,i #aag? ,,congress #a/ ,session ,h4 ,r4 #fjjj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,novemb] #ag1 #bjba,ms4 ,de,gette 7= h]self & ,mr4 ,upton7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 ! ,budget1 ,sci5ce1 ,space1 & ,te*nology1 ,agriculture1 ,education & ,labor1 ,arm$ ,s]vices1 ,natural ,res\rces1 ,vet]ans' ,affairs1 ,homel& ,security1 & ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to cont9ue ! accel]ation ( ! discov]y1 developm5t1 & deliv]y ( #ba/ c5tury cures1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,cures #b4j ,act4 #b4 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4,sec4 #b4 ,table ( cont5ts4,title ,i--,public health,sec4 #aja4 ,fur!r und]/&+ ! implications ( long ,,covid4,sec4 #ajb4 ,national /rategy to prev5t & respond to p&emics4,sec4 #ajc4 ,p&emic prep>$ness r>e disease support program4,sec4 #ajd4 ,vacc9e & immunization programs4,sec4 #aje4 ,develop+ antimicrobial innovations4,title ,,ii--,pati5ts & caregivers,sec4 #bja4 ,educational programs & tra9+ = c>egiv]s4,sec4 #bjb4 ,increas+ heal? lit]acy to promote bett] outcomes = pati5ts4,sec4 #bjc4 ,increas+ div]sity 9 cl9ical trials4,sec4 #bjd4 ,pati5t exp]i5ce data4,sec4 #bje4 ,ensur+ cov]age = cl9ical trials "u exi/+ /&>d ( c>e4,title ,,iii--,food & ,drug ,administration,sec4 #cja4 ,report on collaboration & alignm5t 9 regulat+ digital heal? te*nologies4,sec4 #cjb4 ,grants = novel trial designs & o!r innovations 9 drug developm5t4,sec4 #cjc4 ,,fda cell & g5e !rapy4,sec4 #cjd4 ,increas+ use ( real _w evid5ce4,sec4 #cje4 ,improv+ ,,fda-,,cms communication reg>d+ trans=mative new !rapies4,sec4 #cjf4 ,e/abli%m5t ( additional ,int]c5t] ,in/itutes at ! ,food & ,drug ,adm9i/ration4,sec4 #cjg4 ,accel]at+ timel9e = break?r\gh & ,,rmat designations4,sec4 #cjh4 ,guidance reg>d+ developm5t & submission ( *emi/ry1 manufactur+1 & controls in=mation = exp$it$ approval4,sec4 #cji4 ,po/-approval /udy requirem5ts = accel]at$ approval4,sec4 #caj4 ,recomm5dations to dec5tralize cl9ical trials4,title ,,iv--,c5t]s = ,m$ic>e ,m$icaid ,services,sec4 #dja4 ,,gao /udy & report4,sec4 #djb4 ,/rategies to increase access to teleheal? "u ,m$icaid & ,*ildr5's ,heal? ,insurance ,program4,sec4 #djc4 ,ext5d+ ,m$ic>e teleheal? flexibilities4,sec4 #djd4 ,cov]age & paym5t = break?r\gh devices "u ! ,m$ic>e program4,sec4 #dje4 ,secret>y ( ,heal? & ,human ,s]vices report on cov]age = innovative te*nologies4,sec4 #djf4 ,secret>y ( ,heal? & ,human ,s]vices report on ,,cms comput] sy/ems4,sec4 #djg4 ,precision ,m$ic9e ,answ]s = ,kids ,today4,sec4 #djh4 ,m$ic>e cov]age = consultations4,sec4 #dji4 ,prohibit+ ! use ( geographic track+ features & biometrics )9 ,m$icaid electronic visit v]ification sy/ems4,sec4 #daj4 ,g5]ally accept$ /&>d = electronic prescrib+4,sec4 #daa4 ,mean+ful access to ,f$]al heal? plan claims data4,title ,v--,research,sec4 #eja4 ,advanc$ ,rese>* ,projects ,ag5cy = ,heal?4,sec4 #ejb4 ,rese>* inve/m5t to sp>k ! economy4,sec4 #ejc4 ,rese>* ,policy ,bo>d reau?orization4 ,i ,public heal? #aja4 ,fur!r und]/&+ ! implications ( long ,,covid 7a7 ,s\rces ( cov]age survey ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 conduct a l>ge national survey ( pati5ts :o self-id5tify z hav+ long ,,covid to assess s\rces ( heal? cov]age1 long-t]m c>e cov]age1 & disability cov]age = long ,,covid & relat$ symptoms2 & 7#b7 n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 complete su* survey & submit a report on ! results ( su* survey to ! ,committees on ,en]gy & ,comm]ce1 ,ways & ,means1 & ,education & ,labor ( ! ,h\se ( ,repres5tatives & ! ,committees on ,heal?1 ,education1 ,labor1 & ,p5sions & ,f9ance ( ! ,s5ate4 7b7 ,le>n+ collaborative 7#a7 ,national meet+s ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7,a7 conv5e a s]ies ( n less ?an f\r national meet+s1 t may be virtual1 to s]ve z ! basis ( an ongo+ long ,,covid le>n+ collaborative ) individuals & organizations repres5t+ key sectors ( ! heal? c>e community2 & 7,b7 invite to p>ticipate 9 su* meet+s individuals :o repres5t ! views ( heal? plan repres5tatives1 heal? c>e provid]s 7includ+ hospitals1 physicians1 & nurses71 m$ical & sci5tific rese>*]s1 pati5t & consum] advocates1 data sci5ti/s1 heal? c>e s]vice provid]s1 provid]s ( work]s comp5sation1 employ]s1 & develop]s ( diagno/ic & !rapeutic products1 includ+ cl9ical laboratories4 7#b7 ,t]m9ation ( meet+s ,! ,secret>y %all cont9ue to conv5e national meet+s "u p>agraph 7#a7 =-- 7,a7 n less ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act2 & 7,b7 ea* fiscal ye> !reaft]1 unless ! ,secret>y det]m9es t ! public heal? & m$ical k ) respect to long ,,covid has suffici5tly advanc$ to ensure widespread und]/&+ ( ! *>act]i/ics ( long ,,covid1 includ+-- 7i7 ! etiology1 progression1 simil>ity to o!r conditions1 & duration ( long ,,covid2 & 7ii7 conditions t int]act ) long ,,covid4 7c7 ,long ,,covid sci5tific rese>* = *ildr5 7#a7 ,9 g5]al ,beg9n+ n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all aw>d grants to hospitals = *ildr51 p$iatric rese>*]s1 academic m$ical c5t]s1 & o!r appropriate organizations to rese>* ! long-t]m effects & treatm5t ( ,,covid-#ai 9 *ildr51 includ+ long ,,covid4 7#b7 ,au?orization ( appropriations ,( ! am\nts made available = rese>* & cl9ical trials relat$ to long-t]m /udies ( ,,covid-#ai "u ! head+ ,national ,in/itutes ( ,heal?--,(fice ( ! ,director ( title ,,iii ( ! ,consolidat$ ,appropriations ,act1 #bjba 7,public ,law #aaf-bfj71 !re are au?oriz$ to be appropriat$ su* sums z may be necess>y to c>ry out ?is subsection4 7d7 ,/udy on disp>ities 9 long ,,covid 7#a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all seek to ent] into an arrangem5t ) ! ,national ,academy ( ,m$ic9e "u :i* ! ,academy conducts a /udy to evaluate disp>ities 9 racial & e?nic m9ority gr\ps ) respect to diagnosis (1 sev]ity ( symptoms1 access to c>e1 & treatm5t = long ,,covid4 7#b7 ,cont5t ,! /udy "u p>agraph 7#a7 %all-- 7,a7 ) respect to individuals :o are ,black1 ,hispanic1 ,am]ican ,indian1 ,alaska ,native1 or :o belong to o!r racial & e?nic populations-- 7i7 evaluate ! preval5ce ( long ,,covid2 7ii7 evaluate ! rates ( hospitalization & dea? f ,,covid-#ai2 & 7iii7 evaluate & id5tify factors t increase ! risk ( sev]ity ( long ,,covid2 & 7,b7 include recomm5dations to id5tify & address ! disp>ities describ$ 9 p>agraph 7#a71 includ+ ! causes ( su* disp>ities4 7#c7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is subsection #e1jjj1jjj = fiscal ye> #bjbb1 to rema9 available until exp5d$4 7e7 ,education & dissem9ation ( in=mation ) respect to long-,t]m symptoms ( ,,covid-#ai 7#a7 ,long ,,covid public education program ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all develop & dissem9ate to ! public in=mation reg>d+ long ,,covid1 includ+ in=mation on-- 7,a7 ! aw>5ess1 incid5ce1 & common symptoms ( long ,,covid2 & 7,b7 ! availability1 z m$ically appropriate1 ( treatm5t options = long ,,covid4 7#b7 ,long ,,covid provid] education program ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all 9 consultation ) communities ( individuals diagnos$ ) long ,,covid1 develop & dissem9ate to heal? c>e provid]s in=mation on long ,,covid = ! purpose ( ensur+ t su* provid]s rema9 in=m$ ab\t curr5t in=mation on long ,,covid4 7#c7 ,arrangem5t au?ority ,! ,secret>y ( ,heal? & ,human ,s]vices may dissem9ate in=mation "u p>agraphs 7#a7 & 7#b7 directly or ?r\gh arrangem5ts ) intra-ag5cy initiatives1 nonpr(it organizations1 consum] gr\ps1 in/itutions ( high] le>n+ 7z def9$ 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja771 or ,f$]al1 ,/ate1 or local public private p>tn]%ips4 7#d7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #cj1jjj1jjj = fiscal ye> #bjbb1 :i* %all rema9 available until exp5d$4 #ajb4 ,national /rategy to prev5t & respond to p&emics 7a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,presid5t1 act+ ?r\gh ! ,secret>y ( ,heal? & ,human ,s]vices1 %all-- 7#a7 develop & implem5t a national /rategy to prev5t & respond to p&emics & o!r public heal? em]g5cies = :i* a decl>ation is made "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d72 & 7#b7 base su* /rategy on lessons le>n$1 & be/ practices develop$1 z a result ( ! ,,covid-#ai p&emic4 7b7 ,cont5ts ,! national /rategy "u subsection 7a7 %all at a m9imum address ea* ( ! foll[+3 7#a7 ,/rategies = te/+ 7includ+ po9t-(-c>e te/+ & te/+ at nonm$ical sites7 to fo/] exp$i5t results & p]sonaliz$ m$ical responses = pati5ts & communities1 includ+ = m$ically und]s]v$ populations4 7#b7 ,me?ods ( data %>+ to use te/+ to in=m surveillance & o!r p&emic monitor+ & response ef=ts4 7#c7 ,/rategies to enable ,am]icans to cont9ue to "w1 or return to "w1 or cont9ue to rema9 91 or return to1 9-p]son s*ool & *ildc>e sett+s safely4 7#d7 ,mod]niz+ & exp&+ dome/ic drug manufactur+1 includ+ ?r\gh ! use ( cont9u\s manufactur+4 7#e7 ,develop+ & adm9i/]+ vacc9es1 !rapeutics1 & o!r m$ical supplies1 includ+ = *ildr51 racial & e?nic m9orities1 & p ) disabilities4 #ajc4 ,p&emic prep>$ness r>e disease support program ,subtitle ,b ( title ,,xxviii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj et seq47 is am5d$ by ins]t+ aft] section #bhae ( su* ,act ! foll[+3 #bhaf4 ,p&emic prep>$ness plan 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration & 9 collaboration ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all aw>d grants to eligible organizations to develop a p&emic prep>$ness plan reg>d+-- 7#a7 ! *all5ges fac$ by pati5ts & ! family c>egiv]s ( su* pati5ts s]v$ by ! respective eligible organizations dur+ ! ,,covid-#ai p&emic2 7#b7 pot5tial *all5ges = ! respective eligible organizations dur+ future p&emics & o!r public heal? em]g5cies2 7#c7 h[ ! respective eligible organizations plan to ov]come ! *all5ges describ$ 9 p>agraphs 7#a7 & 7#b71 includ+ h[ ! respective organizations plan to support pati5ts1 _! families1 & heal? c>e provid]s to ov]come su* *all5ges2 & 7#d7 ef=ts to p>tn] ) local1 ,/ate1 & ,f$]al gov]nm5ts to promote a coord9at$ response to future p&emics & o!r public heal? em]g5cies4 7b7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all give priority to eligible organizations t are r>e disease or condition organizations4 7c7 ,def9itions ,9 ?is section3 7#a7 ,! t]m eligible organization means an organization t-- 7,a7 is describ$ 9 section #eja7;c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f tax "u section #eja7;a7 ( su* ,code2 & 7,b7 provides support & o!r res\rces to pati5ts & _! families = access+ & pay+ = m$ical c>e4 7#b7 ,! t]m public heal? em]g5cy means a public heal? em]g5cy decl>$ "u section #cai4 7#c7 ,! t]m r>e disease or condition has ! mean+ giv5 to su* t]m 9 section #ebf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7d7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #be1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbd4 4 #ajd4 ,vacc9e & immunization programs 7a7 ,additional fund+ = vacc9e aw>5ess ,!re are au?oriz$ to be appropriat$ to ! ,c5t]s = ,disease ,control & ,prev5tion #be1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbd = ! purpose ( c>ry+ out an aw>5ess campaign to educate ! public ) respect to ! safety & importance ( vacc9es4 ,! am\nts au?oriz$ by ! prec$+ s5t5ce are 9 addition to am\nts o!rwise available = su* purpose4 7b7 ,/r5g!n+ ! immunization in=mation sy/em ,!re are au?oriz$ to be appropriat$ to ! ,c5t]s = ,disease ,control & ,prev5tion #be1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbd = ! purpose ( /r5g!n+ immunization in=mation sy/ems4 ,! am\nts au?oriz$ by ! prec$+ s5t5ce are 9 addition to am\nts o!rwise available = su* purpose4 #aje4 ,develop+ antimicrobial innovations ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,develop+ antimicrobial innovations #cii,,oo4 ,e/abli%m5t ( ,committee2 subscription model2 advisory gr\p 7a7 ,9 g5]al ,n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is "p1 ! ,secret>y %all e/abli% a ,committee on ,critical ,ne$ ,antimicrobials & appo9t memb]s to ! ,committee4 7b7 ,memb]s 7#a7 ,9 g5]al ,! ,committee %all consi/ ( at lea/ "o repres5tative f ea* ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,food & ,drug ,adm9i/ration1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,vet]ans ,heal? ,adm9i/ration1 & ! ,dep>tm5t ( ,def5se4 7#b7 ,*air ,! ,secret>y %all appo9t "o ( ! memb]s ( ! ,committee to s]ve z ! ,*air ( ! ,committee4 7c7 ,duties ,n lat] ?an #a ye> aft] ! appo9tm5t ( all initial memb]s ( ! ,committee1 ! ,secret>y1 9 collaboration ) ! ,committee1 & 9 consultation ) ! ,critical ,ne$ ,antimicrobials ,advisory ,gr\p e/abli%$ "u subsection 7g71 %all d ! foll[+3 7#a7 ,develop a li/ ( infections = :i* new antimicrobial drug developm5t is ne$$1 tak+ into acc\nt organisms1 sites ( infection1 & type ( infections = :i* !re is an unmet m$ical ne$1 f9d+s f ! mo/ rec5t report entitl$ ,antibiotic ,resi/ance ,?reats 9 ! ,unit$ ,/ates issu$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 or an anticipat$ unmet m$ical ne$1 includ+ a pot5tial global heal? security ?reat4 ,= ! li/ develop$ "u ?is p>agraph1 ! ,secret>y1 9 collaboration ) ! ,committee1 may use ! infection li/ 9 su* mo/ rec5t report = up to #c ye>s foll[+ ! date ( ! enactm5t ( ?is "p & subsequ5tly update ! li/ "u ?is p>agraph 9 accordance ) subsection 7e74 7#b7 ,develop regulations1 9 accordance ) subsection 7d71 outl9+ favor$ *>act]i/ics ( critical ne$ antimicrobial drugs1 t are evid5ce bas$1 cl9ically focus$1 & design$ to treat ! infections describ$ 9 p>agraph 7#a71 & e/abli%+ crit]ia = h[ ea* su* *>act]i/ic w adju/ ! monet>y value ( a subscription contract aw>d$ "u subsection 7f7 or section #cii,,qq4 ,! favor$ *>act]i/ics %all be weigh$ = purposes ( su* monet>y value su* t meet+ c]ta9 *>act]i/ics1 or meet+ m ?an "o su* *>act]i/ic1 increases ! monet>y value4 ,su* favor$ *>act]i/ics ( an antimicrobial drug %all include-- 7,a7 treat+ infections on ! li/ "u p>agraph 7#a72 7,b7 improv+ cl9ical outcomes = pati5ts ) multi-drug-resi/ant infections2 7,c7 be+ a fir/-approv$ antimicrobial drug t has ! pot5tial to address unmet m$ical ne$s = ! treatm5t ( a s]i\s or life-?reat5+ infection1 &1 to a less] ext5t1 second & ?ird drugs t treat su* infections2 7,d7 r\te ( adm9i/ration1 especially ?r\gh oral adm9i/ration2 7,e7 7i7 conta9+ no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 t has be5 approv$ 9 any o!r application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or int5d+ to be ! subject ( a new orig9al biologics lic5se application "u section #cea7;a72 7ii7 be+ a memb] ( a new class ( drugs ) a novel t>get & novel mode ( action t are di/9ctly diff]5t f ! t>get or mode ( any antimicrobial drug approv$ "u section #eje ( su* ,act or lic5s$ "u section #cea1 includ+ r$uc$ toxicity2 7iii7 n be+ affect$ by cross-resi/ance to any antimicrobial drug approv$ "u su* section #eje or lic5s$ "u su* section #cea2 7,f7 address+ a multi-drug-resi/ant infection ?r\gh a novel *emical scaffold or me*anism ( action2 7,g7 hav+ receiv$ a transitional subscription contract "u subsection 7f72 & 7,h7 any o!r *>act]i/ic ! ,secret>y1 9 collaboration ) ! ,committee1 det]m9es necess>y4 7d7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! appo9tm5t ( ! initial memb]s ( ! ,committee1 ! ,secret>y %all issue propos$ regulations :i* %all include-- 7,a7 a process by :i* ! sponsors c apply = an antimicrobial drug to become a critical ne$ antimicrobial drug "u section #cii,,pp2 7,b7 h[ subscription contracts "u su* section %all be e/abli%$ & paid2 7,c7 ! favor$ *>act]i/ics "u subsection 7c77#b71 h[ su* *>act]i/ics w be weigh$1 & ! m9imum numb] & k9d ( favor$ *>act]i/ics ne$$ = an antimicrobial drug to be designat$ a critical ne$ antimicrobial drug2 & 7,d7 o!r elem5ts ( ! subscription contract process1 9 accordance ) ?is "p4 7#b7 ,developm5t ( f9al regulations ,be=e f9aliz+ ! regulations "u p>agraph 7#a71 ! ,secret>y %all solicit public comm5t & hold public meet+s = ! p]iod beg9n+ on ! date on :i* ! propos$ regulations are issu$ & end+ on ! date t is #abj days aft] su* date ( issuance4 ,! ,secret>y %all f9alize & publi% su* regulations n lat] ?an #abj days aft] ! close ( su* p]iod ( public comm5t & meet+s4 7#c7 ,subscription contract (fice ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is "p1 ! ,secret>y %all propose an ag5cy or (fice 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to manage ! e/abli%m5t & paym5t ( subscription contracts aw>d$ "u section #cii,,qq1 includ+ eligibility1 requirem5ts1 & contract am\nts4 ,! ,secret>y %all solicit public comm5t & f9alize ! ag5cy or (fice no lat] ?an #de days foll[+ ! propos$ ag5cy or (fice4 ,su* ag5cy or (fice %all be ref]r$ to z ! ,subscription ,contract ,(fice4 7e7 ,li/ ( infections ,! ,secret>y1 9 collaboration ) ! ,committee1 %all update ! li/ ( infections "u subsection 7c77#a7 at lea/ e #b ye>s4 7f7 ,transitional subscription contracts 7#a7 ,9 g5]al ,n e>li] ?an #cj days aft] ! date ( ! enactm5t ( ?is "p & end+ on ! date t ! ,secret>y f9alizes ! subscription contract regulations "u subsection 7d71 ! ,secret>y may use up to #a1jjj1jjj1jjj ( ! am\nt appropriat$ "u section #cii,,ss7a7 to engage 9 transitional subscription contracts ( up to #c ye>s 9 l5g? ) antimicrobial develop]s1 z det]m9$ by ! ,secret>y1 t h develop$ antimicrobial drugs treat+ infections li/$ 9 ! mo/ rec5t report entitl$ ,antibiotic ,resi/ance ,?reats 9 ! ,unit$ ,/ates issu$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 & may include antimicrobial drugs t are qualifi$ infecti\s disease products 7z def9$ 9 section #eje;,e7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 innovative biological products1 or innovative drugs t a*ieve a cl9ical outcome ?r\gh immunomodulation4 ,su* a contract may au?orize ! contractor to use funds made available "u ! contract = completion ( po/m>ket+ cl9ical /udies1 manufactur+1 & o!r precl9ical & cl9ical ef=ts4 7#b7 ,requirem5ts 7,a7 ,9 g5]al ,! ,secret>y1 ?r\gh ! (fice describ$ 9 p>agraph 7#d71 may ent] into a contract "u p>agraph 7#a7-- 7i7 if ! ,secret>y det]m9es t ! antimicrobial drug is int5d$ to treat an infection = :i* !re is an unmet cl9ical ne$1 an anticipat$ cl9ical ne$1 or drug resi/ance2 7ii7 subject to t]ms includ+-- 7,i7 t ! ,secret>y %all cease any paym5t in/allm5ts "u a transitional subscription contract if ! sponsor does n-- 7aa7 ensure comm]cial & ,f$]al availability ( ! antimicrobial drug )9 #cj days ( receiv+ fir/ paym5t "u ! contract2 7bb7 id5tify1 track1 & publicly report drug resi/ance data & tr5ds us+ available data relat$ to ! antimicrobial drug2 7cc7 develop & implem5t education & communications /rategies1 includ+ communications = individuals ) limit$ ,engli% pr(ici5cy & individuals ) disabilities1 = heal? c>e pr(essionals & pati5ts ab\t appropriate use ( ! antimicrobial drug2 7dd7 submit a plan = regi/]+ ! antimicrobial drug 9 additional c\ntries :]e an unmet m$ical ne$ exi/s1 :i* su* plan may be consi/5t ) ! ,/ew>d%ip & ,access ,plan 7,,sap7 ,developm5t ,guide 7#bjba72 7ee7 subject to subp>agraph 7,b71 ensure a reliable drug supply *a91 ?us lead+ to an int]ruption ( ! supply ( ! antimicrobial drug 9 ! ,unit$ ,/ates = m ?an #fj days2 or 7ff7 make mean+ful progress t[>d completion ( ,food & ,drug ,adm9i/ration-requir$ po/m>ket+ /udies1 includ+ su* /udies t are evid5ce bas$2 & 7,,ii7 o!r t]ms z det]m9$ by ! ,secret>y2 & 7iii7 if-- 7,i7 a phase #c cl9ical /udy has be5 initiat$ = ! antimicrobial drug2 or 7,,ii7 ! antimicrobial drug has be5 approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea7;a74 7,b7 ,waiv] ,! requirem5t "u subp>agraph 7,a77ii77,i77ee7 may be waiv$ 9 ! case t an em]g5cy prohibits access to a reliable drug supply *a94 7#c7 ,transitional guidance ,n lat] ?an #abj days aft] ! appo9tm5t ( ! initial memb]s ( ! ,committee1 ! ,secret>y %all issue1 9 consultation ) ! ,committee1 transitional guidance outl9+ ! antimicrobial drugs t are eligible = transitional subscription contracts "u p>agraph 7#a71 ! requirem5ts to ent] into a transitional subscription contract "u p>agraph 7#b71 & ! process by :i* drug develop]s c ent] into transitional subscription contracts ) ! ,secret>y "u ?is subsection4 7#d7 ,paym5t (fice & me*anism ,n lat] ?an #cj days aft] ! date ( ! enactm5t ( ?is "p1 ! ,secret>y %all det]m9e ! ag5cy or (fice 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices t w manage ! transitional subscription contracts1 includ+ eligibility1 requirem5ts1 & contract am\nts1 dur+ ! p]iod describ$ 9 p>agraph 7#a74 7g7 ,critical ne$ antimicrobial advisory gr\p 7#a7 ,9 g5]al ,n lat] ?an #cj days aft] ! appo9tm5t ( all initial memb]s ( ! ,committee1 ! ,secret>y1 9 collaboration ) ! ,committee1 %all e/abli% a ,critical ,ne$ ,antimicrobial ,advisory ,gr\p 7ref]r$ to 9 ?is subsection z ! ,advisory ,gr\p7 & appo9t memb]s to ! ,advisory ,gr\p4 7#b7 ,memb]s ,! memb]s ( ! ,advisory ,gr\p %all include-- 7,a7 n few] ?an #f individuals :o are-- 7i7 infecti\s disease speciali/s2 or 7ii7 o!r heal? exp]ts ) exp]tise 9 rese>*+ antimicrobial resi/ance1 heal? economics1 or comm]cializ+ antimicrobial drugs2 & 7,b7 n few] ?an #e pati5t advocates4 7#c7 ,*air ,! ,secret>y %all appo9t "o ( ! memb]s ( ! ,advisory ,gr\p to s]ve z ! ,*air4 7#d7 ,conflicts ( int]e/ ,9 appo9t+ memb]s "u p>agraph 7#b71 ! ,secret>y %all ensure t no memb] receives comp5sation 9 any mann] f a comm]cial or =-pr(it entity t develops antimicrobials or t might b5efit f antimicrobial developm5t4 7#e7 ,applicability ( ,,faca ,except z o!rwise provid$ 9 ?is subsection1 ! ,f$]al ,advisory ,committee ,act %all apply to ! ,advisory ,gr\p4 #cii,,pp4 ,critical ne$ antimicrobial drug application & paym5t ?r\gh subscription contracts 7a7 ,9 g5]al 7#a7 ,submission ( reque/ ,! sponsor ( an application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a7 = an antimicrobial drug may reque/ t ! ,secret>y designate ! drug z a critical ne$ antimicrobial4 ,a reque/ = su* designation may be submitt$ aft] ! ,secret>y grants = su* drug an inve/igational new drug exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c71 & %all be submitt$ n lat] ?an #e ye>s aft] ! date ( approval "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea7;a74 7#b7 ,cont5t ( reque/ ,a reque/ "u p>agraph 7#a7 %all include in=mation1 su* z cl9ical1 precl9ical & po/m>ket+ data1 a li/ ( ! favorable *>act]i/ics describ$ 9 section #cii,,oo7c77#b71 & any o!r mat]ial t ! ,secret>y 9 consultation ) ! ,committee requires4 7#c7 ,review by secret>y ,! ,secret>y %all promptly review all reque/s = designation submitt$ "u ?is subsection1 assess all requir$ application compon5ts1 & det]m9e if ! antimicrobial drug is likely to meet ! favorable *>act]i/ics id5tifi$ 9 ! application ^u ! completion ( cl9ical developm5t4 ,aft] review1 ! ,secret>y %all approve or d5y ea* reque/ = designation n lat] ?an #ij days aft] receiv+ a reque/4 ,if ! ,secret>y approves a reque/1 x %all publi% ! value ( ! contract t ! critical ne$ antimicrobial develop] w\ld be eligible to receive if su* develop] successfully demon/rates t ! drug meets ! maximum value ( ! favor$ *>act]i/ics li/$ 9 ! application4 7#d7 ,l5g? ( designation p]iod ,a designation grant$ "u ?is section %all be 9 effect = a p]iod ( #aj ye>s aft] ! date t ! designation is approv$1 & %all rema9 9 effect = su* p]iod ev5 if ! infection treat$ by su* drug is lat] remov$ f ! li/ ( infections "u section #cii,,oo7c77#a74 7#e7 ,subsequ5t reviews ,no soon] ?an #b ye>s aft] a designation approval or d5ial "u subsection 7#c71 ! sponsor may reque/ a subsequ5t review to reevaluate ! value ( a contract to include any new in=mation4 7b7 ,developm5t ( designat$ drugs ,if a critical ne$ antimicrobial designation is grant$ dur+ cl9ical developm5t ( an antimicrobial drug1 ! ,secret>y may "w ) ! sponsor to maximize ! opportunity = ! sponsor to successfully demon/rate t ! antimicrobial drug possesses ! favor$ *>act]i/ics ( high-monet>y valu$ products id5tifi$ "u section #cii,,oo7c77#b74 7c7 ,appropriate use ( critical ne$ antimicrobial 7#a7 ,9 g5]al ,! sponsor ( an antimicrobial drug t receives designation "u subsection 7a7 %all )9 #ij days ( su* designation1 submit to ! ,secret>y a plan = appropriate use ( diagno/ics1 9 ord] = ! ,secret>y & ,committee to consid] su* plan 9 develop+ cl9ical guidel9es4 ,an appropriate use plan-- 7,a7 %all include-- 7i7 ! appropriate use ( ! drug2 & 7ii7 ! appropriate use ( diagno/ic tools1 :]e available1 su* z diagno/ic te/+ = biom>k]s relat$ to antimicrobial-resi/ant pa?og5s1 or o!r t>get$ diagno/ic approa*es1 to in=m use ( ! drug2 & 7,b7 may be develop$ 9 p>tn]%ip ) ! ,secret>y1 infecti\s disease exp]ts1 diagno/ic exp]ts or develop]s1 laboratory exp]ts1 or ano!r entity4 7#b7 ,consultation ,! ,secret>y %all consult ) relevant pr(essional societies & ! ,critical ,ne$ ,antimicrobial ,advisory ,gr\p e/abli%$ "u section #cii,,oo7g7 to ensure t cl9ical guidel9es issu$ by ! ,secret>y "u p>agraph 7#c71 ) respect to an antimicrobial drug designat$ "u subsection 7a71 includes ! use ( appropriate diagno/ic approa*es1 tak+ into consid]ation ! diagno/ic plan submitt$ by a sponsor "u p>agraph 7#a74 7#c7 ,publication ( cl9ical guidel9es ,n lat] ?an #a ye> aft] ! ,secret>y makes ! fir/ designation "u subsection 7a71 & n less ?an e #c ye>s !reaft]1 ! ,secret>y %all publi% cl9ical guidel9es 9 consultation ) relevant pr(essional societies ) respect to ea* antimicrobial drug t has be5 approv$ or lic5s$ z describ$ 9 subsection 7a77#a7 & t has be5 designat$ "u subsection 7a71 :i* guidel9es %all set =? ! evid5ce-bas$ recomm5dations = prescrib+ ! drug1 9 accordance ) ! submissions ( ! sponsor "u p>agraph 7#a7 & aft] consultation "u p>agraph 7#b71 z appropriate4 #cii,,qq4 ,subscription contracts 7a7 ,application = a subscription contract 7#a7 ,submission ( applications ,aft] approval "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea7;a71 ! sponsor ( an antimicrobial drug designat$ z a critical ne$ antimicrobial "u section #cii,,pp may submit an application = a subscription contract ) ! ,secret>y1 "u a proc$ure e/abli%$ by ! ,secret>y4 7#b7 ,review ( applications ,! ,secret>y %all1 9 consultation ) ! ,committee-- 7,a7 review all applications = subscription contracts "u p>agraph 7#a7 & assess all requir$ application compon5ts2 7,b7 det]m9e ! ext5t to :i* ! critical ne$ antimicrobial meets ! favor$ *>act]i/ics id5tifi$ "u section #cii,,oo7c77#b71 & d5y any application = a drug t meets none ( su* *>act]i/ics2 & 7,c7 assign a monet>y value to ! contract bas$ on ! regulations develop$ "u section #cii,,oo7d74 7b7 ,crit]ia ,to qualify = a subscription contract "u ?is section1 ! sponsor ( an antimicrobial drug designat$ z a critical ne$ antimicrobial %all agree to-- 7#a7 ensure comm]cial & ,f$]al availability ( ! antimicrobial drug )9 #cj days ( receiv+ fir/ paym5t "u ! contract1 & suffici5t supply = susceptibility device manufactur]s2 7#b7 id5tify1 track1 & publicly report drug resi/ance data & tr5ds us+ available data relat$ to ! antimicrobial drug2 7#c7 develop & implem5t education & communications /rategies1 includ+ communications = individuals ) limit$ ,engli% pr(ici5cy & individuals ) disabilities1 = heal? c>e pr(essionals & pati5ts ab\t appropriate use ( ! antimicrobial drug2 7#d7 submit an appropriate use assessm5t to ! ,secret>y1 ,committee1 ,food & ,drug ,adm9i/ration1 & ,c5t]s = ,disease ,control & ,prev5tion e #b ye>s reg>d+ use ( ! antimicrobial drug1 includ+ h[ ! drug is be+ m>ket$2 7#e7 submit a plan = regi/]+ ! drug 9 additional c\ntries :]e an unmet m$ical ne$ exi/s2 7#f7 ensure a reliable drug supply *a91 :]e any int]ruption to ! supply *a9 w n la/ = m ?an #fj days 9 ! ,unit$ ,/ates2 7#g7 complete any po/m>ket+ /udies requir$ by ! ,food & ,drug ,adm9i/ration 9 a timely mann]2 7#h7 produce ! drug at a reasonable volume det]m9$ ) ! ,secret>y to ensure pati5t access to ! drug2 7#i7 price ! drug at a price t is n l[] ?an a comp>able g5]ic drug2 7#aj7 abide by ! manufactur+ & environm5tal be/ practices 9 ! supply *a9 to ensure t !re is no dis*>ge into1 or contam9ation (1 ! environm5t by antimicrobial ag5ts or products z a result ( ! manufactur+ process2 & 7#aa7 abide by o!r t]ms z ! ,secret>y may require4 7c7 ,am\nt & t]ms ( contracts 7#a7 ,am\nts ,a subscription contract "u ?is section %all be = ! sale to ! ,secret>y ( any quantity ( ! antimicrobial drug ne$$ ov] ! t]m ( ! contract "u p>agraph 7#b71 at an agre$ ^u price1 = a total project$ am\nt det]m9$ by ! ,secret>y t is n less ?an #gej1jjj1jjj & n m ?an #c1jjj1jjj1jjj1 adju/$ = inflation1 acc\nt+ = ! favor$ *>act]i/ics ( ! drug1 z det]m9$ by ! ,secret>y1 9 consultation ) ! ,committee1 "u subsection 7a77#b71 & %all be allocat$ f ! am\nt made available "u section #cii,,ss7a74 ,n lat] ?an #f mon?s aft] ! subscription contract is grant$ "u subsection 7a71 ! ,secret>y %all provide paym5ts = pur*as$ drugs 9 in/allm5ts e/abli%$ by ! ,secret>y 9 consultation ) ! sponsor ( ! antimicrobial drug & 9 accordance ) subsection 7d77#c74 ,funds receiv$ by ! sponsor %all be us$ to support crit]ia qualification "u subsection 7b71 ! completion ( po/m>ket+ cl9ical /udies1 manufactur+1 o!r precl9ical & cl9ical activities1 or o!r activities agre$ to by ! ,secret>y & sponsor 9 ! contract4 7#b7 ,t]ms 7,a7 ,initial t]m ,! initial t]m ( a contract "u ?is subsection %all be no less ?an #e ye>s or great] ?an ! great] ( #aj ye>s or ! rema9+ p]iod ( "t dur+ :i* ! sponsor has pat5t protections or a rema9+ exclusivity p]iod ) respect to ! antimicrobial drug 9 ! ,unit$ ,/ates1 z li/$ 9 ! publication ( ! ,food & ,drug ,adm9i/ration entitl$ ,approv$ ,drug ,products ) ,!rapeutic ,equival5ce ,evaluations4 ,paym5ts may be 9 equal annual in/allm5ts ) ! option to r$eem #ej p]c5t ( ! la/ ye>'s reimbursem5t 9 ye> #a ( ! contract 9 ord] to (fset co/s ( e/abli%+ manufactur+ capacity1 or ano!r subscription arrangem5t to :i* ! ,secret>y & sponsor agree4 ,subscription contracts %all rema9 9 effect = su* p]iod ev5 if ! infection treat$ by su* antimicrobial drug is lat] remov$ f ! li/ ( infections "u section #cii,,oo7c77#a74 7,b7 ,ext5sion ( contracts ,! ,secret>y may ext5d a subscription contract ) a sponsor "u ?is subsection beyond ! initial contract p]iod4 ,a s+le contract ext5sion may be 9 effect n lat] ?an ! date on :i* all p]iods ( exclusivity grant$ by ! ,food & ,drug ,adm9i/ration expire & %all be 9 an am\nt n to exce$ #be1jjj1jjj p] ye>4 ,all o!r t]ms ( an ext5d$ contract %all be ! same z ! t]ms ( ! initial contract4 ,! total am\nt ( fund+ us$ on su* contract ext5sions %all be no m ?an #a1jjj1jjj1jjj1 & %all be allocat$ f ! am\nt made available "u section #cii,,ss4 7,c7 ,modification ( contracts ,! ,secret>y or sponsor1 #a ye> aft] ! />t ( ! contract p]iod "u ?is subsection & e #b ye>s !reaft]1 may reque/ a modification ( ! am\nt ( ! contract bas$ on in=mation t adju/s favor$ *>act]i/ics 9 section #cii,,oo7c77#b74 7#c7 ,adju/m5t ,9 ! case ( an antimicrobial drug t receiv$ a transitional subscription contract "u section #cii,,oo7f71 ! am\nt ( a subscription contract = su* drug "u ?is section %all be r$uc$ by ! am\nt ( ! transitional subscription contract "u su* section #cii,,oo7f7 = su* drug4 7#d7 ,contracts = g5]ic & biosimil> v]sions ,not)/&+ any o!r provision 9 ?is "p1 ! ,secret>y may aw>d a subscription contract "u ?is section to a manufactur] ( a g5]ic or biosimil> v]sion ( an antimicrobial drug = :i* a subscription contract has be5 aw>d$ "u ?is section4 ,su* contracts %all be aw>d$ 9 accordance ) a proc$ure1 includ+ = det]m9+ ! t]ms & am\nts ( su* contracts1 e/abli%$ by ! ,secret>y4 7d7 ,annual antimicrobial drug sponsor rev5ue limitations 7#a7 ,report+ requirem5t 7,a7 ,9 g5]al ,n lat] ?an a date det]m9$ appropriate by ! ,secret>y foll[+ ! end ( ea* cal5d> ye>1 & n e>li] ?an #f mon?s aft] ! end ( ea* cal5d> ye>1 ! head 7or a designee ( su* head7 ( ea* ,f$]al ag5cy c>ry+ out a specifi$ gov]nm5t program %all1 9 accordance ) ?is p>agraph1 report to ! ,subscription ,contract ,(fice e/abli%$ "u section #cii,,oo7d77#c7 ! total prescription drug sales = ea* applicable antimicrobial drug "u contract ) respect to su* program = su* cal5d> ye>4 7,b7 ,m$ic>e ,"p ,d program ,= purposes ( subp>agraph 7,a71 ! ,secret>y %all report1 = ea* applicable antimicrobial drug cov]$ "u "p ,d ( title ,,xviii ( ! ,social ,security ,act1 ! product (-- 7i7 ! p]-unit +r$i5t co/1 z report$ to ! ,secret>y by prescription drug plans & ,m$ic>e ,advantage prescription drug plans1 m9us any p]-unit rebate1 disc\nt1 or o!r price concession provid$ by ! sponsor ( su* applicable antimicrobial drug1 z report$ to ! ,secret>y by ! prescription drug plans & ! ,m$ic>e ,advantage prescription drug plans2 & 7ii7 ! numb] ( units ( su* applicable antimicrobial drug paid = "u su* "p ,d4 7,c7 ,m$ic>e ,"p ,b program 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 ! ,secret>y %all report1 = ea* applicable antimicrobial drug cov]$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act1 ! product (-- 7,i7 ! p]-unit av]age sales price 7z def9$ 9 section #ahdg;,a7c7 ( su* ,act7 or ! p]-unit paym5t rate "u su* "p ,b = a sep>ately paid prescription drug )\t a report$ av]age sales price2 & 7,,ii7 ! numb] ( units ( su* applicable antimicrobial drug paid = "u su* "p ,b4 7ii7 ,units & allocat$ prices ,! ,secret>y %all e/abli% a process = det]m9+ ! units & ! allocat$ price = purposes ( ?is subp>agraph = ^? applicable antimicrobial drugs t are n sep>ately payable or = :i* ,national ,drug ,codes are n report$4 7,d7 ,m$ic>e ,"p ,a program 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 ! ,secret>y %all report1 = ea* applicable antimicrobial drug cov]$ "u "p ,a ( title ,,xviii ( ! ,social ,security ,act1 ! product (-- 7,i7 ! p]-unit price "u su* "p ,a = ! antimicrobial drug2 & 7,,ii7 ! numb] ( units ( su* antimicrobial drug paid = "u su* "p ,a4 7ii7 ,special rule ,= purposes ( clause 7i71 ! ,secret>y %all e/abli% a process = det]m9+ ! units & ! allocat$ price = ^? prescription drugs t are n sep>ately payable or = :i* ,national ,drug ,codes are n report$ 9 ! diagnosis-relat$ gr\ps4 7,e7 ,m$icaid program ,"u ! au?ority ( section #aijb7;a77#f7 ( ! ,social ,security ,act1 ! ,secret>y %all require ea* ,/ate t makes m$ical assi/ance available "u ! ,/ate plan "u title ,,xix ( su* ,act 7or any waiv] ( su* plan7 = an applicable antimicrobial drug 7includ+1 if applicable1 any su* drug :i* is a cov]$ outpati5t drug "u a rebate agreem5t ent]$ into "u section #aibg ( su* ,act7 to report1 9 a =m consi/5t ) a /&>d report+ =mat e/abli%$ by ! ,secret>y1 n lat] ?an ! date det]m9$ "u subp>agraph 7,a7-- 7i7 in=mation on ! total numb] ( units ( ea* dosage =m & /r5g? & package size ( ea* applicable antimicrobial drug disp5s$ dur+ ! prec$+ cal5d> ye> "u su* ,/ate plan or waiv] 7includ+ any su* drugs disp5s$ to an individual enroll$ ) a m$icaid manag$ c>e organization or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m7 ( su* ,act772 & 7ii7 ) respect to ea* dosage =m & /r5g? & package size ( ea* su* drug1 ! am\nt equal to-- 7,i7 ! product (-- 7aa7 ! total numb] ( units disp5s$ "u ! ,/ate plan or waiv] dur+ ! prec$+ cal5d> ye> 7z det]m9$ "u clause 7i772 & 7bb7 ! p]-unit +r$i5t co/ paid by ! ,/ate = ea* su* unit2 m9us 7,,ii7 any disc\nts or o!r price concessions provid$ & rebates paid to ! ,/ate ) respect to ! dosage =m & /r5g? & package size ( su* drug & su* cal5d> ye> 7includ+ rebates paid "u a rebate agreem5t "u section #aibg ( su* ,act & any ,/ate supplem5tal rebates paid "u a supplem5tal rebate agreem5t74 7,f7 ,dep>tm5t ( ,vet]ans ,affairs ,= purposes ( subp>agraph 7,a71 ! ,secret>y ( ,vet]ans ,affairs %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,vet]ans ,heal? ,adm9i/ration = individuals :o receive heal? c>e f ! ,adm9i/ration4 7,g7 ,dep>tm5t ( ,def5se & ,,tric>e program ,= purposes ( subp>agraph 7,a71 ! ,secret>y ( ,def5se %all report ! sum (-- 7i7 ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,dep>tm5t ( ,def5se = individuals :o receive heal? c>e f ! ,dep>tm5t2 & 7ii7 = ea* applicable antimicrobial drug disp5s$ "u ! ,,tric>e retail ph>macy program "u section #ajgd;g7a77#b77;,e77ii7 ( title #aj1 ,unit$ ,/ates ,code1 ! product (-- 7,i7 ! p]-unit +r$i5t co/1 m9us any p]-unit rebate paid by ! sponsor ( ! applicable antimicrobial drug2 & 7,,ii7 ! numb] ( units ( su* applicable antimicrobial drug disp5s$ "u su* program4 7,h7 ,dep>tm5t ( ,homel& ,security ,= purposes ( subp>agraph 7,a71 ! ,secret>y ( ,homel& ,security %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,dep>tm5t ( ,homel& ,security = individuals :o receive heal? c>e ?r\gh a program c>ri$ out by ! ,dep>tm5t4 7,i7 ,bureau ( ,prisons ,= purposes ( subp>agraph 7,a71 ! ,director ( ! ,bureau ( ,prisons %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,bureau ( ,prisons = individuals :o receive heal? c>e ?r\gh ! ,bureau4 7,j7 ,indian ,heal? ,s]vice ,= purposes ( subp>agraph 7,a71 ! ,secret>y1 act+ ?r\gh ! ,indian ,heal? ,s]vice1 %all report ! total am\nt paid = ea* applicable antimicrobial drug procur$ by ! ,s]vice = individuals :o receive heal? c>e ?r\gh ! ,s]vice4 7#b7 ,regulations ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is "p1 ! ,secret>y1 9 consultation ) ! heads ( ,f$]al ag5cies c>ry+ out specifi$ gov]nm5t programs1 %all issue regulations to assi/ su* heads 7or _! designees7 9 c>ry+ out ! requirem5ts "u ?is section4 7#c7 ,subscription contract adju/m5t ,pursuant to ! contract ent]$ into "u ?is section ) respect to an applicable antimicrobial drug1 = ea* ye> ( ! t]m ( su* contract1 ! ,secret>y %all1 n e>li] ?an #f mon?s aft] ! end ( ea* cal5d> ye>1 subtract f ! paym5t in/allm5ts det]m9$ = su* contract "u subsection 7c77#a7 = su* ye> ! rev5ue ( ! sponsor ( su* drug f ! previ\s ye> f sales ( ! applicable antimicrobial drug report$ "u p>agraph 7#a7 = specifi$ gov]nm5t programs4 7#d7 ,def9itions ,9 ?is subsection3 7,a7 ,applicable antimicrobial drug ,! t]m applicable antimicrobial drug means an antimicrobial drug = :i* ! sponsor ( su* drug receives a subscription contract "u subsection 7a74 7,b7 ,specifi$ gov]nm5t program ,! t]m specifi$ gov]nm5t program means-- 7i7 ! ,m$ic>e "p ,d program "u "p ,d ( title ,,xviii ( ! ,social ,security ,act2 7ii7 ! ,m$ic>e ,"p ,b program "u "p ,b ( su* title ,,xviii2 7iii7 ! ,m$ic>e ,"p ,a program "u "p ,a ( su* title ,,xviii2 7iv7 ! ,m$icaid program e/abli%$ "u title ,,xix ( ! ,social ,security ,act & includes1 ) respect to a ,/ate1 any waiv] 9 effect ) respect to su* program2 7v7 any program "u :i* prescription drugs are procur$ by ! ,dep>tm5t ( ,vet]ans ,affairs2 7vi7 any program "u :i* prescription drugs are procur$ by ! ,dep>tm5t ( ,def5se2 7vii7 ! ,,tric>e retail ph>macy program "u section #ajgd;g7a77#b77;,e77ii7 ( title #aj1 ,unit$ ,/ates ,code2 7viii7 any program "u :i* prescription drugs are procur$ by ! ,dep>tm5t ( ,homel& ,security2 7ix7 any program "u :i* prescription drugs are procur$ by ! ,bureau ( ,prisons2 or 7x7 any program "u :i* prescription drugs are procur$ by ! ,indian ,heal? ,s]vice4 7e7 ,failure ,to adh]e to t]ms ,! ,secret>y %all cease any paym5t in/allm5ts "u a contract "u ?is section if-- 7#a7 ! sponsor-- 7,a7 p]man5tly )draws ! antimicrobial drug f ! m>ket 9 ! ,unit$ ,/ates2 7,b7 fails to meet crit]ia "u subsection 7b72 or 7,c7 does n complete a po/m>ket /udy requir$ by ! ,food & ,drug ,adm9i/ration dur+ ! l5g? ( ! t]m ( ! contract2 7#b7 ! annual int]national & private insurance m>ket rev5ues ) respect to an antimicrobial drug 7n c\nt+ any subscription rev5ues f any s\rce pursuant to a contract "u ?is section or o!r int]national or private entities7 exce$ #e times ! av]age annual am\nt ( ! subscription contract paid by ! ,secret>y z c]tifi$ by ! sponsor annually2 or 7#c7 if ! total rev5ue ( ! sponsor f specifi$ gov]nm5t programs1 z def9$ 9 subsection 7d77#d71 = a ye> exce$s ! am\nt ( ! subscription contract paid by ! ,secret>y = t ye>4 7f7 ,private pay] & int]national pay] p>ticipation ,! ,secret>y %all make ef=ts to increase ! p>ticipation ( dome/ic private payors & int]national payors 9 subscription contracts or o!r types ( value-bas$ arrangem5ts t are simil> to ! subscription contracts au?oriz$ "u ?is section4 #cii,,rr4 ,enc\rag+ appropriate use ( antibiotics & combat+ resi/ance 7a7 ,e/abli%m5t ( hospital grant program 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is "p1 ! ,secret>y & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all coord9ate ) ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 & o!r relevant ag5cies1 to e/abli% a grant program "u ! ,c5t]s = ,disease ,control & ,prev5tion to support hospital & o!r inpati5t facility ef=ts-- 7,a7 to judici\sly use antimicrobial drugs1 su* z by e/abli%+ or implem5t+ appropriate use programs1 includ+ infecti\s disease teleheal? programs1 us+ appropriate diagno/ic tools1 p>tn]+ ) academic hospitals1 increas+ heal? c>e-associat$ infection report+1 & monitor+ antimicrobial resi/ance2 & 7,b7 to p>ticipate 9 ! ,national ,heal?c>e ,safety ,network ,antimicrobial ,use & ,resi/ance ,module or ! ,em]g+ ,infections ,program ,heal?c>e-,associat$ ,infections ,community ,int]face activity ( ! ,c5t]s = ,disease ,control & ,prev5tion or a simil> report+ program1 z specifi$ by ! ,secret>y1 relat+ to antimicrobial drugs4 7#b7 ,prioritization ,9 aw>d+ grants "u p>agraph 7#a71 ! ,secret>y %all prioritize hospitals )\t an exi/+ program to judici\sly use antimicrobial drugs1 subsection 7d7 hospitals 7z def9$ 9 subp>agraph 7,b7 ( section #ahhf7;d77#b7 ( ! ,social ,security ,act t are locat$ 9 rural areas 7z def9$ 9 subp>agraph 7,d7 ( su* section71 critical access hospitals 7z def9$ 9 section #ahfa7mm77#a7 ( su* ,act71 hospitals s]v+ ,tribal-populations1 & safety-net hospitals4 7#c7 ,fund+ ,( ! am\nts appropriat$ "u section #cii,,ss1 ! ,secret>y %all res]ve #ejj1jjj1jjj to c>ry out ?is subsection4 7b7 ,surveillance & report+ ( antibiotic use & resi/ance 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all use ! ,national ,heal?c>e ,safety ,network & o!r appropriate surveillance sy/ems to assess-- 7,a7 appropriate conditions1 outcomes1 & measures causally relat$ to antibact]ial resi/ance1 includ+ types ( infections1 ! causes = infections1 & :e!r infections are acquir$ 9 a community or hospital sett+1 increas$ l5g?s ( hospital /ay1 increas$ co/s1 & rates ( mortality2 & 7,b7 *anges 9 bact]ial resi/ance to antimicrobial drugs 9 relation to pati5t outcomes1 includ+ *anges 9 p]c5t resi/ance1 preval5ce ( antibiotic-resi/ant infections1 & o!r su* *anges4 7#b7 ,antibiotic use data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all "w ) ,f$]al ag5cies 7includ+ ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,homel& ,security1 ! ,bureau ( ,prisons1 ! ,indian ,heal? ,s]vice1 & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices71 private v5dors1 heal? c>e organizations1 ph>macy b5efit manag]s1 & o!r entities z appropriate to obta9 reliable & comp>able human antibiotic drug consumption data 7includ+1 z available & appropriate1 volume antibiotic di/ribution data & antibiotic use data1 includ+ prescription data7 by ,/ate or metropolitan areas4 7#c7 ,antibiotic resi/ance tr5d data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all int5sify & exp& ef=ts to collect antibiotic resi/ance data & enc\rage adoption ( ! ,antibiotic ,use & ,resi/ance ,module )9 ! ,national ,heal?c>e ,safety ,network among all heal? c>e facilities across ! cont9uum ( c>e1 includ+1 z appropriate1 acute c>e hospitals1 dialysis facilities1 nurs+ homes1 ambulatory surgical c5t]s1 & o!r ambulatory heal? c>e sett+s 9 :i* antimicrobial drugs are r\t9ely prescrib$4 ,! ,secret>y %all seek to collect su* data f electronic m$ication adm9i/ration reports & laboratory sy/ems to produce ! reports describ$ 9 p>agraph 7#d74 7#d7 ,public availability ( data ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all1 = ! purposes ( improv+ ! monitor+ ( important tr5ds 9 pati5t outcomes 9 relation to antibact]ial resi/ance-- 7,a7 make ! data d]iv$ f surveillance "u ?is subsection publicly available ?r\gh reports issu$ on a regul> basis t is n less ?an annually2 & 7,b7 exam9e opportunities to make su* data available 9 ne> real "t4 #cii,,ss4 ,appropriations 7a7 ,9 g5]al ,to c>ry out ?is "p1 !re are h]eby appropriat$ to ! ,secret>y1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #aa1jjj1jjj1jjj1 = fiscal ye> #bjbb1 to rema9 available until exp5d$4 7b7 ,em]g5cy designation 7#a7 ,9 g5]al ,! am\nts provid$ by ?is section are designat$ z an em]g5cy requirem5t pursuant to section #d7;g7 ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj4 7#b7 ,designation 9 s5ate ,9 ! ,s5ate1 ?is section is designat$ z an em]g5cy requirem5t pursuant to section #daab7;a7 ( ,h4 ,con4 ,res4 #ga 7#aae? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjah4 #cii,,tt4 ,/udies & reports 7a7 ,9 g5]al ,n lat] ?an #f ye>s aft] ! date ( ! enactm5t ( ?is "p1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all complete a /udy on ! effectiv5ess ( ?is "p 9 develop+ priority antimicrobial drugs4 ,su* /udy %all exam9e ! indications =1 usage (1 developm5t ( resi/ance ) respect to1 & private & societal value ( critical ne$ antimicrobial drugs1 & ! impact ( ! programs "u ?is "p on pati5ts & m>kets ( critical ne$ antimicrobial drugs4 ,! ,comptroll] ,g5]al %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! f9d+s ( su* /udy4 7b7 ,antibiotic use 9 ! ,unit$ ,/ates2 annual reports ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all1 ea* ye>1 update ! report entitl$ ,antibiotic ,use 9 ! ,unit$ ,/ates to include updat$ in=mation on progress & opportunities ) respect to data1 programs1 & res\rces = prescrib]s to promote appropriate use ( antimicrobial drugs4 7c7 ,report on antimicrobial prophylactics ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is "p1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all publi% a report on antimicrobial prophylactics4 #cii,,uu4 ,def9itions ,9 ?is "p-- 7#a7 ! t]m antimicrobial drug-- 7,a7 means1 subject to subp>agraph 7,b71 a product t is-- 7i7 a drug t directly inhibits replication ( or kills bact]ia or fungi relevant to ! propos$ indication at conc5trations likely to be atta9able 9 humans to a*ieve ! int5d$ !rapeutic effect2 or 7ii7 a biological product t acts directly on bact]ia or fungi or on ! sub/ances produc$ by su* bact]ia or fungi2 & 7,b7 does n include-- 7i7 a drug t a*ieves ! effect describ$ by subp>agraph 7,a77i7 only at a conc5tration t _c reasonably be /udi$ 9 humans because ( its anticipat$ toxicity2 or 7ii7 a vacc9e2 & 7#b7 ! t]m ,committee means ! ,committee on ,critical ,ne$ ,antimicrobials e/abli%$ "u section #cii,,oo4 4 ,,ii ,pati5ts & c>egiv]s #bja4 ,educational programs & tra9+ = c>egiv]s ,"p ,d ( title ,,vii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bid et seq47 is am5d$ by add+ at ! end ! foll[+3 #gfj;,a4 ,educational programs & tra9+ = c>egiv]s 7a7 ,9 g5]al ,! ,secret>y may aw>d grants = educational programs & tra9+ = c>egiv]s to le>n skills to emp[] !m-- 7#a7 to be a memb] ( a c>e team2 & 7#b7 to complem5t a cl9ical visit4 7b7 ,types ( programs & tra9+ ,educational programs & tra9+ fund$ "u subsection 7a7 may include-- 7#a7 specializ$ tra9+ 9 m$ication adh]5ce & injections2 7#b7 complem5t>y /rategies to ensure adh]5ce to physical1 occupational1 spee*1 & habilitative !rapy regim5s2 7#c7 nutritional compliance2 7#d7 c>egiv] psy*osocial support 7includ+ cognitive-behavioral1 supportive1 & b]eavem5t c\nsel+72 7#e7 c>egiv] heal? self-managem5t2 & 7#f7 o!r s]vices provid$ 9 ! home4 7c7 ,non-,duplication ,! ,secret>y may n use ! same requirem5ts "u ?is section = a grant1 contract1 or coop]ative agreem5t "u ! ,g]iatric ,work=ce ,enhancem5t ,program "u section #gec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bid;c74 7d7 ,c>egiv] def9$ ,9 ?is section1 ! t]m c>egiv] means an adult family memb] or o!r individual :o has a significant relation%ip )1 & :o provides a broad range ( assi/ance to1 an individual ) a *ronic or o!r heal? condition1 disability1 or functional limitation4 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #be1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbd4 4 #bjb4 ,increas+ heal? lit]acy to promote bett] outcomes = pati5ts 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all issue a reque/ = in=mation to solicit recomm5dations on ways ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices c "w ) /akehold]s ( ! ,f$]al heal? c>e programs 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 to promote increas$ pati5t & family c>egiv] heal? lit]acy1 includ+ recomm5dations =-- 7#a7 id5tify+ culturally compet5t1 evid5ce-bas$ int]v5tions t h be5 prov5 to improve heal? lit]acy 9 populations s]v$ by su* programs2 7#b7 id5tify+ evid5ce-bas$ heal? lit]acy approa*es t c be us$ by ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 a ,/ate plan 7or waiv] ( su* plan7 "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq471 a ,/ate *ild heal? plan 7or waiv] ( su* plan7 "u title ,,xxi ( su* ,act 7#db ,u4,s4,c4 #acig;aa et seq471 or heal? c>e provid]s p>ticipat+ 9 su* program "u su* title ,,xviii1 "u a ,/ate plan 7or waiv] ( su* plan7 "u su* title ,,xix1 or "u a ,/ate *ild heal? plan 7or waiv] ( su* plan7 "u su* title ,,xxi1 & t-- 7,a7 h be5 prov5 to1 or %[ promise to1 r$uce co/s to individuals enroll$ "u a ,/ate plan 7or waiv] ( su* plan7 "u su* title ,,xix1 or "u a ,/ate *ild heal? plan 7or waiv] ( su* plan7 "u su* title ,,xxi1 respectively1 & r$uce exp5ditures "u su* respective titles2 or 7,b7 h be5 prov5 to increase pati5t & family c>egiv] satisfaction or improve ! quality ( c>e = at-risk populations1 includ+ holi/ic & non-m$ication-bas$ =ms ( c>e2 7#c7 h[ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices c enc\rage ! use ( evid5ce-bas$ heal? lit]acy int]v5tions ?r\gh paym5t policies "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 a ,/ate plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq471 a ,/ate *ild heal? plan "u title ,,xxi ( su* ,act 7#db ,u4,s4,c4 #acig et seq472 & 7#d7 improv+ pati5t & family c>egiv] heal? lit]acy ) respect to heal? insurance1 includ+ an und]/&+ ( 9-network provid]s1 d$uctibles1 co-insurance1 co-paym5ts1 & diff]5ces betwe5 payors4 #bjc4 ,increas+ div]sity 9 cl9ical trials 7a7 ,updat$ report+ on inclusion ( demographic subgr\ps ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 submit to ! ,food & ,drug ,adm9i/ration1 & provide to ! ,congress1 an updat$ v]sion ( ! report "u section #ijg7;a7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aae-eb72 & 7#b7 n lat] ?an #a ye> aft] ! publication ( ! updat$ report pursuant to p>agraph 7#a71 publi% on ! website ( ! ,food & ,drug ,adm9i/ration1 & provide to ! ,congress1 an updat$ v]sion ( ! action plan "u section #ijg7;b7 ( su* ,act4 7b7 ,,gao /udy on b>ri]s to p>ticipation ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 complete a /udy-- 7,a7 to review h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices addresses b>ri]s to p>ticipation by individuals f und]repres5t$ populations 9 conduct+ or support+ cl9ical trials2 & 7,b7 to =mulate recomm5dations = address+ su* b>ri]s2 & 7#b7 submit a report to ! ,congress on ! results ( su* /udy4 7c7 ,public aw>5ess campaign ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 c>ry out a public aw>5ess campaign to increase aw>5ess & und]/&+1 p>ticul>ly 9 m9ority communities1 (-- 7,a7 upcom+ & ongo+ cl9ical trials2 7,b7 h[ to enroll z subjects 9 su* cl9ical trials2 & 7,c7 ! availability ( databases & o!r res\rces relevant to cl9ical trial enrollm5t1 su* z ,clinical,trials4gov2 & 7#b7 9 c>ry+ out su* campaign1 utilize a v>iety ( communication *annels1 includ+ ?r\gh use ( ! explanation ( ,m$ic>e b5efits "u section #ahjf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#g74 7d7 ,task =ce = mak+ ,clinical,trials4gov m us]-,fri5dly 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a p]man5t task =ce to propose1 on a bi5nial basis1 recomm5dations = improv+ ,clinical,trials4gov by mak+ x m us]-fri5dly1 includ+ = pati5ts4 7#b7 ,memb]%ip ,! memb]%ip ( ! task =ce %all include repres5tatives (-- 7,a7 ! ,national ,in/itutes ( ,heal?2 7,b7 ! ,food & ,drug ,adm9i/ration2 7,c7 academic rese>*]s2 & 7,d7 pati5t organizations4 7e7 ,def9ition ,9 ?is section1 ! t]m ,clinical,trials4gov ref]s to ! data bank describ$ 9 section #djb7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;i774 #bjd4 ,pati5t exp]i5ce data 7a7 ,policy ,section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is am5d$-- 7#a7 by r$esignat+ subsections 7b7 & 7c7 z subsections 7c7 & 7d71 respectively2 & 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+ new subsection3 7b7 ,collection1 submission1 & use ( data 7#a7 ,9 g5]al ,! ,secret>y %all-- 7,a7 = any drug = :i* an exemption is grant$ = inve/igational use "u section #eje7;i7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 require ! sponsor ( ! drug to collect /&>diz$ pati5t exp]i5ce data z "p ( ! cl9ical trials conduct$ pursuant to su* exemption2 7,b7 require any application = ! approval or lic5s+ ( su* drug "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act to include-- 7i7 ! /&>diz$ pati5t exp]i5ce data s collect$2 & 7ii7 su* relat$ in=mation z ! ,secret>y may require2 & 7,c7 consid] pati5t exp]i5ce data & relat$ in=mation t is submitt$ pursuant to subp>agraph 7,b7 9 decid+ :e!r to approve or lic5se1 z applicable1 ! drug involv$4 7#b7 ,applicability ,p>agraph 7#a7 applies only ) respect to drugs = :i* a reque/ = an exemption describ$ 9 p>agraph 7#a77;,a7 is submitt$ on or aft] ! date ( ! enactm5t ( ! ,cures #b4j ,act1 or an application "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act is fil$1 z applicable1 on or aft] ! day t is #b ye>s aft] ! date ( ! enactm5t ( ! ,cures #b4j ,act4 4 7b7 ,regulations ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all promulgate f9al regulations to implem5t section #efi;,c7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is section4 #bje4 ,ensur+ cov]age = cl9ical trials "u exi/+ /&>d ( c>e 7a7 ,revision to def9ition ( approv$ cl9ical trial 9 individual & gr\p m>ket 7#a7 ,9 g5]al ,subsection 7d77#a7 ( ! fir/ section #bgji ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#h7 7relat+ to cov]age = individuals p>ticipat+ 9 approv$ cl9ical trials7 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,! /udy or inve/igation is approv$ or fund$ 7:i* may include fund+ ?r\gh 9-k9d contributions7 by ! ,pati5t ,c5t]$ ,outcomes ,rese>* ,in/itute e/abli%$ "u section #aaha ( ! ,social ,security ,act4 4 7#b7 ,effective date ,! am5dm5t made by ?is p>agraph %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb4 7b7 ,m$ic>e cov]age ( r\t9e co/s associat$ ) c]ta9 cl9ical trials 7#a7 ,9 g5]al ,section #ahfb7m77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4#aciey7m77#b77 is am5d$1 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 7includ+ a trial fund$ by ! ,pati5t ,c5t]$ ,outcomes ,rese>* ,in/itute e/abli%$ "u section #aaha7 aft] means a trial4 7#b7 ,effective date ,! am5dm5t made by ?is p>agraph %all apply ) respect to items & s]vices furni%$ on or aft] ! date ( ! enactm5t ( ?is ,act4 ,,iii ,food & ,drug ,adm9i/ration #cja4 ,report on collaboration & alignm5t 9 regulat+ digital heal? te*nologies 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit a report to ! ,congress on ! ef=ts to ensure collaboration & alignm5t across ! c5t]s & (fices ( ! ,food & ,drug ,adm9i/ration ) respect to ! regulation ( digital heal? te*nologies4 7b7 ,cont5ts ,! report "u subsection 7a7 %all include a description ( ! foll[+3 7#a7 ,h[ ! ,commission] ( ,food & ,drugs & ! heads ( ! c5t]s & (fices ( ! ,food & ,drug ,adm9i/ration collaborate 9 regulat+ digital heal? te*nologies1 includ+ recomm5dations ) respect to-- 7,a7 ! use ( digital endpo9ts = regulatory review1 includ+ ! validation & qualification ( digital endpo9ts & digital biom>k]s2 7,b7 ! acceptance ( dec5traliz$ trials2 7,c7 ! use ( digital heal? te*nologies 9 pati5t-focus$ developm5t ( products2 & 7,d7 ! use & validation ( digital heal? te*nology tools2 7#b7 ,h[ ! ,food & ,drug ,adm9i/ration coord9ates ) =eign regulators to ensure h>monization on ! regulation & use ( digital heal? te*nologies4 7c7 ,def9ition ,9 ?is section1 ! t]m digital heal? te*nologies includes ^? te*nologies 9 heal? c>e or society t help deliv] or provide access to heal? c>e products & s]vices su* z h>dw>e 7= example1 we>able s5sors1 virtual reality headsets1 & digitally-enabl$ drug deliv]y devices71 advanc$ analytics 7= example1 artificial intellig5ce1 ma*9e le>n+1 & sophi/icat$ computation71 cl\d s]vices 7= example1 /orage1 comput+1 & data process+71 & s(tw>e 7= example1 mobile m$ical applications1 & s(tw>e z a m$ical device74 #cjb4 ,grants = novel trial designs & o!r innovations 9 drug developm5t 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all aw>d grants =-- 7#a7 incorporat+ complex adaptive & o!r novel trial designs into cl9ical protocols & applications = drugs pursuant to an exemption = inve/igational use "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a772 & 7#b7 ! collection ( pati5t exp]i5ce data ) respect to drugs & ! use ( su* data & relat$ in=mation 9 drug developm5t4 7b7 ,prioritization ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all prioritize ! incorporation ( digital heal? te*nologies & real _w evid5ce 9 drug developm5t4 7c7 ,def9itions ,9 ?is section3 7#a7 ,! t]m digital heal? te*nologies has ! mean+ giv5 to su* t]m 9 section #cja4 7#b7 ,! t]m pati5t exp]i5ce data has ! mean+ giv5 to su* t]m by section #efi;,c7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z r$esignat$ by section #bjd ( ?is ,act4 7#c7 ,! t]m real _w evid5ce has ! mean+ giv5 to t t]m 9 section #eje;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g74 7d7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #be1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbd4 #cjc4 ,,fda cell & g5e !rapy ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit a report to ! ,congress on ! foll[+3 7#a7 ,! =eseeable *all5ges to ! ,food & ,drug ,adm9i/ration ) respect to cell & g5e !rapies dur+ ! next t5 ye>s4 7#b7 ,h[ ! ,food & ,drug ,adm9i/ration w address ^! *all5ges4 7#c7 ,! additional res\rces & au?orities ! ,food & ,drug ,adm9i/ration ne$s to address ^! *all5ges4 7#d7 ,! curr5t /ate ( cell & g5e !rapies regulation by ! ,food & ,drug ,adm9i/ration1 includ+-- 7,a7 ! am\nt & nature ( ! submissions fil$ ) ! ,food & ,drug ,adm9i/ration2 7,b7 ! /atus ( su* applications 9 ! review process2 & 7,c7 ! !rapeutic areas int5d$ to be address$ by ! products t are subject to su* applications4 #cjd4 ,increas+ use ( real _w evid5ce 7a7 ,guidance 7#a7 ,issuance ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all issue guidance on ! use ( real _w evid5ce 9 evaluat+ ! safety & effectiv5ess ( break?r\gh devices 7develop$ pursuant to section #eae;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c77 & break?r\gh drugs subsequ5t to ! approval or lic5s+ ( su* drugs pursuant to subsection 7a71 7b71 or 7c7 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 z a break?r\gh !rapy1 a fa/ track product1 or a product consid]$ = accel]at$ approval4 7#b7 ,consid]ations ,! guidance "u p>agraph 7#a7 %all take into consid]ation ea* ( ! foll[+3 7,a7 ,special & und]repres5t$ populations4 7,b7 ,acceptable endpo9ts & outcomes measures4 7,c7 ,data quality /&>ds4 7,d7 ,data transp>5cy requirem5ts4 7,e7 ,/udy design consid]ations4 7b7 ,id5tification & implem5tation ( approa*es 7#a7 ,id5tification ,consi/5t ) ! framework e/abli%$ "u #eje;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 by n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act-- 7,a7 id5tify consi/5t1 cle> approa*es = ! ,dep>tm5t ( ,heal? & ,human ,s]vices to use real _w evid5ce 7z def9$ 9 su* section #eje;,f7-- 7i7 9 conduct+ & support+ rese>*2 & 7ii7 9 regulat+1 pur*as+1 & support+ ! pur*ase ( heal? c>e products & s]vices2 7,b7 include 9 su* approa*es recomm5dations = any additional /atutory au?orities ne$$2 7,c7 publi% su* approa*es 9 ! ,f$]al ,regi/]2 & 7,d7 submit a report to ! ,congress on su* approa*es4 7#b7 ,implem5tation ,^u publication "u p>agraph 7#a7 ( ! approa*es id5tifi$ pursuant to su* p>agraph1 consi/5t ) ! au?orities ve/$ 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices by o!r provisions ( law1 ! ,secret>y take su* actions z may be appropriate to implem5t ! approa*es id5tifi$ pursuant to p>agraph 7#a74 7c7 ,real ,_w ,evid5ce ,task ,=ce 7#a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a p]man5t task =ce1 to be kn[n z ! ,real ,_w ,evid5ce ,task ,=ce 79 ?is subsection ref]r$ to z ! ,task ,=ce7 to coord9ate ! programs & activities ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ) reg>d to ! collection & use ( real _w evid5ce4 7#b7 ,memb]%ip ,! memb]s ( ! ,task ,=ce %all include ! foll[+3 7,a7 ,! ,secret>y 7or ! ,secret>y's designee71 :o %all s]ve z ! ,*air ( ! ,task ,=ce4 7,b7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7or ! ,adm9i/rator's designee74 7,c7 ,! ,commission] ( ,food & ,drugs 7or ! ,commission]'s designee74 7,d7 ,! ,director ( ! ,national ,in/itutes ( ,heal? 7or ! ,director's designee74 7,e7 ,su* additional ,f$]al (ficials 7or _! designees7 z ! ,secret>y det]m9es appropriate4 7,f7 ,private sector repres5tatives1 includ+ pati5t gr\p repres5tatives1 to be appo9t$ by ! ,secret>y4 7#c7 ,recomm5dations ,9 c>ry+ p>agraph 7#a71 ! ,task ,=ce %all-- 7,a7 develop & p]iodically update recomm5dations on ways to enc\rage pati5ts to-- 7i7 engage 9 ! g5]ation ( real _w evid5ce2 & 7ii7 p>ticipate 9 po/approval cl9ical trials = ! collection ( real _w evid5ce2 & 7,b7 n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & e #b ye>s !reaft]1 submit a report to ! ,congress on su* recomm5dations4 #cje4 ,improv+ ,,fda-,,cms communication reg>d+ trans=mative new !rapies 7a7 ,9 g5]al ,^u ! designation ( a product z a break?r\gh !rapy1 a fa/ track product1 or a product eligible = accel]at$ approval "u subsection 7a71 7b71 or 7c71 respectively1 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef71 ! ,commission] ( ,food & ,drugs & ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all-- 7#a7 ma9ta9 communication ) ea* o!r reg>d+ approval & cov]age decisions ) respect to su* product2 & 7#b7 %>e su* in=mation ) ea* o!r z may be appropriate to in=m & coord9ate su* decisions4 7b7 ,sep>ate & di/9ct ,9 approv+ or designat+ a product describ$ 9 subsection 7a71 ! ,commission] ( ,food & ,drugs & ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all ensure t ! process = approval or designation rema9s sep>ate & di/9ct4 #cjf4 ,e/abli%m5t ( additional ,int]c5t] ,in/itutes at ! ,food & ,drug ,adm9i/ration 7a7 ,e/abli%m5t ,subsection 7c7 ( section #ajad ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;g7c77 is am5d$ to read z foll[s3 7c7 ,tim+ ,n lat] ?an ! date t is "o ye> aft] ! date ( ! enactm5t ( ! ,cures #b4j ,act or ! end ( ! coronavirus disease #bjai 7,,covid-#ai7 p&emic public heal? em]g5cy "u section #cai ( ! ,public ,heal? ,s]vice ,act1 :i*ev] is lat]1 ! ,secret>y %all e/abli%1 9 accordance ) ?is section1 at lea/ two additional ,in/itutes "u subsection 7a74 4 7b7 ,crit]ia ,9 e/abli%+ ! focus ( ! two ,in/itutes ref]5c$ 9 ! am5dm5t made by subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all ensure ! foll[+3 7#a7 ,"o ( ! ,in/itutes focuses on a gr\p ( diseases meet+ ! foll[+ crit]ia3 7,a7 ,negatively affects at lea/ "o major body sy/em4 7,b7 ,repres5ts a major disease burd5 9 ! ,unit$ ,/ates4 7,c7 ,repres5ts a lead+ cause ( mortality or disability 9 ! ,unit$ ,/ates4 7,d7 ,accord+ to ! ,national ,in/itutes ( ,heal?1 affects at lea/ an e/imat$ #ej1jjj1jjj ,am]icans ea* ye>4 7,e7 ,contributes to increas+ heal? c>e 7p]sonal1 familial1 private sector1 & gov]nm5tal7 exp5ditures & impacts ! ,unit$ ,/ates economy z a :ole4 7,f7 ,= :i* ! ,,s>s-,co,v-#b virus exac]bates symptoms or causes s]i\s complications4 7,g7 ,= :i* m$ical products are approv$ by ! ,food & ,drug ,adm9i/ration at a mu* l[] rate ?an products = o!r disease areas1 includ+ 9 abbreviat$ pa?ways4 7#b7 ,"o ( ! ,in/itutes focuses on a gr\p ( diseases meet+ ! foll[+ crit]ia3 7,a7 ,affects1 individually1 few] ?an #bjj1jjj p 9 ! ,unit$ ,/ates4 7,b7 ,ov] #ij p]c5t ( su* diseases h no !rapy approv$ by ! ,food & ,drug ,adm9i/ration4 7,c7 ,affects1 9 total1 ov] #cj1jjj1jjj ,am]icans4 7,d7 ,ov] #ej p]c5t ( pati5ts are *ildr54 7c7 ,report on ,int]c5t] ,in/itutes ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate on ! activities ( ! ,in/itutes e/abli%$ pursuant to ?is section4 #cjg4 ,accel]at+ timel9e = break?r\gh & ,,rmat designations 7a7 ,break?r\gh !rapies ,section #ejf7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77#b77 is am5d$ by /rik+ ,a reque/ = ! designation may be made concurr5tly )1 or at any "t aft]1 ! submission ( an application = ! inve/igation ( ! drug "u section #eje7;i7 or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act & ins]t+ ,a reque/ = ! designation may be made at any po9t be=e or aft] submission ( an application = approval ( ! drug "u section #eje7;b7 ( ?is ,act or lic5sure ( ! drug "u section #cea7;a77#b7 ( ! ,public ,heal? ,s]vice ,act & %all include cl9ical evid5ce1 includ+ prelim9>y cl9ical evid5ce f cl9ical trials conduct$ outside ( ! ,unit$ ,/ates4 7b7 ,reg5]ative advanc$ !rapies ,section #ejf7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;g77#c77 is am5d$ by /rik+ concurr5tly )1 or at any "t aft]1 submission ( an application = ! inve/igation ( ! drug "u section #eje7;i7 ( ?is ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act & ins]t+ at any po9t be=e or aft] submission ( an application = approval ( ! drug "u section #eje7;b7 ( ?is ,act or lic5sure ( ! drug "u section #cea7;a77#b7 ( ! ,public ,heal? ,s]vice ,act & %all include cl9ical evid5ce1 includ+ prelim9>y cl9ical evid5ce f cl9ical trials conduct$ outside ( ! ,unit$ ,/ates4 #cjh4 ,guidance reg>d+ developm5t & submission ( *emi/ry1 manufactur+1 & controls in=mation = exp$it$ approval 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 issue draft revis$ guidance to provide cl>ity reg>d+ ! developm5t & submission ( *emi/ry1 manufactur+1 & controls in=mation = purposes ( subsections 7a71 7b71 7c71 & 7g7 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef2 relat+ to break?r\gh !rapies1 fa/ track products1 accel]at$ approval1 & reg5]ative advanc$ !rapies72 & 7#b7 n lat] ?an #ij days aft] ! close ( a p]iod ( public comm5t on su* draft guidance1 f9alize ! guidance4 7b7 ,cont5ts ,! guidance "u subsection 7a7 %all address-- 7#a7 h[ ! ,food & ,drug ,adm9i/ration w det]m9e h[1 & by :51 *emi/ry1 manufactur+1 & controls in=mation is requir$ to be submitt$ ?r\gh\t developm5t & dur+ ! pre- & po/-approval phases1 tak+ into consid]ation-- 7,a7 h[ su* det]m9ations w reflect ! risks & b5efits ( su* in=mation giv5 ! s]i\sness or life-?reat5+ nature ( ! disease ! product is int5d$ to diagnose1 cure1 mitigate1 treat1 or prev5t2 7,b7 ! phase & exp$it$ nature ( developm5t2 & 7,c7 ! availability ( relevant data & in=mation f noncl9ical & cl9ical /udies1 product applications1 & po/-approval ov]sight2 & 7#b7 h[ ! ,food & ,drug ,adm9i/ration w provide ongo+ advice & opportunities = sponsors to int]act ) ! ,food & ,drug ,adm9i/ration on1 & h[ ! ,food & ,drug ,adm9i/ration w facilitate1 ! submission ( *emi/ry1 manufactur+1 & controls in=mation ?r\gh\t ! life cycle ( ! product4 #cji4 ,po/-approval /udy requirem5ts = accel]at$ approval ,section #ejf7;c77#b77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77#b77;,a77 is am5d$ aft] /udies by ins]t+ 1 or o!rwise submit evid5ce bas$ on analyses ( data 9 cl9ical c>e data repositories1 pati5t regi/ries1 or o!r s\rces ( real _w evid5ce14 #caj4 ,recomm5dations to dec5tralize cl9ical trials 7a7 ,9 g5]al ,n lat] ?an ! end ( fiscal ye> #bjbb1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all conv5e a meet+ ( cov]$ repres5tatives to recomm5d to ! ,secret>y innovative approa*es & inc5tives to adopt dec5traliz$ cl9ical trials4 7b7 ,def9itions ,9 ?is section3 7#a7 ,cov]$ repres5tative ,! t]m cov]$ repres5tative means a repres5tative ( ! foll[+3 7,a7 ,sponsors ( an application = approval ( a drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7,b7 ,a manufactur] ( a device 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba774 7,c7 ,cl9ical rese>* organizations4 7,d7 ,! te*nology community4 7,e7 ,! pati5t community4 7#b7 ,dec5traliz$ cl9ical trial ,! t]m dec5traliz$ cl9ical trial means a cl9ical trial me?od t includes ! use ( telem$ic9e or digital te*nologies to all[ = ! remote collection ( cl9ical trial data f subjects1 includ+ 9 ! home or (fice sett+4 ,,iv ,c5t]s = ,m$ic>e ,m$icaid ,s]vices #dja4 ,,gao /udy & report ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on recomm5dations = adm9i/rative actions t may be tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices 7z well z recomm5dations = legislative *anges ne$$7 to-- 7#a7 enhance cov]age & reimbursem5t approa*es "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act = innovative te*nologies t increase access to heal? c>e1 improve heal? c>e quality1 decrease exp5ditures "u su* program1 or o!rwise improve ! ,m$ic>e program or heal? c>e = b5efici>ies "u su* program2 & 7#b7 bett] h>monize & integrate ! op]at+ /ructure ( ! ,m$ic>e program 7& ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices7 to improve int]ag5cy collaboration & communication4 #djb4 ,/rategies to increase access to teleheal? "u ,m$icaid & ,*ildr5's ,heal? ,insurance ,program 7a7 ,guidance ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue & dissem9ate guidance to ,/ates to cl>ify /rategies to ov]come exi/+ b>ri]s & increase access to teleheal? "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 & ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( su* ,act 7#db ,u4,s4,c4 #acig;aa et seq474 ,su* guidance %all include te*nical assi/ance & be/ practices reg>d+-- 7#a7 exi/+ /rategies ,/ates c use to integrate teleheal? & o!r virtual heal? c>e s]vices into value-bas$ heal? c>e models2 & 7#b7 examples ( ,/ates t h us$ waiv]s "u ! ,m$icaid program to te/ exp&$ access to teleheal?1 includ+ dur+ ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 7b7 ,/udies 7#a7 ,teleheal? impact on heal? c>e access ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission %all conduct a /udy1 ) respect to a m9imum ( #aj ,/ates across geographic regions ( ! ,unit$ ,/ates1 & submit to ,congress a report1 on ! impact ( teleheal? on heal? c>e access1 utilization1 co/1 & outcomes1 brok5 d[n by race1 e?nicity1 sex1 age1 disability /atus1 & zip code4 ,su* report %all-- 7,a7 evaluate co/1 access1 utilization1 outcomes1 & pati5t exp]i5ce data f across ! heal? c>e field1 includ+ ,/ates1 ,m$icaid manag$ c>e organizations1 provid] organizations1 & o!r organizations t provide or pay = teleheal? "u ! ,m$icaid program & ,*ildr5's ,heal? ,insurance ,program2 7,b7 id5tify b>ri]s & pot5tial solutions to provid] entry & p>ticipation 9 teleheal? t ,/ates are exp]i5c+1 z well z b>ri]s to provid+ teleheal? across ,/ate l9es1 includ+ dur+ times ( public heal? crisis or public heal? em]g5cy2 7,c7 det]m9e ! frequ5cy at :i* out-(-,/ate teleheal? is provid$ to pati5ts enroll$ 9 ! ,m$icaid program & ! pot5tial impact on access to teleheal? if ,/ate ,m$icaid policies 7 m align$2 & 7,d7 id5tify & evaluate opportunities = m alignm5t among su* policies to promote access to teleheal? across all ,/ates1 ,/ate ,m$icaid plans "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 ,/ate *ild heal? plans "u title ,,xxi ( su* ,act 7#db ,u4,s4,c4 #acig;aa et seq471 & ,m$icaid manag$ c>e organizations1 includ+ ! pot5tial = regional compacts or reciprocity agreem5ts4 7#b7 ,f$]al ag5cy teleheal? collaboration ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy & submit to ,congress a report evaluat+ collaboration betwe5 ,f$]al ag5cies ) respect to teleheal? s]vices furni%$ "u ! ,m$icaid or ,,*ip program to individuals "u ! age ( #ah1 includ+ su* s]vices furni%$ to su* individuals 9 e>ly c>e & education sett+s4 ,su* report %all include recomm5dations on-- 7,a7 opportunities = ,f$]al ag5cies to improve collaboration ) respect to su* teleheal? s]vices2 & 7,b7 opportunities = collaboration betwe5 ,f$]al ag5cies to exp& teleheal? access to su* individuals enroll$ "u ! ,m$icaid or ,,*ip program1 includ+ 9 e>ly c>e & education sett+s4 #djc4 ,ext5d+ ,m$ic>e teleheal? flexibilities 7a7 ,exp&+ access to teleheal? s]vices 7#a7 ,9 g5]al ,section #ahcd7m77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,exp&+ access to teleheal? s]vices ,) respect to teleheal? s]vices furni%$ beg9n+ on ! fir/ day aft] ! end ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b7 ( ?is clause1 ! t]m orig9at+ site means any site at :i* ! eligible teleheal? individual is locat$ at ! "t ! s]vice is furni%$ via a telecommunications sy/em1 includ+ ! home ( an individual4 4 7#b7 ,con=m+ am5dm5ts ,su* section is am5d$-- 7,a7 9 p>agraph 7#b77;,b7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by /rik+ clause 7ii7 & ins]t+ clauses 7ii7 & 7iii72 & 7ii7 by add+ at ! end ! foll[+ new clause3 7iii7 ,no facility fee = new sites ,) respect to teleheal? s]vices furni%$ on or aft] ! date ( ! enactm5t ( ?is clause1 a facility fee %all only be paid "u ?is subp>agraph to an orig9at+ site t is describ$ 9 p>agraph 7#d77;,c77ii7 7o!r ?an subclause 7,x7 ( su* p>agraph74 2 7,b7 9 p>agraph 7#d77;,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ & clause 7iii7 aft] & 7#g72 & 7ii7 9 clause 7ii77,x71 by ins]t+ prior to ! fir/ day aft] ! end ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b7 be=e ! p]iod2 7,c7 9 p>agraph 7#e71 by ins]t+ & prior to ! fir/ day aft] ! end ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b7 aft] ,janu>y #a1 #bjai12 7,d7 9 p>agraph 7#f77;,a71 by ins]t+ & prior to ! fir/ day aft] ! end ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b71 aft] ,janu>y #a1 #bjai12 & 7,e7 9 p>agraph 7#g71 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,sunset ,! provisions ( ?is p>agraph %all n apply ) respect to s]vices furni%$ on or aft] ! fir/ day aft] ! end ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b74 4 7b7 ,exp&+ practition]s eligible ,to furni% teleheal? s]vices ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ 7describ$ 9 section #ahdb7;b77#ah77;,c77 & ins]t+ 7def9$ 9 p>agraph 7#d77;,e772 & 7#b7 9 p>agraph 7#d77;,e7-- 7,a7 by /rik+ ,practition]4--,! t]m & ins]t+ 8,practition]4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! t]m 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,expansion ,! ,secret>y1 aft] consult+ ) /akehold]s reg>d+ s]vices t are cl9ically appropriate1 may exp& ! types ( practition]s :o may furni% teleheal? s]vices to include any heal? c>e pr(essional t is eligible to bill ! program "u ?is title = _! pr(essional s]vices4 4 7c7 ,ret5tion ( additional s]vices & subregulatory process = modifications foll[+ em]g5cy p]iod ,section #ahcd7m77#d77;,f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,f77 is am5d$-- 7#a7 9 clause 7i71 by ins]t+ & clause 7iii7 aft] p>agraph 7#h72 7#b7 9 clause 7ii71 by /rik+ ,! ,secret>y & ins]t+ ,subject to clause 7iii71 ! ,secret>y2 & 7#c7 by add+ at ! end ! foll[+ new clause3 7iii7 ,ret5tion ( additional s]vices & subregulatory process = modifications foll[+ em]g5cy p]iod ,) respect to teleheal? s]vices furni%$ aft] ! la/ day ( ! em]g5cy p]iod describ$ 9 section #aace7;g77#a77;,b71 ! ,secret>y may-- 7,i7 reta9 z appropriate ! exp&$ li/ ( teleheal? s]vices specifi$ 9 clause 7i7 pursuant to ! waiv] au?ority "u section #aace7;b77#h7 dur+ su* em]g5cy p]iod2 & 7,,ii7 reta9 ! subregulatory process us$ to modify ! s]vices includ$ on ! li/ ( su* teleheal? s]vices pursuant to clause 7ii7 dur+ su* em]g5cy p]iod4 4 7d7 ,enhanc+ teleheal? s]vices = f$]ally qualifi$ heal? c5t]s & rural heal? cl9ics ,section #ahcd7m77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#h77 is am5d$-- 7#a7 9 ! p>agraph head+ by ins]t+ & aft] aft] dur+2 7#b7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ & aft] aft] ,dur+2 & 7#c7 9 ! fir/ s5t5ce ( subp>agraph 7,b77i71 by ins]t+ & aft] aft] dur+4 7e7 ,use ( teleheal?1 z cl9ically appropriate1 ,to conduct face-to-,face enc\nt] = hospice c>e ,section #ahad7;a77#g77;,d77i77,,ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii77 is am5d$ by ins]t+ & aft] su* em]g5cy p]iod z cl9ically appropriate aft] #aace7;g77#a77;,b74 7f7 ,use ( teleheal?1 z cl9ically appropriate1 ,to conduct face-to-,face cl9ical assessm5ts = home dialysis ,clause 7iii7 ( section #ahha7;b77#c77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#c77;,b77 is am5d$-- 7#a7 by mov+ su* clause #d ems to ! left2 & 7#b7 by ins]t+ & aft] su* em]g5cy p]iod z cl9ically appropriate be=e ! p]iod4 7g7 ,implem5tation ,not)/&+ any provision ( law1 ! ,secret>y may implem5t ! provisions (1 & am5dm5ts made by1 ?is section by int]im f9al rule1 program in/ruction1 or o!rwise4 #djd4 ,cov]age & paym5t = break?r\gh devices "u ! ,m$ic>e program 7a7 ,9 g5]al ,"p ,e ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #ahii;,c4 ,cov]age ( break?r\gh devices 7a7 ,break?r\gh devices ,= purposes ( ?is section1 ! t]m break?r\gh device means a m$ical device t is a device 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 & t is-- 7#a7 provid$ ) review priority by ! ,secret>y "u subsection 7d77#e7 ( section #eae ( su* ,act2 & 7#b7 approv$ or cle>$ pursuant to section #eaj7k71 #eac7;f71 or #eae ( su* ,act = use 9 treat+ an indication on or aft] ,m>* #ae1 #bjba4 ,su* t]m also includes a break?r\gh device t is a specifi$ break?r\gh device 7z def9$ 9 subsection 7e77#a77;,b77 approv$ or cle>$ pursuant to section #eaj7k71 #eac7;f71 or #eae ( su* ,act = use 9 treat+ an indication on or aft] ,m>* #ae1 #bjba4 7b7 ,cov]age 7#a7 ,transitional cov]age 7,a7 ,9 g5]al ,dur+ ! transitional cov]age p]iod 7z def9$ 9 subp>agraph 7,b77 a break?r\gh device %all be-- 7i7 deem$ to be reasonable & necess>y = purposes ( section #ahfb7;a77#a77;,a72 7ii7 deem$ to be approv$ = an additional paym5t "u section #ahhf7;d77#e77,k7 7o!r ?an ) respect to ! co/ crit]ion "u clause 7ii77,i7 ( su* section72 7iii7 deem$ to be approv$ = pass-?r\gh paym5t "u section #ahcc7t77#f7 & section #ahcc7;i7 7o!r ?an ) respect to ! co/ crit]ion "u section #ahcc7t77#f77;,a77iv772 & 7iv7 ins(> z su* break?r\gh device may be furni%$ 9 a sett+ = :i* paym5t is made "u an applicable paym5t sy/em describ$ 9 subp>agraphs 7,d7 ?r\gh 7,i7 ( subsection 7c77#d71 deem$ eligible = an additional paym5t or paym5t adju/m5t1 z ! case may be1 pursuant to subsection 7d77#c7 :5 furni%$ 9 a sett+ = :i* paym5t is made "u su* an applicable paym5t sy/em dur+ su* transitional cov]age p]iod4 7,b7 ,transitional cov]age p]iod def9$ ,z us$ 9 ?is section1 ! t]m transitional cov]age p]iod means1 ) respect to a break?r\gh device1 ! p]iod t-- 7i7 beg9s on ! date ( ! approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ( ! cle>ance "u section #eaj7k7 ( su* ,act1 z applicable1 ( su* device by ! ,secret>y = ! indication describ$ 9 subsection 7a77#a72 & 7ii7 ends on ! la/ day ( ! #d-ye> p]iod t beg9s on ! date t ! ,secret>y1 pursuant to subsection 7c77#b71 updates ! relevant applicable paym5t sy/em 7z def9$ 9 subsection 7c77#d77 to recognize ! unique tempor>y or p]man5t code or codes assign$ "u subsection 7c77#a7 to su* break?r\gh device1 except z provid$ 9 subsections 7d77#a77;,b7 & 7d77#b77;,b74 7,c7 ,data us$ to meet ! ntap & pass-?r\gh co/ crit]ia ,9 det]m9+ :e!r a break?r\gh device qualifies = an additional paym5t "u section #ahhf7;d77#e77,k7 or = pass-?r\gh paym5t "u section #ahcc7t77#f7 or section #ahcc7;i71 ! ,secret>y %all use ! mo/ rec5tly available data & in=mation on ! co/s ( su* break?r\gh device1 :i* may include li/ prices & invoice prices *>g$ = su* break?r\gh device4 7#b7 ,process = regul> cov]age ,= purposes ( ! application ( section #ahfb7;a77#a77;,a7 to a break?r\gh device furni%$ aft] ! transitional cov]age p]iod 7z def9$ 9 p>agraph 7#a77;,b77 = su* device1 ! ,secret>y %all e/abli% a process = ! cov]age ( su* break?r\gh devices "u ?is title aft] su* p]iod z foll[s3 7,a7 ,id5tification ( additional evid5ce 7i7 ,9 g5]al ,) respect to a break?r\gh device1 n lat] ?an #a ye> aft] ! date ( ! approval ( su* device "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ( ! cle>ance ( su* device "u section #eaj7k7 ( su* ,act1 z applicable1 ! ,secret>y %all id5tify :e!r any additional data or evid5ce is requir$ ) respect to any indications = su* device = purposes ( ! application ( su* section #ahfb7;a77#a77;,a7 to su* device = su* indications4 7ii7 ,non-duplication ( data reque/s ,9 c>ry+ out clause 7i7 ) respect to a break?r\gh device1 ! ,secret>y %all ensure t data or evid5ce id5tifi$-- 7,i7 does n duplicate data requir$ to be collect$ by ! ,food & ,drug ,adm9i/ration ) respect to su* break?r\gh device2 7,,ii7 m9imizes ! adm9i/rative burd5s ( data collection & report+ on provid]s ( s]vices1 suppli]s1 & manufactur]s ( break?r\gh devices2 & 7,,iii7 is n o!rwise unnecess>y or r$undant4 7,b7 ,proposal = cov]age aft] ! transitional cov]age p]iod ,n lat] ?an #b ye>s aft] ! date ( ! approval or cle>ance ( a break?r\gh device by ! ,food & ,drug ,adm9i/ration1 ! ,secret>y %all develop a proposal = cov]age "u ?is title ( su* break?r\gh device = su* indications z ! ,secret>y det]m9es to be appropriate1 bas$ on ! data & evid5ce collect$ "u subp>agraph 7,a71 = su* devices furni%$ aft] ! transitional cov]age p]iod "u p>agraph 7#a7 = su* device4 ,if ! ,secret>y does n1 on a date t is be=e ! end ( su* two-ye> p]iod1 take action to modify ! indications = :i* cov]age ( a break?r\gh device may be provid$ "u ?is title aft] su* p]iod1 = purposes ( section #ahfb7;a77#a77;,a7 cov]age "u ?is title ( su* break?r\gh device %all be made = all indications = :i* su* device is approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or cle>$ "u section #eaj7k7 ( su* ,act4 7#c7 ,rules ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7,a7 affect ! ability ( ! manufactur] ( a break?r\gh device to seek approval = pass-?r\gh paym5t /atus "u section #ahcc7t77#f7 or to seek approval = an additional paym5t "u section #ahhf7;d77#e77,k7 ins(> z su* break?r\gh device does n qualify = transitional cov]age "u p>agraph 7#a72 7,b7 affect ! application & approval process = pass-?r\gh paym5t /atus "u section #ahcc7t77#f7 or = an additional paym5t "u section #ahhf7;d77#e77,k7 9 ! case ( a m$ical device t is n approv$ by ! ,food & ,drug ,adm9i/ration z a break?r\gh device2 or 7,c7 prohibit ! ,secret>y f us+ exi/+ au?ority "u ?is title to susp5d or t]m9ate cov]age ( a break?r\gh device if ! ,secret>y1 bas$ on cl9ical evid5ce1 det]m9es t-- 7i7 su* break?r\gh device (f]s no cl9ical b5efit to ,m$ic>e b5efici>ies2 or 7ii7 furni%+ su* break?r\gh device to ,m$ic>e b5efici>ies causes1 or may cause1 s]i\s h>m to ,m$ic>e b5efici>ies4 7c7 ,cod+ 7#a7 ,prompt assignm5t ,n lat] ?an ?ree mon?s aft] ! date ( approval or cle>ance ( a break?r\gh device by ! ,food & ,drug ,adm9i/ration1 ! ,secret>y %all assign a unique tempor>y or p]man5t code or codes = purposes ( cov]age & paym5t = su* break?r\gh device "u ! applicable paym5t sy/ems 7describ$ 9 p>agraph 7#d774 7#b7 ,updates 7,a7 ,,ipps ,! ,secret>y %all provide = semiannual updates "u ! applicable paym5t sy/em describ$ 9 p>agraph 7#d77;,a7 7relat+ to ! inpati5t hospital prospective paym5t sy/em7 to recognize ! code or codes assign$ "u p>agraph 7#a74 7,b7 ,,opps ,! ,secret>y %all provide = qu>t]ly updates "u ! applicable paym5t sy/em describ$ 9 p>agraph 7#d77;,b7 7relat+ to ! outpati5t hospital prospective paym5t sy/em7 to recognize ! code or codes assign$ "u p>agraph 7#a74 7,c7 ,o!r paym5t sy/ems ,! ,secret>y %all provide = semiannual or qu>t]ly updates1 z ! case may be1 "u ! applicable paym5t sy/ems describ$ 9 subp>agraphs 7,c7 ?r\gh 7,l7 ( p>agraph 7#d7 to recognize ! code or codes assign$ "u p>agraph 7#a74 7#c7 ,transp>5cy ,! process = ! assignm5t ( a code or codes "u ?is subsection %all provide = public notice & a mean+ful opportunity = public comm5t f affect$ p>ties4 7#d7 ,applicable paym5t sy/ems describ$ ,= purposes ( ?is subsection1 ! t]m applicable paym5t sy/ems means-- 7,a7 ) respect to inpati5t hospital s]vices1 ! prospective paym5t sy/em = inpati5t hospital s]vices e/abli%$ "u section #ahhf7;d72 7,b7 ) respect to outpati5t hospital s]vices1 ! prospective paym5t sy/em = cov]$ ,,opd s]vices e/abli%$ "u section #ahcc7t72 7,c7 ) respect to ambulatory surgical c5t] s]vices1 ! fee s*$ule = su* s]vices e/abli%$ "u #ahcc7;i72 7,d7 ) respect to physicians' s]vices1 ! physician fee s*$ules e/abli%$ "u section #ahdh2 7,e7 ) respect to cov]$ items ( durable m$ical equipm5t1 ! applicable fee s*$ules e/abli%$ "u section #ahcd2 7,f7 ) respect to diagno/ic laboratory te/s1 ! paym5t am\nts "u section #ahcd;,a & ! fee s*$ules e/abli% "u section #ahdh1 z ! case may be2 7,g7 ) respect to inpati5t hospital s]vices furni%$ by rehabilitation facilities1 ! prospective paym5t sy/em e/abli%$ "u section #ahhf7;j72 7,h7 ) respect to inpati5t hospital s]vices furni%$ by long-t]m c>e hospitals1 ! prospective paym5t sy/em "u section #ahhf7m72 7,i7 ) respect to inpati5t hospital s]vices furni%$ by psy*iatric hospitals & psy*iatric units1 ! prospective paym5t sy/em "u section #ahhf7s72 7,j7 ) respect to home heal? s]vices1 ! prospective paym5t sy/em "u section #ahie2 & 7,k7 ) respect to items & s]vices1 or a provid] ( s]vices or suppli]1 n describ$ 9 subp>agraphs 7,a7 ?r\gh 7,i71 ! paym5t sy/em e/abli%$ "u ?is title = su* items & s]vices :5 furni%$ by su* provid] ( s]vices or suppli]4 7d7 ,paym5t 7#a7 ,inpati5t hospital prospective paym5t sy/em3 deem$ eligibility = break?r\gh paym5t ,! ,secret>y %all deem ea* break?r\gh device z approv$ = an additional paym5t "u section #ahhf7;d77#e77,k7 = ! #d-ye> p]iod t beg9s-- 7,a7 except z provid$ 9 subp>agraph 7,b71 on ! date t ! ,secret>y1 pursuant to subsection 7c77#b77;,a71 updates ! paym5t sy/em "u section #ahhf7;d7 to recognize ! unique tempor>y or p]man5t code or codes assign$ "u subsection 7c77#a7 to su* break?r\gh device2 or 7,b7 9 ! case ( a device t has n receiv$ approval or cle>ance z a break?r\gh device by ! ,food & ,drug ,adm9i/ration be=e su* paym5t sy/em is updat$ "u subsection 7c77#b77;,a7 to recognize ! unique tempor>y or p]man5t code or codes assign$ "u subsection 7c77#a7 to su* device1 on ! date ( su* approval or cle>ance4 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect ! au?ority ( ! ,secret>y to use claims data to e/abli% new diagnosis or proc$ure codes = break?r\gh devices or to id5tify appropriate diagnosis-relat$ gr\ps = ! assignm5t ( break?r\gh devices "u annual rulemak+ to c>ry out section #ahhf7;d77#e77,k74 7#b7 ,outpati5t prospective paym5t sy/em3 deem$ eligibility = pass-?r\gh paym5t ,! ,secret>y %all deem ea* break?r\gh device z approv$ = pass-?r\gh paym5t "u section #ahcc7t77#f7 7includ+ = purposes ( section #ahcc7;i77#b77;,d77 dur+ ! #d-ye> p]iod t beg9s-- 7,a7 except z provid$ 9 subp>agraph 7,b71 on ! date t ! ,secret>y1 pursuant to subsection 7c77#b77;,b71 updates ! paym5t sy/em "u section #ahcc7t7 to recognize ! unique tempor>y or p]man5t code or codes assign$ "u subsection 7c77#a7 to su* break?r\gh device2 or 7,b7 9 ! case ( a device t has n receiv$ approval or cle>ance z a break?r\gh device by ! ,food & ,drug ,adm9i/ration be=e su* paym5t sy/em is updat$ "u subsection 7c77#b77;,b7 to recognize ! unique tempor>y or p]man5t code or codes assign$ "u subsection 7c77#a7 to su* device1 on ! date ( su* approval or cle>ance4 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect ! au?ority ( ! ,secret>y to use claims data to e/abli% new ambulatory paym5t classification gr\ps = break?r\gh devices or to revise su* gr\ps to take into acc\nt break?r\gh devices "u annual rulemak+ to c>ry out section #ahcc7t74 7#c7 ,o!r paym5t sy/ems 7,a7 ,9 g5]al ,9 ! case ( a break?r\gh device t is furni%$ & = :i* paym5t may be made "u ! paym5t sy/em e/abli%$ "u section #ahcd1 #ahcd;,a1 #ahdh1 #ahhf7;j71 #ahhf7m71 #ahhf7s71 or #ahie or any o!r provision ( ?is title 7o!r ?an sections #ahcc7;i71 #ahcc7t71 & #ahhf7;d771 ! ,secret>y %all provide = an additional paym5t = su* break?r\gh device "u su* applicable paym5t sy/em or an adju/m5t to su* applicable paym5t sy/em1 z ! case may be4 ,! paym5t basis = su* additional paym5t or adju/m5t1 z ! case may be1 %all equal an am\nt t ! ,secret>y det]m9es cov]s ! co/s ( su* break?r\gh device4 7,b7 ,co/ in=mation ,9 det]m9+ ! co/s ( a break?r\gh device = purposes ( det]m9+ an additional paym5t or paym5t adju/m5t "u subp>agraph 7,a71 ! ,secret>y %all use ! mo/ rec5tly available data & in=mation on ! co/s ( su* break?r\gh device1 :i* may include li/ prices & invoice prices *>g$ = su* break?r\gh device4 7,c7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ to affect ! au?ority ( ! ,secret>y to use claims data to e/abli% new or modify exi/+ ambulatory paym5t classification gr\ps1 diagnosis-relat$ gr\ps1 level ,,ii ,,hcpcs codes or su* o!r gr\ps or codes z ! ,secret>y may e/abli% "u ! annual rulemak+ au?ority "u ! provisions ref]r$ to 9 subp>agraph 7,a74 7,d7 ,cl9ical diagno/ic laboratory te/s ,an additional paym5t or paym5t adju/m5t "u subp>agraph 7,a7 = a break?r\gh device "u ! applicable paym5t sy/em e/abli%$ 9 section #ahcd;,a may be 9 ! =m ( an increase to ! am\nt det]m9$ = ! break?r\gh device us+ cross-walk+ "u section #ahcd;,a7c77#a77;,a71 an ext5sion ( ! initial p]iod ( paym5t applicable to advance diagno/ic laboratory te/s "u section #ahcd;,a7d77#a77;,a71 & 9 su* o!r =m or mann] z ! ,secret>y det]m9es reflects ! co/s = su* break?r\gh device "u ! relevant provisions ( section #ahcd;,a4 7#d7 ,paym5t = break?r\gh devices aft] ! transitional cov]age p]iod ,paym5t = a break?r\gh device t is furni%$ aft] ! conclusion ( ! transitional cov]age p]iod "u subsection 7b77#a7 = su* device %all be made pursuant to ! applicable paym5t sy/em involv$1 tak+ into acc\nt ! additional evid5ce & data collect$ "u subsection 7b77#b74 7e7 ,special rules = c]ta9 break?r\gh devices 7#a7 ,cov]age ( specifi$ break?r\gh devices 7,a7 ,9 g5]al ,subject to ! succe$+ provisions ( ?is subsection & not)/&+ any o!r provision ( law1 ! ,secret>y %all provide = cov]age & paym5t pursuant to ?is section ( a specifi$ break?r\gh device 7z def9$ 9 subp>agraph 7,b774 7,b7 ,specifi$ break?r\gh device def9$ ,9 ?is section1 ! t]m specifi$ break?r\gh device means a break?r\gh device ) respect to :i* no ,m$ic>e b5efit category exi/s4 7#b7 ,p]iod ( transitional cov]age 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! provisions ( subsection 7b77#a7 7relat+ to ! transitional cov]age p]iod & paym5t = break?r\gh devices1 includ+ ! use ( ! mo/ rec5tly available data & in=mation on co/s7 %all apply to a specifi$ break?r\gh device 9 ! same mann] z su* provisions apply to a break?r\gh device4 ,! ,secret>y may use me?odologies "u exi/+ paym5t sy/ems e/abli%$ "u ?is title1 may provide = appropriate adju/m5ts to su* me?odologies1 or may e/abli% a new paym5t me?odology "u ?is title1 to provide = paym5t = a specifi$ break?r\gh device to ensure ! paym5t basis = su* paym5t cov]s co/s ( ! specifi$ break?r\gh device are cov]$ by su* paym5t4 7,b7 ,report 7i7 ,9 g5]al ,) respect to ea* specifi$ break?r\gh device1 ! ,secret>y %all submit to ,congress a report on ! cov]age ( & paym5t = su* specifi$ break?r\gh device "u ?is section t includes ! foll[+ in=mation3 7,i7 ,! mann] 9 :i* cov]age is provid$ & paym5t is made = ! specifi$ break?r\gh device1 includ+ h[ su* device 0 classifi$ 7su* z an item ( durable m$ical equipm5t or o!rwise7 & ! paym5t me?odology ! ,secret>y appli$ ) respect to su* device4 7,,ii7 ,! impact ( ! availability ( ! specifi$ break?r\gh device to ,m$ic>e b5efici>ies1 includ+ impacts on ! quality ( pati5t c>e1 pati5t outcomes1 & pati5t exp]i5ce4 7,,iii7 ,! impact ( ! availability ( ! specifi$ break?r\gh device to ,m$ic>e b5efici>ies on program exp5ditures "u ?is title4 7,,iv7 ,su* o!r in=mation z ! ,secret>y det]m9es to be appropriate4 7ii7 ,deadl9e 7,i7 ,9 g5]al ,except z provid$ 9 subclause 7,,ii71 ! ,secret>y %all submit a report requir$ "u ?is subp>agraph no lat] ?an ! end ( ! transitional p]iod ( cov]age & paym5t applicable to su* specifi$ break?r\gh device4 7,,ii7 ,ext5sion to g5]ate additional data ,if ! ,secret>y det]m9es t additional data or evid5ce is requir$ to complete a report requir$ "u ?is subp>agraph ) respect to a specifi$ break?r\gh device1 ! deadl9e "u ?is clause may be ext5d$ = an additional two ye>s4 7,c7 ,additional p]iod ( transitional cov]age to develop additional data ,ins(> z ! ,secret>y det]m9es t additional data or evid5ce is requir$ to complete a report requir$ "u subp>agraph 7,b7 ) respect to a specifi$ break?r\gh device1 ! transitional cov]age p]iod ( cov]age & paym5t = su* device %all be ext5d$ by ! less] (-- 7i7 two ye>s2 or 7ii7 ! am\nt ( additional "t requir$ = ! submission ( ! report ) respect to su* device4 7#c7 ,cov]age & paym5t aft] ! transitional p]iod ,! ,secret>y may cont9ue to provide = cov]age ( & paym5t = a specifi$ break?r\gh device aft] ! end ( ! transitional p]iod ( cov]age & paym5t = break?r\gh devices ?r\gh ! national cov]age det]m9ation process if ! ,secret>y det]m9es t ! specifi$ break?r\gh device-- 7,a7 improves ! quality ( c>e & pati5t outcomes2 7,b7 improves ! deliv]y ( c>e2 or 7,c7 r$uces sp5d+ "u ?is title )\t r$uc+ ! quality ( c>e4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,inpati5t prospective paym5t sy/em ,section #ahhf7;d77#e77,k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77 is am5d$ by add+ at ! end ! foll[+ new clause3 7x7 ,effective = dis*>ges occurr+ on or aft] ,octob] #a1 #bjai1 9 ! case ( a new m$ical s]vice or te*nology t is a break?r\gh device 7z def9$ 9 section #ahii;,c7a771 ! additional paym5t e/abli%$ = su* break?r\gh device "u ?is subp>agraph %all be made = ! #d-ye> p]iod applicable to su* break?r\gh device "u section #ahii;,c7d77#a74 ,9 det]m9+ ! am\nt ( ! additional paym5t = a break?r\gh device "u ?is subp>agraph dur+ su* #d-ye> p]iod1 ! ,secret>y %all apply section #dab4hh7;b7 ( title #db1 ,code ( ,f$]al ,regulations1 z 9 effect on ! date ( ! enactm5t ( ?is clause1 except z if ! ref]5ce 9 su* section to #fe p]c5t 7 a ref]5ce to #fe p]c5t 7or su* great] p]c5t specifi$ by ! ,secret>y74 4 7#b7 ,outpati5t prospective paym5t sy/em ,section #ahcc7t77#f77;,c7 ( su* ,act 7#db ,u4,s4,c4 #aciel7t77#f77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,special rule = break?r\gh devices ,not)/&+ clause 7i7 or 7ii71 or any o!r provision ( ?is p>agraph to ! contr>y1 9 ! case ( a break?r\gh device 7z def9$ 9 section #ahii;,c7a77 t is furni%$ on or aft] ,janu>y #a1 #bjbj1 paym5t "u ?is p>agraph = su* break?r\gh device %all be made = ! #d-ye> p]iod applicable to su* break?r\gh device "u section #ahii;,c7d77#b74 ,! provisions ( ?is clause %all also apply = purposes ( transitional pass-?r\gh paym5t "u section #ahcc7;i77#b77;,d74 4 7c7 ,effective date ,?is section1 & ! am5dm5ts made by ?is section1 %all take effect on ! date ( ! enactm5t ( ?is ,act &1 unless o!rwise specifi$ 9 ?is section 7or 9 an am5dm5t made by ?is section71 %all apply to break?r\gh devices 7z def9$ 9 section #ahii;,c7a7 ( ! ,social ,security ,act1 z add$ by subsection 7a771 approv$ or cle>$ on or aft] ,july #a1 #bjai1 or1 9 ! case ( a specifi$ break?r\gh device 7z def9$ 9 su* section z s add$71 approv$ or cle>$ on or aft] ,decemb] #a1 #bjah4 #dje4 ,secret>y ( ,heal? & ,human ,s]vices report on cov]age = innovative te*nologies ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 collaboration ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & foll[+ a reque/ = in=mation1 %all submit to ,congress a report conta9+ a proposal t-- 7#a7 specifies1 = purposes ( paym5t & cov]age "u title ,,xviii ( ! ,social ,security ,act1 a def9ition = digital alt]natives to treatm5t & !rapies1 includ+ we>ables & digital applications & plat=ms2 7#b7 e/abli%es a /&>diz$ process = det]m9+ :i* te*nologies satisfy ! def9ition pursuant to p>agraph 7#a72 7#c7 e/abli%es a /&>diz$ process = det]m9+ cov]age "u su* title ( digital alt]natives z def9$ pursuant to p>agraph 7#a7 t are prescrib$ by a physician2 & 7#d7 id5tifies an innovative sy/em = paym5t "u su* title = su* alt]natives4 #djf4 ,secret>y ( ,heal? & ,human ,s]vices report on ,,cms comput] sy/ems ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! foll[+3 7#a7 ,! curr5t /ate ( comput] sy/ems ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 includ+ an analysis ( ! capabilities & defici5cies ( su* sy/ems 9 help+ to manag+ ! op]ations ( ! programs adm9i/]$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7#b7 ,! co/1 tak+ into acc\nt ways to l[] or defray co/s to ! ,f$]al ,gov]nm5t1 ( ea* ( ! foll[+3 7,a7 ,replac+ or updat+ su* sy/ems id5tifi$ "u p>agraph 7#a74 7,b7 ,contractors & o!r ?ird p>ties to solve = defici5cies 9 su* sy/em id5tifi$ "u p>agraph 7#a74 #djg4 ,precision ,m$ic9e ,answ]s = ,kids ,today 7a7 ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,guidance on ! ,e>ly & ,p]iodic ,scre5+1 ,diagno/ic1 & ,treatm5t ,b5efit ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all issue guidance to ,/ates on au?ority & requirem5ts "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act to provide m$ically necess>y heal? c>e t falls )9 ! scope ( s]vices specifi$ "u section #aije7r7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7r77 to a *ild1 reg>dless ( :e!r ! s]vice is available = adults "u ! ,/ate plan 7or waiv] ( su* plan7 "u su* title4 ,! guidance %all-- 7#a7 include te*nical & educational assi/ance on h[ to increase ! frequ5cy ( cov]age "u ! ,/ate plan 7or waiv]7 pursuant to p>agraphs 7#d7 & 7#af7 ( section #aije7;a7 ( su* ,act 7#db ,u4,s4,c4 #acif;d7a77 = g5etic & g5omic te/+ diagno/ic s]vices1 includ+ :ole exome sequ5c+1 :ole g5ome sequ5c+1 & g5e panels :5 recomm5d$ by a qualifi$ treat+ provid] z a fir/- or second-ti] te/ = p$iatric pati5ts1 includ+ ^? :o-- 7,a7 h a positive result f a newborn scre5+ program2 7,b7 h "o or m neurodevelopm5tal or cong5ital anomalies2 7,c7 are exp]i5c+ developm5tal delay or intellectual disability2 7,d7 are hav+ seizures2 7,e7 h be5 ref]r$ or admitt$ to a p$iatric or neonatal int5sive c>e unit = a *ronic or undiagnos$ disease2 7,f7 h be5 se5 by at lea/ "o m$ical speciali/ = su* *ronic or undiagnos$ disease2 or 7,g7 are suspect$ by at lea/ "o heal?c>e provid] to h a neonatal- or p$iatric-onset g5etic disease2 7#b7 provide education & support to provid]s to m9imize d5ials ( claims = m$ical assi/ance "u ! ,/ate plan "u title ,,xix ( ! ,social ,security ,act result+ f defici5t or inadequate pap]work2 & 7#c7 ensure t provid]s & ,m$icaid-eligible *ildr5 & ! families are aw>e ( ! ,e>ly & ,p]iodic ,scre5+1 ,diagno/ic & ,treatm5t ,b5efit "u title ,,xix ( ! ,social ,security ,act & h access to requir$ scre5+s & necess>y treatm5t s]vices4 7b7 ,demon/ration program ,to provide g5etic & g5omic te/+ = c]ta9 *ildr5 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into agreem5ts ) up to #ae ,/ates submitt+ applications "u p>agraph 7#c7 = ! purpose ( conduct+1 9 accordance ) ?is subsection1 demon/ration projects "u section #aaae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae7 9 su* ,/ates dur+ ! #c-ye> p]iod beg9n+ on ! fir/ date ( ! fir/ fiscal qu>t] ?an beg9s on or aft] ! date ( ! enactm5t ( ?is subsection to te/ & evaluate ! provision ( m$ical assi/ance "u ! ,/ate plans "u title ,,xix ( su* ,act 7or waiv]s ( su* plans7 to eligible individuals = purposes ( provid+ su* individuals ) g5etic & g5omic te/+4 7#b7 ,demon/ration project paym5t requirem5ts ,"u ea* demon/ration project "u ?is section conduct$ by a ,/ate1 ! foll[+ %all apply3 7,a7 ,! ,/ate %all provide a heal? c>e provid] 7z def9$ by ! ,/ate7 ) paym5ts = ! provision ( g5etic & g5omic te/+ to any eligible individual4 ,paym5ts made to a heal? c>e provid] = su* s]vices %all be treat$ z m$ical assi/ance = purposes ( section #aijc7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7a771 except t ! ,f$]al m$ical assi/ance p]c5tage applicable to su* paym5ts %all be equal to #ajj p]c5t4 7,b7 ,! ,/ate %all specify ! me?odology ! ,/ate w use = det]m9+ paym5t = ! provision ( g5etic & g5omic te/+4 ,su* me?odology = det]m9+ paym5t %all be e/abli%$ consi/5t ) section #aijb7;a77#cj77;,a7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7a77#cj77;,a774 7#c7 ,applications 7,a7 ,9 g5]al ,a ,/ate desir+ to ent] into an agreem5t "u p>agraph 7#a7 ) ! ,secret>y = conduct+ a demon/ration project %all submit to ! ,secret>y an application1 9 accordance ) su* =m & mann]1 & application priorities1 z specifi$ by ! ,secret>y & t at a m9imum includes ! foll[+3 7i7 ,an explanation ( h[ & ! ext5t to :i* g5etic & g5omic te/+ "u ! demon/ration project ( ! ,/ate w provide in=mation & data on h[ su* s]vices improve ! diagnosis ( eligible individuals4 7ii7 ,an explanation ( h[ & ! ext5t to :i* cov]age "u ! ,/ate plan 7or waiv]7 pursuant to ! demon/ration project w increase ! use ( g5etic & g5omic te/+ t may increase ! use ( g5etic & g5omic te/+ t may improve cl9ical outcomes = eligible individuals4 7iii7 ,proc$ures = ref]r+ any eligible individual :o seeks or ne$s treatm5t 9 a hospital em]g5cy dep>tm5t to a heal? c>e provid] :o is qualifi$ 7z det]m9$ by ! ,/ate7 to provide g5etic & g5omic te/+4 7iv7 ,an explanation ( h[ g5etic & g5omic te/+ may improve heal? outcomes = all populations 9 ! ,/ate1 includ+-- 7,i7 individuals ) a r>e g5etic disease1 includ+ a metabolic disease1 neurologic disord]s1 or h]$it>y canc] te/+ 9 ! pres5ce ( a suspect$ or confirm$ canc] diagnosis2 & 7,,ii7 special populations1 includ+ infants & *ildr5 :o are critically ill 7non-infecti\s & non-trauma7 pati5ts1 transplant pati5ts1 individuals ) c>diac disease1 & individuals )1 or :o h a family hi/ory (1 a bir? defect or developm5tal disability4 7,b7 ,pref]5ces 9 consid]+ applications ,9 consid]+ applications submitt$ "u subp>agraph 7,a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all give pref]5ce to ,/ates t c demon/rate und]utilization ( g5etic & g5omic sequ5c+ cl9ical s]vices 7) priority giv5 to ,/ates t d n cov] :ole-g5ome sequ5c+ or d n cov] ! majority ( g5etic & g5omic cl9ical s]vices7 9 p$iatric populations "u ! ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or waiv] ( su* plan74 7#d7 ,te*nical assi/ance ,! ,secret>y ( ,heal? & ,human ,s]vices %all provide te*nical assi/ance to assi/ ,/ates 9 plann+ & design+ ! demon/ration project = purposes ( apply+ = conduct+ su* project "u ?is section4 7#e7 ,reports by ,/ates ,n lat] ?an "o ye> aft] ! date on :i* a ,/ate ent]s into an agreem5t "u p>agraph 7#a7 ) ! ,secret>y = conduct+ a demon/ration project1 ! ,/ate %all submit a report to ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration on ! ext5t to :i* g5etic & g5omic te/+ improv$ outcomes & r$uc$ heal? disp>ities4 ,su* report %all include in=mation on ! numb] ( pati5ts receiv+ g5etic & g5omic te/+1 ! types ( s]vices provid$1 & su* o!r in=mation z ! ,secret>y %all prescribe4 7#f7 ,reports by heal? c>e provid]s ,z a condition = receiv+ paym5t = g5etic & g5omic te/+ provid$ to an eligible individual "u a demon/ration project conduct$ by a ,/ate "u ?is subsection1 a heal? c>e provid] %all report to ! ,/ate1 9 accordance ) su* requirem5ts z ! ,secret>y %all specify1 on all applicable measures = det]m9+ ! quality & efficacy ( su* s]vices4 7#g7 ,def9itions ,9 ?is subsection3 7,a7 ,eligible individual ,! t]m eligible individual means1 ) respect to a ,/ate1 an individual :o-- 7i7 is eligible = m$ical assi/ance "u ! ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or a waiv] ( su* plan72 7ii7 is "u ! age ( #ba 7or1 at ! option ( ! ,/ate1 "u ! age ( #bj1 #ai1 or #ah z ! ,/ate may *oose71 or 9 ! case ( an individual describ$ 9 section #aijb7;a77#aj77;,a77i77,,ix7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77,,ix771 "u ! age ( #bf2 7iii7 has be5 ref]r$ or admitt$ to an int5sive c>e unit1 or has be5 se5 by at lea/ "o m$ical speciali/1 = a suspect$ g5etic or undiagnos$ disease2 or 7iv7 is suspect$ by at lea/ "o m$ical speciali/ to h a neonatal-onset or p$iatric-onset g5etic disease4 7,b7 ,g5etic & g5omic te/+ ,! t]m g5etic & g5omic te/+1 ) respect to an eligible individual-- 7i7 means ! det]m9ation ( a sequ5ce ( deoxyribonucleic acid bases 9 ! g5ome ( su* individual1 &1 if = ! sole b5efit ( ! individual1 a biological p>5t ( su* individual = ! purpose ( det]m9+ :e!r "o or m pot5tially disease-caus+ g5etic v>iants are pres5t 9 ! g5ome ( su* individual or su* biological p>5t2 & 7ii7 includes-- 7,i7 ! sequ5c+ ( ! :ole g5ome1 ! :ole exome1 or a panel ( g5es2 & 7,,ii7 any analysis1 int]pretation1 & data report d]iv$ f su* sequ5c+4 7c7 ,national ,academy ( ,m$ic9e /udy 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into an arrangem5t ) ! ,national ,academy ( ,m$ic9e "u :i* ! ,academy agrees to /udy-- 7,a7 h[ g5etic & g5omic te/+ may improve prev5tative c>e & precision m$ic9e2 7,b7 disp>ities 9 access to precision diagno/ics & associat$ !rapeutics2 7,c7 h[ g5etic & g5omic te/+ may be us$ to r$uce heal? disp>ities 9 m>g9aliz$ communities2 7,d7 h[ ! ,f$]al ,gov]nm5t may help to r$uce b>ri]s to g5etic & g5omic te/+1 includ+-- 7i7 enc\rag+ ! expansion ( heal? insurance cov]age ( g5etic & g5omic te/+1 includ+ diagno/ic1 pr$ictive1 & presymptomatic te/+1 & g5etic & g5omic te/+ 7z def9$ 9 subsection 7b77#g77;,b772 7ii7 support+ ! collection ( evid5ce = ! cl9ical utility & appropriate use ( g5etic & g5omic te/s2 & 7iii7 improv+ access to g5etic c\nselors1 pa?ologi/s1 & o!r relevant pr(essions1 includ+ /r5g!n+ relat$ work=ce education & tra9+ ef=ts2 7,e7 7i7 ! ext5t to :i* cov]age provisions 9 ! ,m$ic>e & ,m$icaid programs "u titles ,,xviii & ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq41 #acif et seq47 may re/ra9 ! use ( g5etic & g5omic te/+ t may improve cl9ical outcomes = b5efici>ies2 7ii7 ! ext5t to :i* cov]age provid$ pursuant to subsection 7a7 increas$ ! use ( g5etic & g5omic te/+ & improv$ cl9ical outcomes = b5efici>ies2 & 7iii7 h[ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices may make cov]age det]m9ations t bett] suit a precision m$ic9e approa* to treatm5t2 & 7,f7 h[ g5etic & g5omic te/+ may improve heal? outcomes = all p$iatric populations 9 ! ,unit$ ,/ates1 includ+-- 7i7 *ildr5 ) a r>e disease1 includ+ a metabolic disease1 neurologic disord]1 or h]$it>y canc] te/+ 9 ! pres5ce ( a suspect$ or confirm$ canc] diagnosis2 & 7ii7 special populations1 includ+-- 7,i7 critically ill 7non-infecti\s & non-trauma7 pati5ts2 7,,ii7 transplant pati5ts2 7,,iii7 individuals ) c>diac disease2 & 7,,iv7 individuals )1 or :o h a family hi/ory (1 a bir? defect or developm5tal disability4 7#b7 ,report 7,a7 ,9 g5]al ,! arrangem5t "u p>agraph 7#a7 %all provide = ! ,national ,academy ( ,m$ic9e to submit1 n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 a report on ! results ( ! /udy "u p>agraph 7#a7 to-- 7i7 ! ,secret>y ( ,heal? & ,human ,s]vices2 7ii7 ! ,committee on ,ways & ,means & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7iii7 ! ,committee on ,f9ance & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7,b7 ,consultation ,! arrangem5t "u p>agraph 7#a7 %all provide = ! ,national ,academy ( ,m$ic9e1 9 develop+ ! report requir$ by subp>agraph 7,a71 to consult ) physicians1 o!r heal? pr(essionals1 heal? educators1 heal? pr(essional organizations1 relevant companies1 pati5ts1 pati5t organizations1 ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 ! ,national ,canc] ,in/itute1 ! ,national ,in/itutes ( ,heal?1 ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,c7 ,use ( in=mation ,! ,national ,academy ( ,m$ic9e %all1 to ! ext5t possible1 9 conduct+ ! /udy "u p>agraph 7#a71 utilize in=mation includ$ 9 ! reports submitt$ pursuant to subsections 7f7 & 7g7 ( section #b4 7d7 ,c5t]s = ,m$ic>e ,m$icaid ,s]vices report on ,m$icaid ,cov]age = g5etic & g5omic te/+ ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft] = ! subsequ5t #c ye>s1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,committees on ,ways & ,means & on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & ! ,committees on ,f9ance & ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! ext5t to :i* ea* ( ! #ej ,/ates provide cov]age "u ! ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or waiv] ( su* plan7 ( g5etic & g5omic te/+ 7z def9$ 9 subsection 7b77#g77;,b77 7includ+ :ole exome1 :ole g5ome1 g5e panels1 s+le g5e te/s1 ,*romosomal micro>ray analysis1 ,fluoresc5ce 9 situ hybridization1 & o!r g5etic & g5omic te/s71 includ+ in=mation on-- 7#a7 h[ (t5 g5etic & g5omic diagno/ic te/+ s]vices are cov]$ & reimburs$2 7#b7 ! frequ5cy ( d5ials = cov]age & ! rationale = d5y+ cov]age2 7#c7 an analysis ( :i* g5etic & g5omic diagno/ic te/s are be+ approv$ or d5i$2 7#d7 h[ (t5 te/ g5etic c\nsel+ is cov]$ pre- & po/-g5etic & g5omic diagno/ic te/+2 7#e7 ! turn-ar\nd "t = prior au?orization reque/s2 & 7#f7 any b>ri]s to cov]age ( g5etic & g5omic te/+ s]vices id5tifi$4 #djh4 ,m$ic>e cov]age = consultations 7a7 ,inclusion ( consultations z a ,m$ic>e b5efit ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$-- 7#a7 9 subsection 7s77#b7-- 7,a7 by /rik+ & at ! end ( subp>agraph 7,,gg72 7,b7 by /rik+ ! p]iod at ! end ( subp>agraph 7,,hh7 & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,,ii7 ph>macog5etic consultations provid$ by a qualifi$ cl9ical ph>maci/1 g5etic c\nselor1 or pa?ologi/ 7z su* t]ms are def9$ 9 subsection 7lll774 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7lll7 ,def9itions ,9 ?is section3 7#a7 ,ph>macog5etic consultation ,! t]m ph>macog5etic consultation means1 ) respect to a g5etic or g5omic te/ furni%$ to an individual1 a consultation ) respect to su* te/ reque/$ by ! physician treat+ su* individual to provide su* physician ) advice & recomm5dations reg>d+ ! dosage1 safety1 & efficacy ( p>ticul> drugs1 biologicals1 & o!r treatm5ts bas$ on ! individual's ph>macog5etic result4 7#b7 ,g5etic c\nselor ,! t]m g5etic c\nselor means an individual :o-- 7,a7 is lic5s$ z a g5etic c\nselor by ! ,/ate 9 :i* ! individual furni%es g5etic c\nsel+ s]vices2 or 7,b7 9 ! case ( an individual practic+ 9 a ,/ate t does n lic5se g5etic c\nselors1 meets su* o!r crit]ia z ! ,secret>y e/abli%es4 7#c7 ,qualifi$ cl9ical ph>maci/ ,! t]m qualifi$ cl9ical ph>maci/ means an individual-- 7,a7 ) a doctoral degree 9 ph>macy2 7,b7 :o is lic5s$ z a ph>maci/ 9 ! ,/ate 9 :i* su* individual furni%es consultations2 7,c7 has appropriate ph>macy specialty c]tifications or appropriate tra9+1 z det]m9$ by ! ,secret>y2 & 7,d7 meets o!r qualifications z specifi$ by ! ,secret>y4 4 7b7 ,paym5t = ph>macog5etic consultation ,section #ahcb7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciek7a77#b77 is am5d$-- 7#a7 by /rik+ & at ! end ( subp>agraph 7,i72 7#b7 by /rik+ ! p]iod at ! end ( subp>agraph 7,j7 & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,k7 ph>macog5etic consultations 7z def9$ 9 subsection 7lll774 4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply to consultations furni%$ dur+ a co/ report+ p]iod beg9n+ on or aft] ! date ( ! enactm5t ( su* subsections4 #dji4 ,prohibit+ ! use ( geographic track+ features & biometrics )9 ,m$icaid electronic visit v]ification sy/ems 7a7 ,9 g5]al ,section #aijc7l77#e77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7l77#e77;,a77 is am5d$ by ins]t+ 7)\t ! use ( geographic track+ or biometrics7 aft] electronically v]ifi$4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to cal5d> qu>t]s beg9n+ on or aft] ,june #a1 #bjbb4 #daj4 ,g5]ally accept$ /&>d = electronic prescrib+ ,section #ahfj;,d-#d7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,g5]ally accept$ /&>ds 7,a7 ,designation ( /&>ds ma9t5ance organization to recognize g5]ally accept$ /&>ds ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is p>agraph1 ! ,secret>y %all designate ?r\gh rulemak+ a /&>ds ma9t5ance organization ) ! au?ority to e/abli%1 ma9ta91 & modify g5]ally accept$ /&>ds = electronic prescrib+ & electronic prior au?orization4 ,! /&>ds ma9t5ance organization nam$ by ! ,secret>y %all be a /&>d sett+ body t-- 7i7 is a n-=-pr(it2 7ii7 has e/abli%$ a multi-/akehold] =um = developm5t & approval ( electronic prescrib+ & electronic prior au?orization /&>ds2 7iii7 is a /&>ds developm5t organization accr$it$ by ! ,am]ican ,national ,/&>ds ,in/itute2 & 7iv7 includes 9 its memb]%ip ph>macies1 prescrib]s1 prescription drug plans1 heal? in=mation te*nology develop]s1 & repres5tatives f ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,food & ,drug ,adm9i/ration4 ,9 provid+ ! /&>ds ma9t5ance organization ) ! au?ority to e/abli%1 ma9ta91 & modify g5]ally accept$ /&>ds1 ! ,secret>y %all p]mit ! /&>ds ma9t5ance organization to recognize up to two v]sions ( a /&>d z be+ g5]ally accept$ to facilitate ! te/+ ( new] /&>ds & to all[ a smoo? transition f "o /&>d to ano!r4 7,b7 ,adoption ( g5]ally accept$ /&>ds ,n lat] ?an six mon?s aft] mak+ ! designation "u p>agraph 7#h71 ! ,secret>y %all require prescriptions & o!r in=mation describ$ 9 p>agraph 7#b77;,a7 = cov]$ ,"p ,d drugs prescrib$ = ,"p ,d eligible individuals t are transmitt$ electronically to be transmitt$ only 9 accordance ) g5]ally accept$ /&>ds1 z designat$ by ! /&>ds ma9t5ance organization nam$ by ! ,secret>y "u subp>agraph 7,a71 "u an electronic prescription drug program t meets ! requirem5ts ( p>agraph 7#b74 4 #daa4 ,mean+ful access to ,f$]al heal? plan claims data 7a7 ,f9d+s ,congress f9ds z foll[s3 7#a7 ,cl9ician-l$ cl9ical data regi/ries s]ve an important role 9 promot+1 facilitat+1 & conduct+ m$ical rese>* & improv+ quality ( heal?c>e by provid+ timely & actionable fe$back to practition]s on _! p]=mance 9 relation to o!r practition]s & be/ cl9ical practices4 7#b7 ,cl9ician-l$ cl9ical data regi/ries are h9d]$ 9 _! ability to promote m$ical rese>* & quality improvem5t by _! lack ( mean+ful access to claims data4 7#c7 ,:ile ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices has e/abli%$ programs = provid+ access to claims data1 ^? programs fail to provide cl9ician-l$ cl9ical data regi/ries ) mean+ful access to su* data4 7#d7 ,ensur+ cl9ician-l$ cl9ical data regi/ries mean+ful access to claims data w enable su* entities to bett] track pati5t outcomes ov] "t1 exp& _! ability to assess ! safety & effectiv5ess ( m$ical treatm5ts1 & provide !m ) ! in=mation necess>y to assess ! co/-effectiv5ess ( !rapies4 7b7 ,ensur+ mean+ful access to claims data 7#a7 ,e/abli%m5t ( a new program ,! ,secret>y %all e/abli% a new program 7sep>ate f any exi/+ data access programs1 includ+1 )\t limitation1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,qualifi$ ,entity 79 ?is section1 ref]r$ to z ,,qe7 ,program 7#db ,u4,s4,c4 #aciekk7e71 #aciekk-#b7 79 ?is section1 ref]r$ to z ! ,m$ic>e ,data ,%>+ = ,p]=mance ,measurem5t ,program7 & ! ,rese>* ,data ,assi/ance ,c5t] 79 ?is section1 ref]r$ to z ! ,res,d,a,c7 process7 "u :i* ! ,secret>y %all1 at ! reque/ ( a cl9ician-l$ cl9ical data regi/ry1 provide timely1 broad1 & cont9u\s access to a database ( claims data to su* cl9ician-l$ cl9ical data regi/ry = purposes ( rese>*1 quality ( c>e measurem5t & report+ to heal? c>e provid]s1 l9k+ su* data ) cl9ical data & p]=m+ risk-adju/$1 sci5tifically valid analyses & rese>* to support quality improvem5t or pati5t safety1 & o!r purposes & uses describ$ h]e9 or approv$ by ! ,secret>y4 ,access to a database ( claims data pursuant to ?is subsection %all n be m re/rictive ?an access to data provid$ "u ! ,,qe ,program or ! ,res,d,a,c process4 7#b7 ,/reaml9$ application process 7,a7 ,initial & rec]tification application ,prior to ga9+ access to a database ( claims data "u ! program e/abli%$ 9 subsection 7a71 a cl9ician-l$ cl9ical data regi/ry %all submit to ! ,secret>y an application demon/rat+ t x is qualifi$ 7z det]m9$ by ! ,secret>y7 to use claims data4 ,^u ! ,secret>y's approval ( a cl9ician-l$ cl9ical data regi/ry's application describ$ 9 ?is subp>agraph1 ! ,secret>y %all provide access to a database ( claims data to su* cl9ician-l$ cl9ical data regi/ry = a p]iod ( at lea/ #e ye>s4 ,aft] ! expiration ( ! "t p]iod describ$ 9 ?is subp>agraph1 ! cl9ician-l$ cl9ical data regi/ry %all reapply to access ! database ( claims data "u ! program e/abli%$ 9 subsection 7a74 7,b7 ,process ,! ,secret>y %all e/abli% a /reaml9$ initial application & rec]tification application process "u :i* ! ,secret>y %all approve or d5y ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 subp>agraph 7#b77;,a7 )9 #fj cal5d> days aft] receiv+ ! application unless ! ,secret>y demon/rates a compell+ reason = ne$+ additional "t to complete ! process4 ,if ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 subp>agraph 7#b77;,a7 is d5i$1 ! ,secret>y %all provide ! reason7s7 = d5ial4 7#c7 ,appeal rights 7,a7 ,opportunity to appeal ,! ,secret>y %all develop & ma9ta9 a process by :i* a cl9ician-l$ cl9ical data regi/ry may appeal-- 7i7 ! ,secret>y's decision to d5y an application describ$ 9 p>agraph 7#b72 & 7ii7 ! ,secret>y's failure to approve or d5y ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 p>agraph 7#b7 )9 a reasonable "t frame e/abli%$ by ! ,secret>y4 7,b7 ,deadl9e = decision ,! ,secret>y %all r5d] a decision ) respect to an appeal fil$ by a cl9ician-l$ cl9ical data regi/ry pursuant to subp>agraph 7,a7 9 a timely mann]1 n to exce$ #fj cal5d> days aft] ! ,secret>y receives ! cl9ician-l$ cl9ical data regi/ry's reque/ = an appeal4 ,notice ( su* decision %all be provid$ to ! cl9ician-l$ cl9ical data regi/ry fil+ ! appeal be=e ! conclusion ( su* #fj-;day p]iod4 7#d7 ,broad & timely access to data ,! ,secret>y %all /ructure its database ( claims data to all[ = v>i\s data set qu]ies1 includ+1 b n limit$ to1 provid]-specific claims data1 cl9ical specialty-specific claims data1 /ate-specific claims data1 & nationwide claims data4 ,! ,secret>y %all promptly make available to a cl9ician-l$ cl9ical data regi/ry access to claims data reque/$ by su* cl9ician-l$ cl9ical data regi/ry )9 a reasonable timeframe1 n to exce$ #cj cal5d> days1 aft] ! ,secret>y approves ! reque/ f ! cl9ician-l$ cl9ical data regi/ry4 7c7 ,p]missible uses ( claims data ,cl9ician-l$ cl9ical data regi/ries may-- 7#a7 make available to ! public reports evaluat+ ! p]=mance ( provid]s ( s]vices & suppli]s us+ ! claims data provid$ to su* cl9ician-l$ cl9ical data regi/ry "u subsection 7a7 9 comb9ation ) regi/ry data2 7#b7 use claims data receiv$ "u subsection 7a7 comb9$ ) regi/ry data to conduct additional nonpublic analyses & provide or *>ge an access fee = su* analyses to au?oriz$ us]s = nonpublic use2 7#c7 provide or *>ge an access fee = data sets t l9k claims data receiv$ "u subsection 7a7 ) regi/ry data to au?oriz$ us]s = nonpublic use2 & 7#d7 provide or *>ge an access fee = claims data receiv$ "u subsection 7a7 to au?oriz$ us]s = nonpublic use4 7d7 ,fees 7#a7 ,claims data provid$ to cl9ician-l$ cl9ical data regi/ries ,claims data %all be provid$ to a cl9ician-l$ cl9ical data regi/ry "u subsection 7a7 at a reasonable fee bas$ on ! co/ ( provid+ su* data to ! cl9ician-l$ cl9ical data regi/ry4 ,su* fee %all be bas$ at lea/ 9 "p on ! numb] ( pati5ts includ$ 9 ! claims data provid$ to su* cl9ician-l$ cl9ical data regi/ry4 ,any fee collect$ pursuant to ! prec$+ s5t5ces %all be deposit$ 9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt4 7#b7 ,analyses & data provid$ to au?oriz$ us]s ,a cl9ician-l$ cl9ical data regi/ry may *>ge a reasonable1 co/-bas$ fee = provid+ to au?oriz$ us]s claims data1 data sets l9k+ claims data ) regi/ry data1 or analyses describ$ 9 subsection 7b74 7e7 ,protection ( in=mation 7#a7 ,privacy1 security1 & disclosure laws ,! ,secret>y %all provide access to a database ( claims data pursuant to subsection 7a7 9 accordance ) applicable in=mation1 privacy1 security1 & disclosure laws1 includ+1 )\t limitation1 ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia7 z am5d$ by ! privacy & security provisions set =? 9 section #acdjj ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7,public ,law #aaa-e71 ! regulations promulgat$ !reund] codifi$ at p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations1 & subp>agraphs 7,a7 ?r\gh 7,b7 ( section #aje7;a77#c7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#c774 7#b7 ,prohibition on us+ analyses or data = m>ket+ purposes ,an au?oriz$ us] %all n use analyses or data provid$ or sold "u p>agraphs 7#b7 ?r\gh 7#d7 ( subsection 7b7 = m>ket+ purposes4 7#c7 ,no r$isclosure ( analyses or data ,an au?oriz$ us] 9 receipt ( an analysis or datum provid$ or sold "u p>agraphs 7#b7 ?r\gh 7#d7 ( subsection 7b7 %all comply ) section #aje7;a77#e7 ( ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#e774 7#d7 ,opportunity = provid]s ( s]vices & suppli]s to review ,prior to a cl9ician-l$ cl9ical data regi/ry us+1 provid+1 or *>g+ an access fee = claims data1 data sets l9k+ claims data ) regi/ry data1 or analyses describ$ 9 subsection 7b71 to ! ext5t t su* data1 data sets1 or analyses w\ld individually id5tify a provid] ( s]vices or suppli] :o is n be+ provid$ or sold su* data1 data sets1 or analyses1 su* cl9ician-l$ cl9ical data regi/ry %all confid5tially make available su* data1 data sets1 or analyses to su* provid] ( s]vices or suppli] & provide su* provid] ( s]vices or suppli] ) ! opportunity to appeal & correct errors4 7f7 ,data use agreem5t ,a cl9ician-l$ cl9ical data regi/ry & an au?oriz$ us] %all ent] into a data use agreem5t reg>d+ ! use or disclosure ( any claims data or data sets t l9k claims data ) regi/ry data t ! cl9ician-l$ cl9ical data regi/ry is provid+ or *>g+ an access fee to ! au?oriz$ us] "u p>agraphs 7#c7 ?r\gh 7#d7 ( subsection 7b74 ,su* agreem5t %all include ! requirem5ts & prohibitions describ$ 9 section #aje7;a77#d7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#d774 7g7 ,assessm5t = a brea* 7#a7 ,9 g5]al ,9 ! case ( a brea* ( a data use agreem5t describ$ 9 subsection 7e71 ! ,secret>y %all impose an assessm5t on ! cl9ician-l$ cl9ical data regi/ry & ! au?oriz$ us]4 7#b7 ,assessm5t ,! assessm5t "u p>agraph 7#a7 %all be 9 an am\nt up to #ajj = ea* individual entitl$ to1 or enroll$ =1 b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act or enroll$ = b5efits "u "p ,b ( su* title = :om ! cl9ician-l$ cl9ical data regi/ry provid$ data on to ! au?oriz$ us]4 7#c7 ,deposit ( am\nts collect$ ,any am\nts collect$ pursuant to ?is subsection %all be deposit$ 9 ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet74 7h7 ,discov]y or admission z evid5ce ,claims data releas$ to a cl9ician-l$ cl9ical data regi/ry "u subsection 7a7 %all n be subject to discov]y or admission z evid5ce 9 judicial or adm9i/rative proce$+s )\t cons5t ( ! applicable provid] ( s]vices or suppli]4 7i7 ,report to ,congress ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft]1 ! ,secret>y %all submit to ,congress a report on ! ext5t to :i* cl9ician-l$ cl9ical data regi/ries are af=d$ mean+ful access to claims data4 7j7 ,def9itions ,9 ?is subtitle3 7#a7 ,au?oriz$ us] ,! t]m au?oriz$ us] has ! mean+ giv5 su* t]m 9 section #aje7;a77#i77;,a7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#i77;,a771 z well z a gov]nm5t ag5cy or o!r gov]nm5tal entity1 rese>*]s1 entities t seek data = purposes ( comply+ ) regulations or o!r requirem5ts ( ! ,f$]al ,food & ,drug ,adm9i/ration1 & o!r entities approv$ by ! ,secret>y4 7#b7 ,claims data ,! t]m claims data has ! mean+ giv5 to ! t]m data 9 section #aje7;b77#a77;,b7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;b77#a77;,b774 7#c7 ,cl9ician-l$ cl9ical data regi/ry ,! t]m cl9ician-l$ cl9ical data regi/ry has ! mean+ giv5 su* t]m 9 section #djje7;b7 ( ! #ba/ ,c5tury ,cures ,act4 7#d7 ,nonpublic use ,! t]m nonpublic use means a use = ! purpose (-- 7,a7 promot+1 facilitat+1 & conduct+ m$ical rese>*1 assi/+ provid]s ( s]vices & suppli]s to improve pati5t safety1 & to develop & p>ticipate 9 quality & pati5t c>e improvem5t activities1 includ+ develop+ new models ( c>e2 7,b7 assi/+ cl9ician-l$ cl9ical data regi/ries 9 develop+ & report+ quality measures to heal? c>e provid]s quality measures2 7,c7 educat+ a gov]nm5t ag5cy or o!r gov]nm5tal entity2 & 7,d7 support+ cl9ical trials & o!r activities necess>y to comply ) pre- or po/-m>ket approval or adv]se ev5t report+ requirem5ts or conditions impos$ by ! ,food & ,drug ,adm9i/ration1 & o!r purpose approv$ by ! ,secret>y4 7#e7 ,provid] ( s]vices ,! t]m provid] ( s]vices has ! mean+ giv5 su* t]m 9 section #ahfa7u7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7u774 7#f7 ,suppli] ,! t]m suppli] has ! mean+ giv5 su* t]m 9 section #ahfa7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7d774 7k7 ,regulations ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all promulgate f9al regulations to implem5t ! provisions ( ! prec$+ sections ( ?is subtitle4 ,v ,rese>* #eja4 ,advanc$ ,rese>* ,projects ,ag5cy = ,heal? 7a7 ,e/abli%m5t ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all e/abli% ! ,advanc$ ,rese>* ,projects ,ag5cy = ,heal? 7to be ref]r$ to 9 ?is ,act z ,,arpa-,h7 to trans=m & improve important areas ( m$ic9e & heal? = ! well-be+ ( all individuals 9 ! ,unit$ ,/ates4 7b7 ,goals 7#a7 ,9 g5]al ,! goals ( ,,arpa-,h %all be to deliv] break?r\gh capabilities ?r\gh te*nologies1 sy/ems1 & plat=ms t-- 7,a7 accel]ate ! discov]y & application ( trans=mational innovations 9 heal? & m$ical product developm5t2 & 7,b7 r$uce ! human & economic co/ ( disease4 7#b7 ,means ,,arpa-,h may a*ieve ! e/abli%$ goals "u p>agraph 7#a71 includ+ by any ( ! foll[+ means3 7,a7 ,promot+ high-risk1 high-rew>d innovation4 7,b7 ,id5tify+ & promot+ revolution>y advances 9 biom$ical & heal? rese>* t enable new p>adigms 9 heal?4 7,c7 ,accel]at+ trans=mational heal? advances 9 areas t ! relevant indu/ries by !mselves are n likely to und]take because ( te*nical1 f9ancial1 or o!r unc]ta9ty4 7,d7 ,prioritiz+ project inve/m5ts bas$ on sci5tific opportunity & uniqu5ess ( fit to ,,arpa-,h /rategies & op]at+ practice1 toge!r ) ! prospective impact on disease burd5 7reg>dless ( disease preval5ce71 bo? human & fiscal1 includ+ ! heal? c>e fiscal liability ( ! ,f$]al gov]nm5t4 7,e7 ,p>tn]+ )1 & provid+ fund+ to1 a broad range ( in/itutions1 includ+ univ]sities1 national laboratories1 public sector organizations1 private companies1 nonpr(it organizations1 & =eign in/itutions4 7c7 ,director 7#a7 ,9 g5]al ,,arpa-,h %all be head$ by a ,director1 :o %all be appo9t$ by & s]ve at ! pleasure ( ! ,presid5t 7ref]r$ to 9 ?is section z ! ,director ( ,,arpa-,h74 7#b7 ,selection ,! ,director ( ,,arpa-,h %all-- 7,a7 be an individual :o1 by reason ( pr(essional backgr\nd & exp]i5ce1 is qualifi$ to advise ! ,secret>y on1 & manage rese>* programs address+1 matt]s p]ta9+ to long-t]m & high-risk b>ri]s to ! developm5t ( heal? innovation2 7,b7 h au?ority to execute contracts develop$ by 9-h\se program manag]s :o select ext]nal p]=m]s1 & ma9ta91 enhance or t]m9ate projects bas$ on p]=mance aga9/ explicit mile/ones2 & 7,c7 h a "t-limit$ appo9tm5t ( #e ye>s ) ! opportunity1 at ! discretion ( ! ,presid5t1 ( "o ext5sion4 7#c7 ,duties ,! duties ( ! ,director ( ,,arpa-,h %all be to-- 7,a7 set national rese>* priorities to advance ! mission ( ! ag5cy z in=m$ by a multi-sectoral bo>d ( advisors2 7,b7 approve all new programs )9 ,,arpa-,h2 7,c7 h f9al fund+ au?ority to initiate & t]m9ate program fund+2 7,d7 e/abli% crit]ia = fund+ & assess+ ! success ( programs ?r\gh ! e/abli%m5t ( te*nical mile/ones2 7,e7 appo9t ! p]sonnel necess>y1 consi/5t ) subsection 7d71 to successfully execute ! goals ( ,,arpa-,h2 & 7,f7 designate employees to s]ve z program manag]s to c>ry out ! duties describ$ 9 subsection 7e7 = ea* ( ! programs e/abli%$ pursuant to ! responsibilities e/abli%$ = ,,arpa-,h4 7#d7 ,au?ority ,! ,director ( ,,arpa-,h is au?oriz$ to-- 7,a7 acquire 7by pur*ase1 lease1 condemnation1 or o!rwise71 con/ruct1 improve1 repair1 op]ate1 & ma9ta9 su* real & p]sonal prop]ty z are necess>y to c>ry out ?is section2 & 7,b7 lease an int]e/ 9 prop]ty = n m ?an #bj ye>s1 not)/&+ section #acda7;a77#a7 ( title #ca1 ,unit$ ,/ates ,code4 7d7 ,p]sonnel managem5t au?ority 7#a7 ,special ,p]sonnel ,managem5t ,au?ority ,! ,director ( ,,arpa-,h may-- 7,a7 make appo9tm5ts to positions ( adm9i/ration or managem5t ( ,,arpa-,h )\t reg>d to any provision 9 title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts "u ! civil s]vice laws & fix ! comp5sation ( su* positions at a rate n to exce$ ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code1 not)/&+ section #bjb ( ,dep>tm5t ( ,heal? & ,human ,s]vices ,appropriations ,act1 #aiic 7,public ,law #ajb-cid72 7,b7 hire p]sonnel "u section #bjg7;f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bji7;f77 & e/abli% gov]n+ crit]ia to recruit1 appo9t1 & comp5sate p]sonnel "u ?is section not)/&+ section #bjb ( ,dep>tm5t ( ,heal? & ,human ,s]vices ,appropriations ,act1 #aiic 7,public ,law #ajb-cid7 or any provision ( title #e1 ,unit$ ,/ates ,code1 gov]n+ ! rates ( pay or classification ( employees 9 ! ,executive bran*2 7,c7 make additional appo9tm5ts ( sci5tific1 m$ical1 & pr(essional p]sonnel "u ?is section )\t reg>d to any provision 9 title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts "u ! civil s]vice laws & fix ! comp5sation ( su* p]sonnel at a rate to be det]m9$ by ! ,director1 up to ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code1 not)/&+ section #bjb ( ,dep>tm5t ( ,heal? & ,human ,s]vices ,appropriations ,act1 #aiic 7,public ,law #ajb-cid7 or any provision ( title #e1 ,unit$ ,/ates ,code1 gov]n+ ! rates ( pay or classification ( employees 9 ! ,executive bran*2 & 7,d7 recruit & reta9 a div]se work=ce1 includ+ individuals und]repres5t$ 9 sci5ce & m$ic9e & racial & e?nic m9orities4 7#b7 ,additional /aff ,! ,director ( ,,arpa-,h may use all au?orities 9 exi/5ce on ! date ( enactm5t ( ?is ,act t are provid$ to ! ,secret>y to hire adm9i/rative1 f9ancial1 in=mation te*nology /aff1 & any o!r /aff ! ,director ( ,,arpa-,h det]m9es are necess>y to c>ry out ?is section4 7#c7 ,limitation on t]m 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! s]vice ( an employee "u an appo9tm5t "u p>agraph 7#a77;,a7 9 ! position ( a program manag] may n exce$ #c ye>s4 7,b7 ,ext5sion ,! ,director ( ,,arpa-,h may1 9 ! case ( a p>ticul> employee1 ext5d ! p]iod to :i* s]vice is limit$ "u subp>agraph 7,a7 by up to #c ye>s if ! ,director det]m9es t su* action is necess>y to promote ! effici5cy ( ,,arpa-,h4 7#d7 ,limitation on additional paym5ts ,! total am\nt ( ! additional paym5ts paid to an employee "u p>agraph 7#a77;,c7 = any #ab-mon? p]iod may n exce$ ! lea/ ( ! foll[+ am\nts3 7,a7 #be1jjj4 7,b7 ,! am\nt equal to #be p]c5t ( ! employee's annual rate ( basic pay4 7,c7 ,! am\nt ( ! limitation t is applicable = a cal5d> ye> "u section #ecjg7;a77#a7 ( title #e1 ,unit$ ,/ates ,code4 7e7 ,program manag]s ,an employee designat$ z a program manag] pursuant to subsection 7c77#c77;,f7 %all-- 7#a7 def9e ! rese>* & developm5t goals & mile/ones ( ! program involv$1 9 l9e ) guidance f ! ,director2 7#b7 track progress & c\rse-correct projects :5 ne$$2 7#c7 recomm5d1 z necess>y1 ! re/ructur+ or t]m9ation ( projects support$ by ,,arpa-,h2 & 7#d7 select1 on ! basis ( m]it & ne$1 ea* ( ! projects to be support$ "u ! program involv$ aft] consid]+-- 7,a7 ! novelty & sci5tific & te*nical m]it ( ! propos$ projects2 7,b7 ! demon/rat$ capabilities ( ! applicants to successfully c>ry out ! propos$ project2 7,c7 ! consid]ation by ! applicant ( future comm]cial applications ( ! project2 or 7,d7 ! unmet ne$ )9 pati5t populations4 7f7 ,reports 7#a7 ,/rategic vision ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,director ( ,,arpa-,h %all provide to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate a report describ+ ! /rategic vision t ,,arpa-,h w use to guide ! *oices ( ,,arpa-,h = future heal? inve/m5ts ov] ! foll[+ #c fiscal ye>s beg9n+ on or aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,annual budget reque/ ,z "p ( ! annual budget reque/ submitt$ = ea* fiscal ye>1 ! ,director ( ,,arpa-,h %all provide to ! congressional committees specifi$ 9 p>agraph 7#a7 a report describ+-- 7,a7 projects support$ by ,,arpa-,h dur+ ! previ\s fiscal ye>1 includ+-- 7i7 ! transition ( projects' outcomes to cl9ical practice2 7ii7 ! impact on cl9ical outcome2 & 7iii7 ! creation ( biom$ical capabilities2 & 7,b7 successes & b>ri]s to sci5tific int]*anges2 7,c7 rapid k transf]2 7,d7 res\rce optimization2 & 7,e7 height5$ inve/m5t impact among collaborators4 7#c7 ,report on coop]ative agreem5ts & o!r transaction ,n lat] ?an #ij days aft] ! end ( ea* fiscal ye>1 ! ,director ( ,,arpa-,h %all submit to ! congressional committees specifi$ 9 p>agraph 7#a7 a report on all coop]ative agreem5ts & o!r transactions 7o!r ?an contracts & grants7 ent]$ into "u ?is subsection dur+ su* fiscal ye>4 ,! report %all conta91 ) respect to su* coop]ative agreem5t & transaction1 ! foll[+3 7,a7 ,a g5]al description ( ! coop]ative agreem5t or o!r transaction 7z ! case may be71 includ+ ! innovations = :i* advanc$ rese>* is provid$ = "u su* agreem5t or transaction4 7,b7 ,! pot5tial cl9ical &1 if any1 comm]cial utility ( su* innovations4 7,c7 ,! reasons = n us+ a contract or grant to provide support = su* advanc$ rese>*4 7,d7 ,! am\nt ( ! paym5ts1 if any1 ref]r$ to 9 subsection 7i77#b7 t 7 receiv$ by ! ,f$]al ,gov]nm5t 9 connection ) su* coop]ative agreem5t or o!r transaction dur+ ! fiscal ye> cov]$ by ! report4 7,e7 ,! am\nt ( ! paym5ts report$ "u subp>agraph 7,d71 if any1 t 7 cr$it$ to ! acc\nt e/abli%$ "u subsection 7i77#g74 7g7 ,coord9ation & nonduplication 7#a7 ,9 g5]al ,! ,director ( ,,arpa-,h %all ensure effective1 e>ly1 & frequ5t coord9ation betwe5 ,,arpa-,h & ! heads ( ! rese>*1 public heal?1 & regulatory ag5cies ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+-- 7,a7 ! ,director ( ! ,national ,in/itutes ( ,heal?2 7,b7 ! ,commission] ( ,food & ,drugs2 7,c7 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7,d7 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,e7 ! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7,f7 ,! ,director ( ! ,national ,sci5ce ,f\ndation4 7,g7 ,! ,director ( ! ,(fice ( ,sci5ce ( ! ,dep>tm5t ( ,en]gy4 7#b7 ,coord9ation ,! ,director %all also coord9ate among ! full set ( advanc$ rese>* project ag5cies includ+-- 7,a7 ! ,def5se ,advanc$ ,rese>* ,project ,ag5cy2 7,b7 ! ,advanc$ ,rese>* ,project ,ag5cy-,en]gy2 & 7,c7 o!rs z !y may be e/abli%$4 7h7 ,advice 7#a7 ,9 g5]al ,! ,director ( ,,arpa-,h may seek advice on any aspect ( ,,arpa-,h f-- 7,a7 any advisory committee t1 z ( ! date ( ! enactm5t ( ?is ,act1 is provid+ advice to ! ,secret>y ( ,heal? & ,human ,s]vices 7or any head ( a rese>*1 public heal?1 or regulatory ag5cy ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices72 & 7,b7 an advisory committee e/abli%$ on or aft] su* date ( ! enactm5t to support ! programs ( ,,arpa-,h & to provide advice & assi/ance on-- 7i7 specific program tasks2 or 7ii7 ov]all direction ( ,,arpa-,h4 7#b7 ,additional s\rces ,9 addition to ! advisory committees specifi$ 9 p>agraph 7#a71 ! ,director ( ,,arpa-,h may seek advice & review f-- 7,a7 ! ,presid5t's ,committee ( ,advisors on ,sci5ce & ,te*nology2 7,b7 any pr(essional or sci5tific organization ) exp]tise 9 specific processes or te*nologies "u developm5t by ,,arpa-,h2 & 7,c7 repres5tatives ( pati5t communities4 7i7 ,coop]ative agreem5ts & o!r transactions 7#a7 ,9 g5]al ,! ,director ( ,,arpa-,h1 9 c>ry+ out advanc$ rese>* projects ?r\gh ,,arpa-,h1 may ent] into grants1 contracts1 coop]ative agreem5ts1 ca% prizes1 & o!r transactions 7z def9$ 9 section #cai,l7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7a777 ) any p]son1 any ag5cy or in/rum5tality ( ! ,unit$ ,/ates1 any unit ( ,/ate or local gov]nm5t1 & any o!r entity in/itutions1 includ+ univ]sities1 national laboratories1 public sector organizations1 private companies1 nonpr(it organizations1 & =eign in/itutions4 7#b7 ,t]ms 7,a7 ,requir$ provisions ,! ,director ( ,,arpa-,h %all ensure t1 9 ent]+ into coop]ative agreem5ts & o!r transactions "u p>agraph 7#a7-- 7i7 to ! ext5t ! ,director ( ,,arpa-,h det]m9es practicable1 ! ,f$]al funds provid$ "u ! coop]ative agreem5t or o!r transaction d n exce$ ! total am\nt provid$ by o!r p>ties to ! coop]ative agreem5t or o!r transaction2 & 7ii7 ! au?ority "u p>agraph 7#a7 is us$ only :5 ! use ( /&>d contracts or grants is n feasible or appropriate4 7,b7 ,optional provision ,coop]ative agreem5ts & o!r transactions ent]$ into by ! ,director ( ,,arpa-,h "u p>agraph 7#a7 may include a clause t requires a p]son or o!r entity to make paym5ts to ,,arpa-,h 7or any o!r dep>tm5t or ag5cy ( ! ,f$]al ,gov]nm5t7 z a condition = receiv+ support "u ! agreem5t or o!r transaction4 7#c7 ,duplicative rese>* ,! ,director ( ,,arpa-,h %all ensure t to ! maximum ext5t practicable1 a coop]ative agreem5t or o!r transaction "u ?is section does n provide = rese>* t duplicates rese>* be+ conduct$ "u exi/+ programs c>ri$ out by ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,def5se1 or o!r ,f$]al ,gov]nm5t entities4 7#d7 ,am\nt ( paym5ts ,! am\nt ( any paym5t receiv$ by ! ,f$]al ,gov]nm5t pursuant to a requirem5t impos$ "u p>agraph 7#a7 may be cr$it$1 to ! ext5t au?oriz$ by ! ,director ( ,,arpa-,h1 to ! acc\nt e/abli%$ "u p>agraph 7#g74 ,am\nts s cr$it$ %all be m]g$ ) o!r funds 9 ! acc\nt & %all be available = ! same purposes & ! same p]iod = :i* o!r funds 9 su* acc\nt are available4 7#e7 ,multi-ye> contracts 7,a7 ,9 g5]al ,! ,director ( ,,arpa-,h may ent] into a multi-ye> contract if-- 7i7 funds are available & obligat$ = ! contract = ! full p]iod ( ! contract1 or = ! fir/ fiscal ye> 9 :i* ! contract is 9 effect1 & = ! e/imat$ co/s associat$ ) a necess>y t]m9ation ( ! contract2 7ii7 ! ,director det]m9es t a multiye> contract w s]ve ! be/ int]e/s ( ! ,f$]al ,gov]nm5t 9 c>ry+ out ?is section2 & 7iii7 ! contract includes a provision t ! contract %all be t]m9at$ if funds are n made available = ! cont9uation ( ! contract 9 a fiscal ye> cov]$ by ! contract4 7,b7 ,t]m9ation co/s ,a provision ref]r$ to 9 subp>agraph 7,a77iii7 %all provide t funds available = pay+ t]m9ation co/s %all rema9 available = t purpose until ! co/s associat$ ) t]m9ation ( ! contract are paid4 7#f7 ,application ( o!r provisions ,! au?ority provid$ "u p>agraph 7#a7 may be ex]cis$ )\t reg>d to section #ccbd ( title #ca1 ,unit$ ,/ates ,code4 7#g7 ,acc\nt ,!re is h]eby e/abli%$ on ! books ( ! ,treasury an acc\nt = support ( advanc$ rese>* projects provid$ = 9 coop]ative agreem5ts & o!r transactions ent]$ into "u p>agraph 7#a74 ,funds 9 su* acc\nt %all be available = ! paym5t ( su* support4 7#h7 ,prize competitions ,! ,director ( ,,arpa-,h may c>ry out prize competitions 9 accordance ) section #bd ( ! ,/ev5son-,wydl] ,te*nology ,innovation ,act ( #aihj 7#ae ,u4,s4,c4 #cgai77 9 support ( ! goals specifi$ 9 subsection 7b74 7#i7 ,nonapplicability ( c]ta9 provisions ,rese>* fund$ pursuant to ?is section %all n be subject to-- 7,a7 advisory c\ncil approval "u section #dje7;b77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd7;b77#b772 7,b7 advisory c\ncil review "u section #djf7;a77#c77;,a77ii7 ( su* ,act 7#db ,u4,s4,c4 #bhd;a7a77#c77;,a77ii772 or 7,c7 ! pe] review requirem5ts "u section #dib ( su* ,act 7#db ,u4,s4,c4 #bhd7;b77#b71 #bhi;a74 7j7 ,confid5tiality 7#a7 ,9 g5]al ,! in=mation specifi$ 9 p>agraph 7#b7 %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act74 7#b7 ,in=mation ,! in=mation specifi$ 9 ?is p>agraph is in=mation collect$ by ,,arpa-,h f recipi5ts ( f9ancial assi/ance aw>ds1 includ+ ! foll[+3 7,a7 ,plans = comm]cialization ( te*nologies develop$ "u ! aw>d1 includ+ bus9ess plans1 te*nology-to-m>ket plans1 m>ket /udies1 & co/ & p]=mance models4 7,b7 ,inve/m5ts provid$ to an aw>dee f ?ird p>ties 7su* z v5ture capital firms1 h$ge funds1 & private equity firms71 includ+ ! am\nts & ! p]c5tage ( own]%ip ( ! aw>dee provid$ 9 return = ! inve/m5ts4 7k7 ,exp$it+ break?r\ghs ?r\gh coop]ation ) ,food & ,drug ,adm9i/ration 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 consultation ) ! ,director ( ,,arpa-,h1 may take actions to facilitate trans=mation ( biom$ical break?r\ghs into tangible solutions = pati5ts & to exp$ite developm5t ( m$ical products1 includ+ ?r\gh any ( ! foll[+ means3 7,a7 ,help+ to ensure t m$ical product developm5t programs1 9 z effici5t a mann] z possible1 ga!r ! noncl9ical & cl9ical data necess>y to advanc+ ! developm5t ( su* products & to obta9+ _! approval1 lic5sure1 or cle>ance1 z applicable1 by ! ,food & ,drug ,adm9i/ration "u sections #eje1 #eaj7k71 & #eae ( su* ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7 & section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,exp$it+ review ( inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 review ( inve/igational device exemptions "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g771 & review ( applications = approval1 lic5sure1 & cle>ance ( m$ical products "u sections #eje1 #eaj7k71 & #eae ( su* ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7 & section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7,c7 ,meet+ at appropriate int]vals ) ! ,director ( ,,arpa-,h & any o!r appropriate m$ical product developm5t p>tn]s1 su* z ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority to discuss ! developm5t /atus ( m$ical products & projects t are ! highe/ priorities to ,,arpa-,h1 unless ! ,director ( ,,arpa-,h & ! ,commission] ( ,food & ,drugs det]m9e t any su* meet+s are n necess>y4 7#b7 ,relation to o!rwise au?oriz$ activities ( ! ,,fda ,! au?ority specifi$ 9 p>agraph 7#a7 %all n be con/ru$ z limit+ ! au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs ) respect to ! review & approval1 cle>ance1 au?orization = em]g5cy use1 or lic5sure ( a m$ical product "u ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba et seq47 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#c7 ,reimbursem5t ,utiliz+ int]ag5cy agreem5ts or o!r appropriate res\rce allocation me*anisms available1 ! ,director ( ,,arpa-,h1 us+ funds made available to ,,arpa-,h1 %all reimburse ! ,food & ,drug ,adm9i/ration = exp5ditures made by ! ,food & ,drug ,adm9i/ration = activities c>ri$ out "u ?is section t h be5 id5tifi$ by ! ,commission] ( ,food & ,drugs & ! ,director ( ,,arpa-,h z be+ c>ri$ out by ! ,food & ,drug ,adm9i/ration4 7#d7 ,m$ical product def9$ ,9 ?is section1 ! t]m m$ical product means a drug 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba771 a device 7z def9$ 9 su* section #bja71 or a biological product 7z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb774 7l7 ,au?orization ( ,appropriations & ,bypass ,budget ,au?ority 7#a7 ,au?orization ( ,appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #f1ejj1jjj1jjj = fiscal ye> #bjbb1 to rema9 available until exp5d$4 7#b7 ,bypass ,budget ,au?ority ,! budget ( ,,arpa-,h %all be a sep>ate l9e item 9 ! annual budget reque/ submitt$ by ! ,presid5t to ! ,congress4 ,,arpa-,h %all h ! au?ority to submit its annual budget reque/ directly to ,congress concurr5tly ) its submission to ! ,(fice ( ,managem5t & ,budget4 #ejb4 ,rese>* inve/m5t to sp>k ! economy 7a7 ,au?ority 7#a7 ,9 g5]al ,ea* (fic] specifi$ 9 p>agraph 7#b7 may ex]cise ! au?orities describ$ 9 p>agraph 7#c74 7#b7 ,(fic]s ,! (fic]s specifi$ 9 ?is p>agraph are z foll[s3 7,a7 ,! ,secret>y ( ,comm]ce1 act+ ?r\gh ! ,adm9i/rator ( ! ,national ,oceanic & ,atmosph]ic ,adm9i/ration & ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology4 7,b7 ,! ,secret>y ( ,agriculture4 7,c7 ,! ,secret>y ( ,def5se4 7,d7 ,! ,secret>y ( ,education4 7,e7 ,! ,secret>y ( ,en]gy1 act+ = ! ,dep>tm5t ( ,en]gy 7) respect to ,en]gy ,effici5cy & ,r5ewable ,en]gy1 ,nucle> ,en]gy1 & ,fossil ,rese>* & ,developm5t7 & ?r\gh ! ,(fice ( ,sci5ce1 ! ,advanc$ ,rese>* ,projects ,ag5cy-,en]gy 7,,arpa-,e71 & ! ,(fice ( ,electricity4 7,f7 ,! ,secret>y ( ! ,int]ior1 act+ ?r\gh ! ,director ( ! ,unit$ ,/ates ,geological ,survey4 7,g7 ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?4 7,h7 ,! ,secret>y ( ,transportation4 7,i7 ,! ,adm9i/rator ( ! ,national ,a]onautics & ,space ,adm9i/ration4 7,j7 ,! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy4 7,k7 ,! ,director ( ! ,national ,sci5ce ,f\ndation4 7#c7 ,au?orities ,! (fic]s specifi$ 9 p>agraph 7#b7 may-- 7,a7 provide supplem5tal fund+ to ext5d ! duration ( an aw>d disrupt$ because ( ! ,,covid-#ai public heal? em]g5cy to a rese>* in/itution1 ,rese>* ,laboratory1 or individual t 0 aw>d$ be=e ! date ( ! enactm5t ( ?is ,act1 or to exp& ! purposes ( su* an aw>d1 9 ord] to-- 7i7 enable a po/second>y /ud5t or po/-doctoral rese>*] to complete "w2 7ii7 enable rese>* sci5ti/s1 te*nical /aff1 rese>* associates1 & pr9cipal inve/igators to complete "w2 7iii7 ext5d ! tra9+ ( a po/second>y /ud5t1 or ! employm5t ( a po/-doctoral rese>*]1 on an ongo+ rese>* project = up to #b ye>s because ( ! disruption ( ! job m>ket2 7iv7 create rese>* opportunities = up to #b ye>s = graduate /ud5ts & po/-doctoral rese>*]s2 7v7 replace1 refurbi%1 or o!rwise make usable laboratory animals1 reag5ts1 equipm5t1 or o!r items requir$ = rese>*2 7vi7 facilitate o!r rese>* 7includ+ field "w71 tra9+1 & ongo+ con/ruction activities1 includ+ at in/itutions t are disproportionately affect$ by ! ,,covid-#ai public heal? em]g5cy 7su* z m9ority-s]v+ in/itutions & #b-ye> in/itutions ( high] education72 7vii7 enable exp]im5tal field campaigns & ma9t5ance ( field infra/ructure1 includ+ ?r\gh replacem5t ( disrupt$ exp]im5tal data to enable completion ( impact$ rese>*2 & 7viii7 support tra9+ 9 onl9e c\rse deliv]y & virtual rese>* exp]i5ces t w improve quality & access ne$$ to cont9ue und]graduate1 graduate1 & po/-doctoral tra9+2 7,b7 issue aw>ds to rese>* in/itutions1 ,rese>* ,laboratories1 or o!r individuals to conduct rese>* on ! effects ( ! ,,covid-#ai & future pot5tial p&emics1 on ! effects & effectiv5ess ( responses to su* diseases1 & on improv+ ! pr$iction ( ! possible c\rses ( su* p&emics2 & 7,c7 provide flexibility on an aw>d = funds made available to an ag5cy1 by any prior or subsequ5t ,act1 by modify+ ! t]ms & conditions ( ! aw>d ) a rese>* in/itution1 ,rese>* ,laboratory1 or individual due to facility closures or o!r limitations dur+ ! ,,covid-#ai public heal? em]g5cy4 7#d7 ,modifications ,! modifications au?oriz$ by p>agraph 7#c77;,c7 include-- 7,a7 ! provision ( supplem5tal fund+ to ext5d ! duration ( ! aw>d conc]n$2 or 7,b7 flexibility on ! all[able exp5ses "u su* aw>d4 7b7 ,proc$ures ,! (fic]s specifi$ 9 subsection 7a77#b7 %all ea* e/abli% proc$ures to c>ry out subsection 7a74 7c7 ,exp$it$ aw>ds ,aw>ds "u subsection 7a7 %all be issu$ z exp$iti\sly z possible4 7d7 ,au?orizations ( appropriations 7#a7 ,dep>tm5t ( ,comm]ce ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,comm]ce1 #dej1jjj1jjj to c>ry out subsection 7a71 ( :i*-- 7,a7 #cjj1jjj1jjj %all be = use by ! ,national ,oceanic & ,atmosph]ic ,adm9i/ration2 & 7,b7 #aej1jjj1jjj %all be = use by ! ,national ,in/itute ( ,/&>ds & ,te*nology4 7#b7 ,dep>tm5t ( ,agriculture ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,agriculture1 #chj1jjj1jjj to c>ry out subsection 7a74 7#c7 ,dep>tm5t ( ,def5se ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,def5se1 #c1jjj1jjj1jjj to c>ry out subsection 7a74 7#d7 ,dep>tm5t ( ,education ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,education1 #bjj1jjj1jjj to c>ry out subsection 7a71 :i* %all be = use by ! ,in/itute = ,education ,sci5ces4 7#e7 ,dep>tm5t ( ,en]gy ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,en]gy1 #e1jjj1jjj1jjj to c>ry out subsection 7a71 ( :i*-- 7,a7 n less ?an #c1jjj1jjj1jjj %all be = use by ! ,(fice ( ,sci5ce2 7,b7 n less ?an #ijj1jjj1jjj %all be = ,en]gy ,effici5cy & ,r5ewable ,en]gy2 7,c7 n less ?an #dej1jjj1jjj %all be = ,nucle> ,en]gy2 7,d7 n less ?an #cjj1jjj1jjj %all be = ,fossil ,rese>* & ,developm5t2 7,e7 n less ?an #aej1jjj1jjj %all be = use by ! ,advanc$ ,rese>* ,projects ,ag5cy-,en]gy2 & 7,f7 n less ?an #ajj1jjj1jjj %all be = use by ! ,(fice ( ,electricity4 7#f7 ,dep>tm5t ( ! ,int]ior ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ! ,int]ior1 #cjj1jjj1jjj to c>ry out subsection 7a71 :i* %all be = use by ! ,unit$ ,/ates ,geological ,survey4 7#g7 ,dep>tm5t ( ,heal? & ,human ,s]vices ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 #aj1jjj1jjj1jjj to c>ry out subsection 7a71 :i* %all be = use by ! ,national ,in/itutes ( ,heal?4 7#h7 ,dep>tm5t ( ,transportation ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,dep>tm5t ( ,transportation1 #cjj1jjj1jjj to c>ry out subsection 7a71 ( :i* n less ?an #acj1jjj1jjj %all be = use by ! ,f$]al ,aviation ,adm9i/ration4 7#i7 ,national ,a]onautics & ,space ,adm9i/ration ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,national ,a]onautics & ,space ,adm9i/ration1 #b1jjj1jjj1jjj to c>ry out subsection 7a74 7#aj7 ,environm5tal ,protection ,ag5cy ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,environm5tal ,protection ,ag5cy1 #bjj1jjj1jjj to c>ry out subsection 7a74 7#aa7 ,national ,sci5ce ,f\ndation ,!re is au?oriz$ to be appropriat$ = fiscal ye> #bjba = ! ,national ,sci5ce ,f\ndation1 #c1jjj1jjj1jjj to c>ry out subsection 7a74 7#ab7 ,availability ( funds = adm9i/ration 7,a7 ,9 g5]al ,am\nts au?oriz$ to be appropriat$ by ?is subsection may be us$ = ! paym5t ( indirect co/s ( ,f$]al aw>ds "u subsection 7a71 up to ! limit o!rwise all[able by law & subject to ! requirem5ts ( "p #bjj ( title #b1 ,code ( ,f$]al ,regulations4 7,b7 ,limitation ,n m ?an #e p]c5t ( ea* ( ! am\nts appropriat$ pursuant to ?is subsection may be us$ = adm9i/ration ( aw>ds "u subsection 7a74 7#ac7 ,duration ( availability ,am\nts au?oriz$ to be appropriat$ by ?is subsection %all be available = ! purposes describ$ 9 ?is subsection ?r\gh fiscal ye> #bjba4 7e7 ,def9itions ,9 ?is section3 7#a7 ,aw>d ,! t]m aw>d includes a grant1 coop]ative agreem5t1 or o!r f9ancial assi/ance4 7#b7 ,,covid-#ai public heal? em]g5cy ,! t]m ,,covid-#ai public heal? em]g5cy means ! public heal? em]g5cy decl>$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 on ,janu>y #ca1 #bjbj1 ) respect to coronavirus disease #bjai 7,,covid-#ai74 7#c7 ,rese>* in/itution ,! t]m rese>* in/itution means ! foll[+3 7,a7 ,an in/itution ( high] education 7z def9$ 9 section #aja7;a7 ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja7;a7774 7,b7 ,a ,tribal ,college or ,univ]sity 7z def9$ 9 section #caf ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajei;c774 7,c7 ,a nonpr(it entity t conducts f$]ally fund$ rese>*4 7#d7 ,rese>* laboratory ,! t]m ,rese>* ,laboratory means ! foll[+3 7,a7 ,a ,national ,laboratory 7z def9$ 9 section #b ( ! ,en]gy ,policy ,act ( #bjje 7#db ,u4,s4,c4 #aehja774 7,b7 ,a ,f$]ally ,fund$ ,rese>* & ,developm5t ,c5t] = purposes ( section #c4e4jag ( title #dh1 ,code ( ,f$]al ,regulations4 #ejc4 ,rese>* ,policy ,bo>d reau?orization 7a7 ,ext5sion ( sunset ,section #bjcd7;f77#f7 ( ! #ba/ ,c5tury ,cures ,act 7#db ,u4,s4,c4 #ceja note7 is am5d$ by /rik+ ,septemb] #cj1 #bjba & ins]t+ ,septemb] #cj1 #bjbf4 7b7 ,p>ticipation by ,director ( ,,nih 7#a7 ,inclusion z memb] ,section #bjcd7;f77#b77;,a7 ( ! #ba/ ,c5tury ,cures ,act 7#db ,u4,s4,c4 #ceja note7 is am5d$-- 7,a7 by r$esignat+ clause 7v7 z clause 7vi72 7,b7 by ins]t+ aft] clause 7iv7 ! foll[+3 7iv7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 4 7#b7 ,limitations relat+ to indirect co/s ,section #bjcd7;f77#b7 ( ! #ba/ ,c5tury ,cures ,act 7#db ,u4,s4,c4 #ceja note7 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,limitations relat+ to indirect co/s ,not)/&+ any o!r provision ( law1 ! ,director ( ! ,national ,in/itutes ( ,heal? may p>ticipate 9 ! activities ( ! ,bo>d1 includ+ ! =mulation ( recomm5dations1 )\t reg>d to limitations relat+ to indirect co/s 9 "p #ge ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 4