( p>agraph 7#a77;,a77i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,survey ( retail prices ,! ,secret>y %all conduct a survey ( retail community drug prices1 to include at lea/ ! national av]age drug acquisition co/1 z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation on a mon?ly basis ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs = su* ph>macies1 net ( all disc\nts & rebates 7to ! ext5t any in=mation ) respect to su* disc\nts & rebates is available71 ! av]age reimbursem5t receiv$ = su* drugs by su* ph>macies f all s\rces ( paym5t1 includ+ ?ird p>ties1 &1 to ! ext5t available1 ! usual & cu/om>y *>ges to consum]s = su* drugs2 & 2 7,b7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,9 ord] to meet ! requirem5t ( section #aijb7;a77#ed71 a ,/ate %all require t any retail community ph>macy 9 ! ,/ate t receives any paym5t1 adm9i/rative fee1 disc\nt1 or rebate relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 fee1 disc\nt1 or rebate is receiv$ f ! ,/ate or a manag$ c>e entity directly or f a ph>macy b5efit manag] or ano!r entity t has a contract ) ! ,/ate or a manag$ c>e entity1 %all respond to surveys ( retail prices conduct$ "u ?is subsection4 7,g7 ,survey in=mation ,in=mation on retail community prices obta9$ "u ?is p>agraph %all be made publicly available & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate ( ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ frame & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,*>act]i/ics ( report+ ph>macies1 includ+ type 7su* z indep5d5t or *a971 geographic or regional location1 & disp5s+ volume4 7iv7 ,report+ ( a sep>ate national av]age drug acquisition co/ = ea* drug = indep5d5t retail ph>macies & *a9 op]at$ ph>macies4 7v7 ,in=mation on price concessions includ+ on & (f invoice disc\nts1 rebates1 & o!r price concessions4 7vi7 ,in=mation on av]age pr(essional disp5s+ fees paid4 7,h7 ,p5alties 7i7 ,failure to provide timely in=mation ,a retail community ph>macy t fails to respond to a survey conduct$ "u ?is subsection on a timely basis may be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$4 7ii7 ,false in=mation ,a retail community ph>macy t kn[+ly provides false in=mation 9 response to a survey conduct$ "u ?is subsection may be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7iii7 ,o!r p5alties ,any civil money p5alties impos$ "u ?is subp>agraph %all be 9 addition to o!r p5alties z may be prescrib$ by law4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+s "u section #aabh;,a7a74 7,i7 ,report on specialty ph>macies 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! effective date ( ?is subp>agraph1 ! ,secret>y %all submit a report to ,congress exam9+ specialty drug cov]age & reimbursem5t "u ?is title4 7ii7 ,cont5t ( report ,su* report %all include a description ( h[ ,/ate ,m$icaid programs def9e specialty drugs1 h[ mu* ,/ate ,m$icaid programs pay = specialty drugs1 h[ ,/ates & manag$ c>e plans det]m9e paym5t = specialty drugs1 ! sett+s 9 :i* specialty drugs are disp5s$ 7su* z retail community ph>macies or specialty ph>macies71 :e!r acquisition co/s = specialty drugs are captur$ 9 ! national av]age drug acquisition co/ survey1 & recomm5dations z to :e!r specialty ph>macies %\ld be includ$ 9 ! survey ( retail prices to ensure national av]age drug acquisition co/s capture drugs sold at specialty ph>macies & h[ su* specialty ph>macies %\ld be def9$4 2 7,c7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ paym5ts rates "u ,m$icaid manag$ c>e plans1 aft] "u ?is title2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ & ! basis = su* disp5s+ fees be=e ! semicolon2 & 7,d7 9 p>agraph 7#d71 by ins]t+ 1 & #e1jjj1jjj = fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 aft] #bjaj4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection take effect on ! #a/ day ( ! #a/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7c7 ,manufactur] report+ ( :olesale acquisition co/ ,section #aibg7;b77#c7 ( su* ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a77i7-- 7,a7 9 subclause 7,i71 by /rik+ & aft] ! semicolon2 7,b7 9 subclause 7,,ii71 by add+ & aft] ! semicolon2 7,c7 by mov+ ! left m>g9s ( subclause 7,i7 & 7,,ii7 #b ems to ! "r2 & 7,d7 by add+ at ! end ! foll[+3 7,,iii7 9 ! case ( rebate p]iods t beg9 on or aft] ! date ( enactm5t ( ?is subclause1 on ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = cov]$ outpati5t drugs = ! rebate p]iod "u ! agreem5t 7includ+ = all su* drugs t are sold "u a new drug application approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act72 2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ & clause 7vii7 ( ?is subp>agraph aft] #ahdg;,a2 7,b7 9 clause 7v71 by /rik+ & aft] ! comma2 7,c7 9 clause 7vi71 by /rik+ ! p]iod & ins]t+ 1 &2 & 7,d7 by ins]t+ aft] clause 7vi7 ! foll[+3 7vii7 to ! ,secret>y to disclose 7?r\gh a website accessible to ! public7 ! mo/ rec5tly report$ :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = ea* cov]$ outpati5t drug 7includ+ = all su* drugs t are sold "u a new drug application approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 z report$ "u subp>agraph 7,a77i77,,iii74 4 #haf4 ,graduate m$ical education improvem5ts 9 rural & und]s]v$ communities ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #cii,v-#g4 ,graduate m$ical education improvem5ts 9 rural & und]s]v$ communities 7a7 ,rural & und]s]v$ community ,,gme grant program ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y71 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all e/abli% a rural & und]s]v$ community graduate m$ical education grant program "u :i* ! ,secret>y %all aw>d grants to specifi$ hospitals 7z def9$ 9 subsection 7b77 t h n e/abli%$ an approv$ m$ical resid5cy tra9+ program 7z def9$ = purposes ( section #ahhf7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7h777 9 ord] to enc\rage su* hospitals to e/abli% su* a program1 or to e/abli% an affiliation ) a hospital t has e/abli%$ su* a program 9 ord] to ho/ resid5ts "u su* program4 7b7 ,use ( funds ,grants aw>d$ "u subsection 7a7 may be us$ by a specifi$ hospital = any initial co/s associat$ ) e/abli%+ su* a program or su* an affiliation1 includ+ co/s associat$ ) faculty developm5t1 adm9i/ration1 infra/ructure1 supplies1 & legal & consultant s]vices4 7c7 ,specifi$ hospital def9$ ,= purposes ( subsection 7a71 ! t]m specifi$ hospital means a hospital or critical access hospital 7z su* t]ms are def9$ 9 section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex77 t-- 7#a7 is-- 7,a7 locat$ 9 a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d7 ( su* ,act 7#db ,u4,s4,c4 #acieww7d77#b77;,d7772 or 7,b7 treat$ z be+ locat$ 9 a rural area pursuant to section #ahhf7;d77#h77;,e7 ( su* ,act 7#db ,u4,s4,c4 #acieww7d77#h77;,e772 & 7#b7 is locat$ 9 a m$ically und]s]v$ area 7z def9$ 9 section #ccj;,i7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#ad7;a7774 7d7 ,critical access hospital grant program ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all e/abli% a grant program "u :i* ! ,secret>y aw>ds grants to critical access hospitals 7z def9$ 9 section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex77 t d n h 9 effect an affiliation ) a hospital ) an approv$ m$ical resid5cy tra9+ program to ho/ resid5ts ( su* program 9 ord] to assi/ su* critical access hospitals 9 sett+ up su* affiliations 9 ord] to ho/ su* resid5ts4 7e7 ,limitation on grant am\nts ,no hospital may receive an aggregate am\nt ( grants "u ?is section 9 excess ( #bej1jjj4 7f7 ,reports 7#a7 ,,hhs ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on graduate m$ical resid5cy tra9+ programs ( hospitals t receiv$ a grant "u subsection 7a7 or 7d74 ,su* report %all include ! foll[+3 7,a7 ,! numb] ( hospitals t appli$ = a grant "u ?is section4 7,b7 ,! numb] ( hospitals t 7 aw>d$ su* a grant4 7,c7 ,! numb] ( resid5cy positions creat$ by hospitals receiv+ su* a grant4 7,d7 ,an e/imate ( ! numb] ( su* positions su* hospitals w create aft] ! date ( ! submission ( su* report4 7,e7 ,a description ( any *all5ges fac$ by hospitals 9 apply+ = su* a grant or us+ funds aw>d$ "u su* a grant4 7#b7 ,,gao ,n lat] ?an #aj ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ an analysis (-- 7,a7 ! numb] ( resid5ts :o tra9$ at a hospital or critical access hospital t receiv$ a grant "u subsection 7a7 or 7d72 & 7,b7 :e!r su* resid5ts cont9u$ to practice m$ic9e 9 a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#b77;,d777 or 9 a m$ically und]s]v$ area 7z def9$ 9 section #ccj;,i7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#ad7;a777 aft] complet+ su* tra9+4 7g7 ,fund+ ,!re are au?oriz$ to be appropriat$ su* sums z are necess>y = purposes ( mak+ grants "u ?is section = ea* ( fiscal ye>s #bjbj ?r\gh #bjbi4 4 ,pass$ ! ,h\se ( ,repres5tatives ,decemb] #ab1 #bjai4;,cl]k4