,,ii #aai? ,,congress #a/ ,session ,s4 #agjb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #h1 #bjbe,mrs4 ,capito 7= h]self & ,mrs4 ,%ahe57 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d titles ,,xviii & ,,xix ( ! ,social ,security ,act to provide = cov]age ( prescription digital !rapeutics "u su* titles1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,access to ,prescription ,digital ,!rapeutics ,act ( #bjbe4 #b4 ,cov]age & paym5t ( prescription digital !rapeutics "u ! ,m$ic>e program 7a7 ,prescription digital !rapeutic def9$ ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7nnn7 ,prescription digital !rapeutic ,! t]m prescription digital !rapeutic means a product1 device1 int]net application1 or o!r te*nology t-- 7#a7 is cle>$ or approv$ "u section #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7#b7 has a cle>$ or approv$ indication = ! prev5tion1 managem5t1 or treatm5t ( a m$ical disease1 condition1 or disord]2 7#c7 prim>ily uses s(tw>e to a*ieve its int5d$ result2 & 7#d7 is a device t is exempt f section #ejb7;f77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act "u section #hja4aji ( title #ba ( ! ,code ( ,f$]al ,regulations 7or any successor regulation74 4 7b7 ,cov]age z m$ical & o!r heal? s]vice ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$-- 7#a7 9 subp>agraph 7,,ii71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,,jj71 by add+ & at ! end2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,,kk7 prescription digital !rapeutics furni%$ on or aft] ,janu>y #a1 #bjbf2 4 7c7 ,requirem5ts = prescription digital !rapeutics "u ,m$ic>e ,"p ,b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 is am5d$ by ins]t+ aft] section #ahcd;,a ! foll[+ new section3 #ahcd;,b4 ,requirem5ts = prescription digital !rapeutics 7a7 ,paym5t 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all e/abli% a paym5t me?odology = manufactur]s ( prescription digital !rapeutics1 :i* may consi/ ( a "o-"t paym5t or p]iodic paym5ts1 z det]m9$ appropriate by ! ,secret>y4 7#b7 ,consid]ations = paym5t me?odology ,= purposes ( e/abli%+ ! paym5t me?odology "u p>agraph 7#a71 ! ,secret>y %all consid]-- 7,a7 ! actual li/ *>ge ( su* prescription digital !rapeutic2 7,b7 ! weight$ m$ian 7calculat$ by array+ ! di/ribution ( all paym5t rates report$ = ! mo/ rec5t p]iod = :i* su* rates 7 report$ "u subsection 7c77#a7 = ea* prescription digital !rapeutic weight$ by volume = ea* payor & ea* manufactur]7 = su* prescription digital !rapeutic2 7,c7 9 ! case ( a prescription digital !rapeutic t requires ongo+ use1 ! am\nt = su* ongo+ use2 & 7,d7 o!r factors z det]m9$ by ! ,secret>y4 7b7 ,cod+ 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all e/abli% product-specific ,,hcpcs codes = prescription digital !rapeutic cov]$ "u ?is title4 7#b7 ,tempor>y code ,! ,secret>y %all adopt tempor>y product-specific ,,hcpcs codes = purposes ( provid+ paym5t "u ?is title until a p]man5t product-specific ,,hcpcs code has be5 e/abli%$ "u p>agraph 7#a74 7c7 ,manufactur] report+ 7#a7 ,9 g5]al ,beg9n+ on ,janu>y #a1 #bjbf1 ea* manufactur] ( a prescription digital !rapeutic cov]$ "u ?is title %all submit to ! ,secret>y1 at su* "t & 9 su* mann] z specifi$ by ! ,secret>y1 & annually !reaft]1 a report describ+-- 7,a7 ! paym5t rate t 0 paid by ea* private payor = ea* prescription digital !rapeutic dur+ ! p]iod specifi$ by ! ,secret>y2 7,b7 ! volume ( su* prescription digital !rapeutic di/ribut$ to ea* su* payor = su* p]iod2 & 7,c7 ! numb] ( individual us]s ( su* prescription digital !rapeutic = su* p]iod4 7#b7 ,treatm5t ( disc\nts ,! paym5t rate report$ by a manufactur] 9 accordance ) p>agraph 7#a77;,a7 %all reflect all disc\nts1 rebates1 c\pons1 & o!r price concessions1 includ+ ^? describ$ 9 section #ahdg;,a7c77#c74 7#c7 ,civil monet>y p5alty 7,a7 ,9 g5]al ,if ! ,secret>y det]m9es t a manufactur] has fail$ to report1 or made a misrepres5tation or omission 9 report+1 in=mation "u ?is subsection ) respect to a prescription digital !rapeutic1 ! ,secret>y may apply a civil money p5alty 9 an am\nt ( up to #aj1jjj p] day = ea* failure to report or ea* su* misrepres5tation or omission4 7,b7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z !y apply to a civil money p5alty or proce$+ "u section #aabh;,a7a74 7#d7 ,confid5tiality ,in=mation report$ "u ?is subsection %all be treat$ 9 ! same mann] 9 :i* in=mation disclos$ by a manufactur] or a :olesal] ( a cov]$ outpati5t drug is treat$ "u section #aibg7;b77#c77;,d74 7d7 ,def9itions ,= purposes ( ?is section3 7#a7 ,actual li/ *>ge ,! t]m actual li/ *>ge means ! publicly available paym5t rate = a prescription digital !rapeutic on ! fir/ day t su* prescription digital !rapeutic is available = pur*ase by a private payor4 7#b7 ,,hcpcs ,! t]m ,,hcpcs means1 ) respect to an item1 ! code "u ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em 7,,hcpcs7 7or a successor code7 = su* item4 7#c7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 su* t]m by section #hbj4c7o7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#d7 ,prescription digital !rapeutic ,! t]m prescription digital !rapeutic has ! mean+ giv5 su* t]m 9 section #ahfa7nnn74 7#e7 ,private payor ,! t]m private payor has ! mean+ giv5 su* t]m 9 section #ahcd;,a7a77#h74 4 #c4 ,cov]age ( prescription digital !rapeutics "u ! ,m$icaid program ,section #aije7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is am5d$-- 7#a7 9 p>agraph 7#ca71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 by r$esignat+ p>agraph 7#cb7 z p>agraph 7#cc72 & 7#c7 by ins]t+ ! foll[+ p>agraph aft] p>agraph 7#ca73 7#cb7 prescription digital !rapeutics 7z def9$ 9 section #ahfa7nnn772 & 4