,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fehj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #aj1 #bjbe,mrs4 ,mill]-,meeks introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,vet]ans' ,affairs ,a ,,bill ,to am5d title #ch1 ,unit$ ,/ates ,code1 to make c]ta9 improvem5ts 9 ! adm9i/ration ( ! national =mul>y ( ! ,dep>tm5t ( ,vet]ans ,affairs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,va ,national ,=mul>y ,act ( #bjbe4 #b4 ,codification & improvem5t ( ,dep>tm5t ( ,vet]ans ,affairs national =mul>y 7a7 ,9 g5]al ,*apt] #gc ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new sub*apt]3 ,,vi ,national ,=mul>y #gche4 ,national =mul>y 7a7 ,e/abli%m5t ,! ,secret>y %all ma9ta9 a national =mul>y t %all consi/ ( a li/ ( all drugs & supplies t %all be available by prescription ?r\gh all m$ical facilities ( ! ,dep>tm5t4 ,! ,ph>macy ,b5efits ,managem5t ,s]vice ( ! ,dep>tm5t %all be responsible = manag+ ! national =mul>y4 7b7 ,local =mul>y re/rictions 7#a7 ,! national =mul>y %all be implem5t$ uni=mly across all ,dep>tm5t m$ical facilities4 ,except z provid$ 9 p>agraph 7#b71 no ,vet]ans ,integrat$ ,s]vice ,network or individual m$ical c5t] may ma9ta9 a local =mul>y t includes a drug or m$ication n li/$ on ! national =mul>y4 7#b7 ,a drug t is n on ! national =mul>y may be provid$ to a vet]an if-- 7,a7 ! drug is provid$ "u ! non=mul>y m$ication reque/ process "u section #gchg ( ?is title2 or 7,b7 ! ,"u ,secret>y = ,heal? 7or ! ,"u ,secret>y's designee at ! national level7 has explicitly approv$ a waiv] all[+ a ,vet]ans ,integrat$ ,s]vice ,network or facility to c>ry ! drug = a def9$ pati5t population or cl9ical program4 7#c7 7,a7 ,! ,director ( a ,vet]ans ,integrat$ ,s]vice ,network or ( a m$ical facility may reque/ a waiv] "u p>agraph 7#b77;,b7 ?r\gh ! ,ph>macy ,b5efits ,managem5t ,s]vices4 7,b7 ,! ,secret>y %all e/abli% a c5traliz$ review process = consid]+ su* waiv] reque/s1 :i* %all include an assessm5t ( cl9ical ne$1 safety1 & co/-effectiv5ess4 ,a waiv] issu$ "u ?is p>agraph %all be "t-limit$ & review$ p]iodically = cont9u+ necessity4 7,c7 ,no?+ 9 ?is subsection %all be con/ru$ to limit ! ability ( a cl9ician to prescribe a non=mul>y drug = a vet]an :5 m$ically necess>y 9 accordance ) section #gchg ( ?is title4 7c7 ,public communication ( =mul>y decisions 7#a7 ,! ,secret>y %all communicate regul>ly ) ! g5]al public reg>d+ ! managem5t ( ! national =mul>y4 ,su* communication may include public brief+s or onl9e ann\ncem5ts to expla9 =mul>y decisions4 7#b7 ,9 ! case ( any *ange to ! national =mul>y t ! ,secret>y det]m9es may significantly affect vet]an c>e or access 7includ+ ! exclusion ( a m$ication t 0 previ\sly commonly us$1 or ! addition ( a new high-co/ !rapy ) usage re/rictions71 ! ,secret>y %all publi% a summ>y ( ! rationale = ! *ange 7includ+ consid]ation ( cl9ical evid5ce & outcomes7 &1 :5 feasible1 hold a public brief+ or /akehold] call to discuss ! *ange & address que/ions4 7d7 ,report+ requirem5ts 7#a7 ,! ,secret>y %all submit to ! ,committees on ,vet]ans' ,affairs ( ! ,s5ate & ,h\se ( ,repres5tatives an annual appeals report t includes a detail$ description ( non=mul>y decisions & appeals made dur+ ! ye> cov]$ by ! report4 7#b7 ,n less frequ5tly ?an annually dur+ ! five-ye> p]iod beg9n+ on ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all submit to ! ,committees on ,vet]ans' ,affairs ( ! ,s5ate & ,h\se ( ,repres5tatives1 & make publicly available1 a report t includes a summ>y ( any *anges made to ! national =mul>y ( ! ,dep>tm5t dur+ ! prec$+ ye>4 ,ea* su* report %all include a li/ ( all drugs add$ to or remov$ f ! =mul>y1 & any modifications to usage crit]ia or prior au?orization requirem5ts1 dur+ ! ye> cov]$ by ! report4 #gchf4 ,ph>macy & ,!rapeutics ,committee 7a7 ,e/abli%m5t ,!re is e/abli%$ )9 ! ,vet]ans ,heal? ,adm9i/ration a ,ph>macy & ,!rapeutics ,committee 79 ?is section ref]r$ to z ! ,committee7 to support ! ,ph>macy ,b5efits ,managem5t ,s]vices 9 manag+ ! national =mul>y ( ! ,dep>tm5t4 7b7 ,composition ,! memb]s ( ! ,committee %all be select$ by ! ,secret>y & %all be physicians f major cl9ical specialties1 cl9ical ph>maci/s1 & ph>macoeconomi/s :o are employees ( ! ,dep>tm5t4 ,9 select+ memb]s ( ! ,committee1 ! ,secret>y %all ensure ! inclusion ( individuals ) exp]tise 9 g]iatric c>e & m5tal heal? c>e = vet]ans4 7c7 ,conflicts ( int]e/ 7#a7 ,! ,secret>y %all ensure t ea* memb] ( ! ,committee is free ( any conflict ( int]e/ ) ! ph>maceutical indu/ry4 7#b7 ,! ,secret>y %all-- 7,a7 require ea* memb] ( ! ,committee to annually disclose f9ancial int]e/s2 & 7,b7 prohibit ! p>ticipation by any memb] 9 =mul>y decisions = :i* ! memb] has a f9ancial conflict ( int]e/4 7d7 ,timely review ( new m$ications ,! ,committee %all meet n less (t5 ?an mon?ly 7or bimon?ly7 to review newly approv$ drugs by ! ,food & ,drug ,adm9i/ration4 ,! goal ( ! ,committee ) respect to ea* su* newly approv$ drug %all be to make a national =mul>y inclusion or exclusion decision by n lat] ?an #abj days aft] ! date on :i* ! drug is approv$1 to ! ext5t practicable4 7e7 ,evid5ce-,bas$ decision mak+ ,! ,committee %all make decisions ) respect to ! national =mul>y ( ! ,dep>tm5t bas$ on evid5ce-bas$ drug monographs1 cl9ical data 7includ+ data on real-_w use & outcomes71 & ph>macoeconomic analyses ( co/-effectiv5ess4 ,9 mak+ su* decisions1 ! ,committee %all consid] ! applicable cl9ical practice guidel9es ( ! ,dep>tm5t & ( ! ,dep>tm5t ( ,def5se to ensure alignm5t ) be/ practices 9 vet]an c>e4 7f7 ,transp>5cy ( decisions ,= ea* significant addition to or removal f ! national =mul>y ( ! ,dep>tm5t1 ! ,secret>y %all make publicly available on an appropriate website ( ! ,dep>tm5t a summ>y ( ! cl9ical rationale = ! addition or removal1 includ+ a description ( ! evid5ce & guidel9es consid]$4 ,su* summ>ies may n include propriet>y pric+ in=mation or trade secrets4 #gchg4 ,non=mul>y drug reque/ process 7a7 ,electronic reque/ sy/em ,! ,secret>y %all acquire or develop & implem5t a /&>diz$ electronic sy/em = h&l+ reque/s by cl9icians ( ! ,dep>tm5t = drugs n includ$ 9 ! national =mul>y ( ! ,dep>tm5t4 ,?is sy/em %all be integrat$ ) ! electronic heal? record sy/em ( ! ,dep>tm5t to all[ treat+ cl9icians to submit non=mul>y drug reque/s z "p ( ! prescrib+ workfl[4 7b7 ,timel9ess ( decisions ,! ,secret>y %all e/abli% a process to ensure t any reque/ by a ,dep>tm5t cl9ician = a non=mul>y drug is decid$ ^u promptly4 ,"u su* process1 an initial decision on a non=mul>y reque/ %all be communicat$ to ! reque/+ cl9ician )9 #if h\rs aft] ! reque/ is submitt$4 ,9 any case :]e a non=mul>y reque/ is d5i$1 ! vet]an 7& ! reque/+ cl9ician7 %all be in=m$ ( ! d5ial & ( ! "r to appeal "u subsection 7e74 ,if an appeal is fil$1 a decision ) respect to ! appeal %all be r5d]$ n lat] ?an sev5 days aft] ! date on :i* ! appeal is submitt$4 7c7 ,consi/5t crit]ia & approval /&>ds ,! ,secret>y %all e/abli% uni=m crit]ia = evaluat+ non=mul>y drug reque/s1 :i* %all be appli$ across all ,vet]ans ,integrat$ ,s]vice ,networks 7h]9aft] ref]r$ to z ,v,i,s,ns7 & m$ical facilities ( ! ,dep>tm5t to ensure consi/5cy4 ,su* crit]ia %all be evid5ce-bas$ & %all be made available to ,dep>tm5t cl9icians4 7d7 ,portability ( approvals ,an approval = a non=mul>y drug "u ?is section %all be valid ?r\gh\t ! ,vet]ans ,heal? ,adm9i/ration4 ,9 ! case ( a vet]an = :om a non=mul>y drug has be5 approv$ & :o *ooses to receive hospital c>e or m$ical s]vices at a diff]5t m$ical c5t] or ,,visn ( ! ,dep>tm5t1 ! non=mul>y approval 7includ+ any e/abli%$ r5ewal date or duration ( approval7 %all rema9 9 effect at ! new location1 subject to ! same cl9ical conditions or monitor+ requirem5ts t 7 orig9ally impos$4 7e7 ,appeals process 7#a7 ,! ,secret>y %all e/abli% a ti]$ appeals process = non=mul>y drug decisions4 ,at a m9imum1 su* process %all provide-- 7,a7 an opportunity = review ( an initial d5ial by a second>y cl9ical review] or ph>macy committee at ! regional or ,,visn level2 & 7,b7 a fur!r opportunity = appeal to a national-level au?ority )9 ! ,ph>macy ,b5efits ,managem5t ,s]vices ( ! ,dep>tm5t1 ^: decision %all be f9al )9 ! ,dep>tm5t4 7#b7 ,! ,secret>y %all ensure t all cl9icians ( ! ,dep>tm5t are in=m$ ( ! appeals process & t appeals are resolv$ )9 ! timeframe specifi$ 9 subsection 7b74 #gchh4 ,=mul>y managem5t & drug !rapy programs 7a7 ,p]iodic !rapeutic class reviews ,9 ord] to ma9ta9 a cl9ically appropriate & up-to-date =mul>y1 ! ,secret>y %all require regul> reviews ( gr\ps ( drugs by !rapeutic class4 7b7 ,m$ication !rapy managem5t & drug use review 7#a7 ,! ,secret>y %all provide drug !rapy managem5t = vet]ans1 ) a p>ticul> focus on polyph>macy & high-risk m$ications4 7#b7 ,z "p ( su* drug !rapy managem5t1 cl9ical ph>macy speciali/s %all provide compreh5sive drug reviews = vet]ans :o are on complex regim5s ( drugs or are at increas$ risk ( adv]se drug ev5ts4 7#c7 ,! ,secret>y %all-- 7,a7 conduct regul> reviews ( drug use to id5tify tr5ds1 includ+ inappropriate prescrib+1 drug duplication1 or ne$ = dose optimization2 & 7,b7 provide int]v5tions1 includ+ provid] education or pati5t outrea*1 bas$ on ! results ( su* reviews 9 ord] to improve !rapeutic outcomes & promote drug safety & adh]5ce4 4 7b7 ,cl]ical am5dm5t ,! table ( sections at ! beg9n+ ( su* *apt] is am5d$ by add+ at ! end ! foll[+ new items3 ,sub*apt] ,,vi--,national ,=mul>y#gche4 ,national =mul>y4#gchf4 ,ph>macy & ,!rapeutics ,committee4#gchg4 ,non=mul>y drug reque/ process4#gchh4 ,=mul>y managem5t & drug !rapy programs4 4 #c4 ,dep>tm5t ( ,vet]ans ,affairs ph>maceutical pur*as+ agreem5ts 7a7 ,=mul>y-,bas$ pric+ & value-,bas$ agreem5ts 7#a7 ,9 g5]al ,sub*apt] ,,ii ( *apt] #ha ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] section #habi ! foll[+ new section3 #hacj4 ,ph>maceutical pur*as+ agreem5ts & value-bas$ initiatives 7a7 ,negotiation ( supplem5tal disc\nts 7#a7 ,9 addition to ! limitations on ! prices ( drugs 9 effect pursuant to section #habf ( ?is title1 ! ,secret>y may negotiate additional disc\nts or price concessions ) manufactur]s ( drugs procur$ by ! ,dep>tm5t4 7#b7 ,9 conduct+ negotiations "u ?is p>agraph1 ! ,secret>y may-- 7,a7 take into consid]ation ! placem5t or ti]$ /atus ( a drug on ! national =mul>y ( ! ,dep>tm5t2 & 7,b7 ent] into an agreem5t ) a manufactur] "u :i* ! manufactur] (f]s a disc\nt$ price or rebate = a drug 9 ex*ange = pref]r$ /atus = ! drug on ! national =mul>y ( ! ,dep>tm5t1 if ! ,secret>y det]m9es ! agreem5t w provide cl9ically appropriate outcomes = vet]ans & net co/ sav+s or value to ! ,dep>tm5t4 7#c7 ,no?+ 9 ?is subsection %all be con/ru$ to sup]s$e ! price limitations "u section #habf ( ?is title4 ,! ,secret>y %all ensure t any agreem5t ent]$ into "u ?is subsection ) respect to a drug t is a cov]$ drug "u su* section results 9 prices t are l[] ?an ! maximum price all[$ "u su* section = su* drug4 7b7 ,use ( flexible pur*as+ arrangem5ts 7#a7 ,to ! ext5t practicable1 ! ,secret>y %all use indu/ry be/ practices 9 ! procurem5t ( drugs & m$ical supplies1 includ+ ! use ( blanket pur*ase agreem5ts1 ord]+ agreem5ts1 & o!r volume-lev]ag+ contracts to a*ieve favorable pric+4 7#b7 ,! ,secret>y may pursue value-bas$ pur*as+ arrangem5ts ) manufactur]s ( drugs & biological products to be includ$ on ! national =mul>y4 ,su* arrangem5ts may include contracts "u :i* ! manufactur] agrees to provide ! drugs or biological products to ! ,secret>y 9 ex*ange = paym5t 9 an am\nt t is det]m9$ bas$ ^u ! effectiv5ess ( ! drug or biological product = vet]ans to :om ! drug or biological product is prescrib$4 ,if ! ,secret>y ent]s into su* a contract "u ?is p>agraph1 ! ,secret>y %all ensure t ! contract includes a me*anism to monitor ! effectiv5ess ( ! drug or biological product & to adju/ paym5ts or rebates accord+ly4 7c7 ,outcome & co/-,effectiv5ess evaluations 7#a7 ,! ,secret>y %all conduct p]iodic reviews ( ! outcomes & budget>y effects associat$ ) major *anges to ! national =mul>y or ph>maceutical initiatives ( ! ,dep>tm5t4 ,n lat] ?an #ahj days aft] conclud+ a p]iodic review "u ?is p>agraph1 ! ,secret>y %all submit to ! ,committees on ,vet]ans' ,affairs ( ! ,s5ate & ,h\se ( ,repres5tatives ! results ( ! review4 7#b7 ,n lat] ?an "o ye> aft] implem5t+ any significant action affect+ ! national =mul>y1 includ+ add+ a high-co/ drug ) usage crit]ia or remov+ a cl9ically us$ drug f ! =mul>y1 ! ,secret>y %all evaluate ! effects ( t action on vet]an heal? outcomes1 drug use patt]ns1 & ov]all co/s to ! ,dep>tm5t4 ,! ,secret>y %all make f9d+s f su* evaluations available to ! ,committees on ,vet]ans' ,affairs ( ! ,s5ate & ,h\se ( ,repres5tatives & use ! f9d+s to in=m future =mul>y decisions & pur*as+ agreem5ts4 7d7 ,biological product def9$ ,9 ?is section1 ! t]m biological product has ! mean+ giv5 su* t]m 9 section #cea7;i77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a774 4 7#b7 ,cl]ical am5dm5t ,! table ( sections at ! beg9n+ ( su* *apt] is am5d$ by add+ at ! end ! foll[+ new item3 #hacj4 ,ph>maceutical pur*as+ agreem5ts & value-bas$ initiatives4 4 7b7 ,e/abli%m5t ( ti]$ s*$ule = copaym5ts 7#a7 ,9 g5]al ,section #agbb;,a ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new subsection3 7d7 7#a7 ,= ! purpose ( enc\rag+ ! use ( cl9ically appropriate1 co/-effective drugs by vet]ans :ile ma9ta9+ access to non=mul>y drugs t are m$ically necess>y1 ! ,secret>y %all e/abli% a ti]$ s*$ule = ! am\nt ( ! copaym5ts *>g$ to vet]ans = drugs furni%$ "u ?is *apt]4 7#b7 ,"u ! ti]$ s*$ule e/abli%$ "u ?is subsection1 ! am\nt ( a copaym5t = a #cj-;day supply ( a g5]ic drug or a drug li/$ on ! national =mul>y ( ! ,dep>tm5t %all be l[] ?an am\nt ( a copaym5t a #cj-;day supply ( a br&-"n drug or a drug n includ$ on su* national =mul>y4 4 7#b7 ,update ( cross-ref]5ce ,subsection 7a77#c77;,d7 ( su* section is am5d$ by /rik+ section #dia & ins]t+ section #bgcb4 #d4 ,vet]ans ,=mul>y ,advisory ,committee 7a7 ,e/abli%m5t ,! ,secret>y ( ,vet]ans ,affairs %all e/abli% an advisory committee1 to be kn[n z ! ,vet]ans ,=mul>y ,advisory ,committee 79 ?is section ref]r$ to z ! ,advisory ,committee74 ,! ,advisory ,committee %all provide vet]an & cl9ician input on ! national =mul>y ( ! ,dep>tm5t ( ,vet]ans ,affairs4 7b7 ,memb]%ip ,! ,advisory ,committee %all consi/ ( n m ?an t5 memb]s & %all include front-l9e cl9ical provid]s or ph>maci/s ( ! ,dep>tm5t :o are n involv$ 9 national =mul>y decision-mak+ & o!r /akehold] repres5tatives z ! ,secret>y consid]s appropriate4 7c7 ,meet+s ,! ,advisory ,committee %all meet at regul> int]vals 7at lea/ semiannually7 & %all review propos$ =mul>y *anges4 7d7 ,responsibilities ,! ,advisory ,committee may provide to ! ,secret>y & to ! ,ph>macy & ,!rapeutics ,committee e/abli%$ "u section #gchf ( title #ch1 ,unit$ ,/ates ,code1 ! indep5d5t fe$back or recomm5dations ( ! ,advisory ,committee reg>d+ propos$ additions1 removals1 & re/rictions p]ta9+ to ! national =mul>y1 includ+ ) respect to any pot5tial effects on vet]an pati5ts4 ,recomm5dations ( ! ,advisory ,committee %all be advisory 9 nature4 7e7 ,t]m9ation ,! ,advisory ,committee %all t]m9ate on ! date t is two ye>s aft] ! date ( ! e/abli%m5t ( ! ,advisory ,committee4