,i #aac? ,,congress #b;d ,session ,h4 ,r4 #efdd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #ah1 #bjad ,mr4 ,re$ 7= himself1 ,ms4 ,de,gette1 & ,mr4 ,:itfield7 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 specify cov]age ( cont9u\s glucose monitor+ devices1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ic>e ,,cgm ,access ,act ( #bjad4 #b4 ,m$ic>e cov]age ( cont9u\s glucose monitor+ devices 7a7 ,9 g5]al ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$-- 7#a7 9 subsection 7s77#b7-- 7,a7 9 subp>agraph 7,,ee71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,,ff71 by add+ &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,,gg7 cont9u\s glucose monitor+ devices 7z def9$ 9 subsection 7iii77#a77 furni%$ to a ,,cgm qualifi$ individual 7z def9$ 9 subsection 7iii77#b772 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7iii7 ,cont9u\s ,glucose ,monitor+ ,device2 ,,cgm qualifi$ individual 7#a7 7,a7 ,! t]m cont9u\s glucose monitor+ device means a class ,,iii m$ical device approv$ by ! ,food & ,drug ,adm9i/ration t cont9u\sly monitors & tr5ds glucose levels 9 body fluid4 7,b7 ,su* t]m applies to su* m$ical device-- 7i7 z a /&-alone product2 7ii7 :5 integrat$ ) an insul9 pump2 or 7iii7 z an integral compon5t ( any o!r m$ical device cle>$ or approv$ by ! ,food & ,drug ,adm9i/ration1 su* z artificial pancreas device sy/ems4 7,c7 ,) respect to a cont9u\s glucose monitor+ device t is describ$ 9 clause 7ii7 or 7iii7 ( subp>agraph 7,b71 ! ,secret>y %all treat an insul9 pump or o!r m$ical device t has a cont9u\s glucose monitor+ device z an integrat$ or integral compon5t z a s+le m$ical device4 7,d7 ,su* t]m includes compon5ts1 accessories1 & supplies t are necess>y & relat$ to ! op]ation ( ! class ,,iii m$ical device1 su* z s5sors1 transmitt]s1 receiv]s1 & requisite s(tw>e4 7#b7 ,! t]m ,,cgm qualifi$ individual means any ( ! foll[+3 7,a7 ,an individual ) ,type ,i diabetes-- 7i7 :o is foll[+ an int5sive insul9 treatm5t regim5 t consi/s ( #c or m insul9 injections p] day or ! use ( a subcutane\s insul9 infusion pump2 7ii7 subject to p>agraph 7#c71 ^: att5d+ physician c]tifies t ! individual's condition _c be safely & effectively manag$ ) self-monitor+ ( blood glucose2 & 7iii7 :o-- 7,i7 has be5 unable to a*ieve optimum glycemic control 9 accordance ) evid5ce-bas$ guidel9es2 or 7,,ii7 has exp]i5c$ hypoglycemia unaw>5ess or frequ5t hypoglycemic episodes4 7,b7 ,an individual n describ$ 9 subp>agraph 7,a7 :o meets su* o!r m$ical crit]ia z ! ,secret>y may specify = ! furni%+ ( a cont9u\s glucose monitor+ device bas$ on available m$ical evid5ce & tak+ into acc\nt any anticipat$ pa?way to ! developm5t ( artificial pancreas device sy/ems4 7,c7 ,an individual ) diabetes :o has be5 regul>ly us+ a cont9u\s glucose monitor+ device be=e becom+ entitl$ to1 or enroll+ 91 "p ,a1 or enroll+ 9 "p ,b1 or bo?4 7#c7 ,= purposes ( a c]tification by an att5d+ physician describ$ 9 p>agraph 7#b77;,a77ii71 su* c]tification %all n be requir$ m frequ5tly ?an once e #c ye>s4 4 7b7 ,paym5t 7#a7 ,9 g5]al ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7 by /rik+ & be=e 7,z72 & 7,b7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,aa7 ) respect to cont9u\s glucose monitor+ devices "u section #ahfa7s77#b77;,,gg771 ! am\nt paid %all be an am\nt equal to #hj p]c5t ( ! am\nt det]m9$ "u ! fee s*$ule e/abli%$ "u section #ahcd7r74 7#b7 ,con=m+ am5dm5t ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7r7 ,fee s*$ule = cont9u\s glucose monitor+ devices 7#a7 ,e/abli%m5t 7,a7 ,9 g5]al ,) respect to cont9u\s glucose monitor+ devices 7z def9$ 9 section #ahfa7;iii77#a77 furni%$ dur+ a ye>1 ! am\nt ( paym5t "u ?is "p = su* devices %all be det]m9$ "u a fee s*$ule e/abli%$ by ! ,secret>y 9 accordance ) ?is subsection4 7,b7 ,cl>ification ( application ( fee s*$ule to devices hav+ ,,cgm z an integral compon5t ,paym5t %all be calculat$ & made "u ! fee s*$ule e/abli%$ "u ?is subsection = any insul9 pump or o!r m$ical device t has a cont9u\s glucose monitor+ device z an integrat$ or integral compon5t4 7#b7 ,initial paym5t rate 7,a7 ,9 g5]al ,) respect to ea* di/9ct type ( cont9u\s glucose monitor+ device1 ! ,secret>y %all e/abli% an initial paym5t rate "u ! fee s*$ule e/abli%$ "u ?is subsection = ! fir/ ye>1 :i* may be a p>tial ye>1 dur+ :i* paym5t may be made = su* cont9u\s glucose monitor+ device "u ?is "p4 7,b7 ,data ,) respect to a cont9u\s glucose monitor+ device1 ! initial paym5t rate "u subp>agraph 7,a7 %all-- 7i7 reflect m>ket rates = su* device2 & 7ii7 take into acc\nt ! mo/ rec5t available data on prices = su* device4 7,c7 ,acc\nt+ = diff]5ces 9 functionalities among v>i\s ,,cgm devices ,= purposes ( ! initial paym5t rates e/abli%$ "u subp>agraph 7,a71 ! ,secret>y %all e/abli% a new ,,hcpcs code = ea* di/9ct type ( class ,,iii m$ical device cle>$ or approv$ by ! ,food & ,drug ,adm9i/ration t includes a cont9u\s glucose monitor+ device1 su* z a m$ical device describ$ 9 clause 7ii7 or 7iii7 ( section #ahfa7;iii77#a77;,b74 ,su* ,,hcpcs codes %all di/+ui% among ! diff]5t functionalities ( su* devices 9 a mann] t reflects ! classifications ( ! ,food & ,drug ,adm9i/ration 9 cle>+ or approv+ su* devices4 7#c7 ,updates to paym5t rates ,) respect to ea* ye> beg9n+ aft] ! ye>1 or p>tial ye>1 ref]r$ to 9 p>agraph 7#b77;,a7 dur+ :i* an initial paym5t rate is e/abli%$ = a di/9ct cont9u\s glucose monitor+ device1 ! ,secret>y %all provide = annual updates to ! paym5t rate "u ! fee s*$ule e/abli%$ "u ?is subsection = ea* su* device = ! prec$+ ye> by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! prec$+ ye>4 7#d7 ,adju/m5t = geographic v>iations ,! ,secret>y %all provide = adju/m5ts to ! paym5t rates "u ! fee s*$ule e/abli%$ "u ?is subsection to take into acc\nt geographic v>iations 9 ! prices ( cont9u\s glucose monitor+ devices4 4 7c7 ,ensur+ b5efici>y access to appropriate compon5ts ,section #ahdg7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,ensur+ b5efici>y access to appropriate compon5ts 7,a7 ,9 g5]al ,9 c>ry+ out ! programs "u ?is section ) respect to glucose met]s requir$ = cont9u\s glucose monitor+ devices 7z def9$ 9 section #ahfa7;iii77#a77 t are furni%$ to ,,cgm qualifi$ individuals 7z def9$ 9 section #ahfa7;iii77#b771 ! ,secret>y %all ensure t su* ,,cgm qualifi$ individuals are furni%$ ! br& ( diabetic te/+ supplies 7z def9$ 9 subp>agraph 7,b77 t function ) su* cont9u\s glucose monitor+ devices1 su* z 9 ! case :]e !re is only "o br& ( glucose met] t is compatible ) a p>ticul> cont9u\s glucose monitor+ device4 7,b7 ,def9ition ,9 ?is p>agraph1 ! t]m diabetic te/+ supplies means glucose met]s & diabetic te/+ /rips4 4 7d7 ,effective date2 ,rulemak+ 7#a7 ,effective date ,! am5dm5ts made by ?is section %all apply to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjae4 7#b7 ,rulemak+ 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is p>agraph ref]r$ to z ! ,secret>y7 %all implem5t ! am5dm5ts made by ?is section ?r\gh notice & comm5t rulemak+4 7,b7 ,consultation ,z "p ( ! rulemak+ process "u subp>agraph 7,a71 ! ,secret>y %all consult ) national organizations repres5t+ individuals ) diabetes1 physicians ) relevant cl9ical exp]tise 9 endocr9ology1 & o!r relevant /akehold]s to develop cl9ical crit]ia = ! det]m9ation ( :e!r an individual qualifies z hav+ ,type ,i diabetes "u section #ahfa7;iii77#b77;,a7 ( ! ,social ,security ,act1 z add$ by subsection 7a77#b74 ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all conv5e a meet+ ( ^? /akehold]s to develop cons5sus recomm5dations = su* cl9ical crit]ia4 ,! ,secret>y %all take su* recomm5dations into acc\nt 9 implem5t+ ! am5dm5ts made by ?is section4