,,ii #aad? ,,congress #b;d ,session ,s4 #cjge ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #af1 #bjaf ,mr4 ,durb9 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to e/abli% programs relat$ to prev5tion ( prescription opioid misuse1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,addiction ,prev5tion & ,responsible ,opioid ,practices ,act4 #b4 ,opioid action plan 7a7 ,advisory ,committee 7#a7 ,new drug application ,except z provid$ 9 p>agraph 7#d71 prior to ! approval ( a new drug t is an opioid "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 ! ,commission] ( ,food & ,drugs %all ref] su* drug to an advisory committee ( ! ,food & ,drug ,adm9i/ration to seek recomm5dations f su* ,committee4 7#b7 ,p$iatric opioid label+ ,! ,commission] ( ,food & ,drugs %all conv5e ! ,p$iatric ,advisory ,committee ( ! ,food & ,drug ,adm9i/ration to seek recomm5dations f su* ,committee reg>d+ a framework = ! inclusion ( in=mation 9 ! label+ ( drugs t are opioids relat+ to ! use ( su* drugs 9 p$iatric populations be=e su* ,commission] approves any label+ *anges = drugs t are opioids int5d$ = use 9 p$iatric populations4 7#c7 ,public heal? exemption ,if ! ,commission] ( ,food & ,drugs f9ds t ref]r+ a new opioid drug or drugs to an advisory committee ( ! ,food & ,drug ,adm9i/ration z requir$ "u p>agraph 7#a7 is n 9 ! int]e/ ( protect+ & promot+ public heal?1 & has submitt$ a notice conta9+ ! rationale = su* a f9d+ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 or if ! matt] t w\ld be consid]$ by su* advisory committee ) respect to any su* drug or drugs conc]ns bioequival5ce1 sam5ess ( active +r$i5t1 or o!r crit]ia applicable to applications submitt$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 ! ,commission] %all n be requir$ to ref] su* drug or drugs to an advisory committee z requir$ "u p>agraph 7#a74 7#d7 ,sunset ,unless ,congress reau?orizes p>agraphs 7#a7 & 7#b71 ! requirem5ts ( su* p>agraphs %all cease to be effective on ,octob] #a1 #bjbb4 7b7 ,education = prescrib]s ( opioids ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 z "p ( ! ,food & ,drug ,adm9i/ration's evaluation ( ! ,ext5d$-,release_/,long-,act+ ,opioid ,analgesics ,risk ,evaluation & ,mitigation ,/rategy1 & 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,director ( ! ,national ,in/itutes ( ,heal?1 ! ,adm9i/rator ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration1 & relevant /akehold]s1 %all develop recomm5dations reg>d+ education programs = prescrib]s ( opioids requir$ to be dissem9at$ "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 includ+ recomm5dations = :i* prescrib]s %\ld p>ticipate 9 su* programs & h[ (t5 p>ticipation 9 su* programs is necess>y4 7c7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,commission] ( ,food & ,drugs %all issue guidance on if & h[ ! approv$ label+ ( a drug t is an opioid & is ! subject ( an application "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 may include /atem5ts t su* drug det]s abuse4 #c4 ,opioid in=mational docum5ts 7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #eje-a ! foll[+3 #eje-b4 ,opioid in=mational docum5ts 7a7 ,developm5t ( mat]ials ,! ,commission] %all develop in=mational docum5ts describ+ to consum]s ( opioid drugs ! risk factors = opioid-relat$ h>m1 & %all submit su* docum5ts to ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion = approval4 7b7 ,label+ requirem5t ,! manufactur] ( any opioid drug approv$ "u section #eje %all ensure t ! appropriate in=mational docum5ts develop$ "u subsection 7a71 & approv$ by ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 are includ$ 9 ! label+ ( su* drug4 4 7b7 ,en=cem5t ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7dd7 ,if x is an opioid drug & ! label+ does n include ! in=mational docum5ts requir$ "u section #eje-b4 4 #d4 ,/r5g!n+ consid]ations = ,,dea n>cotic quotas ,section #cjf ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbf7 is am5d$ by add+ at ! end ! foll[+3 7i7 7#a7 ,9 fix+ manufactur+ quotas "u ?is section ! ,attorney ,g5]al %all take into consid]ation ! impact ( ! manufactur+ quotas on div]sion & ef=ts to r$uce ! co/s1 injuries1 & dea?s associat$ ) ! abuse ( prescription opioids & h]o9 9 ! ,unit$ ,/ates4 7#b7 7,a7 ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is subsection & e ye> !reaft]1 ! ,attorney ,g5]al %all publi% ! approv$ manufactur+ quota = ea* manufactur] ( f5tanyl1 oxycodone1 hyrdocodone1 oxymorphone1 & hyrdomorphone = t ye>4 7,b7 ,= any ye> 9 :i* ! approv$ manufactur+ quota = a manufactur] = any sub/ance describ$ 9 subp>agraph 7,a7 is high] ?an ! approv$ manufactur+ quota = a manufactur] = ! sub/ance 9 ! previ\s ye>1 ! ,attorney ,g5]al %all publi% a report expla9+ :y ! public heal? b5efits ( increas+ su* quota outweigh ! consequ5ces ( hav+ an increas$ volume ( su* sub/ance available = sale1 & pot5tial div]sion1 9 ! ,unit$ ,/ates4 7,c7 ,= any sub/ance describ$ 9 subp>agraph 7,a7 t is approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all publi% a report expla9+ :at factors 7 tak5 into consid]ation 9 sett+ ! manufactur+ quota = ! sub/ance4 7#c7 ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all submit to ,congress a report on-- 7,a7 h[ ! ,attorney ,g5]al w ensure t ! process ( fix+ manufactur+ quotas "u ?is section takes into consid]ation ef=ts to r$uce ! co/s1 injuries1 & dea?s associat$ ) ! abuse ( prescription opioids & h]o92 7,b7 =mal /eps t w be tak5 to improve data collection f approv$ drug collection receptacles1 mail-back programs1 & take-back ev5ts on ! volume & class ( controll$ sub/ances t are collect$2 & 7,c7 h[ ! in=mation describ$ 9 subp>agraphs 7,a7 & 7,b7 w influ5ce ! quota-sett+ process ( ! ,attorney ,g5]al 9 ! foll[+ ye>4 4 #e4 ,cont9u+ m$ical education & prescription drug monitor+ program regi/ration = prescrib]s ,section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is am5d$ by add+ at ! end ! foll[+3 7k7 7#a7 ,! ,attorney ,g5]al %all n regi/]1 or r5ew ! regi/ration (1 a practition] "u subsection 7f7 :o is lic5s$ "u ,/ate law to prescribe controll$ sub/ances 9 s*$ule ,,ii1 ,,iii1 or ,,iv1 unless ! practition] submits to ! ,attorney ,g5]al1 = ea* su* regi/ration or r5ewal reque/1 a writt5 c]tification t-- 7,a7 7i7 ! practition] has1 dur+ ! #a-ye> p]iod prec$+ ! regi/ration or r5ewal reque/1 complet$ a tra9+ program describ$ 9 p>agraph 7#b72 or 7ii7 ! practition]1 dur+ ! applicable regi/ration p]iod1 w n prescribe su* controll$ sub/ances 9 am\nts 9 excess ( a #gb-;h\r supply 7= :i* no refill is available72 & 7,b7 ! practition] has regi/]$ ) ! prescription drug monitor+ program ( ! ,/ate 9 :i* ! practition] practices1 if ! ,/ate has su* program4 7#b7 ,a tra9+ program describ$ 9 ?is p>agraph is a tra9+ program t-- 7,a7 foll[s ! be/ practices = pa9 managem5t1 z describ$ 9 ! ,guidel9e = ,prescrib+ ,opioids = ,*ronic ,pa9 z publi%$ by ! ,c5t]s = ,disease ,control & ,prev5tion 9 #bjaf1 or any successor !reto2 7,b7 includes in=mation on-- 7i7 recomm5d+ non-opioid & non-ph>macological !rapy2 7ii7 e/abli%+ treatm5t goals & evaluat+ pati5t risks2 7iii7 prescrib+ ! l[e/ dose & fewe/ numb] ( pills consid]$ effective2 7iv7 addictive & ov]dose risks ( opioids2 7v7 diagnos+ & manag+ sub/ance use disord]s1 includ+ l9k+ pati5ts to evid5ce-bas$ treatm5t2 7vi7 id5tify+ n>cotics-seek+ behaviors2 & 7vii7 us+ prescription drug monitor+ programs2 & 7,c7 is approv$ by ! ,secret>y ( ,heal? & ,human ,s]vices4 4 #f4 ,report on prescrib] education c\rses = m$ical & d5tal /ud5ts ,ea* s*ool ( m$ic9e1 s*ool ( o/eopa?ic m$ic9e1 & s*ool ( d5ti/ry p>ticipat+ 9 a program "u title ,,iv ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajgj;a et seq471 z a condition = su* p>ticipation1 %all submit an annual report to ,congress on any prescrib] education c\rses focus$ specifically on pa9 managem5t & responsible opioid prescrib+ practices t su* s*ool requires /ud5ts to take1 & :e!r su* c\rses are consi/5t ) ! mo/ rec5tly publi%$ v]sion ( ! ,guidel9e = ,prescrib+ ,opioids = ,*ronic ,pa9 ( ! ,c5t]s = ,disease ,control & ,prev5tion4 #g4 ,requirem5ts "u ,prescription ,drug ,monitor+ ,programs 7a7 ,9 g5]al ,beg9n+ #a ye> aft] ! date ( enactm5t ( ?is ,act1 ea* ,/ate t receives fund+ "u ! ,h>old ,rog]s ,prescription ,drug ,monitor+ ,program e/abli%$ "u ! ,dep>tm5ts ( ,comm]ce1 ,ju/ice1 & ,/ate1 ! ,judici>y1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjjb 7,public ,law #ajg-gg2 #aae ,/at4 #gdh71 ! controll$ sub/ance monitor+ program "u section #cii,o ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#c71 or ! ,prescription ,drug ,ov]dose3 ,prev5tion = ,/ates program ( ! ,c5t]s = ,disease ,control & ,prev5tion %all-- 7#a7 require practition]s1 or _! designees1 9 ! ,/ate to consult ! database ( ! prescription drug monitor+ program be=e writ+ prescriptions = controll$ sub/ances 7z su* t]m is def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb77 9 s*$ule ,,ii1 ,,iii1 or ,,iv "u section #bjb ( su* ,act 7#ba ,u4,s4,c4 #hab72 7#b7 require disp5s]s ( controll$ sub/ances 9 s*$ule ,,ii1 ,,iii1 or ,,iv1 or _! designees1 to input data into ! database ( ! prescription drug monitor+ program )9 #bd h\rs ( fill+ a qualify+ prescription1 z requir$ by ! ,attorney ,g5]al & ! ,secret>y ( ,heal? & ,human ,s]vices1 includ+ pati5t id5tifi] in=mation1 ! national drug code ( ! disp5s$ drug1 date ( disp5s+ ! drug1 quantity & dosage ( ! drug disp5s$1 =m ( paym5t1 ,drug ,en=cem5t ,adm9i/ration regi/ration numb] ( ! practition]1 ,drug ,en=cem5t ,adm9i/ration regi/ration numb] ( ! disp5s]2 7#c7 all[ practition]s & disp5s]s to designate o!r appropriate individuals to act z ag5ts ( su* practition]s & disp5s]s = purposes ( obta9+ & input+ data f ! database = purposes ( comply+ ) p>agraphs 7#a7 & 7#b71 z applicable2 7#d7 provide in=mational mat]ials = practition]s & disp5s]s to id5tify & ref] pati5ts ) possible sub/ance use disord]s to pr(essional treatm5t speciali/s2 7#e7 e/abli% =mal data %>+ agreem5ts to fo/] electronic connectivity ) ! prescription drug monitor+ programs ( ea* ,/ate 7if su* ,/ate has su* a program7 ) :i* ! ,/ate %>es a bord]1 to facilitate ! ex*ange ( in=mation ?r\gh an e/abli%$ te*nology ar*itecture t ensures common data /&>ds1 privacy protection1 & secure & /reaml9$ in=mation %>+2 7#f7 not)/&+ section #cii,o7f77#a77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#c7;f77#a77;,b771 au?orize direct access to ! ,/ate's database ( ! prescription drug monitor+ program to all ,/ate law en=cem5t ag5cies1 ,/ate bo>ds responsible = ! lic5sure1 regulation1 or discipl9e ( practition]s1 ph>maci/s1 or o!r p]sons au?oriz$ to prescribe1 adm9i/]1 or disp5se controll$ sub/ances2 & 7#g7 9 ord] to enhance acc\ntability 9 prescrib+ & disp5s+ patt]ns1 n few] ?an #d times p] ye>1 proactively provide in=mational reports on aggregate tr5ds & individual outli]s1 bas$ on in=mation available ?r\gh ! ,/ate prescription drug monitor+ program to-- 7,a7 ! ,/ate entities & p]sons describ$ 9 p>agraph 7#f72 & 7,b7 ! ,m$icaid ag5cy1 work]s comp5sation programs1 & ! dep>tm5t ( public heal? ( ! ,/ate4 7b7 ,transp>5cy 9 ,prescrib+ ,practices & ,int]v5tion = ,high ,prescrib]s 7#a7 ,/ate report+ requirem5t ,ea* ,/ate t receives fund+ "u ! ,h>old ,rog]s ,prescription ,drug ,monitor+ ,program e/abli%$ "u ! ,dep>tm5ts ( ,comm]ce1 ,ju/ice1 & ,/ate1 ! ,judici>y1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjjb 7,public ,law #ajg-gg2 #aae ,/at4 #gdh71 ! controll$ sub/ance monitor+ program "u section #cii,o ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#c71 or ! ,prescription ,drug ,ov]dose3 ,prev5tion = ,/ates program ( ! ,c5t]s = ,disease ,control & ,prev5tion %all1 twice p] ye>1 submit to ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration-- 7,a7 a li/ ( all practition]s & disp5s]s :o1 9 ! applicable report+ p]iod1 h prescrib$ or disp5s$ s*$ule ,,ii1 ,,iii1 or ,,iv opioids 9 ! ,/ate2 7,b7 ! am\nt ( s*$ule ,,ii1 ,,iii1 or ,,iv opioids t 7 prescrib$ & disp5s$ by ea* individual practition] & disp5s] describ$ 9 subp>agraph 7,a72 & 7,c7 any additional in=mation t ! ,secret>y & ,adm9i/rator may require to support surveillance & evaluation ( tr5ds 9 prescrib+ or disp5s+ ( s*$ule ,,ii1 ,,iii1 or ,,iv opioids1 or to id5tify possible non-m$ical use & div]sion ( su* sub/ances4 7#b7 ,annual report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration1 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,vet]ans ,affairs1 & ! ,director ( ! ,indian ,heal? ,s]vice1 %all submit to ,congress1 & make public1 a report id5tify+ ! geographic areas ) ! highe/ rates ( opioid prescrib+ 9 ! ,nation1 by zip code4 7#c7 ,developm5t ( action plan 7,a7 ,initial plan ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration1 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,vet]ans ,affairs1 & ! ,director ( ! ,indian ,heal? ,s]vice1 %all submit to ,congress a plan ( action1 includ+ w>n+ lett]s & en=cem5t me*anisms1 = address+ outli]s 9 opioid prescrib+ practices & ensur+ an adequate ,f$]al response to protect ! public heal?4 7,b7 ,updat$ plan ,! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress updates to ! plan ( action describ$ 9 subp>agraph 7,a71 z su* ,secret>y1 9 consultation ) ! heads ( ag5cies describ$ 9 su* subp>agraph1 det]m9es appropriate4 7c7 ,def9itions ,9 ?is section1 ! t]ms disp5s] & practition] h ! mean+s giv5 su* t]ms 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb74 7d7 ,au?orization ( appropriations ,9 addition to any o!r am\nts appropriat$ to c>ry out ! ,prescription ,drug ,ov]dose3 ,prev5tion = ,/ates program ( ! ,c5t]s = ,disease ,control & ,prev5tion1 = purposes ( enhanc+ ! utilization1 int]op]ability1 & integration ( ,/ate prescription drug monitor+ programs1 !re are au?oriz$ to be appropriat$ #gj1jjj1jjj = ea* ( fiscal ye>s #bjag ?r\gh #bjba4 #h4 ,developm5t ( new pa9-relat$ measures "u ! ,m$ic>e hospital value-bas$ pur*as+ program to elim9ate f9ancial inc5tives to ov]-prescribe opioids ,section #ahhf7o77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7o77#b77;,b77 is am5d$-- 7#a7 9 clause 7i77,,ii71 by ins]t+ 1 subject to clause 7iii71 aft] %all2 & 7#b7 by add+ at ! end ! foll[+ new clause3 7iii7 ,developm5t ( new pa9-relat$ measures 7,i7 ,moratorium until new measures applicable ,= value-bas$ inc5tive paym5ts made ) respect to dis*>ges occurr+ dur+ fiscal ye> #bjah & ea* subsequ5t fiscal ye> 7be=e ! fir/ fiscal ye> 9 :i* new measures are applicable "u subclause 7,,ii77cc771 ! ,secret>y %all ensure t measures select$ "u subp>agraph 7,a7 7su* z measures relat$ to ! ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey7 d n include measures bas$ on any assessm5ts by pati5ts1 ) respect to hospital /ays ( su* pati5ts1 (-- 7aa7 ! ne$ ( su* pati5ts1 dur+ su* /ay1 = m$ic9e = pa92 7bb7 h[ (t51 dur+ su* /ay1 ! pa9 ( su* pati5ts 0 well controll$2 or 7cc7 h[ (t51 dur+ su* /ay1 ! /aff ( ! hospital 9 :i* su* /ay occurr$ did ev]y?+ !y c\ld to help ! pati5t ) ! pa9 exp]i5c$ by ! pati5t4 7,,ii7 ,developm5t ( new measures 7aa7 ,developm5t ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is clause1 ! ,secret>y %all develop measures ( pati5t exp]i5ce ( c>e ) respect to pa9 managem5t t balance ! bread? ( effective pa9 managem5t tools ) aw>5ess = ! role ( ov]-prescrib+ 7includ+1 if appropriate1 opioid-seek+ behaviors7 9 ! prescription opioid epidemic4 7bb7 ,consultation ,! ,secret>y %all consult ) relevant /akehold]s 9 develop+ measures "u item 7aa74 7cc7 ,application = value-bas$ inc5tive paym5ts ,= value-bas$ inc5tive paym5ts made ) respect to dis*>ges occurr+ dur+ a fiscal ye> beg9n+ on or aft] ! date on :i* ! ,secret>y develops new measures "u item 7aa71 ! ,secret>y %all ensure t measures select$ "u subp>agraph 7,a7 7su* z measures relat$ to ! ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey7 include su* new measures4 4 #i4 ,national ,academy ( ,m$ic9e ,/udy 7a7 ,/udy ,! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into a contract ) ! ,national ,academy ( ,m$ic9e to c>ry out a /udy on ! addition ( cov]age "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act ( alt]native treatm5t modalities 7su* z integrative m$ic9e1 includ+ acupuncture & ex]cise !rapy1 neural /imulation1 bi(e$back1 radi(requ5cy ablation1 & trigg] po9t injections7 furni%$ to ,m$ic>e b5efici>ies :o suff] f acute or *ronic l[] back pa94 ,su* /udy %all1 pursuant to ! contract "u ?is p>agraph1 include an analysis (-- 7#a7 sci5tific rese>* on ! %ort-t]m & long-t]m impact ( ! addition ( su* cov]age on cl9ical efficacy = pa9 managem5t ( su* b5efici>ies2 7#b7 :e!r ! lack ( ,m$ic>e cov]age = alt]native treatm5t modalities impacts ! volume ( opioids prescrib$ = b5efici>ies2 & 7#c7 ! co/ to ! ,m$ic>e program ( ! addition ( su* cov]age to treat pa9 & mitigate ! progression ( *ronic pa91 z weigh$ aga9/ ! co/ ( opioid use disord]1 ov]dose1 readmission1 subsequ5t surg]ies1 & utilization & exp5ditures "u p>ts ,b & ,d ( su* title4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 pursuant to ! contract "u subsection 7a71 ! ,national ,academy ( ,m$ic9e %all submit to ,congress a report on ! /udy "u subsection 7a74 7c7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ su* sums z may be necess>y4 #aj4 ,excise tax on opioid pa9 reliev]s 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #daib4 ,opioid pa9 reliev]s 7a7 ,9 g5]al ,!re is h]eby impos$ on ! manufactur] or produc] ( any taxable active opioid a tax equal to ! am\nt det]m9$ "u subsection 7b74 7b7 ,am\nt det]m9$ ,! am\nt det]m9$ "u ?is subsection ) respect to a manufactur] or produc] = a cal5d> ye> is #a c5t p] milligram ( taxable active opioid 9 ! production or manufactur+ quota det]m9$ = su* manufactur] or produc] = ! cal5d> ye> "u section #cjf ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbf74 7c7 ,taxable active opioid ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,! t]m taxable active opioid means any controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb71 z 9 effect on ! date ( ! enactm5t ( ?is section7 manufactur$ 9 ! ,unit$ ,/ates :i* is opium1 an opiate1 or any d]ivative !re(4 7#b7 ,exclusions 7,a7 ,o!r +r$i5ts ,9 ! case ( a product t includes a taxable active opioid & ano!r +r$i5t1 subsection 7a7 %all apply only to ! portion ( su* product t is a taxable active opioid4 7,b7 ,drugs us$ 9 addiction treatm5t ,! t]m taxable active opioid %all n include any controll$ sub/ance 7z s def9$7 :i* is us$ exclusively = ! treatm5t ( opioid addiction z "p ( a m$ication-assi/$ treatm5t4 4 7b7 ,cl]ical am5dm5ts 7#a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,o!r m$ical products4 7#b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,o!r m$ical products 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,opioid pa9 reliev]s4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to cal5d> ye>s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #aa4 ,opioid consum] abuse r$uction program 7a7 ,opioid take-,back program ,section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ by add+ at ! end ! foll[+3 7h7 7#a7 ,! ,attorney ,g5]al %all e/abli% a national take-back program = ! safe & environm5tally responsible disposal ( controll$ sub/ances4 7#b7 ,9 e/abli%+ ! take-back program requir$ "u p>agraph 7#a71 ! ,attorney ,g5]al-- 7,a7 %all consult ) ! ,secret>y & ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy2 & 7,b7 may coord9ate ) ,/ates1 law en=cem5t ag5cies1 wat] res\rce managem5t ag5cies1 manufactur]s1 practition]s1 ph>maci/s1 public heal? entities1 transportation & inc9]ation s]vice contractors1 & o!r entities & individuals1 z appropriate4 7#c7 ,! take-back program e/abli%$ "u p>agraph 7#a7-- 7,a7 %all-- 7i7 ensure appropriate geographic di/ribution s z to provide-- 7,i7 reasonably conv5i5t & equitable access to p]man5t take-back locations1 includ+ n less ?an #a disposal site = e #be1jjj resid5ts & n less ?an #a physical disposal site p] t[n1 city1 c\nty1 or o!r unit ( local gov]nm5t1 :]e possible2 & 7,,ii7 p]iodic collection ev5ts & mail-back programs1 includ+ public notice ( su* ev5ts & programs1 z a supplem5t to ! p]man5t take-back locations describ$ 9 subclause 7,i71 p>ticul>ly 9 areas 9 :i* ! provision ( access to su* locations at ! level describ$ 9 t subclause is n possible2 7ii7 e/abli% a process = ! accurate catalogu+ & report+ ( ! quantities ( controll$ sub/ances collect$2 & 7iii7 include a public aw>5ess campaign & education ( practition]s & ph>maci/s2 & 7,b7 may "w 9 coord9ation ) ,/ate & locally implem5t$ public & private take-back programs4 7#d7 ,f "t to "t1 beg9n+ 9 ! second cal5d> ye> t beg9s aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y ( ! ,treasury %all transf] f ! g5]al fund ( ! ,treasury an am\nt equal to "o-half ( ! total am\nt ( taxes collect$ "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf to ! ,attorney ,g5]al to c>ry out ?is subsection4 ,am\nts transf]r$ "u ?is subp>agraph %all rema9 available until exp5d$4 4 7b7 ,fund+ ( sub/ance abuse programs ,f "t to "t1 beg9n+ 9 ! second cal5d> ye> t beg9s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ! ,treasury %all transf] f ! g5]al fund ( ! ,treasury an am\nt equal to "o-half ( ! total am\nt ( taxes collect$ "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf1 z add$ by ?is ,act1 to ! ,director ( ! ,c5t] = ,sub/ance ,abuse ,treatm5t ( ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration = programs ( ! ,c5t]1 includ+ ! ,block ,grants = ,prev5tion & ,treatm5t ( ,sub/ance ,abuse program "u subp>t ,,ii ( "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#ba et seq47 & ,programs ( ,regional & ,national ,significance4 ,am\nts transf]r$ "u ?is subsection %all rema9 available until exp5d$4 #ab4 ,,gao /udy ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy evaluat+ ! v>i\s ,/ate laws1 comm]cial insurance me?ods1 & exi/+ rese>* on requirem5ts t place limitations on opioid prescrib+ practices & provide analysis on be/ practices to address ov]-prescrib+ ( opioids1 :ile ensur+ t individuals :o ne$ su* opioids c access !m safely4 ,su* /udy %all provide recomm5dations1 includ+ ) respect to-- 7#a7 limit+ fir/-"t opioid prescriptions to a pati5t = acute pa9 to a #gb-;h\r supply2 7#b7 all[+ pati5ts or practition]s to reque/ t a prescription = a s*$ule ,,ii opioid be p>tially fill$ by a ph>maci/2 & 7#c7 pa9 managem5t treatm5t contracts betwe5 practition]s & pati5ts t e/abli% in=m$ cons5t reg>d+ ! expectations1 risks1 long-t]m effects1 & b5efits ( ! c\rse ( opioid treatm5t1 treatm5t goals1 ! pot5tial = opioid misuse1 abuse1 or div]sion1 & requirem5ts & responsibilities ( pati5ts1 su* z submitt+ to a ur9e drug scre5+4