,i #aac? ,,congress #b;d ,session ,h4 ,r4 #edce ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #aj1 #bjad ,mr4 ,engel 7= himself1 ,mr4 ,tib]i1 ,mr4 ,l>son ( ,connecticut1 ,mr4 ,h>p]1 ,mr4 ,meehan1 ,ms4 ,p+ree ( ,ma9e1 & ,mr4 ,pet]son7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = 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 am5d title ,,xviii ( ! ,social ,security ,act to provide = ! cov]age ( home z a site ( c>e = infusion !rapy "u ! ,m$ic>e ,program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ic>e ,home ,infusion ,site ( ,c>e ,act ( #bjad4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,! ,m$ic>e fee-=-s]vice program cov]s infusion !rapy 9 ! hospital1 skill$ nurs+ facility1 physician (fice1 & hospital outpati5t dep>tm5t1 b does n cov] ! full range ( s]vices = ! provision ( infusion !rapies 9 a pati5t's home4 7#b7 ,! ,m$ic>e program is pres5tly ! only major heal? c>e pay] 9 ! ,unit$ ,/ates t does n provide compreh5sive cov]age ( home infusion !rapy4 7#c7 ,z a result ( ! ,m$ic>e program n provid+ = compreh5sive cov]age ( home infusion !rapy1 _m ,m$ic>e b5efici>ies are unable to obta9 infusion !rapy 9 ! mo/ co/-effective & conv5i5t sett+ ( _! home1 & physicians are depriv$ ( ! ability to select ! be/ site ( c>e = _! pati5ts4 7#d7 ,! ,m$ic>e program is pay+ = in/itutional c>e = ! provision ( infusion !rapy 9 _m in/ances :5 su* in/itutional c>e c\ld be avoid$ if ! ,m$ic>e program provid$ cov]age = home infusion !rapy4 7#e7 ,! ,gov]nm5t ,acc\ntability ,(fice f\nd 9 a #bjaj report t home infusion !rapy is utiliz$ widely by private pay]s provid+ heal? insurance cov]age = individuals enroll$ "u su* cov]age & t su* private pay]s g5]ally are satisfi$ ) ! quality ( c>e & ! sav+s !y a*ieve ?r\gh avoid$ in/itutionalizations4 7#f7 ,a rec5t /udy has report$ a pot5tial sav+s = ,m$ic>e if infusion !rapies 7 cov]$ 9 ! home site ( c>e4 #c4 ,m$ic>e cov]age ( home infusion !rapy 7a7 ,9 g5]al ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$-- 7#a7 9 subsection 7s77#b7-- 7,a7 by /rik+ & at ! end ( subp>agraph 7,,ee72 7,b7 by ins]t+ & at ! end ( subp>agraph 7,,ff72 & 7,c7 by ins]t+ at ! end ! foll[+ new subp>agraph3 7,,gg7 home infusion !rapy 7z def9$ 9 subsection 7iii77#a772 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7iii7 ,home ,infusion ,!rapy 7#a7 ,! t]m home infusion !rapy means ! items & s]vices describ$ 9 p>agraph 7#b7 furni%$ to an individual1 :o is "u ! c>e ( a physician1 :i* are provid$ by a qualifi$ home infusion !rapy suppli] "u a plan 7= furni%+ su* items & s]vices to su* individual7 e/abli%$ & p]iodically review$ by a physician1 :i* items & s]vices are provid$ 9 an integrat$ mann] 9 ! individual's home 9 con=mance ) uni=m /&>ds ( c>e e/abli%$ by ! ,secret>y & 9 coord9ation ) ! provision ( cov]$ infusion drugs "u "p ,d4 ,! ,secret>y %all e/abli% su* /&>ds aft] tak+ into acc\nt ! /&>ds commonly us$ = home infusion !rapy by ,m$ic>e ,advantage plans & 9 ! private sector & aft] consultation ) all int]e/$ /akehold]s4 7#b7 ,! items & s]vices describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,pr(essional s]vices1 includ+ nurs+ s]vices 7o!r ?an nurs+ s]vices cov]$ z home heal? s]vices71 provid$ 9 accordance ) ! plan 7includ+ adm9i/rative1 comp\nd+1 disp5s+1 di/ribution1 cl9ical monitor+1 & c>e coord9ation s]vices7 & all necess>y supplies & equipm5t 7includ+ m$ical supplies su* z /]ile tub+ & infusion pumps74 7,b7 ,o!r items & s]vices ! ,secret>y det]m9es appropriate to adm9i/] infusion drug !rapies to an individual safely & effectively 9 ! home4 7#c7 ,= purposes ( ?is subsection3 7,a7 ,! t]m home means a place ( resid5ce us$ z an individual's home & includes su* o!r alt]nate sett+s z ! ,secret>y det]m9es4 7,b7 ,! t]m qualifi$ home infusion !rapy suppli] means any ph>macy1 physician1 or o!r provid] lic5s$ by ! ,/ate 9 :i* ! ph>macy1 physician1 or provid] resides or provides s]vices1 ^: ,/ate au?oriz$ scope ( practice includes disp5s+ au?ority & t-- 7i7 has exp]tise 9 ! prep>ation ( p>5t]al m$ications 9 compliance ) en=ceable /&>ds ( ! ,unit$ ,/ates ,ph>macopoeia & o!r nationally recogniz$ /&>ds t regulate prep>ation ( p>5t]al m$ications z det]m9$ by ! ,secret>y & meets su* /&>ds2 7ii7 provides infusion !rapy to pati5ts ) acute or *ronic conditions requir+ p>5t]al adm9i/ration ( drugs & biologicals adm9i/]$ ?r\gh ca!t]s or ne$les1 or bo?1 9 a home2 & 7iii7 meets su* o!r uni=m requirem5ts z ! ,secret>y det]m9es are necess>y to ensure ! safe & effective provision & adm9i/ration ( home infusion !rapy on a #g-;day-a-week1 #bd-;h\r basis 7tak+ into acc\nt ! /&>ds ( c>e = home infusion !rapy e/abli%$ by ,m$ic>e ,advantage plans & 9 ! private sector71 & ! effici5t adm9i/ration ( ! home infusion !rapy b5efit4 7#d7 ,a qualifi$ home infusion !rapy suppli] may subcontract ) a ph>macy1 physician1 provid]1 or suppli] to meet ! requirem5ts ( p>agraph 7#c77;,b74 4 7b7 ,paym5t = ,home ,infusion ,!rapy ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7p7 ,paym5t = home infusion !rapy 7#a7 ,9 g5]al ,! ,secret>y %all det]m9e a p] diem s*$ule = paym5t = ! pr(essional s]vices 7includ+ nurs+ s]vices71 supplies1 & equipm5t describ$ 9 section #ahfa7;iii77#b77;,a7 = ea* infusion !rapy type t reflects ! reasonable co/s :i* mu/ be incurr$ by effici5tly & economically op]at$ qualifi$ home infusion !rapy suppli]s to provide su* s]vices1 supplies1 & equipm5t 9 con=mity ) applicable ,/ate & ,f$]al laws1 regulations1 & ! uni=m quality & safety /&>ds develop$ "u section #ahfa7;iii77#a7 & to assure t ,m$ic>e b5efici>ies h reasonable access to su* !rapy4 7#b7 ,consid]ations ,9 develop+ ! p] diem s*$ule "u ?is subsection1 ! ,secret>y %all consid] rec5t cr$ible /udies ab\t ! co/s ( provid+ infusion !rapy 9 ! home1 consult ) home infusion !rapy suppli]s1 consid] paym5t am\nts e/abli%$ by ,m$ic>e ,advantage plans & private pay]s = home infusion !rapy1 &1 if necess>y1 conduct a /ati/ically valid national m>ket analysis involv+ ! co/s ( adm9i/]+ infusion drugs & ( provid+ pr(essional s]vices necess>y = ! drugs' adm9i/ration4 7#c7 ,annual updates ,! ,secret>y %all update su* s*$ule f ye> to ye> by ! p]c5tage increase 9 ! ,consum] ,price ,index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! prec$+ ye>4 ,! ,secret>y may modify ! p] diem s*$ule ) respect to b5efici>ies :o qualify = home infusion !rapy s]vices "u section #ahfa7;iii77#a7 b :o receive nurs+ s]vices z home heal? s]vices4 4 7c7 ,con=m+ am5dm5ts 7#a7 ,paym5t ref]5ce ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciea7;a77#a77 is am5d$-- 7,a7 by /rik+ & be=e 7,z72 & 7,b7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,aa7 ) respect to home infusion !rapy1 ! am\nts paid %all be det]m9$ "u section #ahcd7p74 7#b7 ,direct paym5t ,! fir/ s5t5ce ( section #ahdb7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f77 is am5d$-- 7,a7 by /rik+ & be=e 7,h72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,i7 9 ! case ( home infusion !rapy1 paym5t %all be made to ! qualifi$ home infusion !rapy suppli]4 7#c7 ,exclusion f durable m$ical equipm5t & home heal? s]vices ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$-- 7,a7 9 subsection 7m77#e7-- 7i7 by /rik+ & be=e durable m$ical equipm5t & ins]t+ a comma2 & 7ii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & supplies us$ 9 ! provision ( home infusion !rapy aft] exclud+ o!r drugs & biologicals2 & 7,b7 9 subsection 7n71 by add+ at ! end ! foll[+3 ,su* t]m does n include home infusion !rapy1 o!r ?an equipm5t & supplies us$ 9 ! provision ( insul944 7#d7 ,application ( accr$itation provisions ,! provisions ( section #ahfe7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;bb7a77 apply to ! accr$itation ( qualifi$ home infusion !rapy suppli]s 9 ! same way z !y apply to o!r suppli]s4 #d4 ,m$ic>e cov]age ( home infusion drugs ,section #ahfj;,d-#b7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ or at ! end ( subp>agraph 7,a72 7,b7 by /rik+ ! comma at ! end ( subp>agraph 7,b7 & ins]t+1 2 or2 & 7,c7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+ new subp>agraph3 7,c7 an infusion drug 7z def9$ 9 p>agraph 7#e771 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,infusion drug def9$ ,= purposes ( ?is "p1 ! t]m infusion drug means a p>5t]al drug or biological adm9i/]$ via an intrav5\s1 intrasp9al1 intra-art]ial1 intra!cal1 epidural1 subcutane\s1 or intramuscul> access device or injection1 & may include a drug us$ = ca!t] ma9t5ance & declott+1 a drug conta9$ 9 a device1 additives includ+ b n limit$ to vitam9s1 m9]als1 solutions1 & dilu5ts1 & o!r compon5ts us$ 9 ! provision ( home infusion !rapy4 4 #e4 ,ensur+ b5efici>y access to home infusion !rapy 7a7 ,objectives 9 implem5tation ,! ,secret>y ( ,heal? & ,human ,s]vices %all implem5t ! ,m$ic>e home infusion !rapy b5efit "u ! am5dm5ts made by ?is ,act 9 a mann] t ensures t ,m$ic>e b5efici>ies h timely & appropriate access to infusion !rapy 9 _! homes & t !re is rapid & seamless coord9ation betwe5 drug cov]age "u "p ,d ( title ,,xviii ( ! ,social ,security ,act & cov]age = home infusion !rapy s]vices "u "p ,b ( su* title to avoid ! fil+ ( duplicative or o!rwise improp] claims4 ,specifically1 ! ,secret>y %all ensure t-- 7#a7 ! b5efit is practical & workable ) m9imal adm9i/rative burd5 = b5efici>ies1 qualifi$ home infusion !rapy suppli]s1 physicians1 prescription drug plans1 ,,ma-,,pd plans1 & ,m$ic>e ,advantage plans1 & ! ,secret>y %all consid] ! use ( consolidat$ claims encompass+ cov]$ "p ,d drugs & "p ,b s]vices1 supplies1 & equipm5t "u su* "p ,b to ensure ! effici5t op]ation ( ?is b5efit2 7#b7 any prior au?orization or utilization review process is exp$iti\s1 all[+ ,m$ic>e b5efici>ies mean+ful access to home infusion !rapy2 7#c7 m$ical necessity det]m9ations = home infusion !rapy w be made-- 7,a7 except z provid$ 9 subp>agraph 7,b71 by ,m$ic>e adm9i/rative contractors "u su* "p ,b & communicat$ to ! appropriate prescription drug plans2 or 7,b7 9 ! case ( an individual enroll$ 9 a ,m$ic>e ,advantage plan1 by ! ,m$ic>e ,advantage organization (f]+ ! plan2 & an individual may be initially qualifi$ = cov]age = su* b5efit = a #ij-;day p]iod & subsequ5t #ij-;day p]iods !reaft]2 7#d7 except z o!rwise provid$ 9 ?is section1 ! b5efit is model$ on curr5t private sector cov]age & cod+ = home infusion !rapy2 & 7#e7 prescription drug plans & ,,ma-,,pd plans /ructure _! =mul>ies1 utilization review protocols1 & policies 9 a mann] t ensures t ,m$ic>e b5efici>ies h timely & appropriate access to infusion !rapy 9 _! homes4 7b7 ,report ,n lat] ?an ,janu>y #a1 #bjah1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ,congress on ,m$ic>e b5efici>y access to home infusion !rapy4 ,su* report %all specifically address :e!r ! objectives specifi$ 9 subsection 7a7 h be5 met & %all make recomm5dations to ,congress & ! ,secret>y ( ,heal? & ,human ,s]vices on h[ to improve ! b5efit & bett] ensure t ,m$ic>e b5efici>ies h timely & appropriate access to infusion !rapy 9 _! homes4 #f4 ,effective date ,! am5dm5ts made by ?is ,act %all apply to home infusion !rapy furni%$ on or aft] ,janu>y #a1 #bjae4