,,ii #aah? ,,congress #b;d ,session ,s4 #eejb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #ab1 #bjbd,mrs4 ,%ahe5 7= h]self & ,ms4 ,coll9s7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to ensure cont9u$ access to diabetes te*nology ^u ,m$ic>e enrollm5t1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,diabetes ,int]v5tions ,address+ ,b>ri]s to ,enrollm5t1 ,te*nology1 & ,education ,s]vices 7,,diabetes7 ,act or ! ,diabetes ,act4 #b4 ,f9d+s2 ,s5se ( ,congress 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,accord+ to ! ,c5t]s = ,disease ,control & ,prev5tion1 9 #bjba1 an e/imat$ #ch1djj1jjj ,am]icans1 or #aa4f p]c5t ( ! entire ,unit$ ,/ates population1 h diabetes4 7#b7 ,! total numb] ( individuals ) diabetes is project$ to increase to an e/imat$ #ed1ijj1jjj individuals by #bjcj4 7#c7 ,diabetes disproportionately impacts ! ,m$ic>e population1 z ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices f\nd 9 #bjbb1 & #bf p]c5t ( ,m$ic>e b5efici>ies h diabetes4 7#d7 ,bo? type #a & #b diabetes c significantly h>m long-t]m heal? & is associat$ ) num]\s comorbidities su* z canc]1 he>t disease1 *ronic kidney disease1 bl9dness1 & amputations4 7#e7 ,! direct & indirect co/ ( diabetes is significant z ! ,am]ican ,diabetes ,association f\nd t ! total annual co/ ( diabetes 9 #bjbb 0 #dab1ijj1jjj1jjj1 #cjf1fjj1jjj1jjj ( :i* is attributable to direct m$ical co/s4 7#f7 ,! ,am]ican ,diabetes ,association & ! ,am]ican ,association ( ,cl9ical ,endocr9ology h set =? cl9ical guidel9es t include ! use ( cont9u\s glucose monitors1 insul9 pumps1 automat$ insul9 deliv]y sy/ems1 & diabetes self-managem5t tra9+ = individuals ) diabetes4 7#g7 ,an automat$ insul9 deliv]y sy/em consi/s ( a cont9u\s glucose monitor1 an insul9 pump1 & an algori?m or s(tw>e4 7#h7 ,! algori?m or s(tw>e is a critical compon5t ( an automat$ insul9 deliv]y sy/em z x cont9u\sly le>ns ! us]'s behavior & physiological responses & automatically adm9i/]s ! appropriate am\nt ( insul94 7#i7 ,m$ic>e curr5tly fails to sep>ately reimburse = ! ess5tial algori?ms & s(tw>e t drive automat$ insul9 deliv]y 7,,aid7 sy/ems1 :i* may /ifle future innovation & ma9t5ance1 & imp$e b5efici>y access4 7#aj7 ,m$ic>e has an exi/+ pa?way to sep>ately reimburse = ! algori?m or s(tw>e 9 an automat$ insul9 deliv]y sy/em1 ! ,m$ic>e durable m$ical equipm5t b5efit4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t ! ,secret>y ( ,heal? & ,human ,s]vices %\ld commit to take adm9i/rative action to-- 7#a7 recognize t ! algori?m or s(tw>e 9 an automat$ insul9 deliv]y sy/em is a reasonable & necess>y item = ! diagnosis or treatm5t ( illness or injury or to improve ! function+ ( a mal=m$ body memb] consi/5t ) ,m$ic>e cov]age requirem5ts "u section #ahfb7;a77#a77;,a7 ( ! ,social ,security ,act2 7#b7 ensure ! algori?m or s(tw>e 9 an automat$ insul9 deliv]y sy/em is treat$ z a sep>ately payable supply to durable m$ical equipm5t2 & 7#c7 :5 applicable1 recognize ! algori?m or s(tw>e 9 an automat$ insul9 deliv]y sy/em z m$ical supplies associat$ ) ! injection ( insul9 consi/5t ) section #ahfj;,d-#b7;e77#a7 ( ! ,social ,security ,act4 #c4 ,cont9u$ access to diabetes relat$ te*nologies 7a7 ,9 g5]al ,section #ahfa7ww7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ & aft] ^u ! agreem5t ) ! individual12 & 7,b7 by ins]t+ & ensur+ c>e cont9uity = individuals us+ diabetes te*nology cov]$ "u "p ,b z describ$ 9 p>agraph 7#e71 aft] 7z def9$ 9 p>agraph 7#d7712 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 7,a7 ,subject to subp>agraphs 7,b7 & 7,c7 ( ?is p>agraph1 dur+ ! fir/ #ab mon?s ( an individual's enrollm5t = b5efits "u "p ,b1 a provid] 7z def9$ 9 subp>agraph 7,e77 may c]tify to ! ,secret>y t an individual is us+ #a or multiple diabetes te*nologies cov]$ "u "p ,b 7z def9$ 9 subp>agraph 7,d774 7,b7 ,dur+ ! initial prev5tive physical exam9ation or o!r cov]$ s]vice z det]m9$ appropriate by ! ,secret>y dur+ ! p]iod describ$ 9 subp>agraph 7,a71 ! provid] may make a det]m9ation ( ! individual's use ( diabetes te*nology cov]$ "u "p ,b4 ,9 ! case :]e ! provid] makes su* det]m9ation1 ! provid] %all submit a c]tification to ! ,secret>y z requir$ "u subp>agraph 7,c74 7,c7 ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all-- 7i7 issue a f9aliz$ c]tification =m1 develop$ pursuant to public notice & opportunity = comm5t1 = use "u ?is p>agraph2 7ii7 issue guidance & in/ructions to m$ic>e adm9i/rative contractors 7z def9$ 9 section #ahgd;,a7#c771 t require ! relevant m$ic>e adm9i/rative contractors to only assess :e!r ! c]tification =m is includ$ 9 ! individual's m$ical records :5 mak+ a det]m9ation ( :e!r cov]age ( ! diabetes te*nology cov]$ "u "p ,b is reasonable & necess>y z describ$ 9 section #ahfb7;a77#a77;,a72 7iii7 develop a process ?r\gh notice & comm5t rulemak+ = consid]+ :e!r an individual's diabetes te*nology t is n cov]$ "u "p ,b at ! "t ( ! c]tification describ$ 9 subp>agraph 7,a7 %\ld be a cov]$ b5efit "u exi/+ /atutory au?ority2 & 7iv7 issue appropriate guidance to relevant audit & ov]sight entities to ensure ^? entities d n inappropriately cause disruptions 9 access to diabetes te*nology cov]$ "u "p ,b4 7,d7 ,= purposes ( ?is p>agraph1 ! t]m diabetes te*nology cov]$ "u "p ,b means1 ) respect to an individual1 any device1 relat$ supplies1 & s(tw>e or algori?m t1 at ! "t ! c]tification describ$ 9 subp>agraph 7,c7 is made ) respect to ! individual1 is cov]$ "u "p ,b = an individual t has diabetes "u ! applicable ,,icd-#aj code li/ z det]m9$ by ! ,secret>y4 7,e7 ,= purposes ( ?is p>agraph1 ! t]m provid] means a physician 7z def9$ 9 section #ahfa7r771 nurse practition]1 cl9ical nurse speciali/1 physician assi/ant1 7z ^? t]ms are def9$ 9 section #ahfa7;aa77#e771 or c]tifi$ nurse-midwife 7z def9$ 9 section #ahfa7;gg77#b771 or o!r provid] ( s]vices or suppli] z det]m9$ appropriate 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 #d4 ,exp&+ access to diabetes outpati5t self-managem5t tra9+ s]vices 7a7 ,9 g5]al ,section #ahfa7qq7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7qq77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by ins]t+ & consi/5t ) p>agraph 7#b77;,c7 aft] z ! ,secret>y det]m9es appropriate2 7,b7 by ins]t+ or qualifi$ non-physician practition] aft] only if ! physician2 & 7,c7 by ins]t+ 7or o!r physician or qualifi$ non-physician practition] furni%+ items or s]vices to su* individual1 9 coord9ation ) ! physician or qualifi$ non-physician practition] manag+ su* individual's diabetic condition7 aft] manag+ ! individual's diabetic condition2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ p>agraph & ins]t+ subp>agraph2 & 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ ! foll[+ new subp>agraph3 7,c7 ! times det]m9$ appropriate by ! ,secret>y %all 9 no way limit ! quantity or duration ( educational & tra9+ s]vices furni%$ by a c]tifi$ provid] to an individual ) diabetes if su* s]vice is deem$ m$ically necess>y by a physician or qualifi$ non-physician practition]4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjbf4 #e4 ,provid+ insul9 pump tra9+ & education 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all e/abli% new ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em codes "u ! fee s*$ule e/abli%$ "u section #ahdh7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;b77 t describe hook-up1 calibration1 & pati5t tra9+ ) respect to an insul9 pump simil> to ,curr5t ,proc$ural ,t]m9ology codes #iebdi & #iebej 7& any succe$+ codes74 ,! ,secret>y %all ensure ! newly e/abli%$ codes suffici5tly describe pati5t education & tra9+ z well z insul9 pump placem5t s]vices = te*nologies cov]$ "u section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 & "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 7b7 ,education & outrea* ,! ,secret>y %all use exi/+ communications & me*anisms to provide education & outrea* to /akehold]s ) respect to ! ability ( heal? pr(essionals to bill ! newly e/abli%$ codes describ$ 9 subsection 7a74 #f4 ,national cov]age det]m9ation on insul9 pumps ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue a propos$ national cov]age det]m9ation 7z def9$ 9 section #ahfi7;f77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;ff7f77#a77;,b77 = infusion pumps1 cont9u\s subcutane\s insul9 infusion 7,,csii71 numb] #bhj4ad pursuant to section #ahfb7l7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l774 #g4 ,report on enrollee access to diabetes-relat$ s]vices & te*nologies 9 ,f$]al heal? c>e programs 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 9 collaboration ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all submit to ! ,committee on ,f9ance & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives1 a report t assesses ! b>ri]s individuals face 9 access+ diabetes te*nologies & diabetes self-managem5t education & support s]vices across ,f$]al heal? c>e programs4 ,! report %all specifically review b>ri]s1 :i* include prior au?orization practices1 ! use ( pref]r$ =mul>ies1 cov]age int5sity limitations1 & o!r utilization managem5t te*niques1 to access+ diabetes te*nologies & diabetes self-managem5t education & support s]vices fac$ by individuals enroll$ 9 a ,f$]al heal? c>e program1 & :e!r any ,f$]al law1 regulation1 or policy adv]sely affects access to ^? cov]$ s]vices or limits ! ability ( individuals ) diabetes to receive s]vices t align ) /&>ds ( c>e4 7b7 ,def9itions ,9 ?is section3 7#a7 ,diabetes te*nologies ,! t]m diabetes te*nologies means items describ$ 9 section #ahfa7ww77#e77;,d7 ( ! ,social ,security ,act1 z add$ by section #c1 & any device1 relat$ supplies1 & s(tw>e or algori?m t monitors or manages an individual's diabetes t is m$ically necess>y = ! individual's diagnosis ( diabetes1 reg>dless ( :e!r ! device1 relat$ supplies1 & s(tw>e or algori?m is cov]$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 ,su* t]m includes glucose monitors1 insul9 deliv]y te*nologies1 relat$ supplies1 & s(tw>e or algori?ms4 7#b7 ,diabetes self-managem5t education & support s]vices ,! t]m diabetes self-managem5t education & support s]vices means s]vices describ$ 9 section #ahfa7qq7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7qq774 7#c7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program means any plan or program t provides heal? b5efits1 :e!r ?r\gh insurance or o!rwise1 t is directly fund$ 9 :ole or 9 "p1 by ! ,unit$ ,/ates ,gov]nm5t1 includ+ a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 & a heal? b5efits plan "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code4