,,ii #aaf? ,,congress #a/ ,session ,s4 #bija ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,novemb] #ai1 #bjai ,ms4 ,coll9s 7= h]self & ,mrs4 ,%ahe57 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to e/abli% )9 ! ,(fice ( ! ,secret>y ( ,heal? & ,human ,s]vices a special task =ce on ensur+ ,m$ic>e b5efici>y access to innovative diabetes te*nologies & s]vices4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,improv+ ,m$ic>e ,b5efici>y ,access to ,innovative ,diabetes ,te*nologies ,act ( #bjai4 #b4 ,e/abli%m5t ( ,,hhs ,task ,=ce on cov]age & paym5t = innovative diabetes te*nologies & s]vices 7a7 ,def9itions ,9 ?is section3 7#a7 ,,cms ,! t]m ,,cms means ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7#b7 ,,fda ,! t]m ,,fda means ! ,food & ,drug ,adm9i/ration4 7#c7 ,innovative diabetes te*nologies & s]vices ,! t]m innovative diabetes te*nologies & s]vices means m$ical te*nologies & s]vices = ! treatm5t & managem5t ( diabetes = :i* cov]age is n available "u ! ,m$ic>e fee-=-s]vice program4 7#d7 ,m$ic>e ,! t]m ,m$ic>e means ! program ( heal? insurance = ! ag$ & disabl$ e/abli%$ "u title ,,xviii ( ! ,social ,security ,act4 7#e7 ,m$ic>e b5efici>y ,! t]m ,m$ic>e b5efici>y means an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act1 or enroll$ "u "p ,b ( su* title1 or bo?4 7#f7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7b7 ,e/abli%m5t2 mission 7#a7 ,e/abli%m5t ,!re is e/abli%$ )9 ! ,(fice ( ! ,secret>y ! ,task ,=ce on ,innovative ,diabetes ,te*nologies & ,s]vices 79 ?is section ref]r$ to z ! ,task ,=ce74 7#b7 ,mission ,! mission ( ! ,task ,=ce is to-- 7,a7 advise ! ,secret>y ) respect to accessibility to innovative diabetes te*nologies & s]vices "u ,m$ic>e2 7,b7 make recomm5dations to support curr5t & future access to innovative diabetes te*nologies & s]vices "u ,m$ic>e2 & 7,c7 recomm5d *anges to ,m$ic>e to ensure appropriate access by ,m$ic>e b5efici>ies to su* innovative diabetes te*nologies & s]vices4 7c7 ,memb]%ip 7#a7 ,appo9tm5t ,! ,secret>y %all appo9t individuals ) relevant exp]tise to ! ,task ,=ce1 :i* %all include ! foll[+ vot+ memb]s3 7,a7 ,,cms (ficials 7i7 ,! ,director ( ! ,c5t] = ,m$ic>e4 7ii7 ,n m ?an #b additional (ficials or s5ior /aff ( ,,cms z ! ,secret>y may specify4 7,b7 ,b5efici>y ombudsman ,! ,m$ic>e ,b5efici>y ,ombudsman4 7,c7 ,ph>maceutical & ,te*nology ,ombudsman ,! ,m$ic>e ,ph>maceutical & ,te*nology ,ombudsman4 7,d7 ,,fda (ficials ,n m ?an #b (ficials or s5ior /aff f ! ,diabetes ,bran* ( ! ,c5t] = ,devices & ,radiological ,heal? ( ,,fda z ! ,commission] ( ,food & ,drugs may specify4 7,e7 ,pati5t gr\ps ,repres5tatives (-- 7i7 ,m$ic>e b5efici>ies2 7ii7 individuals enroll$ "u a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or a waiv] ( su* a plan72 & 7iii7 individuals n describ$ 9 clause 7i7 or 7ii7 :o h a diagnosis ( diabetes4 7,f7 ,heal? c>e provid]s ,repres5tatives ( provid]s ( s]vices1 physicians1 & practition]s :o treat individuals ) a diagnosis ( diabetes4 7,g7 ,manufactur]s ,repres5tatives ( manufactur]s ( diabetes te*nologies1 includ+ innovative diabetes te*nologies & s]vices4 7#b7 ,co-*airs 7,a7 ,9 g5]al ,( ! memb]s ( ! ,task ,=ce-- 7i7 "o co-*air %all be ! ,director ( ! ,c5t] = ,m$ic>e2 & 7ii7 "o co-*air %all be designat$ by ! ,secret>y f among vot+ memb]s appo9t$ "u subp>agraph 7,e71 7,f71 or 7,g7 ( p>agraph 7#a74 7,b7 ,rotation ( non-gov]nm5t co-*air ,! ,secret>y %all rotate designations ( co-*airs "u subp>agraph 7,a77ii7 f among vot+ memb]s appo9t$ "u subp>agraph 7,e71 7,f71 or 7,g7 ( p>agraph 7#a74 7,c7 ,t]m ( s]vice = non-gov]nm5t co-*air ,ea* co-*air designat$ "u subp>agraph 7,a77ii7 %all s]ve a t]m ( #b ye>s4 7#c7 ,comp5sation 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 memb]s ( ! ,task ,=ce %all s]ve )\t comp5sation4 7,b7 ,travel exp5ses ,a memb] ( ! ,task ,=ce may be all[$ travel exp5ses1 includ+ p] diem 9 lieu ( subsi/5ce1 at rates au?oriz$ = an employee ( an ag5cy "u sub*apt] ,i ( *apt] #eg ( title #e1 ,unit$ ,/ates ,code1 :ile away f ! home or regul> place ( bus9ess ( ! memb] 9 ! p]=mance ( ! duties ( ! ,task ,=ce4 7d7 ,meet+s ,! ,secret>y %all conv5e ! ,task ,=ce n less frequ5tly ?an #d times ea* ye>4 ,! ,secret>y %all conv5e ! fir/ meet+ ( ! ,task ,=ce no lat] ?an ,july #a1 #bjbj4 7e7 ,duties ,! ,task ,=ce %all c>ry out ! foll[+ duties3 7#a7 ,id5tification ( innovative diabetes te*nologies & s]vices ,! ,task ,=ce %all-- 7,a7 id5tify innovative diabetes te*nologies & s]vices = ! treatm5t ( type ,i diabetes1 type ,,ii diabetes1 or bo?1 t are 9 developm5t or t h be5 cle>$ or approv$ by ,,fda & t are :olly or p>tially inaccessible to ,m$ic>e b5efici>ies ) diabetes "u ,m$ic>e2 7,b7 develop & consid] possible alt]native approa*es to enable ,m$ic>e b5efici>ies to access innovative diabetes te*nologies & s]vices2 & 7,c7 det]m9e :e!r ! exi/+ adm9i/rative sy/ems1 b5efit categories1 & cov]age1 cod+ & paym5t policies "u ,m$ic>e w\ld provide or imp$e access to1 & appropriate paym5t =1 innovative diabetes te*nologies & s]vices4 7#b7 ,analysis ( access disp>ities 7,a7 ,private payor policies ,! ,task ,=ce %all review cov]age policies develop$ by private payors = innovative diabetes te*nologies & s]vices & det]m9e :e!r disp>ities exi/ betwe5 pati5ts ) diabetes insur$ by private payors z comp>$ to ,m$ic>e b5efici>ies ) diabetes4 7,b7 ,case /udies ,! ,task ,=ce %all recomm5d to ! ,secret>y ! developm5t ( real-_w pati5t case /udies & heal? c>e provid] case /udies t id5tify b>ri]s to access1 & access disp>ities1 "u ,m$ic>e ) respect to innovative diabetes te*nologies & s]vices4 7#c7 ,id5tification ( *anges 9 relevant ,,fda approval & ,,cms cov]age policies 7,a7 ,,cms regulatory b>ri]s to cov]age ,! ,task ,=ce %all-- 7i7 id5tify all ! categories ( items & s]vices = :i* cov]age is available "u ,m$ic>e :e!r e/abli%$ by title ,,xviii ( ! ,social ,security ,act or o!rwise 79 ?is section ref]r$ to z b5efit categories7 t may be us$ to provide = cov]age ( diabetes te*nologies & s]vices1 includ+ innovative diabetes te*nologies & s]vices2 7ii7 review regulations & subregulatory guidance = ! b5efit categories id5tifi$ "u clause 7i7 to id5tify policies t limit cov]age (1 & paym5t =1 diabetes te*nologies & s]vices "u ,m$ic>e1 especially innovative diabetes te*nologies & s]vices2 & 7iii7 recomm5d specific *anges to su* regulations & subregulatory guidance to provide = cov]age (1 & paym5t =1 innovative diabetes te*nologies & s]vices "u ,m$ic>e4 7,b7 ,int]ag5cy collaboration ,! ,task ,=ce %all id5tify /rategies to improve collaboration betwe5 ,,fda & ,,cms t facilitate exp$iti\s cle>ance or approval ( innovative diabetes te*nologies & s]vices by ,,fda & exp$iti\s cov]age ( innovative diabetes te*nologies & s]vices "u ,m$ic>e4 7#d7 ,id5tification ( /rategies to support cov]age ( innovative diabetes te*nologies & s]vices ,! ,task ,=ce %all id5tify /rategies n o!rwise describ$ 9 ?is subsection to facilitate access to innovative diabetes te*nologies & s]vices by ,m$ic>e b5efici>ies z well z by o!r pati5ts & _! heal? c>e provid]s4 7f7 ,recomm5dations ,n less frequ5tly ?an annually1 ! ,task ,=ce %all make recomm5dations to ! ,secret>y ) respect to-- 7#a7 exi/+ b5efit categories "u :i* innovative diabetes te*nologies & s]vices %\ld be cov]$2 7#b7 legislative *anges to title ,,xviii ( ! ,social ,security ,act & adm9i/rative *anges to regulations promulgat$ & subregulatory guidance issu$ ) respect to exi/+ b5efit categories t are necess>y to provide = cov]age (1 & paym5t =1 innovative diabetes te*nologies & s]vices2 7#c7 elim9ation ( o!r unnecess>y burd5s t imp$e cov]age (1 & paym5t =1 innovative diabetes te*nologies & s]vices "u ,m$ic>e2 7#d7 proposals = a new ,m$ic>e b5efit category to provide = cov]age ( innovative diabetes te*nologies & s]vices t _c o!rwise be cov]$ ?r\gh adm9i/rative *anges to regulations & subregulatory guidance = exi/+ b5efit categories1 & specifications = any new b5efit category2 & 7#e7 proposals to /reaml9e int]ag5cy adm9i/rative processes ?r\gh great] collaboration betwe5 ,,fda & ,,cms to facilitate prompt approval or cle>ance & cov]age "u ,m$ic>e ( innovative diabetes te*nologies & s]vices = ,m$ic>e b5efici>ies ) diabetes4 7g7 ,response 7#a7 ,9 g5]al ,) respect to ea* recomm5dation made by ! ,task ,=ce "u subsection 7f71 n lat] ?an #ij days aft] ! date ( receipt ( ea* su* recomm5dation1 ! ,secret>y %all make a det]m9ation :e!r to implem5t or reject ! recomm5dation4 7#b7 ,implem5tation ,9 ! case ( a det]m9ation by ! ,secret>y to implem5t a recomm5dation "u p>agraph 7#a71 ! ,secret>y %all provide ! ,task ,=ce ) a plan = su* implem5tation1 includ+ specific details ab\t & a timetable = ! implem5tation4 7#c7 ,rejection ,9 ! case ( a det]m9ation by ! ,secret>y to reject a recomm5dation "u p>agraph 7#a71 ! ,secret>y %all provide ! ,task ,=ce )-- 7,a7 a detail$ explanation ( ! rationale = ! det]m9ation2 & 7,b7 recomm5dations = alt]native policies = consid]ation by ! ,task ,=ce4 7h7 ,report ,! ,secret>y %all submit an annual report to ,congress t describes ! activities ( ! ,task ,=ce = ! ye> involv$4 ,ea* su* report %all include su* recomm5dations = improv+ access to innovative diabetes te*nologies & s]vices z ! ,task ,=ce det]m9es appropriate4 7i7 ,application ( ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 o!r ?an section #ad ( su* ,act1 %all apply to ! ,task ,=ce4 7j7 ,rule ( con/ruction ,! delib]ations ( ! ,task ,=ce %all n be con/ru$ z int]f]+ ) or imp$+ any decision1 det]m9ation1 rulemak+1 or issuance ( subregulatory guidance by ! ,secret>y t provides = cov]age (1 & paym5t =1 innovative diabetes te*nologies & s]vices4