,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fbad ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,novemb] #bj1 #bjbe,mrs4 ,mill] ( ,we/ ,virg9ia 7= h]self & ,ms4 ,sewell7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,ways & ,means1 & 9 addition to ! ,committee on ,en]gy & ,comm]ce1 = 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 improve access to innovative treatm5t options = end-/age r5al disease "u ! ,m$ic>e program1 & = o!r purposes4 #a4 ,%ort title 7a7 ,9 g5]al ,?is ,act may be cit$ z ! ,kidney ,c>e ,access ,protection ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4,title ,i--,protect+ ,pati5t ,access to ,kidney ,c>e ,innovation,sec4 #aja4 ,ref9+ ! end-/age r5al disease paym5t sy/em to improve access to innovative treatm5t options4,sec4 #ajb4 ,ensur+ ,m$ic>e ,advantage supports kidney c>e innovative !rapies4,title ,,ii--,address+ ,/aff+ ,b>ri]s ) ,,esrd ,m>ket ,basket ,labor ,adjustments,sec4 #bja4 ,ensur+ accuracy & /ability 9 kidney c>e paym5t4,title ,,iii--,prev5t+ ,kidney ,disease & ,exp&+ ,aw>5ess & ,education,sec4 #cja4 ,exp&+ m$ic>e annual wellness b5efit to include kidney disease scre5+4,sec4 #cjb4 ,increas+ access to m$ic>e kidney disease education b5efit4 ,i ,protect+ ,pati5t ,access to ,kidney ,c>e ,innovation #aja4 ,ref9+ ! end-/age r5al disease paym5t sy/em to improve access to innovative treatm5t options 7a7 ,ext5sion ( ,transitional ,drug ,add-,on ,paym5t ,adju/m5t 7,,tdapa7 p]iod ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all pay ! transitional drug add-on paym5t adju/m5t "u section #dac4bcd7;c7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 = n less ?an #c ye>s = any new r5al dialysis drug or biological product-- 7#a7 approv$ by ! ,food & ,drug ,adm9i/ration on or aft] ,janu>y #a1 #bjbj1 "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7#b7 t qualifies = su* adju/m5t "u su* section2 & 7#c7 t is furni%$ on or aft] ,janu>y #a1 #bjbf4 7b7 ,p]man5t po/-,,tdapa adju/m5t ,section #ahha7;b77#ad7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,j7 ,paym5t = new & innovative drugs1 biologicals1 & devices t are r5al dialysis s]vices 7i7 ,9 g5]al ,= any new r5al dialysis drug or biological product t is us$ to treat or manage a condition z def9$ 9 section #dac4bcd7;a7 ( title #db1 ,code ( ,f$]al ,regulations t receiv$ a transitional drug add-on paym5t adju/m5t 7ref]r$ to 9 ?is subp>agraph z ,,tdapa7 "u section #dac4bcd7;c7 ( su* title1 & 0 furni%$ on or aft] ,janu>y #a1 #bjbd1 ! ,secret>y %all e/abli% a p]man5t add-on adju/m5t to ! base rate = claims submitt$ on or aft] ,janu>y #a1 #bjbf1 t includes ! adm9i/ration ( su* drugs or biologicals4 7ii7 ,calculation ( ! po/-,,tdapa add-on adju/m5t ,9 calculat+ ! add-on adju/m5t describ$ 9 clause 7i71 ! ,secret>y %all-- 7,i7 base ! calculation on-- 7aa7 except z provid$ 9 items 7bb7 & 7cc71 ! mo/ rec5t #ab-mon? p]iod ( utilization = ! new r5al dialysis drug or biological product & ! mo/ rec5t available full cal5d> qu>t] ( av]age sales price data = su* drug or product2 7bb7 if ! mo/ rec5t available full cal5d> qu>t] ( av]age sales price data reflects #j or negative sales1 #ajj p]c5t ( ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77 ( su* drug or product2 or 7cc7 if ! :olesale acquisition co/ is n available1 ! drug manufactur]'s invoice2 7,,ii7 calculate ! po/-,,tdapa add-on paym5t adju/m5t z ! exp5ditures = ! new r5al dialysis drug or biological product divid$ by ! total numb] ( r5al dialysis s]vices dur+ :i* su* drug or biological 0 adm9i/]$ dur+ ! same p]iod2 7,,iii7 set ! am\nt ( ! add-on adju/m5t z an am\nt equal to #fe p]c5t ( ! am\nt calculat$ "u subclause 7,,ii72 7,,iv7 update ! add-on adju/m5t annually to acc\nt = inflation>y *anges2 & 7,v7 apply ! add-on adju/m5t am\nt imm$iately ^u ! expiration ( ! ,,tdapa p]iod & availability ( ! po/-,,tdapa add-on adju/m5t4 7iii7 ,implem5tation ,?is subp>agraph %all n be implem5t$ 9 a budget neutral mann] & %all n be adju/$ by any applicable pati5t-level case-mix adju/m5ts describ$ 9 section #dac4bce ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation74 4 7c7 ,cl>ification to def9ition ( r5al dialysis s]vices ,section #ahha7;b77#ad77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77;,b77 is am5d$-- 7#a7 by r$esignat+ clauses 7i7 ?r\gh 7iv7 z subclauses 7,i7 ?r\gh 7,,iv71 respectively2 7#b7 by ins]t+ 7i7 aft] 7,b72 7#c7 9 clause 7i77,,iv71 z add$ by p>agraph 7#b71 by /rik+ clause 7i7 & ins]t+ subclause 7,i72 7#d7 9 ! flu% text at ! end1 by /rik+ ,su* t]m does n & ins]t+ ! foll[+3 7ii7 ,su* t]m-- 7,i7 does n 2 7#e7 9 clause 7ii71 z add$ by p>agraph 7#b7-- 7,a7 9 subclause 7,i71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,b7 by add+ at ! end ! foll[+3 7,,ii7 does n include drugs or biological products us$ to treat a comorbid disease or condition 7includ+ c>diovascul> disease1 an inflammatory condition1 canc]1 diabetes1 & obesity7 t may occur 9 an individual :o has be5 det]m9$ to h end-/age r5al diseases & is receiv+ dialysis &-- 7aa7 t h be5 approv$ by ! ,food & ,drug ,adm9i/ration aft] ,decemb] #ca1 #bjbe2 & 7bb7 d n sub/itute = a drug or biological includ$ 9 ! ,,esrd prospective paym5t sy/em base rate4 2 & 7#f7 by add+ at ! end ! foll[+ new clause3 7iii7 ,implem5tation ,beg9n+ on ! date ( enactm5t ( ?is clause1 = purposes ( implem5t+ clause 7ii77,,ii71 ! ,secret>y %all require t a claim = a drug or biological product describ$ 9 su* clause1 t is payable "u ?is "p & is furni%$ by a provid] ( s]vices or r5al dialysis facility1 conta9 ! ,,ay modifi] 7or a successor modifi]74 4 7d7 ,revisions to ,transitional ,add-,on ,paym5t ,adju/m5t = ,new & ,innovative ,equipm5t & ,supplies 7,,tpnies7 7#a7 ,ext5sion ( p]iod ,! ,secret>y %all pay ! transitional add-on paym5t adju/m5t = new & innovative equipm5t & supplies "u section #dac4bcf ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 = n less ?an #c ye>s = any new r5al dialysis device t-- 7,a7 qualifies = su* adju/m5t2 & 7,b7 is furni%$ on or aft] ,janu>y #a1 #bjbf4 7#b7 ,eligibility ( break?r\gh devices ,beg9n+ ,janu>y #a1 #bjbf1 a device designat$ = exp$it$ developm5t & priority review "u section #eae;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c7 %all be eligible = a transitional add-on paym5t adju/m5t = new & innovative equipm5t & supplies "u section #dac4bcf ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation74 7#c7 ,inclusion ( capital-relat$ assets 9 ! transitional add-on paym5t adju/m5t = new & innovative equipm5t & supplies & po/-,transitional ,add-,on ,paym5t ,adju/m5t = ,new & ,innovative ,equipm5t & ,supplies ,beg9n+ ,janu>y #a1 #bjbf1 ! ,secret>y %all n apply ! crit]ion describ$ 9 section #dac4bcf7;b77#f7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 t excludes capital-relat$ assets f ! transitional add-on paym5t adju/m5t = new & innovative equipm5t & supplies & %all calculate su* adju/m5t = capital-relat$ assets t are devices t o!rwise meet ! requirem5ts = ! transitional add-on paym5t adju/m5t = new & innovative equipm5t4 7e7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ,janu>y #a1 #bjbf1 & apply to items & s]vices furni%$ on or aft] su* date4 #ajb4 ,ensur+ ,m$ic>e ,advantage supports kidney c>e innovative !rapies 7a7 ,9 g5]al ,section #ahec7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,treatm5t ( innovative products = enrollees ) end /age r5al disease 7,a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 ! ,secret>y %all make direct paym5t adju/m5ts to provid]s ( s]vices or r5al dialysis facilities =-- 7i7 any new r5al dialysis drug or biological product t receives a transitional drug add-on paym5t adju/m5t "u section #dac4bcd7;c7 ( title #db1 ,code ( ,f$]al ,regulations2 or 7ii7 an item or s]vice t receives a transitional add-on paym5t adju/m5t = new & innovative equipm5t & supplies "u section #dac4bcf ( su* title4 7,b7 ,am\nt ( direct paym5t ,! am\nt ( ! adju/m5t %all equal ! am\nt det]m9$ "u ! end-/age r5al disease prospective paym5t sy/em describ$ 9 section #ahha7;b77#ad74 7,c7 ,duration ( direct paym5t ,! ,secret>y %all make paym5ts "u subp>agraph 7,a7 = ! duration ( ! transitional paym5t "u ! end-/age r5al disease prospective paym5t sy/em describ$ 9 su* section4 4 7b7 ,con=m+ am5dm5ts ,section #ahea7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ #ahec7;c77#h71 aft] #ahhf7;h77#c77;,d712 & 7#b7 9 p>agraph 7#b71 by ins]t+ #ahec7;c77#h71 aft] #ahec7;h714 ,,ii ,address+ ,/aff+ ,b>ri]s ) ,,esrd ,m>ket ,basket ,labor ,adju/m5ts #bja4 ,ensur+ accuracy & /ability 9 kidney c>e paym5t ,section #ahha7;b77#ad77;,f77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77;,f77i77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ subclauses 7,,ii7 & 7,,iii7 & ins]t+ subclauses 7,,ii71 7,,iii71 & 7,,iv72 7#b7 9 subclause 7,,ii71 by ins]t+ & aft] application ( subclause 7,,iv7 aft] subclause 7,i72 & 7#c7 by add+ at ! end ! foll[+ new subclause3 7,,iv7 ,beg9n+ ) #bjbf1 ! ,secret>y %all compute an adju/m5t to ! increase factor describ$ 9 subclause 7,i7 = ! annual update ( ! paym5t am\nts e/abli%$ "u ?is p>agraph = ! previ\s ye> to acc\nt = =eca/ error 7ref]r$ to 9 ?is subclause z ! =eca/ error adju/m5t74 ,! initial adju/m5t 79 #bjbf7 to ! increase factor %all take into acc\nt ! cumulative =eca/ error = #bjba & #bjbb4 ,subsequ5t adju/m5ts 9 succe$+ ye>s %all take into acc\nt ! =eca/ error f ! mo/ rec5tly available ye> = :i* !re is f9al data4 ,! =eca/ error adju/m5t "u ?is subclause %all apply :5ev] ! diff]5ce betwe5 ! =eca/$ & actual p]c5tage *ange 9 ! prices ( an appropriate mix ( goods & s]vices includ$ 9 r5al dialysis s]vices exce$s #j4e p]c5tage po9ts4 4 ,,iii ,prev5t+ ,kidney ,disease & ,exp&+ ,aw>5ess & ,education #cja4 ,exp&+ m$ic>e annual wellness b5efit to include kidney disease scre5+ 7a7 ,9 g5]al ,section #ahfa7ww77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77#b77 is am5d$-- 7#a7 by r$esignat+ subp>agraph 7,o7 z subp>agraph 7,p72 & 7#b7 by ins]t+ aft] subp>agraph 7,n7 ! foll[+ new subp>agraph3 7,o7 ,*ronic kidney disease scre5+ z def9$ by ! ,secret>y4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjbf4 #cjb4 ,increas+ access to m$ic>e kidney disease education b5efit 7a7 ,9 g5]al ,section #ahfa7;ggg7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ggg77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ or /age ,v aft] /age ,,iv2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ or ( a physician assi/ant1 nurse practition]1 or cl9ical nurse speciali/ 7z def9$ 9 section #ahfa7;aa77#e77 assi/+ 9 ! treatm5t ( ! individual's kidney condition aft] kidney condition2 & 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ subp>agraph 7,b72 & 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ 7,a7 aft] 7#b72 7ii7 by /rik+ & at ! end ( clause 7i72 7iii7 by /rik+ ! p]iod at ! end ( clause 7ii7 & ins]t+ 2 &2 7iv7 by r$esignat+ clauses 7i7 & 7ii7 z subp>agraphs 7,a7 & 7,b71 respectively2 & 7v7 by add+ at ! end ! foll[+3 7,c7 a r5al dialysis facility subject to ! requirem5ts ( section #ahha7;b77#a7 ) p]sonnel :o-- 7i7 provide ! s]vices describ$ 9 p>agraph 7#a72 & 7ii7 is a physician 7z def9$ 9 subsection 7r77#a77 or a physician assi/ant1 nurse practition]1 or cl9ical nurse speciali/ 7z def9$ 9 subsection 7aa77#e774 4 7b7 ,paym5t to r5al dialysis facilities ,section #ahha7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ae7 ,= purposes ( p>agraph 7#ad71 ! s+le paym5t = r5al dialysis s]vices "u su* p>agraph %all n take into acc\nt ! am\nt ( paym5t = kidney disease education s]vices 7z def9$ 9 section #ahfa7;ggg774 ,in/ead1 paym5t = su* s]vices %all be made to ! r5al dialysis facility on an assignm5t-relat$ basis "u section #ahdh4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to kidney disease education s]vices furni%$ on or aft] ,janu>y #a1 #bjbf4