#aah? ,,congress #a/ ,session ,h4 ,r4 #ecgh ,,an ,,act ,to promote price transp>5cy 9 ! heal? c>e sector1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,co/s1 ,m ,transp>5cy ,act4 #b4 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4 ,sec4 #b4 ,table ( cont5ts4 ,title ,i--,improv+ ,heal? ,c>e ,transp>5cy ,sec4 #aja4 ,hospital price transp>5cy4 ,sec4 #ajb4 ,cl9ical diagno/ic laboratory te/ price transp>5cy4 ,sec4 #ajc4 ,imag+ price transp>5cy4 ,sec4 #ajd4 ,ambulatory surgical c5t] price transp>5cy4 ,sec4 #aje4 ,heal? cov]age price transp>5cy4 ,sec4 #ajf4 ,ph>macy b5efits price transp>5cy4 ,sec4 #ajg4 ,reports on heal? c>e transp>5cy tools & data4 ,sec4 #ajh4 ,report on integration 9 ,m$ic>e4 ,sec4 #aji4 ,advisory ,committee4 ,sec4 #aaj4 ,report on impact ( ,m$ic>e regulations on provid] & pay] consolidation4 ,sec4 #aaa4 ,implem5tation fund+4 ,title ,,ii--,r$uc+ ,heal? ,c>e ,co/s = ,pati5ts ,sec4 #bja4 ,increas+ transp>5cy 9 g5]ic drug applications4 ,sec4 #bjb4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid4 ,sec4 #bjc4 ,p>ity 9 ,m$ic>e paym5ts = hospital outpati5t dep>tm5t s]vices furni%$ (f-campus4 ,sec4 #bjd4 ,requir+ a sep>ate id5tification numb] & an atte/ation = ea* (f-campus outpati5t dep>tm5t ( a provid]4 ,title ,,iii--,support+ ,pati5ts1 ,heal? ,c>e ,work]s1 ,community ,heal? ,c5t]s1 & ,hospitals ,sec4 #cja4 ,ext5sion = community heal? c5t]s1 ! national heal? s]vice corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs4 ,sec4 #cjb4 ,ext5sion ( special diabetes programs4 ,sec4 #cjc4 ,delay+ c]ta9 disproportionate %>e paym5t cuts4 ,sec4 #cjd4 ,m$icaid improvem5t fund4 ,title ,,iv--,increas+ access to quality heal? data & l[]+ hidd5 fees ,sec4 #dja4 ,increas+ ,plan ,fiduci>ies' ,access to ,heal? ,data4 ,sec4 #djb4 ,hidd5 ,fees ,disclosure ,requirem5ts4 ,sec4 #djc4 ,prescription drug price in=mation requirem5t4 ,sec4 #djd4 ,implem5tation fund+4 ,i ,improv+ ,heal? ,c>e ,transp>5cy #aja4 ,hospital price transp>5cy 7a7 ,m$ic>e ,"p ,e ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #ahii;,c4 ,hospital price transp>5cy 7a7 ,transp>5cy requirem5t 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 ea* specifi$ hospital t receives paym5t "u ?is title = furni%+ items & s]vices %all comply ) ! price transp>5cy requirem5t describ$ 9 p>agraph 7#b74 7#b7 ,requirem5t describ$ 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! price transp>5cy requirem5t describ$ 9 ?is p>agraph is1 ) respect to a specifi$ hospital1 t su* hospital1 9 accordance ) a me?od & =mat e/abli%$ by ! ,secret>y "u subp>agraph 7,c71 compile & make public 7)\t subscription & free ( *>ge7 = ea* ye>-- 7i7 all ( ! hospital's /&>d *>ges 7includ+ ! in=mation describ$ 9 subp>agraph 7,b77 = ea* item & s]vice furni%$ by su* hospital2 7ii7 in=mation 9 a consum]-fri5dly =mat 7z specifi$ by ! ,secret>y7-- 7,i7 on ! hospital's prices 7includ+ ! in=mation describ$ 9 subp>agraph 7,b77 = z _m ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vices t are furni%$ by ! hospital1 & z _m additional hospital-select$ %oppable s]vices 7or all su* additional s]vices1 if su* hospital furni%es few] ?an #cjj %oppable s]vices7 z may be necess>y = a comb9$ total ( at lea/ #cjj %oppable s]vices2 & 7,,ii7 t includes1 ) respect to ea* ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vice t is n furni%$ by ! hospital1 an indication t su* s]vice is n s furni%$2 & 7iii7 an atte/ation t all in=mation made public pursuant to ?is subp>agraph is complete & accurate4 7,b7 ,in=mation describ$ ,= purposes ( subp>agraph 7,a71 ! in=mation describ$ 9 ?is subp>agraph is1 ) respect to /&>d *>ges & prices1 z applicable1 made public by a specifi$ hospital1 ! foll[+3 7i7 ,a pla9 language description ( ea* item or s]vice1 accompani$ by1 z applicable1 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code1 ! diagnosis-relat$ gr\p1 ! national drug code1 or o!r id5tifi] us$ or approv$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ii7 ,! gross *>ge1 z applicable1 express$ z a doll> am\nt1 = ea* su* item or s]vice1 :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+4 7iii7 ,! disc\nt$ ca% price1 z applicable1 express$ z a doll> am\nt1 = ea* su* item or s]vice :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+ 7or1 9 ! case no disc\nt$ ca% price is available = an item or s]vice1 ! m$ian ca% price *>g$ by ! hospital to self-pay individuals = su* item or s]vice :5 provid$ 9 su* sett+s = ! previ\s ?ree ye>s1 express$ z a doll> am\nt1 z well z1 ) respect to prices made public pursuant to subp>agraph 7,a77ii71 a l9k to a consum]-fri5dly docum5t t cle>ly expla9s ! hospital's *>ity c>e policy t includes1 if applicable1 any slid+ scale paym5t /ructure employ$ = det]m9+ *>ges = a self-pay individual74 7iv7 ,! pay]-specific negotiat$ *>ges1 z applicable1 cle>ly associat$ ) ! "n ( ! ?ird p>ty pay] & plan & express$ z a doll> am\nt1 t apply to ea* su* item or s]vice :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+4 7v7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges1 z applicable1 = ea* su* item or s]vice4 7vi7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges & prices = an item or s]vice1 except in=mation t is duplicative ( any o!r report+ requirem5t "u ?is subsection4 ,9 ! case ( /&>d *>ges & prices = an item or s]vice includ$ z "p ( a bundl$1 p] diem1 episodic1 or o!r simil> arrangem5t1 ! in=mation describ$ 9 ?is subp>agraph %all be made available z det]m9$ appropriate by ! ,secret>y4 7,c7 ,uni=m me?od & =mat ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = specifi$ hospitals to use 9 compil+ & mak+ public /&>d *>ges pursuant to subp>agraph 7,a77i7 & a /&>d1 uni=m me?od & =mat = su* hospitals to use 9 compil+ & mak+ public prices pursuant to subp>agraph 7,a77ii74 ,su* me?ods & =mats-- 7i7 %all1 9 ! case ( su* me?od & =mat = mak+ public /&>d *>ges pursuant to subp>agraph 7,a77i71 ensure t su* *>ges are made available 9 a ma*9e-readable =mat 7or a successor te*nology specifi$ by ! ,secret>y72 7ii7 may be simil> to any template made available by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices z ( ! date ( ! enactm5t ( ?is subp>agraph2 7iii7 %all meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* *>ges & prices2 & 7iv7 %all be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#c7 ,monitor+ compliance ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+ & 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 ,su* process %all ensure t ea* specifi$ hospital's compliance ) ?is subsection is review$ n less frequ5tly ?an once e #c ye>s4 7#d7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( a specifi$ hospital t fails to comply ) ! requirem5ts ( ?is subsection-- 7i7 n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s1 ! ,secret>y %all submit to su* hospital a notification ( su* det]m9ation 7:i* may include1 z det]m9$ appropriate by ! ,secret>y1 a reque/ = a corrective action plan to comply ) su* requirem5ts72 & 7ii7 9 ! case ( a hospital t does n receive a reque/ = a corrective action plan z "p ( a notification submitt$ by ! ,secret>y "u clause 7i7-- 7,i7 ! ,secret>y %all1 n lat] ?an #de days aft] su* notification is s5t1 det]m9e :e!r su* hospital is 9 compliance ) su* requirem5ts2 & 7,,ii7 if ! ,secret>y det]m9es "u subclause 7,i7 t su* hospital is n 9 compliance ) su* requirem5ts1 ! ,secret>y %all ei!r-- 7aa7 submit to su* hospital a reque/ = a corrective action plan to comply ) su* requirem5ts2 or 7bb7 if ! ,secret>y det]m9es t su* hospital has n tak5 mean+ful actions to come into compliance s9ce su* notification 0 s5t1 impose a civil monet>y p5alty 9 accordance ) subp>agraph 7,b74 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,subject to clause 7vii71 9 addition to any o!r en=cem5t actions or p5alties t may apply "u ano!r provision ( law1 a specifi$ hospital t has receiv$ a reque/ = a corrective action plan "u clause 7i7 or 7ii7 ( subp>agraph 7,a7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #de days aft] su* reque/ is made1 & a specifi$ hospital ) respect to :i* ! ,secret>y has made a det]m9ation describ$ 9 clause 7ii77,,ii77bb7 ( su* subp>agraph1 %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* hospital 0 n comply+ ) su* requirem5ts7 dur+ :i* su* failure 0 ongo+4 ,su* am\nt %all n exce$-- 7,i7 9 ! case ( a specifi$ hospital ) #cj or few] b$s1 #cjj p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #djj p] day72 7,,ii7 9 ! case ( a specifi$ hospital ) m ?an #cj b$s b few] ?an #aja b$s1 #ab4ej p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #ae p] b$ p] day72 7,,iii7 9 ! case ( a specifi$ hospital ) m ?an #ajj b$s b few] ?an #bja b$s1 #ag4ej p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #bj p] b$ p] day72 7,,iv7 9 ! case ( a specifi$ hospital ) m ?an #bjj b$s b few] ?an #eja b$s1 #bj p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #be p] b$ p] day72 & 7,v7 9 ! case ( a specifi$ hospital ) m ?an #ejj b$s1 #be p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #ce p] b$ p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to violations occurr+ 9 #bjbg or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase-- 7,i7 ! limitation on ! p] day am\nt ( any p5alty applicable to a specifi$ hospital "u clause 7i77,i72 7,,ii7 ! limitations on ! p] b$ p] day am\nt ( any p5alty applicable "u any ( subclauses 7,,ii7 ?r\gh 7,v7 ( clause 7i72 & 7,,iii7 ! am\nts specifi$ 9 clause 7iii77,,ii74 7iii7 ,p]si/5t noncompliance 7,i7 ,9 g5]al ,9 ! case ( a specifi$ hospital 7o!r ?an a specifi$ hospital ) #cj or few] b$s7 t ! ,secret>y has det]m9$ to be kn[+ly & willfully noncompliant ) ! provisions ( ?is subsection two or m times dur+ a #a-ye> p]iod1 ! ,secret>y may increase any p5alty o!rwise applicable "u ?is subp>agraph by ! am\nt specifi$ 9 subclause 7,,ii7 ) respect to su* hospital & may require su* hospital to complete su* additional corrective actions plans z ! ,secret>y may specify4 7,,ii7 ,specifi$ am\nt ,= purposes ( subclause 7,i71 ! am\nt specifi$ 9 ?is subclause is1 ) respect to a specifi$ hospital-- 7aa7 ) m ?an #cj b$s b few] ?an #aja b$s1 an am\nt t is n less ?an #ejj1jjj & n m ?an #a1jjj1jjj2 7bb7 ) m ?an #ajj b$s b few] ?an #cja b$s1 an am\nt t is great] ?an #a1jjj1jjj & n m ?an #b1jjj1jjj2 7cc7 ) m ?an #cjj b$s b few] ?an #eja b$s1 an am\nt t is great] ?an #b1jjj1jjj & n m ?an #d1jjj1jjj2 & 7dd7 ) m ?an #ejj b$s1 & am\nt t is n less ?an #e1jjj1jjj & n m ?an #aj1jjj1jjj4 7iv7 ,au?ority to waive or r$uce p5alty 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 ! ,secret>y may waive any p5alty1 or r$uce any p5alty by n m ?an #ge p]c5t1 o!rwise applicable "u ?is subp>agraph ) respect to a specifi$ hospital locat$ 9 a rural or und]s]v$ area if ! ,secret>y c]tifies t imposition ( su* p5alty w\ld result 9 an imm$iate ?reat to access to c>e = individuals 9 ! s]vice area ( su* hospital4 7,,ii7 ,limitation on application ,! ,secret>y may n elect to waive a p5alty "u subclause 7,i7 ) respect to a specifi$ hospital m ?an once 9 a #f-ye> p]iod & may n elect to r$uce su* a p5alty ) respect to su* a hospital m ?an once 9 su* a p]iod4 ,no?+ 9 ! prec$+ s5t5ce %all be con/ru$ z prohibit+ ! ,secret>y f bo? waiv+ & r$uc+ a p5alty ) respect to a specifi$ hospital dur+ a #f-ye> p]iod4 7v7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is subsection to specifi$ hospitals reque/+ su* assi/ance4 7vi7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7vii7 ,nonduplication ( c]ta9 p5alties ,! ,secret>y may n subject a specifi$ hospital to a civil monet>y p5alty "u ?is subp>agraph ) respect to noncompliance ) ! provisions ( ?is section = a p]iod if ! ,secret>y has impos$ a civil monet>y p5alty on su* hospital "u section #bgah7;f7 ( ! ,public ,heal? ,s]vice ,act = failure to comply ) ! provisions ( su* section = su* p]iod4 7,c7 ,publication ( hospital price transp>5cy in=mation ,beg9n+ on ,janu>y #a1 #bjbf1 ! ,secret>y %all make publicly available on ! public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices in=mation ) respect to compliance ) ! requirem5ts ( ?is subsection & en=cem5t activities und]tak5 by ! ,secret>y "u ?is subsection4 ,su* in=mation %all be updat$ 9 real "t & include-- 7i7 ! numb] ( reviews ( compliance ) ?is subsection und]tak5 by ! ,secret>y2 7ii7 ! numb] ( notifications describ$ 9 subp>agraph 7,a77i7 s5t by ! ,secret>y2 7iii7 ! id5tity ( ea* specifi$ hospital t 0 s5t su* a notification & a description ( ! nature ( su* hospital's noncompliance ) ?is subsection2 7iv7 ! am\nt ( any civil monet>y p5alty impos$ on su* hospital "u subp>agraph 7,b72 7v7 :e!r su* hospital subsequ5tly came into compliance ) ?is subsection2 7vi7 any waiv]s or r$uctions ( p5alties made pursuant to a c]tification by ! ,secret>y "u subp>agraph 7,b77iv71 includ+-- 7,i7 ! "n ( any specifi$ hospital t receiv$ su* a waiv] or r$uction2 7,,ii7 ! doll> am\nt ( ea* su* p5alty s waiv$ or r$uc$2 & 7,,iii7 ! rationale = ! grant+ ( ea* su* waiv] or r$uction2 & 7vii7 any o!r in=mation z det]m9$ by ! ,secret>y4 7b7 ,ensur+ accessibility ?r\gh implem5tation ,9 implem5t+ ! am5dm5ts made by ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all ?r\gh rulemak+ ensure t a hospital submitt+ *>ges & in=mation pursuant to su* am5dm5ts takes reasonable /eps 7z specifi$ by ! ,secret>y7 to ensure ! accessibility ( su* *>ges & in=mation to individuals ) limit$ ,engli% pr(ici5cy4 ,su* /eps may include ! hospital's provision ( int]pretation s]vices or ! hospital's provision ( translations ( *>ges & in=mation4 7c7 ,def9itions ,= purposes ( ?is section3 7#a7 ,disc\nt$ ca% price ,! t]m disc\nt$ ca% price means ! *>ge t applies to an individual :o pays ca%1 or ca% equival5t1 = an item or s]vice4 7#b7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program has ! mean+ giv5 su* t]m 9 section #aabh;,b4 7#c7 ,gross *>ge ,! t]m gross *>ge means ! *>ge = an individual item or s]vice t is reflect$ on a specifi$ hospital's or provid] ( s]vice's or suppli]'s1 z applicable1 *>gema/]1 abs5t any disc\nts4 7#d7 ,gr\p heal? plan2 gr\p heal? insurance cov]age2 individual heal? insurance cov]age ,! t]ms gr\p heal? plan1 gr\p heal? insurance cov]age1 & individual heal? insurance cov]age h ! mean+ giv5 su* t]ms 9 section #bgia ( ! ,public ,heal? ,s]vice ,act4 7#e7 ,pay]-specific negotiat$ *>ge ,! t]m pay]-specific negotiat$ *>ge means ! *>ge t a specifi$ hospital or provid] ( s]vices or suppli]1 z applicable1 has negotiat$ ) a ?ird p>ty pay] = an item or s]vice4 7#f7 ,%oppable s]vice ,! t]m %oppable s]vice means a s]vice t c be s*$ul$ by a heal? c>e consum] 9 advance & includes all ancill>y items & s]vices cu/om>ily furni%$ z "p ( su* s]vice4 7#g7 ,specifi$ hospital ,! t]m specifi$ hospital means a hospital 7z def9$ 9 section #ahfa7;e771 a critical access hospital 7z def9$ 9 section #ahfa7mmm77#a771 or a rural em]g5cy hospital 7z def9$ 9 section #ahfa7kkk774 7#h7 ,?ird p>ty pay] ,! t]m ?ird p>ty pay] means an entity t is1 by /atute1 contract1 or agreem5t1 legally responsible = paym5t ( a claim = a heal? c>e item or s]vice4 4 7b7 ,,phsa 7#a7 ,9 g5]al ,section #bgah ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ah7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,hospital transp>5cy requirem5t 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 ea* hospital %all comply ) ! price transp>5cy requirem5t describ$ 9 p>agraph 7#b74 7#b7 ,requirem5t describ$ 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! price transp>5cy requirem5t describ$ 9 ?is p>agraph is1 ) respect to a hospital1 t su* hospital1 9 accordance ) a me?od & =mat e/abli%$ by ! ,secret>y "u subp>agraph 7,c71 compile & make public 7)\t subscription & free ( *>ge7 = ea* ye>-- 7i7 all ( ! hospital's /&>d *>ges 7includ+ ! in=mation describ$ 9 subp>agraph 7,b77 = ea* item & s]vice furni%$ by su* hospital2 7ii7 in=mation 9 a consum]-fri5dly =mat 7z specifi$ by ! ,secret>y7-- 7,i7 on ! hospital's prices 7includ+ ! in=mation describ$ 9 subp>agraph 7,b77 = z _m ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vices t are furni%$ by ! hospital1 & z _m additional hospital-select$ %oppable s]vices 7or all su* additional s]vices1 if su* hospital furni%es few] ?an #cjj %oppable s]vices7 z may be necess>y = a comb9$ total ( at lea/ #cjj %oppable s]vices2 & 7,,ii7 t includes1 ) respect to ea* ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vice t is n furni%$ by ! hospital1 an indication t su* s]vice is n s furni%$2 & 7iii7 an atte/ation t all in=mation made public pursuant to ?is subp>agraph is complete & accurate4 7,b7 ,in=mation describ$ ,= purposes ( subp>agraph 7,a71 ! in=mation describ$ 9 ?is subp>agraph is1 ) respect to /&>d *>ges & prices1 z applicable1 made public by a hospital1 ! foll[+3 7i7 ,a pla9 language description ( ea* item or s]vice1 accompani$ by1 z applicable1 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code1 ! diagnosis-relat$ gr\p1 ! national drug code1 curr5t proc$ure t]m9ology codes1 or o!r id5tifi] us$ or approv$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ii7 ,! gross *>ge1 z applicable1 express$ z a doll> am\nt1 = ea* su* item or s]vice1 :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+4 7iii7 ,! disc\nt$ ca% price1 z applicable1 express$ z a doll> am\nt1 = ea* su* item or s]vice :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+ 7or1 9 ! case no disc\nt$ ca% price is available = an item or s]vice1 ! m$ian ca% price *>g$ by ! hospital to self-pay individuals = su* item or s]vice :5 provid$ 9 su* sett+s = ! previ\s ?ree ye>s1 express$ z a doll> am\nt1 z well z1 ) respect to prices made public pursuant to subp>agraph 7,a77ii71 a l9k to a consum]-fri5dly docum5t t cle>ly expla9s ! hospital's *>ity c>e policy t includes1 if applicable1 any slid+ scale paym5t /ructure employ$ = det]m9+ *>ges = a self-pay individual74 7iv7 ,! pay]-specific negotiat$ *>ges1 z applicable1 cle>ly associat$ ) ! "n ( ! ?ird p>ty pay] & plan & express$ z a doll> am\nt1 t apply to ea* su* item or s]vice :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+4 7v7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges1 z applicable1 = ea* su* item or s]vice4 7vi7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges & prices = an item or s]vice1 except in=mation t is duplicative ( any o!r report+ requirem5t "u ?is subsection4 ,9 ! case ( /&>d *>ges & prices = an item or s]vice includ$ z "p ( a bundl$1 p] diem1 episodic1 or o!r simil> arrangem5t1 ! in=mation describ$ 9 ?is subp>agraph %all be made available z det]m9$ appropriate by ! ,secret>y4 7,c7 ,uni=m me?od & =mat ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = hospitals to use 9 compil+ & mak+ public /&>d *>ges pursuant to subp>agraph 7,a77i7 & a /&>d1 uni=m me?od & =mat = su* hospitals to use 9 compil+ & mak+ public prices pursuant to subp>agraph 7,a77ii74 ,su* me?ods & =mats-- 7i7 %all1 9 ! case ( su* me?od & =mat = mak+ public /&>d *>ges pursuant to subp>agraph 7,a77i71 ensure t su* *>ges are made available 9 a ma*9e-readable =mat 7or a successor te*nology specifi$ by ! ,secret>y72 7ii7 may be simil> to any template made available by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices z ( ! date ( ! enactm5t ( ?is subp>agraph2 7iii7 %all meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* *>ges & prices2 & 7iv7 %all be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#c7 ,monitor+ compliance ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+ & 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 ,su* process %all ensure t ea* hospital's compliance ) ?is subsection is review$ n less frequ5tly ?an once e #c ye>s4 7#d7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( a hospital t fails to comply ) ! requirem5ts ( ?is subsection-- 7i7 n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s1 ! ,secret>y %all submit to su* hospital a notification ( su* det]m9ation 7:i* may include1 z det]m9$ appropriate by ! ,secret>y1 a reque/ = a corrective action plan to comply ) su* requirem5ts72 & 7ii7 9 ! case ( a hospital t does n receive a reque/ = a corrective action plan z "p ( a notification submitt$ by ! ,secret>y "u clause 7i7-- 7,i7 ! ,secret>y %all1 n lat] ?an #de days aft] su* notification is s5t1 det]m9e :e!r su* hospital is 9 compliance ) su* requirem5ts2 & 7,,ii7 if ! ,secret>y det]m9es "u subclause 7,i7 t su* hospital is n 9 compliance ) su* requirem5ts1 ! ,secret>y %all ei!r-- 7aa7 submit to su* hospital a reque/ = a corrective action plan to comply ) su* requirem5ts2 or 7bb7 if ! ,secret>y det]m9es t su* hospital has n tak5 mean+ful actions to come into compliance s9ce su* notification 0 s5t1 impose a civil monet>y p5alty 9 accordance ) subp>agraph 7,b74 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,9 addition to any o!r en=cem5t actions or p5alties t may apply "u ano!r provision ( law1 a hospital t has receiv$ a reque/ = a corrective action plan "u clause 7i7 or 7ii7 ( subp>agraph 7,a7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #de days aft] su* reque/ is made1 & a hospital ) respect to :i* ! ,secret>y has made a det]m9ation describ$ 9 clause 7ii77,,ii77bb7 ( su* subp>agraph1 %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* hospital 0 n comply+ ) su* requirem5ts7 dur+ :i* su* failure 0 ongo+4 ,su* am\nt %all n exce$-- 7,i7 9 ! case ( a hospital ) #cj or few] b$s1 #cjj p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #djj p] b$ p] day72 7,,ii7 9 ! case ( a hospital ) m ?an #cj b$s b few] ?an #aja b$s1 #ab4ej p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #ae p] b$ p] day72 7,,iii7 9 ! case ( a hospital ) m ?an #ajj b$s b few] ?an #bja b$s1 #ag4ej p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #bj p] b$ p] day72 7,,iv7 9 ! case ( a hospital ) m ?an #bjj b$s b few] ?an #eja b$s1 #bj p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #be p] b$ p] day72 & 7,v7 9 ! case ( a hospital ) m ?an #ejj b$s1 #be p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #ce p] b$ p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to violations occurr+ 9 #bjbg or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase-- 7,i7 ! limitation on ! p] day am\nt ( any p5alty applicable to a hospital "u clause 7i77,i72 7,,ii7 ! limitations on ! p] b$ p] day am\nt ( any p5alty applicable "u any ( subclauses 7,,ii7 ?r\gh 7,v7 ( clause 7i72 & 7,,iii7 ! am\nts specifi$ 9 clause 7iii77,,ii74 7iii7 ,p]si/5t noncompliance 7,i7 ,9 g5]al ,9 ! case ( a hospital 7o!r ?an a hospital ) #cj or few] b$s7 t ! ,secret>y has det]m9$ to be kn[+ly & willfully noncompliant ) ! provisions ( ?is subsection two or m times dur+ a #a-ye> p]iod1 ! ,secret>y may increase any p5alty o!rwise applicable "u ?is subp>agraph by ! am\nt specifi$ 9 subclause 7,,ii7 ) respect to su* hospital & may require su* hospital to complete su* additional corrective actions plans z ! ,secret>y may specify4 7,,ii7 ,specifi$ am\nt ,= purposes ( subclause 7,i71 ! am\nt specifi$ 9 ?is subclause is1 ) respect to a hospital-- 7aa7 ) m ?an #cj b$s b few] ?an #aja b$s1 an am\nt t is n less ?an #ejj1jjj & n m ?an #a1jjj1jjj2 7bb7 ) m ?an #ajj b$s b few] ?an #cja b$s1 an am\nt t is great] ?an #a1jjj1jjj & n m ?an #b1jjj1jjj2 7cc7 ) m ?an #cjj b$s b few] ?an #eja b$s1 an am\nt t is great] ?an #b1jjj1jjj & n m ?an #d1jjj1jjj2 & 7dd7 ) m ?an #ejj b$s1 & am\nt t is n less ?an #e1jjj1jjj & n m ?an #aj1jjj1jjj4 7iv7 ,au?ority to waive or r$uce p5alty 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 ! ,secret>y may waive any p5alty1 or r$uce any p5alty by n m ?an #ge p]c5t1 o!rwise applicable "u ?is subp>agraph ) respect to a hospital locat$ 9 a rural or und]s]v$ area if ! ,secret>y c]tifies t imposition ( su* p5alty w\ld result 9 an imm$iate ?reat to access to c>e = individuals 9 ! s]vice area ( su* hospital4 7,,ii7 ,limitation on application ,! ,secret>y may n elect to waive a p5alty "u subclause 7,i7 ) respect to a hospital m ?an once 9 a #f-ye> p]iod & may n elect to r$uce su* a p5alty ) respect to su* a hospital m ?an once 9 su* a p]iod4 ,no?+ 9 ! prec$+ s5t5ce %all be con/ru$ z prohibit+ ! ,secret>y f bo? waiv+ & r$uc+ a p5alty ) respect to a hospital dur+ a #f-ye> p]iod4 7v7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is section to hospitals reque/+ su* assi/ance4 7vi7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7vii7 ,nonduplication ( p5alties ,! ,secret>y may n subject a hospital to a civil monet>y p5alty "u ?is subp>agraph ) respect to noncompliance ) ! provisions ( ?is subsection = a p]iod if ! ,secret>y has impos$ a civil monet>y p5alty on su* hospital "u section #ahii;,c ( ! ,social ,security ,act = failure to comply ) ! provisions ( su* section = su* p]iod4 7,c7 ,publication ( hospital price transp>5cy in=mation ,beg9n+ on ,janu>y #a1 #bjbf1 ! ,secret>y %all make publicly available on ! public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices in=mation ) respect to compliance ) ! requirem5ts ( ?is subsection & en=cem5t activities und]tak5 by ! ,secret>y "u ?is subsection4 ,su* in=mation %all be updat$ 9 real "t & include-- 7i7 ! numb] ( reviews ( compliance ) ?is subsection und]tak5 by ! ,secret>y2 7ii7 ! numb] ( notifications describ$ 9 subp>agraph 7,a77i7 s5t by ! ,secret>y2 7iii7 ! id5tity ( ea* hospital t 0 s5t su* a notification & a description ( ! nature ( su* hospital's noncompliance ) ?is subsection2 7iv7 ! am\nt ( any civil monet>y p5alty impos$ on su* hospital "u subp>agraph 7,b72 7v7 :e!r su* hospital subsequ5tly came into compliance ) ?is subsection2 7vi7 any waiv]s or r$uctions ( p5alties made pursuant to a c]tification by ! ,secret>y "u subp>agraph 7,b77iv71 includ+-- 7,i7 ! "n ( any hospital t receiv$ su* a waiv] or r$uction2 7,,ii7 ! doll> am\nt ( ea* su* p5alty s waiv$ or r$uc$2 & 7,,iii7 ! rationale = ! grant+ ( ea* su* waiv] or r$uction2 & 7vii7 any o!r in=mation z det]m9$ by ! ,secret>y4 7#e7 ,ensur+ accessibility ?r\gh implem5tation ,9 implem5t+ ! am5dm5ts made by ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all ?r\gh rulemak+ ensure t a hospital submitt+ *>ges & in=mation pursuant to su* am5dm5ts takes reasonable /eps 7z specifi$ by ! ,secret>y7 to ensure ! accessibility ( su* *>ges & in=mation to individuals ) limit$ ,engli% pr(ici5cy4 ,su* /eps may include ! hospital's provision ( int]pretation s]vices or ! hospital's provision ( translations ( *>ges & in=mation4 7#f7 ,def9itions ,= purposes ( ?is subsection3 7,a7 ,disc\nt$ ca% price ,! t]m disc\nt$ ca% price means ! *>ge t applies to an individual :o pays ca%1 or ca% equival5t1 = a hospital-furni%$ item or s]vice4 7,b7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program has ! mean+ giv5 su* t]m 9 section #aabh;,b ( ! ,social ,security ,act4 7,c7 ,gross *>ge ,! t]m gross *>ge means ! *>ge = an individual item or s]vice t is reflect$ on a hospital's *>gema/]1 abs5t any disc\nts4 7,d7 ,pay]-specific negotiat$ *>ge ,! t]m pay]-specific negotiat$ *>ge means ! *>ge t a hospital has negotiat$ ) a ?ird p>ty pay] = an item or s]vice4 7,e7 ,%oppable s]vice ,! t]m %oppable s]vice means a s]vice t c be s*$ul$ by a heal? c>e consum] 9 advance & includes all ancill>y items & s]vices cu/om>ily furni%$ z "p ( su* s]vice4 7,f7 ,?ird p>ty pay] ,! t]m ?ird p>ty pay] means an entity t is1 by /atute1 contract1 or agreem5t1 legally responsible = paym5t ( a claim = a heal? c>e item or s]vice4 4 7#b7 ,con=m+ am5dm5ts ,section #bgah ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ah7 is am5d$-- 7,a7 9 subsection 7b77#c71 by ins]t+ 7o!r ?an ! provisions ( subsection 7f77 aft] ?is section2 & 7,b7 9 subsection 7e71 by add+ at ! end ! foll[+ new s5t5ce3 ,! prec$+ provisions ( ?is subsection %all n apply beg9n+ on ,janu>y #a1 #bjbf44 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all apply beg9n+ ,janu>y #a1 #bjbf4 7c7 ,accessibility ?r\gh implem5tation ,9 implem5t+ ! am5dm5ts made by ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all ?r\gh rulemak+ ensure t a hospital submitt+ *>ges & in=mation pursuant to su* am5dm5ts takes reasonable /eps 7z specifi$ by ! ,secret>y7 to ensure ! accessibility ( su* *>ges & in=mation to individuals ) limit$ ,engli% pr(ici5cy4 ,su* /eps may include ! hospital's provision ( int]pretation s]vices or ! hospital's provision ( translations ( *>ges & in=mation4 #ajb4 ,cl9ical diagno/ic laboratory te/ price transp>5cy ,section #ahdf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#b7 is am5d$-- 7#a7 9 ! head]1 by ins]t+ & additional requirem5ts aft] sanctions2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7c7 ,price transp>5cy requirem5t 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 any applicable laboratory t receives paym5t "u ?is title = furni%+ any specifi$ cl9ical diagno/ic laboratory te/ "u ?is title %all-- 7,a7 make publicly available on an int]net website ! in=mation describ$ 9 p>agraph 7#b7 ) respect to ea* su* specifi$ cl9ical diagno/ic laboratory te/ t su* laboratory s furni%es2 & 7,b7 ensure t su* in=mation is updat$ n less frequ5tly ?an annually4 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to an applicable laboratory & a specifi$ cl9ical diagno/ic laboratory te/1 ! foll[+3 7,a7 ,! disc\nt$ ca% price = su* te/ 7or1 if no su* price exi/s1 ! gross *>ge = su* te/74 7,b7 ,! deid5tifi$ m9imum pay]-specific negotiat$ *>ge betwe5 su* laboratory & any ?ird p>ty pay] = su* te/4 7,c7 ,! deid5tifi$ maximum pay]-specific negotiat$ *>ge betwe5 su* laboratory & any ?ird p>ty pay] = su* te/4 7#c7 ,uni=m me?od & =mat ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = applicable laboratories to use 9 compil+ & mak+ public in=mation pursuant to p>agraph 7#a74 ,su* me?od & =mat-- 7,a7 may be simil> to any template made available by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7z describ$ 9 section #ahii;,c7a77#b77;,c77ii772 7,b7 %all meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* in=mation2 & 7,c7 %all be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#d7 ,inclusion ( ancill>y s]vices ,any price or rate = a specifi$ cl9ical diagno/ic laboratory te/ available to be furni%$ by an applicable laboratory made publicly available 9 accordance ) p>agraph 7#a7 %all include ! price or rate 7z applicable7 = any ancill>y item or s]vice 7su* z specim5 collection s]vices7 t w\ld normally be furni%$ by su* laboratory z "p ( su* te/1 z specifi$ by ! ,secret>y4 7#e7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case t ! ,secret>y det]m9es t an applicable laboratory is n 9 compliance ) p>agraph 7#a7-- 7i7 n lat] ?an #cj days aft] su* det]m9ation1 ! ,secret>y %all notify su* laboratory ( su* det]m9ation2 & 7ii7 if su* laboratory cont9ues to fail to comply ) su* p>agraph aft] ! date t is #ij days aft] su* notification is s5t1 ! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #cjj = ea* 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* laboratory 0 fail+ to comply ) su* p>agraph7 dur+ :i* su* failure is ongo+4 7,b7 ,increase au?ority ,9 apply+ ?is p>agraph ) respect to violations occurr+ 9 #bjbg or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase ! p] day limitation on civil monet>y p5alties "u subp>agraph 7,a77ii74 7,c7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is p>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7#f7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is subsection to applicable laboratories reque/+ su* assi/ance4 7#g7 ,def9itions ,9 ?is subsection3 7,a7 ,applicable laboratory ,! t]m applicable laboratory has ! mean+ giv5 su* t]m 9 section #dad4ejb1 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 except t su* t]m does n include a laboratory ) respect to :i* /&>d *>ges & prices = specifi$ cl9ical diagno/ic laboratory te/s furni%$ by su* laboratory are made available by a hospital pursuant to section #ahii;,c or section #bgah7;f7 ( ! ,public ,heal? ,s]vice ,act4 7,b7 ,disc\nt$ ca% price ,! t]m disc\nt$ ca% price means ! *>ge t applies to an individual :o pays ca%1 or ca% equival5t1 = an item or s]vice4 7,c7 ,gross *>ge ,! t]m gross *>ge means ! *>ge = an individual item or s]vice t is reflect$ on an applicable laboratory's *>gema/]1 abs5t any disc\nts4 7,d7 ,pay]-specific negotiat$ *>ge ,! t]m pay]-specific negotiat$ *>ge means ! *>ge t an applicable laboratory has negotiat$ ) a ?ird p>ty pay] = an item or s]vice4 7,e7 ,specifi$ cl9ical diagno/ic laboratory te/ ! t]m specifi$ cl9ical diagno/ic laboratory te/ means a cl9ical diagno/ic laboratory te/ t is includ$ on ! li/ ( %oppable s]vices specifi$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7z describ$ 9 section #ahii;,c7a77#b77;,a77ii77,i771 o!r ?an su* a te/ t is only available to be furni%$ by a s+le provid] ( s]vices or suppli]4 7,f7 ,?ird p>ty pay] ,! t]m ?ird p>ty pay] means an entity t is1 by /atute1 contract1 or agreem5t1 legally responsible = paym5t ( a claim = a heal? c>e item or s]vice4 4 #ajc4 ,imag+ price transp>5cy ,section #ahii;,c ( ! ,social ,security ,act1 z add$ by section #aja1 is am5d$-- 7#a7 by r$esignat+ subsection 7b7 z subsection 7c72 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+ new subsection3 7b7 ,imag+ s]vices price transp>5cy 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbh1 ea* provid] ( s]vices & suppli] t receives paym5t "u ?is title = furni%+ a specifi$ imag+ s]vice1 o!r ?an su* a provid] or suppli] ) respect to :i* /&>d *>ges & prices = su* s]vices furni%$ by su* provid] or suppli] are made available by a hospital pursuant to section #ahii;,c or section #bgah7;f7 ( ! ,public ,heal? ,s]vice ,act1 %all-- 7,a7 make publicly available 79 accordance ) p>agraph 7#c77 on an int]net website ! in=mation describ$ 9 p>agraph 7#b7 ) respect to ea* su* s]vice t su* provid] ( s]vices or suppli] furni%es2 & 7,b7 ensure t su* in=mation is updat$ n less frequ5tly ?an annually4 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to a provid] ( s]vices or suppli] & a specifi$ imag+ s]vice1 ! foll[+3 7,a7 ,! disc\nt$ ca% price = su* s]vice 7or1 if no su* price exi/s1 ! gross *>ge = su* s]vice74 7,b7 ,if requir$ by ! ,secret>y1 ! deid5tifi$ m9imum pay]-specific negotiat$ *>ge = su* s]vice & ! deid5tifi$ maximum pay]-specific negotiat$ *>ge = su* s]vice4 7#c7 ,uni=m me?od & =mat ,n lat] ?an ,janu>y #a1 #bjbh1 ! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = provid]s ( s]vices & suppli]s to use 9 mak+ public in=mation describ$ 9 p>agraph 7#b74 ,any su* me?od & =mat-- 7,a7 may be simil> to any template made available by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7z describ$ 9 section #ahii;,c7a77#b77;,c77ii772 7,b7 %all meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* in=mation2 & 7,c7 %all be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#d7 ,monitor+ compliance ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+ & 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 7#e7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case t ! ,secret>y det]m9es t a provid] ( s]vices or suppli] is n 9 compliance ) p>agraph 7#a7-- 7i7 n lat] ?an #cj days aft] su* det]m9ation1 ! ,secret>y %all notify su* provid] or suppli] ( su* det]m9ation2 7ii7 ^u reque/ ( ! ,secret>y1 su* provid] or suppli] %all submit to ! ,secret>y1 n lat] ?an #de days aft] ! date ( su* reque/1 a corrective action plan to comply ) su* p>agraph2 & 7iii7 if su* provid] or suppli] cont9ues to fail to comply ) su* p>agraph aft] ! date t is #ij days aft] su* notification is s5t 7or1 9 ! case ( su* a provid] or suppli] t has submitt$ a corrective action plan describ$ 9 clause 7ii7 9 response to a reque/ s describ$1 aft] ! date t is #ij days aft] su* submission71 ! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #cjj = ea* day 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* provid] or suppli] 0 fail+ to comply ) su* p>agraph7 dur+ :i* su* failure to comply or failure to submit is ongo+4 7,b7 ,increase au?ority ,9 apply+ ?is p>agraph ) respect to violations occurr+ 9 #bjbi or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase ! am\nt ( ! civil monet>y p5alty "u subp>agraph 7,a77iii74 7,c7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is p>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7,d7 ,au?ority to waive or r$uce p5alty 7i7 ,9 g5]al ,subject to clause 7ii71 ! ,secret>y may waive or r$uce any p5alty o!rwise applicable ) respect to a provid] ( s]vices or suppli] "u ?is subp>agraph if ! ,secret>y c]tifies t imposition ( su* p5alty w\ld result 9 an imm$iate ?reat to access to c>e = individuals 9 ! s]vice area ( su* provid] or suppli]4 7ii7 ,limitation ,! ,secret>y may n elect to waive or r$uce a p5alty "u clause 7i7 ) respect to a specific provid] ( s]vices or suppli] m ?an #c times4 7,e7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is subsection to provid]s ( s]vices & suppli]s reque/+ su* assi/ance4 7,f7 ,cl>ification ( nonapplicability ( o!r en=cem5t provisions ,not)/&+ any o!r provision ( ?is title1 ?is p>agraph %all be ! sole means ( en=c+ ! provisions ( ?is subsection4 2 & 7#c7 9 subsection 7c71 z s r$esignat$ by p>agraph 7#a7-- 7,a7 by r$esignat+ p>agraph 7#h7 z p>agraph 7#i72 & 7,b7 by ins]t+ aft] p>agraph 7#g7 ! foll[+ new p>agraph3 7#h7 ,specifi$ imag+ s]vice ! t]m specifi$ imag+ s]vice means an imag+ s]vice t is a ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vice 7z describ$ 9 subsection 7a77#b77;,a77ii77,i774 4 #ajd4 ,ambulatory surgical c5t] price transp>5cy ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7aa7 ,ambulatory surgical c5t] price transp>5cy 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 ea* ambulatory surgical c5t] t receives paym5t "u ?is title = furni%+ items & s]vices %all comply ) ! price transp>5cy requirem5t describ$ 9 p>agraph 7#b74 7#b7 ,requirem5t describ$ 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! price transp>5cy requirem5t describ$ 9 ?is subsection is1 ) respect to an ambulatory surgical c5t]1 t su* surgical c5t] 9 accordance ) a me?od & =mat e/abli%$ by ! ,secret>y "u subp>agraph 7,c71 compile & make public 7)\t subscription & free ( *>ge71 = ea* ye>-- 7i7 all ( ! ambulatory surgical c5t]'s /&>d *>ges 7includ+ ! in=mation describ$ 9 subp>agraph 7,b77 = ea* item & s]vice furni%$ by su* surgical c5t]2 7ii7 in=mation on ! ambulatory surgical c5t]'s prices 7includ+ ! in=mation describ$ 9 subp>agraph 7,b77 = z _m ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vices t are furni%$ by su* surgical c5t]1 & z _m additional ambulatory surgical c5t]-select$ %oppable s]vices 7or all su* additional s]vices1 if su* surgical c5t] furni%es few] ?an #cjj %oppable s]vices7 z may be necess>y = a comb9$ total ( at lea/ #cjj %oppable s]vices2 & 7iii7 ) respect to ea* ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vice t is n furni%$ by ! ambulatory surgical c5t]1 an indication t su* s]vice is n s furni%$4 7,b7 ,in=mation describ$ ,= purposes ( subp>agraph 7,a71 ! in=mation describ$ 9 ?is subp>agraph is1 ) respect to /&>d *>ges & prices 7z applicable7 made public by an ambulatory surgical c5t]1 ! foll[+3 7i7 ,a pla9 language description ( ea* item or s]vice1 accompani$ by1 z applicable1 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code1 ! diagnosis-relat$ gr\p1 ! national drug code1 or o!r id5tifi] us$ or approv$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ii7 ,! gross *>ge1 z applicable1 express$ z a doll> am\nt1 = ea* su* item or s]vice4 7iii7 ,! disc\nt$ ca% price1 z applicable1 express$ z a doll> am\nt1 = ea* su* item or s]vice 7or1 9 ! case no disc\nt$ ca% price is available = an item or s]vice1 ! m$ian ca% price *>g$ to self-pay individuals = su* item or s]vice = ! previ\s ?ree ye>s1 express$ z a doll> am\nt74 7iv7 ,! curr5t pay]-specific negotiat$ *>ges1 cle>ly associat$ ) ! "n ( ! ?ird p>ty pay] & plan & express$ z a doll> am\nt1 t applies to ea* su* item or s]vice4 7v7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges1 z applicable1 = ea* su* item or s]vice4 7vi7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges & prices = an item or s]vice1 except in=mation t is duplicative ( any o!r report+ requirem5t "u ?is subsection4 7,c7 ,uni=m me?od & =mat ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = ambulatory surgical c5t]s to use 9 mak+ public /&>d *>ges & a /&>d1 uni=m me?od & =mat = su* c5t]s to use 9 mak+ public prices pursuant to subp>agraph 7,a74 ,any su* me?od & =mat-- 7i7 %all1 9 ! case ( su* *>ges made public by an ambulatory surgical c5t]1 ensure t su* *>ges are made available 9 a ma*9e-readable =mat 7or successor te*nology72 7ii7 may be simil> to any template made available by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices z ( ! date ( ! enactm5t ( ?is p>agraph2 7iii7 %all meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* *>ges & prices2 & 7iv7 %all be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#c7 ,monitor+ compliance ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+ & 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 ,su* process %all ensure t ea* ambulatory surgical c5t]'s compliance ) ?is subsection is review$ n less frequ5tly ?an once e #c ye>s4 7#d7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( an ambulatory surgical c5t] t fails to comply ) ! requirem5ts ( ?is subsection-- 7i7 ! ,secret>y %all notify su* ambulatory surgical c5t] ( su* failure n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s2 & 7ii7 ^u reque/ ( ! ,secret>y1 ! ambulatory surgical c5t] %all submit to ! ,secret>y1 n lat] ?an #de days aft] ! date ( su* reque/1 a corrective action plan to comply ) su* requirem5ts4 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,9 addition to any o!r en=cem5t actions or p5alties t may apply "u ano!r provision ( law1 an ambulatory surgical c5t] t has receiv$ a notification "u subp>agraph 7,a77i7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #ij days aft] su* notification 7or1 9 ! case ( an ambulatory surgical c5t] t has submitt$ a corrective action plan describ$ 9 subp>agraph 7,a77ii7 9 response to a reque/ s describ$1 by ! date t is #ij days aft] su* submission7 %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* subsequ5t day dur+ :i* su* failure is ongo+ 7n to exce$ #cjj p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to violations occurr+ 9 #bjbg or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase ! limitation on ! p] day am\nt ( any p5alty applicable to an ambulatory surgical c5t] "u clause 7i74 7iii7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7iv7 ,au?ority to waive or r$uce p5alty 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 ! ,secret>y may waive any p5alty1 or r$uce any p5alty by n m ?an #ge p]c5t1 o!rwise applicable "u ?is subp>agraph ) respect to an ambulatory surgical c5t] locat$ 9 a rural or und]s]v$ area if ! ,secret>y c]tifies t imposition ( su* p5alty w\ld result 9 an imm$iate ?reat to access to c>e = individuals 9 ! s]vice area ( su* surgical c5t]4 7,,ii7 ,limitation on application ,! ,secret>y may n elect to waive a p5alty "u subclause 7,i7 ) respect to an ambulatory surgical c5t] m ?an once 9 a #f-ye> p]iod & may n elect to r$uce su* a p5alty ) respect to su* a surgical c5t] m ?an once 9 su* a p]iod4 ,no?+ 9 ! prec$+ s5t5ce %all be con/ru$ z prohibit+ ! ,secret>y f bo? waiv+ & r$uc+ a p5alty ) respect to an ambulatory surgical c5t] dur+ a #f-ye> p]iod4 7#e7 ,def9itions ,= purposes ( ?is section3 7,a7 ,disc\nt$ ca% price ,! t]m disc\nt$ ca% price means ! *>ge t applies to an individual :o pays ca%1 or ca% equival5t1 = a item or s]vice furni%$ by an ambulatory surgical c5t]4 7,b7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program has ! mean+ giv5 su* t]m 9 section #aabh;,b4 7,c7 ,gross *>ge ,! t]m gross *>ge means ! *>ge = an individual item or s]vice t is reflect$ on an ambulatory surgical c5t]'s *>gema/]1 abs5t any disc\nts4 7,d7 ,gr\p heal? plan2 gr\p heal? insurance cov]age2 individual heal? insurance cov]age ,! t]ms gr\p heal? plan1 gr\p heal? insurance cov]age1 & individual heal? insurance cov]age h ! mean+ giv5 su* t]ms 9 section #bgia ( ! ,public ,heal? ,s]vice ,act4 7,e7 ,pay]-specific negotiat$ *>ge ,! t]m pay]-specific negotiat$ *>ge means ! *>ge t an ambulatory surgical c5t] has negotiat$ ) a ?ird p>ty pay] = an item or s]vice4 7,f7 ,%oppable s]vice ,! t]m %oppable s]vice means a s]vice t c be s*$ul$ by a heal? c>e consum] 9 advance & includes all ancill>y items & s]vices cu/om>ily furni%$ z "p ( su* s]vice4 7,g7 ,?ird p>ty pay] ,! t]m ?ird p>ty pay] means an entity t is1 by /atute1 contract1 or agreem5t1 legally responsible = paym5t ( a claim = a heal? c>e item or s]vice4 4 #aje4 ,heal? cov]age price transp>5cy 7a7 ,price transp>5cy requirem5ts 7#a7 ,,irc 7,a7 ,9 g5]al ,section #ihai ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 #ihai4 ,transp>5cy 9 cov]age 7a7 ,co/-%>+ transp>5cy 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 a gr\p heal? plan %all p]mit a p>ticipant or b5efici>y to le>n ! am\nt ( co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 "u ! p>ticipant or b5efici>y's plan t ! p>ticipant or b5efici>y w\ld be responsible = pay+ ) respect to ! furni%+ ( a specific item or s]vice by a provid] 9 a timely mann] ^u ! reque/ ( ! p>ticipant or b5efici>y4 ,at a m9imum1 su* in=mation %all include ! in=mation specifi$ 9 p>agraph 7#b7 & %all be made available to su* p>ticipant or b5efici>y ?r\gh a self-s]vice tool t meets ! requirem5ts ( p>agraph 7#c7 or1 at ! option ( su* p>ticipant or b5efici>y1 ?r\gh a pap] disclosure or phone or o!r electronic disclosure 7z select$ by su* p>ticipant or b5efici>y & provid$ at no co/ to su* p>ticipant or b5efici>y7 t meets su* requirem5ts z ! ,secret>y may specify4 7#b7 ,specifi$ in=mation ,= purposes ( p>agraph 7#a71 ! in=mation specifi$ 9 ?is p>agraph is1 ) respect to an item or s]vice = :i* b5efits are available "u a gr\p heal? plan furni%$ by a heal? c>e provid] to a p>ticipant or b5efici>y ( su* plan1 ! foll[+3 7,a7 ,if su* provid] is a p>ticipat+ provid] ) respect to su* item or s]vice1 ! 9-network rate 7z def9$ 9 subsection 7c77 = su* item or s]vice4 7,b7 ,if su* provid] is n a p>ticipat+ provid] ) respect to su* item or s]vice1 ! maximum all[$ am\nt or o!r doll> am\nt t su* plan or cov]age w recognize z paym5t = su* item or s]vice1 along ) a notice t su* p>ticipant or b5efici>y may be liable = additional *>ges4 7,c7 ,! e/imat$ am\nt ( co/ %>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 t ! p>ticipant or b5efici>y w incur = su* item or s]vice 7:i*1 9 ! case su* item or s]vice is to be furni%$ by a provid] describ$ 9 subp>agraph 7,b71 %all be calculat$ us+ ! maximum all[$ am\nt or o!r doll> am\nt describ$ 9 su* subp>agraph74 7,d7 ,! am\nt ! p>ticipant or b5efici>y has already accumulat$ ) respect to any d$uctible or out ( pocket maximum "u ! plan 7brok5 d[n1 9 ! case sep>ate d$uctibles or maximums apply to sep>ate p>ticipants & b5efici>ies enroll$ 9 ! plan1 by su* sep>ate d$uctibles or maximums1 9 addition to any cumulative d$uctible or maximum74 7,e7 ,9 ! case su* plan imposes any frequ5cy or volume limitations ) respect to su* item or s]vice 7exclud+ m$ical necessity det]m9ations71 ! am\nt t su* p>ticipant or b5efici>y has accru$ t[>ds su* limitation ) respect to su* item or s]vice4 7,f7 ,any prior au?orization1 concurr5t review1 /ep !rapy1 fail fir/1 or simil> requirem5ts applicable to cov]age ( su* item or s]vice "u su* plan4 7,g7 ,any %>$ sav+s 7su* z any cr$it1 paym5t1 or o!r b5efit provid$ by su* plan7 available to ! p>ticipant or b5efici>y ) respect to su* item or s]vice furni%$ by su* provid] kn[n at ! "t su* reque/ is made4 7#c7 ,self-s]vice tool ,= purposes ( p>agraph 7#a71 a self-s]vice tool e/abli%$ by a gr\p heal? plan meets ! requirem5ts ( ?is p>agraph if su* tool-- 7,a7 is bas$ on an ,int]net website 7or successor te*nology specifi$ by ! ,secret>y72 7,b7 provides = real-"t responses to reque/s describ$ 9 p>agraph 7#a72 7,c7 is updat$ 9 a mann] su* t in=mation provid$ ?r\gh su* tool is timely & accurate at ! "t su* reque/ is made2 7,d7 all[s su* a reque/ to be made ) respect to an item or s]vice furni%$ by-- 7i7 a specific provid] t is a p>ticipat+ provid] ) respect to su* item or s]vice2 or 7ii7 all provid]s t are p>ticipat+ provid]s ) respect to su* item or s]vice2 7,e7 provides t su* a reque/ may be made ) respect to an item or s]vice ?r\gh use ( ! bill+ code = su* item or s]vice or ?r\gh use ( a descriptive t]m = su* item or s]vice2 & 7,f7 meets any o!r requirem5t det]m9$ appropriate by ! ,secret>y to ensure ! accessibility & usability ( in=mation provid$ ?r\gh su* tool4 ,! ,secret>y may require su* tool1 z a condition ( comply+ ) subp>agraph 7,e71 to l9k multiple bill+ codes to a s+le descriptive t]m if ! ,secret>y det]m9es t ! bill+ codes to be s l9k$ correspond to simil> items & s]vices4 7b7 ,rate & paym5t in=mation 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 ea* gr\p heal? plan 7o!r ?an a gr&fa!r$ heal? plan 7z def9$ 9 section #abea7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act77 %all1 = ea* mon?1 n lat] ?an ! t5? day ( su* mon?1 make available to ! public ! rate & paym5t in=mation describ$ 9 p>agraph 7#b7 9 accordance ) p>agraph 7#c74 7#b7 ,rate & paym5t in=mation describ$ ,= purposes ( p>agraph 7#a71 ! rate & paym5t in=mation describ$ 9 ?is p>agraph is1 ) respect to a gr\p heal? plan1 ! foll[+3 7,a7 ,) respect to ea* item or s]vice 7o!r ?an a drug7 = :i* b5efits are available "u su* plan1 ! 9-network rate 7express$ z a doll> am\nt7 9 effect z ( ! date on :i* su* in=mation is made public ) ea* provid] t is a p>ticipat+ provid] ) respect to su* item or s]vice4 7,b7 ,) respect to ea* drug 7id5tifi$ by national drug code7 = :i* b5efits are available "u su* plan-- 7i7 ! 9-network rate 7express$ z a doll> am\nt7 9 effect z ( ! fir/ day ( ! mon? 9 :i* su* in=mation is made public ) ea* provid] t is a p>ticipat+ provid] ) respect to su* drug2 & 7ii7 ! av]age am\nt paid by su* plan 7net ( rebates1 disc\nts1 & price concessions7 = su* drug disp5s$ or adm9i/]$ dur+ ! #ij-;day p]iod beg9n+ #ahj days be=e su* date ( publication to ea* provid] t 0 a p>ticipat+ provid] ) respect to su* drug1 brok5 d[n by ea* su* provid]1 o!r ?an su* an am\nt paid to a provid] t1 dur+ su* p]iod1 submitt$ few] ?an #bj claims = su* drug to su* plan4 7,c7 ,) respect to ea* item or s]vice = :i* b5efits are available "u su* plan1 ! am\nt bill$1 & ! am\nt all[$ by ! plan1 = ea* su* item or s]vice furni%$ dur+ ! #ij-;day p]iod specifi$ 9 subp>agraph 7,b7 by a provid] t 0 n a p>ticipat+ provid] ) respect to su* item or s]vice1 brok5 d[n by ea* su* provid]4 7#c7 ,mann] ( publication ,rate & paym5t in=mation requir$ to be made available "u ?is subsection %all be s made available 9 doll> am\nts ?r\gh sep>ate ma*9e-readable files 7& any successor te*nology1 su* z application program int]face te*nology1 det]m9$ appropriate by ! ,secret>y7 correspond+ to ! in=mation describ$ 9 ea* ( subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b7 t meet su* requirem5ts z specifi$ by ! ,secret>y ?r\gh subregulatory guidance4 ,su* requirem5ts %all ensure t su* files are limit$ to an appropriate size1 d n include disclosure ( unnecess>y duplicative in=mation conta9$ 9 o!r files made available "u ?is subsection1 are made available 9 a widely available =mat ?r\gh a publicly available website t all[s = in=mation conta9$ 9 su* files to be comp>$ across gr\p heal? plans & gr\p or individual heal? insurance cov]age1 & are accessible to individuals at no co/ & )\t ! ne$ to e/abli% a us] acc\nt or provide o!r cr$5tials4 7#d7 ,us] in/ructions ,ea* gr\p heal? plan %all make available to ! public in/ructions writt5 9 pla9 language expla9+ h[ individuals may se>* = in=mation describ$ 9 p>agraph 7#b7 9 files submitt$ 9 accordance ) p>agraph 7#c74 ,! ,secret>y %all develop & publi% ?r\gh subregulatory guidance a template t su* a plan may use 9 develop+ in/ructions = purposes ( ! prec$+ s5t5ce4 7#e7 ,summ>y ,= ea* plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbf1 ea* gr\p heal? plan %all make public a data file1 9 a mann] t ensures t su* file may be easily d[nload$ & read by /&>d spread%eet s(tw>e & t meets su* requirem5ts z e/abli%$ by ! ,secret>y1 conta9+ a summ>y ( all rate & paym5t in=mation made public by su* plan ) respect to su* plan dur+ su* plan ye>4 ,su* file %all include ! foll[+3 7,a7 ,! mean1 m$ian1 & int]qu>tile range ( ! 9-network rate1 & ! am\nt all[$ = an item or s]vice :5 n furni%$ by a p>ticipat+ provid]1 9 effect z ( ! fir/ day ( su* plan ye> = ea* item or s]vice 7id5tifi$ by pay] id5tifi] approv$ or us$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices7 = :i* b5efits are available "u ! plan1 brok5 d[n by ! type ( provid] furni%+ ! item or s]vice & by ! geographic area 9 :i* su* item or s]vice is furni%$4 7,b7 ,tr5ds 9 paym5t rates = su* items & s]vices ov] su* plan ye>1 includ+ an id5tification ( in/ances 9 :i* su* rates h increas$1 decreas$1 or rema9$ ! same4 7,c7 ,! "n ( su* plan1 a description ( ! type ( network ( p>ticipat+ provid]s us$ by su* plan1 & a description ( :e!r su* plan is self-insur$ or fully-insur$4 7,d7 ,= ea* item or s]vice :i* is paid z "p ( a bundl$ rate-- 7i7 a description ( ! =mulae1 pric+ me?odologies1 or o!r in=mation us$ to calculate ! paym5t rate = su* bundle2 & 7ii7 a li/ ( ! items & s]vices includ$ 9 su* bundle4 7,e7 ,! p]c5tage ( items & s]vices t are paid = on a fee-=-s]vice basis & ! p]c5tage ( items & s]vices t are paid = z "p ( a bundl$ rate1 capitat$ paym5t rate1 or o!r alt]native paym5t model4 7#f7 ,atte/ation ,ea* gr\p heal? plan %all po/1 along ) rate & paym5t in=mation made public by su* plan1 an atte/ation t su* in=mation is complete & accurate4 7c7 ,accessibility ,a gr\p heal? plan %all take reasonable /eps 7z specifi$ by ! ,secret>y7 to ensure t in=mation provid$ 9 response to a reque/ describ$ 9 subsection 7a71 & rate & paym5t in=mation made public "u subsection 7b71 is provid$ 9 pla91 easily und]/&able language & t int]pretation1 translations1 & assi/ive s]vices are provid$ to ^? ) limit$ ,engli% pr(ici5cy & ^? ) disabilities4 7d7 ,def9itions ,9 ?is section3 7#a7 ,p>ticipat+ provid] ,! t]m p>ticipat+ provid] means1 ) respect to an item or s]vice & a gr\p heal? plan1 a physician or o!r heal? c>e provid] :o is act+ )9 ! scope ( practice ( t provid]'s lic5se or c]tification "u applicable ,/ate law & :o has a contractual relation%ip ) ! plan1 respectively1 = furni%+ su* item or s]vice "u ! plan1 & includes facilities1 respectively4 7#b7 ,provid] ,! t]m provid] includes a heal? c>e facility4 7#c7 ,9-network rate ,! t]m 9-network rate means1 ) respect to a gr\p heal? plan & an item or s]vice furni%$ by a provid] t is a p>ticipat+ provid] ) respect to su* plan & item or s]vice1 ! contract$ rate 7reflect$ z a doll> am\nt7 9 effect betwe5 su* plan & su* provid] = su* item or s]vice1 reg>dless ( :e!r su* rate is calculat$ bas$ on a set am\nt1 a fee s*$ule1 or an am\nt d]iv$ f ano!r am\nt1 or a =mula1 or o!r me?od4 4 7,b7 ,cl]ical am5dm5t ,! item relat+ to section #ihai ( ! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 ,sec4 #ihai4 ,transp>5cy 9 cov]age4 4 7#b7 ,,phsa ,section #bgii;,a-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aad7 is am5d$ to read z foll[s3 #bgii;,a-#d4 ,transp>5cy 9 cov]age 7a7 ,co/-%>+ transp>5cy 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all p]mit an individual enroll$ "u su* plan or cov]age to le>n ! am\nt ( co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 "u ! individual's plan or cov]age t ! individual w\ld be responsible = pay+ ) respect to ! furni%+ ( a specific item or s]vice by a provid] 9 a timely mann] ^u ! reque/ ( ! individual4 ,at a m9imum1 su* in=mation %all include ! in=mation specifi$ 9 p>agraph 7#b7 & %all be made available to su* individual ?r\gh a self-s]vice tool t meets ! requirem5ts ( p>agraph 7#c7 or1 at ! option ( su* individual1 ?r\gh a pap] disclosure or phone or o!r electronic disclosure 7z select$ by su* individual & provid$ at no co/ to su* individual7 t meets su* requirem5ts z ! ,secret>y may specify4 7#b7 ,specifi$ in=mation ,= purposes ( p>agraph 7#a71 ! in=mation specifi$ 9 ?is p>agraph is1 ) respect to an item or s]vice = :i* b5efits are available "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age furni%$ by a heal? c>e provid] to an individual enroll$ "u su* plan or cov]age1 ! foll[+3 7,a7 ,if su* provid] is a p>ticipat+ provid] ) respect to su* item or s]vice1 ! 9-network rate 7z def9$ 9 subsection 7c77 = su* item or s]vice4 7,b7 ,if su* provid] is n a p>ticipat+ provid] ) respect to su* item or s]vice1 ! maximum all[$ am\nt or o!r doll> am\nt t su* plan or cov]age w recognize z paym5t = su* item or s]vice1 along ) a notice t su* individual may be liable = additional *>ges4 7,c7 ,! e/imat$ am\nt ( co/ %>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 t ! individual w incur = su* item or s]vice 7:i*1 9 ! case su* item or s]vice is to be furni%$ by a provid] describ$ 9 subp>agraph 7,b71 %all be calculat$ us+ ! maximum all[$ am\nt or o!r doll> am\nt describ$ 9 su* subp>agraph74 7,d7 ,! am\nt ! individual has already accumulat$ ) respect to any d$uctible or out ( pocket maximum "u ! plan or cov]age 7brok5 d[n1 9 ! case sep>ate d$uctibles or maximums apply to sep>ate individuals enroll$ 9 ! plan or cov]age1 by su* sep>ate d$uctibles or maximums1 9 addition to any cumulative d$uctible or maximum74 7,e7 ,9 ! case su* plan imposes any frequ5cy or volume limitations ) respect to su* item or s]vice 7exclud+ m$ical necessity det]m9ations71 ! am\nt t su* individual has accru$ t[>ds su* limitation ) respect to su* item or s]vice4 7,f7 ,any prior au?orization1 concurr5t review1 /ep !rapy1 fail fir/1 or simil> requirem5ts applicable to cov]age ( su* item or s]vice "u su* plan or cov]age4 7,g7 ,any %>$ sav+s 7su* z any cr$it1 paym5t1 or o!r b5efit provid$ by su* plan or issu]7 available to ! individual ) respect to su* item or s]vice furni%$ by su* provid] kn[n at ! "t su* reque/ is made4 7#c7 ,self-s]vice tool ,= purposes ( p>agraph 7#a71 a self-s]vice tool e/abli%$ by a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age meets ! requirem5ts ( ?is p>agraph if su* tool-- 7,a7 is bas$ on an int]net website 7or successor te*nology specifi$ by ! ,secret>y72 7,b7 provides = real-"t responses to reque/s describ$ 9 p>agraph 7#a72 7,c7 is updat$ 9 a mann] su* t in=mation provid$ ?r\gh su* tool is timely & accurate at ! "t su* reque/ is made2 7,d7 all[s su* a reque/ to be made ) respect to an item or s]vice furni%$ by-- 7i7 a specific provid] t is a p>ticipat+ provid] ) respect to su* item or s]vice2 or 7ii7 all provid]s t are p>ticipat+ provid]s ) respect to su* item or s]vice2 7,e7 provides t su* a reque/ may be made ) respect to an item or s]vice ?r\gh use ( ! bill+ code = su* item or s]vice or ?r\gh use ( a descriptive t]m = su* item or s]vice2 & 7,f7 meets any o!r requirem5t det]m9$ appropriate by ! ,secret>y to ensure ! accessibility & usability ( in=mation provid$ ?r\gh su* tool4 ,! ,secret>y may require su* tool1 z a condition ( comply+ ) subp>agraph 7,e71 to l9k multiple bill+ codes to a s+le descriptive t]m if ! ,secret>y det]m9es t ! bill+ codes to be s l9k$ correspond to simil> items & s]vices4 7b7 ,rate & paym5t in=mation 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age 7o!r ?an a gr&fa!r$ heal? plan 7z def9$ 9 section #abea7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act77 %all1 = ea* mon?1 n lat] ?an ! t5? day ( su* mon?1 make available to ! public ! rate & paym5t in=mation describ$ 9 p>agraph 7#b7 9 accordance ) p>agraph 7#c74 7#b7 ,rate & paym5t in=mation describ$ ,= purposes ( p>agraph 7#a71 ! rate & paym5t in=mation describ$ 9 ?is p>agraph is1 ) respect to a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! foll[+3 7,a7 ,) respect to ea* item or s]vice 7o!r ?an a drug7 = :i* b5efits are available "u su* plan or cov]age1 ! 9-network rate 7express$ z a doll> am\nt7 9 effect z ( ! date on :i* su* in=mation is made public ) ea* provid] t is a p>ticipat+ provid] ) respect to su* item or s]vice4 7,b7 ,) respect to ea* drug 7id5tifi$ by national drug code7 = :i* b5efits are available "u su* plan or cov]age-- 7i7 ! 9-network rate 7express$ z a doll> am\nt7 9 effect z ( ! fir/ day ( ! mon? 9 :i* su* in=mation is made public ) ea* provid] t is a p>ticipat+ provid] ) respect to su* drug2 & 7ii7 ! av]age am\nt paid by su* plan 7net ( rebates1 disc\nts1 & price concessions7 = su* drug disp5s$ or adm9i/]$ dur+ ! #ij-;day p]iod beg9n+ #ahj days be=e su* date ( publication to ea* provid] t 0 a p>ticipat+ provid] ) respect to su* drug1 brok5 d[n by ea* su* provid]1 o!r ?an su* an am\nt paid to a provid] t1 dur+ su* p]iod1 submitt$ few] ?an #bj claims = su* drug to su* plan or cov]age4 7,c7 ,) respect to ea* item or s]vice = :i* b5efits are available "u su* plan or cov]age1 ! am\nt bill$1 & ! am\nt all[$ by ! plan1 = ea* su* item or s]vice furni%$ dur+ ! #ij-;day p]iod specifi$ 9 subp>agraph 7,b7 by a provid] t 0 n a p>ticipat+ provid] ) respect to su* item or s]vice1 brok5 d[n by ea* su* provid]4 7#c7 ,mann] ( publication ,rate & paym5t in=mation requir$ to be made available "u ?is subsection %all be s made available 9 doll> am\nts ?r\gh sep>ate ma*9e-readable files 7& any successor te*nology1 su* z application program int]face te*nology1 det]m9$ appropriate by ! ,secret>y7 correspond+ to ! in=mation describ$ 9 ea* ( subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b7 t meet su* requirem5ts z specifi$ by ! ,secret>y ?r\gh subregulatory guidance4 ,su* requirem5ts %all ensure t su* files are limit$ to an appropriate size1 d n include disclosure ( unnecess>y duplicative in=mation conta9$ 9 o!r files made available "u ?is subsection1 are made available 9 a widely-available =mat ?r\gh a publicly-available website t all[s = in=mation conta9$ 9 su* files to be comp>$ across gr\p heal? plans & gr\p or individual heal? insurance cov]age1 & are accessible to individuals at no co/ & )\t ! ne$ to e/abli% a us] acc\nt or provide o!r cr$5tials4 7#d7 ,us] in/ructions ,ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all make available to ! public in/ructions writt5 9 pla9 language expla9+ h[ individuals may se>* = in=mation describ$ 9 p>agraph 7#b7 9 files submitt$ 9 accordance ) p>agraph 7#c74 ,! ,secret>y %all develop & publi% ?r\gh subregulatory guidance a template t su* a plan may use 9 develop+ in/ructions = purposes ( ! prec$+ s5t5ce4 7#e7 ,summ>y ,= ea* plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbf1 ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all make public a data file1 9 a mann] t ensures t su* file may be easily d[nload$ & read by /&>d spread%eet s(tw>e & t meets su* requirem5ts z e/abli%$ by ! ,secret>y1 conta9+ a summ>y ( all rate & paym5t in=mation made public by su* plan or issu] ) respect to su* plan or cov]age dur+ su* plan ye>4 ,su* file %all include ! foll[+3 7,a7 ,! mean1 m$ian1 & int]qu>tile range ( ! 9-network rate1 & ! am\nt all[$ = an item or s]vice :5 n furni%$ by a p>ticipat+ provid]1 9 effect z ( ! fir/ day ( su* plan ye> = ea* item or s]vice 7id5tifi$ by pay] id5tifi] approv$ or us$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices7 = :i* b5efits are available "u ! plan or cov]age1 brok5 d[n by ! type ( provid] furni%+ ! item or s]vice & by ! geographic area 9 :i* su* item or s]vice is furni%$4 7,b7 ,tr5ds 9 paym5t rates = su* items & s]vices ov] su* plan ye>1 includ+ an id5tification ( in/ances 9 :i* su* rates h increas$1 decreas$1 or rema9$ ! same4 7,c7 ,! "n ( su* plan1 a description ( ! type ( network ( p>ticipat+ provid]s us$ by su* plan or cov]age1 &1 9 ! case ( a gr\p heal? plan1 a description ( :e!r su* plan is self-insur$ or fully-insur$4 7,d7 ,= ea* item or s]vice :i* is paid z "p ( a bundl$ rate-- 7i7 a description ( ! =mulae1 pric+ me?odologies1 or o!r in=mation us$ to calculate ! paym5t rate = su* bundle2 & 7ii7 a li/ ( ! items & s]vices includ$ 9 su* bundle4 7,e7 ,! p]c5tage ( items & s]vices t are paid = on a fee-=-s]vice basis & ! p]c5tage ( items & s]vices t are paid = z "p ( a bundl$ rate1 capitat$ paym5t rate1 or o!r alt]native paym5t model4 7#f7 ,atte/ation ,ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all po/1 along ) rate & paym5t in=mation made public by su* plan or issu]1 an atte/ation t su* in=mation is complete & accurate4 7c7 ,accessibility ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all take reasonable /eps 7z specifi$ by ! ,secret>y7 to ensure t in=mation provid$ 9 response to a reque/ describ$ 9 subsection 7a71 & rate & paym5t in=mation made public "u subsection 7b71 is provid$ 9 pla91 easily und]/&able language & t int]pretation1 translations1 & assi/ive s]vices are provid$ to ^? ) limit$ ,engli% pr(ici5cy & ^? ) disabilities4 7d7 ,def9itions ,9 ?is section3 7#a7 ,p>ticipat+ provid] ,! t]m p>ticipat+ provid] means1 ) respect to an item or s]vice & a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 a physician or o!r heal? c>e provid] :o is act+ )9 ! scope ( practice ( t provid]'s lic5se or c]tification "u applicable ,/ate law & :o has a contractual relation%ip ) ! plan or issu]1 respectively1 = furni%+ su* item or s]vice "u ! plan or cov]age1 & includes facilities1 respectively4 7#b7 ,provid] ,! t]m provid] includes a heal? c>e facility4 7#c7 ,9-network rate ,! t]m 9-network rate means1 ) respect to a gr\p heal? plan or gr\p or individual heal? insurance cov]age & an item or s]vice furni%$ by a provid] t is a p>ticipat+ provid] ) respect to su* plan or cov]age & item or s]vice1 ! contract$ rate 7reflect$ z a doll> am\nt7 9 effect betwe5 su* plan or cov]age & su* provid] = su* item or s]vice1 reg>dless ( :e!r su* rate is calculat$ bas$ on a set am\nt1 a fee s*$ule1 or an am\nt d]iv$ f ano!r am\nt1 or a =mula1 or o!r me?od4 4 7#c7 ,,erisa 7,a7 ,9 g5]al ,section #gai ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;h7 is am5d$ to read z foll[s3 #gai4 ,transp>5cy 9 cov]age 7a7 ,co/-,%>+ transp>5cy 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all p]mit a p>ticipant or b5efici>y to le>n ! am\nt ( co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 "u ! p>ticipant or b5efici>y's plan or cov]age t ! p>ticipant or b5efici>y w\ld be responsible = pay+ ) respect to ! furni%+ ( a specific item or s]vice by a provid] 9 a timely mann] ^u ! reque/ ( ! p>ticipant or b5efici>y4 ,at a m9imum1 su* in=mation %all include ! in=mation specifi$ 9 p>agraph 7#b7 & %all be made available to su* p>ticipant or b5efici>y ?r\gh a self-s]vice tool t meets ! requirem5ts ( p>agraph 7#c7 or1 at ! option ( su* p>ticipant or b5efici>y1 ?r\gh a pap] disclosure or phone or o!r electronic disclosure 7z select$ by su* p>ticipant or b5efici>y & provid$ at no co/ to su* p>ticipant or b5efici>y7 t meets su* requirem5ts z ! ,secret>y may specify4 7#b7 ,specifi$ in=mation ,= purposes ( p>agraph 7#a71 ! in=mation specifi$ 9 ?is p>agraph is1 ) respect to an item or s]vice = :i* b5efits are available "u a gr\p heal? plan or gr\p heal? insurance cov]age furni%$ by a heal? c>e provid] to a p>ticipant or b5efici>y ( su* plan or cov]age1 ! foll[+3 7,a7 ,if su* provid] is a p>ticipat+ provid] ) respect to su* item or s]vice1 ! 9-network rate 7z def9$ 9 subsection 7c77 = su* item or s]vice4 7,b7 ,if su* provid] is n a p>ticipat+ provid] ) respect to su* item or s]vice1 ! maximum all[$ am\nt or o!r doll> am\nt t su* plan or cov]age w recognize z paym5t = su* item or s]vice1 along ) a notice t su* p>ticipant or b5efici>y may be liable = additional *>ges4 7,c7 ,! e/imat$ am\nt ( co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 t ! p>ticipant or b5efici>y w incur = su* item or s]vice 7:i*1 9 ! case su* item or s]vice is to be furni%$ by a provid] describ$ 9 subp>agraph 7,b71 %all be calculat$ us+ ! maximum all[$ am\nt or o!r doll> am\nt describ$ 9 su* subp>agraph74 7,d7 ,! am\nt ! p>ticipant or b5efici>y has already accumulat$ ) respect to any d$uctible or out ( pocket maximum "u ! plan or cov]age 7brok5 d[n1 9 ! case sep>ate d$uctibles or maximums apply to sep>ate p>ticipants & b5efici>ies enroll$ 9 ! plan or cov]age1 by su* sep>ate d$uctibles or maximums1 9 addition to any cumulative d$uctible or maximum74 7,e7 ,9 ! case su* plan imposes any frequ5cy or volume limitations ) respect to su* item or s]vice 7exclud+ m$ical necessity det]m9ations71 ! am\nt t su* p>ticipant or b5efici>y has accru$ t[>ds su* limitation ) respect to su* item or s]vice4 7,f7 ,any prior au?orization1 concurr5t review1 /ep !rapy1 fail fir/1 or simil> requirem5ts applicable to cov]age ( su* item or s]vice "u su* plan or cov]age4 7,g7 ,any %>$ sav+s 7su* z any cr$it1 paym5t1 or o!r b5efit provid$ by su* plan or issu]7 available to ! p>ticipant or b5efici>y ) respect to su* item or s]vice furni%$ by su* provid] kn[n at ! "t su* reque/ is made4 7#c7 ,self-s]vice tool ,= purposes ( p>agraph 7#a71 a self-s]vice tool e/abli%$ by a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age meets ! requirem5ts ( ?is p>agraph if su* tool-- 7,a7 is bas$ on an int]net website 7or successor te*nology specifi$ by ! ,secret>y72 7,b7 provides = real-"t responses to reque/s describ$ 9 p>agraph 7#a72 7,c7 is updat$ 9 a mann] su* t in=mation provid$ ?r\gh su* tool is timely & accurate at ! "t su* reque/ is made2 7,d7 all[s su* a reque/ to be made ) respect to an item or s]vice furni%$ by-- 7i7 a specific provid] t is a p>ticipat+ provid] ) respect to su* item or s]vice2 or 7ii7 all provid]s t are p>ticipat+ provid]s ) respect to su* item or s]vice2 7,e7 provides t su* a reque/ may be made ) respect to an item or s]vice ?r\gh use ( ! bill+ code = su* item or s]vice or ?r\gh use ( a descriptive t]m = su* item or s]vice2 & 7,f7 meets any o!r requirem5t det]m9$ appropriate by ! ,secret>y to ensure ! accessibility & usability ( in=mation provid$ ?r\gh su* tool4 ,! ,secret>y may require su* tool1 z a condition ( comply+ ) subp>agraph 7,e71 to l9k multiple bill+ codes to a s+le descriptive t]m if ! ,secret>y det]m9es t ! bill+ codes to be s l9k$ correspond to simil> items & s]vices4 7b7 ,rate & paym5t in=mation 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbf1 ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p heal? insurance cov]age 7o!r ?an a gr&fa!r$ heal? plan 7z def9$ 9 section #abea7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act77 %all1 = ea* mon?1 n lat] ?an ! t5? day ( su* mon?1 make available to ! public ! rate & paym5t in=mation describ$ 9 p>agraph 7#b7 9 accordance ) p>agraph 7#c74 7#b7 ,rate & paym5t in=mation describ$ ,= purposes ( p>agraph 7#a71 ! rate & paym5t in=mation describ$ 9 ?is p>agraph is1 ) respect to a gr\p heal? plan or gr\p heal? insurance cov]age1 ! foll[+3 7,a7 ,) respect to ea* item or s]vice 7o!r ?an a drug7 = :i* b5efits are available "u su* plan or cov]age1 ! 9-network rate 7express$ z a doll> am\nt7 9 effect z ( ! date on :i* su* in=mation is made public ) ea* provid] t is a p>ticipat+ provid] ) respect to su* item or s]vice4 7,b7 ,) respect to ea* drug 7id5tifi$ by national drug code7 = :i* b5efits are available "u su* plan or cov]age-- 7i7 ! 9-network rate 7express$ z a doll> am\nt7 9 effect z ( ! fir/ day ( ! mon? 9 :i* su* in=mation is made public ) ea* provid] t is a p>ticipat+ provid] ) respect to su* drug2 & 7ii7 ! av]age am\nt paid by su* plan 7net ( rebates1 disc\nts1 & price concessions7 = su* drug disp5s$ or adm9i/]$ dur+ ! #ij-;day p]iod beg9n+ #ahj days be=e su* date ( publication to ea* provid] t 0 a p>ticipat+ provid] ) respect to su* drug1 brok5 d[n by ea* su* provid]1 o!r ?an su* an am\nt paid to a provid] t1 dur+ su* p]iod1 submitt$ few] ?an #bj claims = su* drug to su* plan or cov]age4 7,c7 ,) respect to ea* item or s]vice = :i* b5efits are available "u su* plan or cov]age1 ! am\nt bill$1 & ! am\nt all[$ by ! plan1 = ea* su* item or s]vice furni%$ dur+ ! #ij-;day p]iod specifi$ 9 subp>agraph 7,b7 by a provid] t 0 n a p>ticipat+ provid] ) respect to su* item or s]vice1 brok5 d[n by ea* su* provid]4 7#c7 ,mann] ( publication ,rate & paym5t in=mation requir$ to be made available "u ?is subsection %all be s made available 9 doll> am\nts ?r\gh sep>ate ma*9e-readable files 7& any successor te*nology1 su* z application program int]face te*nology1 det]m9$ appropriate by ! ,secret>y7 correspond+ to ! in=mation describ$ 9 ea* ( subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b7 t meet su* requirem5ts z specifi$ by ! ,secret>y ?r\gh subregulatory guidance4 ,su* requirem5ts %all ensure t su* files are limit$ to an appropriate size1 d n include disclosure ( unnecess>y duplicative in=mation conta9$ 9 o!r files made available "u ?is subsection1 are made available 9 a widely available =mat ?r\gh a publicly available website t all[s = in=mation conta9$ 9 su* files to be comp>$ across gr\p heal? plans & gr\p or individual heal? insurance cov]age1 & are accessible to individuals at no co/ & )\t ! ne$ to e/abli% a us] acc\nt or provide o!r cr$5tials4 7#d7 ,us] in/ructions ,ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all make available to ! public in/ructions writt5 9 pla9 language expla9+ h[ individuals may se>* = in=mation describ$ 9 p>agraph 7#b7 9 files submitt$ 9 accordance ) p>agraph 7#c74 ,! ,secret>y %all develop & publi% ?r\gh subregulatory guidance a template t su* a plan may use 9 develop+ in/ructions = purposes ( ! prec$+ s5t5ce4 7#e7 ,summ>y ,= ea* plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbf1 ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all make public a data file1 9 a mann] t ensures t su* file may be easily d[nload$ & read by /&>d spread%eet s(tw>e & t meets su* requirem5ts z e/abli%$ by ! ,secret>y1 conta9+ a summ>y ( all rate & paym5t in=mation made public by su* plan or issu] ) respect to su* plan or cov]age dur+ su* plan ye>4 ,su* file %all include ! foll[+3 7,a7 ,! mean1 m$ian1 & int]qu>tile range ( ! 9-network rate1 & ! am\nt all[$ = an item or s]vice :5 n furni%$ by a p>ticipat+ provid]1 9 effect z ( ! fir/ day ( su* plan ye> = ea* item or s]vice 7id5tifi$ by pay] id5tifi] approv$ or us$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices7 = :i* b5efits are available "u ! plan or cov]age1 brok5 d[n by ! type ( provid] furni%+ ! item or s]vice & by ! geographic area 9 :i* su* item or s]vice is furni%$4 7,b7 ,tr5ds 9 paym5t rates = su* items & s]vices ov] su* plan ye>1 includ+ an id5tification ( in/ances 9 :i* su* rates h increas$1 decreas$1 or rema9$ ! same4 7,c7 ,! "n ( su* plan1 a description ( ! type ( network ( p>ticipat+ provid]s us$ by su* plan or cov]age1 &1 9 ! case ( a gr\p heal? plan1 a description ( :e!r su* plan is self-insur$ or fully-insur$4 7,d7 ,= ea* item or s]vice :i* is paid z "p ( a bundl$ rate-- 7i7 a description ( ! =mulae1 pric+ me?odologies1 or o!r in=mation us$ to calculate ! paym5t rate = su* bundle2 & 7ii7 a li/ ( ! items & s]vices includ$ 9 su* bundle4 7,e7 ,! p]c5tage ( items & s]vices t are paid = on a fee-=-s]vice basis & ! p]c5tage ( items & s]vices t are paid = z "p ( a bundl$ rate1 capitat$ paym5t rate1 or o!r alt]native paym5t model4 7#f7 ,atte/ation ,ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all po/1 along ) rate & paym5t in=mation made public by su* plan or issu]1 an atte/ation t su* in=mation is complete & accurate4 7c7 ,accessibility ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all take reasonable /eps 7z specifi$ by ! ,secret>y7 to ensure t in=mation provid$ 9 response to a reque/ describ$ 9 subsection 7a71 & rate & paym5t in=mation made public "u subsection 7b71 is provid$ 9 pla91 easily und]/&able language & t int]pretation1 translations1 & assi/ive s]vices are provid$ to ^? ) limit$ ,engli% pr(ici5cy & ^? ) disabilities4 7d7 ,def9itions ,9 ?is section3 7#a7 ,p>ticipat+ provid] ,! t]m p>ticipat+ provid] means1 ) respect to an item or s]vice & a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 a physician or o!r heal? c>e provid] :o is act+ )9 ! scope ( practice ( t provid]'s lic5se or c]tification "u applicable ,/ate law & :o has a contractual relation%ip ) ! plan or issu]1 respectively1 = furni%+ su* item or s]vice "u ! plan or cov]age1 & includes facilities1 respectively4 7#b7 ,provid] ,! t]m provid] includes a heal? c>e facility4 7#c7 ,9-network rate ,! t]m 9-network rate means1 ) respect to a gr\p heal? plan or gr\p heal? insurance cov]age & an item or s]vice furni%$ by a provid] t is a p>ticipat+ provid] ) respect to su* plan or cov]age & item or s]vice1 ! contract$ rate 7reflect$ z a doll> am\nt7 9 effect betwe5 su* plan or cov]age & su* provid] = su* item or s]vice1 reg>dless ( :e!r su* rate is calculat$ bas$ on a set am\nt1 a fee s*$ule1 or an am\nt d]iv$ f ano!r am\nt1 or a =mula1 or o!r me?od4 4 7,b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by /rik+ ! item relat+ to section #gai & ins]t+ ! foll[+ new item3 ,sec4 #gai4 ,transp>5cy 9 cov]age4 4 7b7 ,application programm+ int]face report ,n lat] ?an ,janu>y #a1 #bjbe1 & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 & /akehold]s1 submit to ! ,h\se ,committees on ,education & ! ,work=ce1 ,en]gy & ,comm]ce1 & ,ways & ,means1 & ! ,s5ate ,committees on ,f9ance & ,heal?1 ,education1 ,labor1 & ,p5sions a report on ! use ( /&>ds-bas$ application programm+ int]faces 79 ?is subsection ref]r$ to z ,a,p,is7 to facilitate access to heal? c>e price transp>5cy in=mation & ! int]op]ability ( o!r m$ical in=mation4 ,su* report %all include an evaluation ( ! capacity ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 & ! ,dep>tm5t ( ! ,treasury to regulate & implem5t /&>ds relat$ to ,a,p,is & recomm5dations = improv+ su* capacity4 ,su* report %all include ! foll[+3 7#a7 ,a description ( curr5t use1 & propos$ use1 ( ,a,p,is "u ,f$]al rules to facilitate int]op]ability1 includ+ in=mation relat$ to capacity con/ra9ts )9 ! ag5cies1 b>ri]s to adoption1 privacy & security1 adm9i/rative burd5s & effici5cies1 c>e coord9ation1 & levels ( compliance4 7#b7 ,a description ( ! feasibility ( ag5cy p>ticipation 9 ! developm5t ( ,a,p,is to enable application access to price transp>5cy data "u ! am5dm5ts made by subsection 7a74 7#c7 ,a specification ( ! timel9e = :i* su* data /&>ds c be requir$ to make su* data accessible via an ,,api4 7#d7 ,an analysis ( ! b5efits & *all5ges ( implem5t+ /&>ds-bas$ ,a,p,is = price transp>5cy data1 includ+ ! ability = consum]s to access rate & paym5t in=mation & ! am\nt ( co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 "u ! consum]'s plan ?r\gh ?ird-p>ty int]net-bas$ tools & applications4 7#e7 ,an analysis ( ! impact t ,a,p,is :i* provide real-"t access to pric+ & co/-%>+ in=mation may h 9 increas+ ! am\nt ( s]vices %oppable = individuals1 su* z by /&>diz+ m heal? c>e sp5d via episode bundles4 7#f7 ,an analysis ( :i* heal? c>e items & s]vices may be useful "u ,,api1 su* z ^? = :i* prices *ange ) ! greate/ frequ5cy4 7#g7 ,an analysis ( ! co/ ( ,,api /&>ds implem5tation on issu]s1 employ]s1 & o!r private-sector entities4 7#h7 ,an analysis ( ! ability ( ,/ate regulators to en=ce ,,api /&>ds & ! co/s to ! ,f$]al ,gov]nm5t & ,/ates to regulate & en=ce ,,api /&>ds4 7#i7 ,an analysis ( ! int]action ) ,,api /&>ds & ,f$]al heal? in=mation privacy /&>ds4 7c7 ,provid] tool report 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all1 9 consultation ) /akehold]s1 conduct a /udy & submit to ! ,h\se ,committees on ,education & ! ,work=ce1 ,en]gy & ,comm]ce1 & ,ways & ,means1 & ! ,s5ate ,committees on ,f9ance & ,heal?1 ,education1 ,labor1 & ,p5sions a report on ! usefulness & feasibility ( ! e/abli%m5t ( a provid] tool by a gr\p heal? plan1 or a heal? insurance issu] (f]+ gr\p & individual heal? insurance cov]age1 9 facilitat+ ! provision ( in=mation made available pursuant to ! am5dm5ts made by subsection 7a74 ,su* report %all include ! foll[+3 7,a7 ,a description ( ! feasibility ( e/abli%+ a requirem5t = ! v>i\s types ( plans & cov]age to (f] su* a provid] tool1 includ+ any *all5ges to e/abli%+ a provid] tool us+ ! same te*nology plat=m z ! self-s]vice tool describ$ 9 su* am5dm5ts4 7,b7 ,an evaluation on ! usefulness ( a provid] tool to aid pati5t-decision mak+ & h[ su* tool w\ld coord9ate ) o!r in=mation available to a pati5t & _! provid] "u o!r ,f$]al requirem5ts 9 place or "u consid]ation4 7,c7 ,an evaluation ( :e!r ! in=mation provid$ by su* tool w\ld be duplicative ( ! advanc$ explanation ( b5efits requir$ "u ,f$]al law or any o!r exi/+ requirem5t4 7,d7 ,a description ( ! usability & expect$ utilization ( su* tool among provid]s1 includ+ among diff]5t provid] types4 7,e7 ,an analysis ( ! impact ( a provid] tool 9 value-bas$ c>e arrangem5ts4 7,f7 ,an analysis on ! pot5tial impact ( ! provid] tool on-- 7i7 pati5ts' out-(-pocket sp5d+2 7ii7 plan design1 includ+ impacts on co/-%>+ requirem5ts2 7iii7 c>e coord9ation & quality2 7iv7 plan premiums2 7v7 ov]all heal? c>e sp5d+ & utilization2 & 7vi7 heal? c>e access 9 rural areas4 7,g7 ,an analysis ( ! feasibility ( a provid] tool to include additional functionality to facilitate & improve ! adm9i/ration ( ! requirem5ts on provid]s to submit notifications to su* plan or cov]age "u section #bgii;,b-#f ( ! ,public ,heal? ,s]vice ,act & ! requirem5ts on su* plan or cov]age to provide an advanc$ explanation ( b5efits to individuals "u section #bgii;,a-#a7;f7 ( su* ,act4 7,h7 ,an analysis ( :i* heal? c>e items & s]vices1 w\ld be mo/ useful = pati5ts utiliz+ a provid] tool4 7,i7 ,an analysis ( rulemak+ requir$ to ensure su* a tool complies ) f$]al heal? in=mation privacy /&>ds4 7,j7 ,an analysis ( ! burd5 & co/ ( ! creation ( a provid] tool by plans & cov]age on provid]s1 issu]s1 employ]s1 & o!r private-sector entities4 7,k7 ,an analysis ( ! ability ( /ate regulators to en=ce provid] tool /&>ds & ! co/s to ! ,dep>tm5t & /ates to regulate & en=ce provid] tool /&>ds4 7#b7 ,def9ition ,! t]m provid] tool means a tool design$ to facilitate ! provision ( in=mation made available pursuant to ! am5dm5ts made by subsection 7a7 & e/abli%$ by a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p & individual heal? insurance cov]age t all[s provid]s to access ! in=mation su* plan or cov]age mu/ provide ?r\gh ! self-s]vice tool describ$ 9 su* am5dm5ts to an individual ) :om ! provid] is actively treat+ at ! "t ( su* reque/1 ^u ! reque/ ( ! provid]1 & ) ! cons5t ( su* individual4 7d7 ,reports 7#a7 ,compliance ,n lat] ?an ,janu>y #a1 #bjbg1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+-- 7,a7 an analysis ( compliance ) ! am5dm5ts made by ?is section2 7,b7 an analysis ( en=cem5t ( su* am5dm5ts by ! ,secret>ies ( ,heal? & ,human ,s]vices1 ,labor1 & ! ,treasury2 7,c7 recomm5dations relat+ to improv+ su* en=cem5t2 & 7,d7 recomm5dations relat+ to improv+ public disclosure1 & public aw>5ess1 ( in=mation requir$ to be made available by gr\p heal? plans & heal? insurance issu]s pursuant to su* am5dm5ts4 7#b7 ,prices ,n lat] ?an ,janu>y #a1 #bjbh1 & bi5nially !reaft]1 ! ,secret>ies ( ,heal? & ,human ,s]vices1 ,labor1 & ! ,treasury %all jo9tly submit to ,congress a report conta9+ an assessm5t ( diff]5ces 9 negotiat$ prices 7& any tr5ds 9 su* prices7 9 ! private m>ket betwe5-- 7,a7 rural & urban areas2 7,b7 ! individual1 small gr\p1 & l>ge gr\p m>kets2 7,c7 consolidat$ & nonconsolidat$ heal? c>e provid] areas 7z specifi$ by ! ,secret>y ( ,heal? & ,human ,s]vices72 7,d7 nonpr(it & =-pr(it hospitals2 7,e7 nonpr(it & =-pr(it insur]s2 & 7,f7 insur]s s]v+ local or regional areas & insur]s s]v+ multi/ate or national areas4 7e7 ,quality report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>ies ( ,heal? & ,human ,s]vices1 ,labor1 & ! ,treasury %all jo9tly submit to ,congress a report on ! feasibility ( includ+ data relat+ to ! quality ( heal? c>e items & s]vices ) ! price transp>5cy in=mation requir$ to be made available "u ! am5dm5ts made by subsection 7a74 ,su* report %all include recomm5dations = legislative & regulatory actions to id5tify appropriate metrics = assess+ & comp>+ quality ( c>e4 7f7 ,cont9u$ applicability ( rules = previ\s ye>s ,no?+ 9 ! am5dm5ts made by subsection 7a7 may be con/ru$ z affect+ ! applicability ( ! rule entitl$ ,transp>5cy 9 ,cov]age publi%$ by ! ,dep>tm5t ( ! ,treasury1 ! ,dep>tm5t ( ,labor1 & ! ,dep>tm5t ( ,heal? & ,human ,s]vices on ,novemb] #ab1 #bjbj 7#he ,f$4 ,reg4 #gbaeh71 = any plan ye> beg9n+ be=e ,janu>y #a1 #bjbf4 #ajf4 ,ph>macy b5efits price transp>5cy 7a7 ,,phsa ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$-- 7#a7 9 "p ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,ov]sight ( ph>macy b5efits manag] s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is section1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity or subsidi>y provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or issu]1 %all n ent] into a contract ) a drug manufactur]1 di/ributor1 :olesal]1 subcontractor1 rebate aggregator1 or any o!r ?ird p>ty t limits 7or delays beyond ! applicable report+ p]iod describ$ 9 subsection 7b77#a77 ! disclosure ( in=mation to gr\p heal? plans 9 su* a mann] t prev5ts su* plan1 issu]1 or entity f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,) respect to plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is section1 n less frequ5tly ?an e #f mon?s 7or at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 b "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or issu]1 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 a ma*9e-readable =mat & %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age dur+ ea* report+ p]iod-- 7,a7 9 ! case ( su* a plan (f]$ by a specifi$ l>ge employ] 7or su* cov]age (f]$ 9 connection ) su* a plan (f]$ by a specifi$ l>ge employ]7-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! br& "n1 *emical entity1 & ,national ,drug ,code2 7,,ii7 ! type ( disp5s+ *annel us$ to furni% su* drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,iii7 ) respect to ea* drug disp5s$ "u ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants1 b5efici>ies1 & enrollees = :om a claim = su* drug 0 fil$2 7,,cc7 dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,iv7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan or cov]age aft] manufactur] rebates1 fees1 & o!r remun]ation or adju/m5ts2 7,v7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants1 b5efici>ies1 & enrollees on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7,,vi7 ! total net sp5d+ by ! plan or cov]age dur+ ! report+ p]iod2 7,,vii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or cov]age f any entity 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f an entity or any ?ird p>ty 7includ+ gr\p pur*as+ organizations7 o!r ?an ! plan sponsor2 7,,viii7 ! total am\nt receiv$1 or expect$ to be receiv$ by ! plan or issu]1 f drug manufactur]s 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 t has be5 paid1 or is to be paid1 by drug manufactur]s = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization rebates = su* drug2 & 7,,ix7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copay assi/ance on behalf ( su* drug manufactur]7 to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan or cov]age = su* drug2 7ii7 = ea* category or class ( drugs = :i* a claim 0 fil$1 a breakd[n ( ! total gross sp5d+ on drugs 9 su* category or class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f drug manufactur]s1 & ! net sp5d+ aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f drug manufactur]s1 includ+-- 7,i7 ! numb] ( p>ticipants1 b5efici>ies1 & enrollees :o fill$ a prescription = a drug 9 su* category or class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,ii7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t category or class2 & 7,,iii7 ! total out-(-pocket sp5d+ "u ! plan or cov]age by p>ticipants1 b5efici>ies1 & enrollees1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7iii7 9 ! case ( a drug = :i* gross sp5d+ by su* plan1 cov]age1 or entity exce$$ #aj1jjj dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic category or class2 & 7,,ii7 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 if applicable2 & 7iv7 9 ! case su* plan or cov]age 7or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age7 has an affiliat$ ph>macy or ph>macy "u common own]%ip-- 7,i7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to individuals enroll$ 9 su* plan or cov]age2 7,,ii7 a li/ ( all drugs disp5s$ by su* ph>macies to individuals enroll$ 9 su* plan or cov]age1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan or issu]1 & to p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan or cov]age2 7bb7 ! m$ian am\nt *>g$ to su* plan or issu]1 & ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants1 b5efici>ies1 & enrollees1 :5 ! same drug is disp5s$ by o!r ph>macies t are n affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( su* plan or cov]age2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan & p>ticipants1 b5efici>ies1 & enrollees1 t is available f any ph>macy includ$ 9 ! network ( su* plan or cov]age2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 7,b7 9 ! case ( a plan or cov]age n describ$ 9 subp>agraph 7,a7-- 7i7 ! total net sp5d+ by ! plan or cov]age = all drugs cov]$ by su* plan or cov]age dur+ su* report+ p]iod2 7ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or cov]age f any entity 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f an entity or any ?ird p>ty 7includ+ gr\p pur*as+ organizations7 o!r ?an ! plan sponsor = all su* drugs2 & 7iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copay assi/ance on behalf ( su* drug manufactur]7 to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan or cov]age = su* drugs2 7,c7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa7 ( ! ,employee ,retirem5t ,income ,security ,act7 to brok]s1 consultants1 advisors1 or any o!r individual or firm1 = ! ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to an entity provid+ ph>macy b5efits managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,d7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants1 b5efici>ies1 & enrollees 9 su* plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7,e7 total gross sp5d+ on all drugs dur+ ! report+ p]iod4 7#c7 ,privacy requirem5ts 7,a7 ,9 g5]al ,heal? insurance issu]s (f]+ gr\p heal? insurance cov]age & entities provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan %all provide in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy1 security1 & brea* notification regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,cl9ical ,heal? ,act & consi/5t ) ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy1 security1 & brea* notification regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation7 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act74 7#d7 ,disclosure & r$isclosure 7,a7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa ,privacy ,rule 7#de ,,cfr p>ts #afj & #afd1 subp>ts ,a & ,e74 7,b7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or cov]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates4 7,c7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to gr\p heal? plans :]e ! plan sponsors ( su* plans are drug manufactur]s1 drug :olesal]s1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,report to ,,gao ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age1 %all submit to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #d reports submitt$ to a gr\p heal? plan "u p>agraph 7#a7 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#c71 ! disclosure & r$isclosure /&>ds "u p>agraph 7#d71 ! /&>ds specifi$ pursuant to p>agraph 7#f71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #ajf7;d7 ( ! ,l[] ,co/s1 ,m ,transp>5cy ,act4 7#f7 ,/&>d =mat ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ /&>ds = gr\p heal? plans1 heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 & entities provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plans or cov]age1 requir$ to submit reports "u p>agraph 7#a7 to submit su* reports 9 a /&>d =mat4 7c7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y %all en=ce ?is section4 7#b7 ,failure to provide in=mation ,a heal? insurance issu] or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age t violates sub-section 7a7 or fails to provide ! in=mation requir$ "u subsection 7b7 %all be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7#c7 ,false in=mation ,a heal? insurance issu] or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or cov]age t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7#d7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u su* section4 7#e7 ,waiv]s ,! ,secret>y may waive p5alties "u p>agraph 7#b71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( ?is section t has made a good-fai? ef=t to comply ) ! requirem5ts 9 ?is section4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a gr\p heal? plan1 heal? insurance issu]1 or entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age1 to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsection 7a7 or 7b7 by entities subject to su* subsection4 7e7 ,def9itions ,9 ?is section3 7#a7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>4 7#b7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 2 & 7#b7 9 section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an subsections 7a7 & 7b7 ( section #bgii;,a-#aa7 aft] "p ,d2 & 7ii7 9 p>agraph 7#b71 by ins]t+ 7o!r ?an subsections 7a7 & 7b7 ( section #bgii;,a-#aa7 aft] "p ,d2 & 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an subsections 7a7 & 7b7 ( section #bgii;,a-#aa7 aft] "p ,d2 7ii7 9 p>agraph 7#b77;,a71 by ins]t+ 7o!r ?an subsections 7a7 & 7b7 ( section #bgii;,a-#aa7 aft] "p ,d2 & 7iii7 9 p>agraph 7#b77;,c77ii71 by ins]t+ 7o!r ?an subsections 7a7 & 7b7 ( section #bgii;,a-#aa7 aft] "p ,d4 7b7 ,,erisa 7#a7 ,9 g5]al ,subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is am5d$-- 7,a7 9 subp>t ,b ( "p #g 7#bi ,u4,s4,c4 #aahe et seq471 by add+ at ! end ! foll[+3 #gbf4 ,ov]sight ( ph>macy b5efit manag] s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is section1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity or subsidi>y provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or issu]1 %all n ent] into a contract ) a drug manufactur]1 di/ributor1 :olesal]1 subcontractor1 rebate aggregator1 or any o!r ?ird p>ty t limits 7or delays beyond ! applicable report+ p]iod describ$ 9 subsection 7b77#a77 ! disclosure ( in=mation to gr\p heal? plans 9 su* a mann] t prev5ts su* plan1 issu]1 or entity f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,) respect to plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is section1 n less frequ5tly ?an e #f mon?s 7or at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 b "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or issu]1 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 a ma*9e-readable =mat & %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age dur+ ea* report+ p]iod-- 7,a7 9 ! case ( su* a plan (f]$ by a specifi$ l>ge employ] 7or su* cov]age (f]$ 9 connection ) su* a plan (f]$ by a specifi$ l>ge employ]7-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! br& "n1 *emical entity1 & ,national ,drug ,code2 7,,ii7 ! type ( disp5s+ *annel us$ to furni% su* drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,iii7 ) respect to ea* drug disp5s$ "u ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$2 7,,cc7 dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,iv7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan or cov]age aft] manufactur] rebates1 fees1 & o!r remun]ation or adju/m5ts2 7,v7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants1 b5efici>ies1 & enrollees on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7,,vi7 ! total net sp5d+ by ! plan or cov]age dur+ ! report+ p]iod2 7,,vii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or cov]age f any entity 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f an entity or any ?ird p>ty 7includ+ gr\p pur*as+ organizations7 o!r ?an ! plan sponsor2 7,,viii7 ! total am\nt receiv$1 or expect$ to be receiv$ by ! plan or issu]1 f drug manufactur]s 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 t has be5 paid1 or is to be paid1 by drug manufactur]s = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization rebates = su* drug2 & 7,,ix7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copay assi/ance on behalf ( su* drug manufactur]7 to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan or cov]age = su* drug2 7ii7 = ea* category or class ( drugs = :i* a claim 0 fil$1 a breakd[n ( ! total gross sp5d+ on drugs 9 su* category or class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f drug manufactur]s1 & ! net sp5d+ aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f drug manufactur]s1 includ+-- 7,i7 ! numb] ( p>ticipants1 b5efici>ies1 & enrollees :o fill$ a prescription = a drug 9 su* category or class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,ii7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t category or class2 & 7,,iii7 ! total out-(-pocket sp5d+ "u ! plan or cov]age by p>ticipants1 b5efici>ies1 & enrollees1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7iii7 9 ! case ( a drug = :i* gross sp5d+ by su* plan1 cov]age1 or entity exce$$ #aj1jjj dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic category or class2 & 7,,ii7 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 if applicable2 & 7iv7 9 ! case su* plan or cov]age 7or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age7 has an affiliat$ ph>macy or ph>macy "u common own]%ip-- 7,i7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to individuals enroll$ 9 su* plan or cov]age2 7,,ii7 a li/ ( all drugs disp5s$ by su* ph>macies to individuals enroll$ 9 su* plan or cov]age1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan or issu]1 & to p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan or cov]age2 7bb7 ! m$ian am\nt *>g$ to su* plan or issu]1 & ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants1 b5efici>ies1 & enrollees1 :5 ! same drug is disp5s$ by o!r ph>macies t are n affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( su* plan or cov]age2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan & p>ticipants1 b5efici>ies1 & enrollees1 t is available f any ph>macy includ$ 9 ! network ( su* plan or cov]age2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 7,b7 9 ! case ( a plan or cov]age n describ$ 9 subp>agraph 7,a7-- 7i7 ! total net sp5d+ by ! plan or cov]age = all drugs cov]$ by su* plan or cov]age dur+ su* report+ p]iod2 7ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or cov]age f any entity 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f an entity or any ?ird p>ty 7includ+ gr\p pur*as+ organizations7 o!r ?an ! plan sponsor = all su* drugs2 & 7iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copay assi/ance on behalf ( su* drug manufactur]7 to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan or cov]age = su* drugs2 7,c7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa77 to brok]s1 consultants1 advisors1 or any o!r individual or firm1 = ! ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to an entity provid+ ph>macy b5efits managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,d7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants1 b5efici>ies1 & enrollees 9 su* plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7,e7 total gross sp5d+ on all drugs dur+ ! report+ p]iod4 7#c7 ,privacy requirem5ts 7,a7 ,9 g5]al ,heal? insurance issu]s (f]+ gr\p heal? insurance cov]age & entities provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan %all provide in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy1 security1 & brea* notification regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,cl9ical ,heal? ,act & consi/5t ) ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy1 security1 & brea* notification regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation7 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act74 7#d7 ,disclosure & r$isclosure 7,a7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa ,privacy ,rule 7#de ,,cfr p>ts #afj & #afd1 subp>ts ,a & ,e74 7,b7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or cov]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates4 7,c7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to gr\p heal? plans :]e ! plan sponsors ( su* plans are drug manufactur]s1 drug :olesal]s1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,report to ,,gao ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age1 %all submit to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #d reports submitt$ to a gr\p heal? plan "u p>agraph 7#a7 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#c71 ! disclosure & r$isclosure /&>ds "u p>agraph 7#d71 ! /&>ds specifi$ pursuant to p>agraph 7#f71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #ajf7;d7 ( ! ,l[] ,co/s1 ,m ,transp>5cy ,act4 7#f7 ,/&>d =mat ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ /&>ds = gr\p heal? plans1 heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 & entities provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plans or cov]age1 requir$ to submit reports "u p>agraph 7#a7 to submit su* reports 9 a /&>d =mat4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a gr\p heal? plan1 heal? insurance issu]1 or entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or cov]age1 to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y ( ,labor to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsection 7a7 or 7b7 by entities subject to su* subsection4 7d7 ,def9itions ,9 ?is section3 7#a7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>4 7#b7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 4 7,b7 9 section #ejb 7#bi ,u4,s4,c4 #aacb7-- 7i7 9 subsection 7b77#c71 by /rik+ "u subsection 7c77#i77 & ins]t+ "u p>agraphs 7#i7 & 7#ac7 ( subsection 7c772 & 7ii7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#ac7 ,secret>ial en=cem5t au?ority relat+ to ov]sight ( ph>macy b5efits manag] s]vices 7,a7 ,failure to provide in=mation ,! ,secret>y may impose a p5alty aga9/ any heal? insurance issu] or entity provid+ ph>macy b5efits managem5t s]vices t violates section #gbf7;a7 or fails to provide in=mation requir$ "u section #gbf7;b7 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7,b7 ,false in=mation ,! ,secret>y may impose a p5alty aga9/ a heal? insurance issu] or entity provid+ ph>macy b5efits managem5t s]vices t kn[+ly provides false in=mation "u section #gbf 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7,c7 ,waiv]s ,! ,secret>y may waive p5alties "u subp>agraph 7,a71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( section #gbf1 = an entity 9 violation ( su* section t has made a good-fai? ef=t to comply ) su* section4 4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is am5d$ by ins]t+ aft] ! item relat+ to section #gbe ! foll[+ new item3 ,sec4 #gbf4 ,ov]sight ( ph>macy b5efits manag] s]vices4 4 7c7 ,,irc 7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+3 #ihbf4 ,ov]sight ( ph>macy b5efit manag] s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is section1 a gr\p heal? plan1 or an entity or subsidi>y provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan1 %all n ent] into a contract ) a drug manufactur]1 di/ributor1 :olesal]1 subcontractor1 rebate aggregator1 or any o!r ?ird p>ty t limits 7or delays beyond ! applicable report+ p]iod describ$ 9 subsection 7b77#a77 ! disclosure ( in=mation to gr\p heal? plans 9 su* a mann] t prev5ts su* plan or entity f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,) respect to plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is section1 n less frequ5tly ?an e #f mon?s 7or at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 b "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 a gr\p heal? plan1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan1 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 a ma*9e-readable =mat & %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( su* a plan (f]$ by a specifi$ l>ge employ]-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! br& "n1 *emical entity1 & ,national ,drug ,code2 7,,ii7 ! type ( disp5s+ *annel us$ to furni% su* drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,iii7 ) respect to ea* drug disp5s$ "u ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants1 b5efici>ies1 & enrollees = :om a claim = su* drug 0 fil$2 7,,cc7 dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,iv7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan aft] manufactur] rebates1 fees1 & o!r remun]ation or adju/m5ts2 7,v7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants1 b5efici>ies1 & enrollees on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7,,vi7 ! total net sp5d+ by ! plan dur+ ! report+ p]iod2 7,,vii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan f any entity 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f an entity or any ?ird p>ty 7includ+ gr\p pur*as+ organizations7 o!r ?an ! plan sponsor2 7,,viii7 ! total am\nt receiv$1 or expect$ to be receiv$ by ! plan1 f drug manufactur]s 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 t has be5 paid1 or is to be paid1 by drug manufactur]s = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization rebates = su* drug2 & 7,,ix7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copay assi/ance on behalf ( su* drug manufactur]7 to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan = su* drug2 7ii7 = ea* category or class ( drugs = :i* a claim 0 fil$1 a breakd[n ( ! total gross sp5d+ on drugs 9 su* category or class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f drug manufactur]s1 & ! net sp5d+ aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f drug manufactur]s1 includ+-- 7,i7 ! numb] ( p>ticipants1 b5efici>ies1 & enrollees :o fill$ a prescription = a drug 9 su* category or class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,ii7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t category or class2 7,,iii7 ! total out-(-pocket sp5d+ "u ! plan by p>ticipants1 b5efici>ies1 & enrollees1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 & 7iii7 9 ! case ( a drug = :i* gross sp5d+ by su* plan or entity exce$$ #aj1jjj dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic category or class2 & 7,,ii7 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 if applicable2 & 7iv7 9 ! case su* plan 7or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan7 t has an affiliat$ ph>macy or ph>macy "u common own]%ip-- 7,i7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to individuals enroll$ 9 su* plan2 7,,ii7 a li/ ( all drugs disp5s$ by su* ph>macies to individuals enroll$ 9 su* plan1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan1 & to p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan2 7bb7 ! m$ian am\nt *>g$ to su* plan1 & ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants1 b5efici>ies1 & enrollees1 :5 ! same drug is disp5s$ by o!r ph>macies t are n affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( su* plan2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan & p>ticipants1 b5efici>ies1 & enrollees1 t is available f any ph>macy includ$ 9 ! network ( su* plan2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 7,b7 9 ! case ( a plan n describ$ 9 subp>agraph 7,a7-- 7i7 ! total net sp5d+ by ! plan = all drugs cov]$ by su* plan dur+ su* report+ p]iod2 7ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan f any entity 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f an entity or any ?ird p>ty 7includ+ gr\p pur*as+ organizations7 o!r ?an ! plan sponsor = all su* drugs2 & 7iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copay assi/ance on behalf ( su* drug manufactur]7 to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ 9 su* plan = su* drugs2 7,c7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa7 ( ! ,employee ,retirem5t ,income ,security ,act7 to brok]s1 consultants1 advisors1 or any o!r individual or firm1 = ! ref]ral ( ! gr\p heal? plan's bus9ess to an entity provid+ ph>macy b5efits managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,d7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants1 b5efici>ies1 & enrollees 9 su* plan to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices "u su* plan1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7,e7 total gross sp5d+ on all drugs dur+ ! report+ p]iod4 7#c7 ,privacy requirem5ts 7,a7 ,9 g5]al ,entities provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan %all provide in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy1 security1 & brea* notification regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,cl9ical ,heal? ,act & consi/5t ) ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy1 security1 & brea* notification regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation7 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act74 7#d7 ,disclosure & r$isclosure 7,a7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa ,privacy ,rule 7#de ,,cfr p>ts #afj & #afd1 subp>ts ,a & ,e74 7,b7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* a plan or cov]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates4 7,c7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to gr\p heal? plans :]e ! plan sponsors ( su* plans are drug manufactur]s1 drug :olesal]s1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,report to ,,gao ,a gr\p heal? plan1 or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan1 %all submit to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #d reports submitt$ to a gr\p heal? plan "u p>agraph 7#a7 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#c71 ! disclosure & r$isclosure /&>ds "u p>agraph 7#d71 ! /&>ds specifi$ pursuant to p>agraph 7#f71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #ajf7;d7 ( ! ,l[] ,co/s1 ,m ,transp>5cy ,act4 7#f7 ,/&>d =mat ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ /&>ds = gr\p heal? plans1 & entities provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plans1 requir$ to submit reports "u p>agraph 7#a7 to submit su* reports 9 a /&>d =mat4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a gr\p heal? plan or entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan1 to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y ( ,heal? & ,human ,s]vices to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a7 or 7b7 by entities subject to su* subsection4 7d7 ,def9itions ,9 ?is section3 7#a7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>4 7#b7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbf4 ,ov]sight ( ph>macy b5efits manag] s]vices4 4 7d7 ,,gao reports 7#a7 ,report on ph>macy network design 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on-- 7i7 ph>macy networks t h contract$ ) gr\p heal? plans1 heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 or entities provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plans or issu]s1 includ+ networks ) ph>macies t are "u common own]%ip 79 :ole or "p7 ) su* plans1 issu]s1 or entities 7includ+ entities t provide ph>macy b5efits adm9i/rative s]vices on behalf ( su* plans or issu]s72 7ii7 ph>macy network design p>amet]s t enc\rage individuals enroll$ 9 su* plans or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially own$ by a plan1 issu]1 or entity2 7iii7 :e!r su* plans & issu]s h options to elect diff]5t network pric+ arrangem5ts 9 ! m>ketplace ) entities t provide ph>macy b5efits managem5t s]vices & ! preval5ce ( elect+ su* diff]5t network pric+ arrangem5ts2 7iv7 ) respect to ph>macy networks t include ph>macies "u common own]%ip describ$ 9 clause 7i7-- 7,i7 :e!r su* networks are design$ to enc\rage individuals enroll$ 9 a gr\p heal? plan or heal? insurance cov]age to use su* ph>macies ov] o!r network ph>macies = specific s]vices or drugs1 & if s1 ! reasons ! networks give = enc\rag+ use ( su* ph>macies2 & 7,,ii7 :e!r su* ph>macies are us$ by enrollees disproportionately m 9 ! aggregate or = specific s]vices or drugs comp>$ to o!r network ph>macies2 7v7 ! degree to :i* mail ord]1 specialty1 or retail ph>macies t disp5se prescription drugs to an enrollee 9 a plan or cov]age t are "u common own]%ip 79 :ole or "p7 ) plans1 issu]s1 or entities provid+ ph>macy b5efits managem5t s]vices or ph>macy b5efits adm9i/rative s]vices on behalf ( su* plan or cov]age receive reimbursem5t t is great] ?an ! m$ian price *>g$ to ! plan or issu] :5 ! same drug is disp5s$ to enrollees 9 ! plan or cov]age by o!r ph>macies includ$ 9 ! ph>macy network ( t plan1 issu]1 or entity t are n :olly or p>tially own$ by ! plan or issu]1 or entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or issu]4 7,b7 ,requirem5t ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all ensure t ! report "u subp>agraph 7,a7 does n conta9 in=mation t w\ld id5tify a specific gr\p heal? plan or heal? insurance issu] 7or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( su* plan or issu]71 or o!rwise conta9 comm]cial or f9ancial in=mation t is privileg$ or confid5tial4 7,c7 ,def9itions ,9 ?is p>agraph1 ! t]ms gr\p heal? plan1 heal? insurance cov]age1 & heal? insurance issu] h ! mean+s giv5 su* t]ms 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74 7#b7 ,report on copay assi/ance programs ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on :at is kn[n ab\t ! role ( copay assi/ance programs & ! impact ( su* programs on comm]cial heal? insurance1 /op loss1 & drug prices4 ,su* report %all include to ! ext5t feasible-- 7,a7 a description ( copay assi/ance programs1 includ+-- 7i7 ! types ( programs available & ! me?ods ( provid+ copay assi/ance ?r\gh su* programs1 includ+ ca% disc\nts1 copay c>ds1 or drugs provid$ to an individual at no co/2 7ii7 h[ su* programs are fund$2 7iii7 ! types ( entities t own1 op]ate1 or o!rwise conduct su* programs1 ! types ( in=mation su* entities collect1 & ! direct & indirect contractual relation%ips betwe5 ! entities 9 ! drug supply *a9 t int]act ) su* programs1 su* z a drug manufactur]1 ph>macy1 :olesal]1 swit*1 rebate aggregator1 ph>macy b5efit manag]1 & o!r entities 9 ! drug supply *a92 7iv7 ! effect ( su* programs on pati5t out-(-pocket sp5d+1 includ+ = /op-loss insurance1 & drug utilization1 includ+ drug adh]5ce2 & 7v7 pati5t eligibility crit]ia = su* programs2 & 7,b7 an analysis (-- 7i7 ! s\rces ( fund+ = su* programs2 & 7ii7 ! effects ( su* programs on ,f$]al heal? c>e programs & ! individuals enroll$ 9 su* ,f$]al heal? c>e programs4 #ajg4 ,reports on heal? c>e transp>5cy tools & data 7a7 ,initial report ,n lat] ?an ,decemb] #ca1 #bjbd1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committees 7z def9$ 9 subsection 7d77 an initial report t-- 7#a7 id5tifies & describes heal? c>e transp>5cy tools & ,f$]al heal? c>e report+ requirem5ts 7z describ$ 9 subsection 7d77 t are 9 effect z ( ! date ( ! submission ( su* initial report1 includ+ ! frequ5cy ( reports ) respect to ea* su* requirem5t & :e!r any su* requirem5ts are duplicative2 7#b7 reviews h[ su* report+ requirem5ts are en=c$2 7#c7 analyzes :e!r ! public availability ( heal? c>e transp>5cy tools1 & ! publication ( data pursuant to su* report+ requirem5ts1 has-- 7,a7 be5 utiliz$ & valu$ by consum]s1 includ+ reasons = su* utilization 7or lack !re(72 & 7,b7 assi/$ heal? insurance plan sponsors & fiduci>ies improve b5efits1 l[] heal? c>e co/s = plan p>ticipants1 & meet fiduci>y requirem5ts2 7#d7 includes recomm5dations to ! ,committees1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury to-- 7,a7 improve ! effici5cy1 accuracy1 & usability ( heal? c>e transp>5cy tools2 7,b7 /reaml9e ,f$]al heal? c>e report+ requirem5ts to elim9ate duplicative requirem5ts & r$uce ! burd5 on entities requir$ to submit reports pursuant to su* provisions2 7,c7 improve ! accuracy & effici5cy ( su* reports :ile ma9ta9+ ! integrity & usability ( ! data provid$ by su* reports2 7,d7 address any gaps 9 data provid$ by su* reports2 & 7,e7 ensure t ! data & in=mation report$ is comp>able & usable to consum]s1 includ+ pati5ts1 plan sponsors1 & policy mak]s4 7b7 ,f9al report ,n lat] ?an ,decemb] #ca1 #bjbh1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committees a report t includes-- 7#a7 ! in=mation provid$ 9 ! initial report1 along ) any updates to su* in=mation2 & 7#b7 any new in=mation ) respect to heal? c>e transp>5cy tools t h be5 releas$ foll[+ ! submission ( su* initial report1 or new report+ requirem5ts 9 effect z ( ! date ( ! submission ( ! f9al report4 7c7 ,report on exp&+ price transp>5cy requirem5ts ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 heal? c>e provid] gr\ps1 & pati5t advocacy gr\ps1 %all submit to ! ,committees a report t includes recomm5dations to exp& price transp>5cy report+ requirem5ts to additional c>e sett+s1 ) an emphasis on sett+s :]e %oppable s]vices 7z def9$ 9 subsection 7d77 are furni%$4 7d7 ,def9itions ,9 ?is section3 7#a7 ,committees ,! t]m ,committees means ! ,committee on ,ways & ,means1 ! ,committee on ,en]gy & ,comm]ce1 & ! ,committee on ,education & ! ,work=ce ( ! ,h\se ( ,repres5tatives1 & ! ,committee on ,f9ance & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7#b7 ,f$]al heal? c>e report+ requirem5ts ,! t]m ,f$]al heal? c>e report+ requirem5ts includes regulatory & /atutory requirem5ts ) respect to ! report+ & publication ( heal? c>e price1 co/ access1 & quality data1 includ+ requirem5ts e/abli%$ by ! ,consolidat$ ,appropriations ,act ( #bjba 7,public ,law #aaf-bfj71 ?is ,act1 & o!r report+ & publication requirem5ts ) respect to transp>5cy 9 heal? c>e z id5tifi$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates4 7#c7 ,%oppable s]vice ,! t]m %oppable s]vice means a s]vice t c be s*$ul$ by a heal? c>e consum] 9 advance & includes all ancill>y items & s]vices cu/om>ily furni%$ z "p ( su* s]vice4 #ajh4 ,report on integration 9 ,m$ic>e 7a7 ,requir$ ,,ma & ,,pdp report+ 7#a7 ,,ma plans ,section #aheg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,requir$ disclosure ( c]ta9 in=mation relat+ to heal? c>e provid] own]%ip 7,a7 ,9 g5]al ,= plan ye> #bjbe & = e ?ird plan ye> !reaft]1 ea* applicable ,,ma organization (f]+ an ,,ma plan "u ?is "p dur+ su* plan ye> %all submit to ! ,secret>y1 at a "t & 9 a mann] specifi$ by ! ,secret>y-- 7i7 ! taxpay] id5tification numb] = ea* heal? c>e provid] t 0 a specifi$ heal? c>e provid] ) respect to su* organization dur+ su* ye>2 7ii7 ! total am\nt ( inc5tive-bas$ paym5ts made to1 & ! total am\nt ( %>$ losses rec\pm5ts collect$ f1 su* specifi$ heal? c>e provid]s dur+ su* plan ye>2 & 7iii7 ! total am\nt ( inc5tive-bas$ paym5ts made to1 & ! total am\nt ( %>$ losses rec\pm5ts collect$ f1 provid]s ( s]vices & suppli]s n describ$ 9 clause 7ii7 dur+ su* plan ye>4 7,b7 ,def9itions ,= purposes ( ?is p>agraph3 7i7 ,applicable ,,ma organization ,! t]m applicable ,,ma organization means1 ) respect to a plan ye>1 an ,,ma organization ) at lea/ #be1jjj individuals enroll$ "u ,m$ic>e ,advantage plans (f]$ by su* organization dur+ su* plan ye>4 7ii7 ,specifi$ heal? c>e provid] ,! t]m specifi$ heal? c>e provid] means1 ) respect to an applicable ,,ma organization & a plan ye>1 a provid] ( s]vices or suppli] ) respect to :i* su* organization 7or any p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c77 9 su* organization7 is a p]son ) an own]%ip or control int]e/ 7z s def9$74 4 7#b7 ,prescription drug plans ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,provision ( in=mation relat+ to ph>macy own]%ip 7,a7 ,9 g5]al ,= plan ye> #bjbe & = e ?ird plan ye> !reaft]1 ea* ,,pdp sponsor (f]+ a prescription drug plan "u ?is "p dur+ su* plan ye> %all submit to ! ,secret>y1 at a "t & 9 a mann] specifi$ by ! ,secret>y1 ! taxpay] id5tification numb] & ,national ,provid] ,id5tifi] = ea* ph>macy t 0 a specifi$ ph>macy ) respect to su* sponsor dur+ su* ye>4 7,b7 ,def9ition ,= purposes ( ?is p>agraph1 ! t]m specifi$ ph>macy means1 ) respect to an ,,pdp sponsor (f]+ a prescription drug plan & a plan ye>1 a ph>macy ) respect to :i*-- 7i7 su* sponsor 7or any p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c77 9 su* sponsor7 is a p]son ) an own]%ip or control int]e/ 7z s def9$72 or 7ii7 a ph>macy b5efit manag] (f]+ s]vices "u su* plan 7or any p]son ) an own]%ip or control int]e/ 7z s def9$7 9 su* sponsor7 is a p]son ) an own]%ip or control int]e/ 7z s def9$74 4 7b7 ,med,p,a,c reports ,"p ,e ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex et seq471 z am5d$ by section #aja1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #ahii;,d4 ,reports on v]tical integration "u ,m$ic>e 7a7 ,9 g5]al ,n lat] ?an ,june #ae1 #bjbi1 & e #c ye>s !reaft]1 ! ,m$ic>e ,paym5t ,advisory ,commission %all submit to ,congress a report on ! /ate ( v]tical integration 9 ! heal? c>e sector dur+ ! applicable ye> ) respect to entities p>ticipat+ 9 ! ,m$ic>e program1 includ+ heal? c>e provid]s1 ph>macies1 prescription drug plan sponsors1 ,m$ic>e ,advantage organizations1 & ph>macy b5efit manag]s4 ,su* report %all include-- 7#a7 ) respect to ,m$ic>e ,advantage organizations1 ! evaluation describ$ 9 subsection 7b72 7#b7 ) respect to prescription drug plans1 ph>macy b5efit manag]s1 & ph>macies1 ! comp>isons & evaluations describ$ 9 subsection 7c72 7#c7 ) respect to ,m$ic>e ,advantage plans "u :i* b5efits are available = physician-adm9i/]$ drugs1 ! in=mation describ$ 9 subsection 7d72 7#d7 ! id5tifications describ$ 9 subsection 7e72 & 7#e7 an analysis ( ! impact ( su* integration on heal? c>e access1 price1 quality1 & outcomes4 7b7 ,m$ic>e ,advantage organizations ,= purposes ( subsection 7a77#a71 ! evaluation describ$ 9 ?is subsection is1 ) respect to ,m$ic>e ,advantage organizations & an applicable ye>1 an evaluation1 tak+ into acc\nt pati5t acuity & ! types ( areas s]vic$ by su* organization1 (-- 7#a7 ! av]age numb] ( qualify+ diagnoses made dur+ su* ye> ) respect to enrollees ( a ,m$ic>e ,advantage plan (f]$ by su* organization :o1 dur+ su* ye>1 receiv$ a heal? risk assessm5t f a specifi$ heal? c>e provid]2 7#b7 ! av]age risk score = su* enrollees :o receiv$ su* an assessm5t dur+ su* ye>2 7#c7 any relation%ip betwe5 su* risk scores = su* enrollees receiv+ su* an assessm5t f su* a provid] dur+ su* ye> & inc5tive paym5ts made to su* provid]s2 7#d7 ! av]age risk score = enrollees ( su* plan :o receiv$ any item or s]vice f a specifi$ heal? c>e provid] dur+ su* ye>2 7#e7 any relation%ip betwe5 ! risk scores ( enrollees "u su* plan & :e!r ! enrollees h receiv$ any item or s]vice f a specifi$ provid]2 & 7#f7 any relation%ip betwe5 ! risk scores ( enrollees "u su* plan t h receiv$ any item or s]vice f a specifi$ provid] & inc5tive paym5ts made "u ! plan to specifi$ provid]s4 7c7 ,prescription drug plans ,= purposes ( subsection 7a77#b71 ! comp>isons & evaluations describ$ 9 ?is subsection are1 ) respect to prescription drug plans & an applicable ye>1 ! foll[+3 7#a7 ,= ea* cov]$ "p ,d drug = :i* b5efits are available "u su* a plan1 a comp>ison ( ! av]age negotiat$ rate 9 effect ) specifi$ ph>macies ) su* rates 9 effect = 9-network ph>macies t are n specifi$ ph>macies4 7#b7 ,comp>isons ( ! foll[+3 7,a7 ,! total am\nt paid by ph>macy b5efit manag]s to specifi$ ph>macies = cov]$ "p ,d drugs & ! total am\nt s paid to ph>macies t are n specifi$ ph>macies = su* drugs4 7,b7 ,! total am\nt paid by su* sponsors to specifi$ ph>macy b5efit manag]s z reimbursem5t = cov]$ "p ,d drugs & ! total am\nt s paid to ph>macy b5efit manag]s t are n specifi$ ph>macy b5efit manag]s z su* reimbursem5t4 7,c7 ,fees paid "u by plan to specifi$ ph>macy b5efit manag]s comp>$ to su* fees paid to ph>macy b5efit manag]s t are n specifi$ ph>macy b5efit manag]s4 7#c7 ,an evaluation ( ! total am\nt ( direct & indirect remun]ation = cov]$ "p ,d drugs pass$ ?r\gh to prescription drug plan sponsors & ! total am\nt reta9$ by ph>macy b5efit manag]s 7includ+ entities "u contract ) su* a manag]74 7#d7 ,to ! ext5t t ! available data p]mits1 an evaluation ( fees *>g$ by rebate aggregators t are affiliat$ ) plan sponsors4 7d7 ,physician-adm9i/]$ drugs ,= purposes ( subsection 7a77#c71 ! in=mation describ$ 9 ?is subsection is1 ) respect to physician-adm9i/]$ drugs = :i* b5efits are available "u a ,m$ic>e ,advantage plan dur+ an applicable ye>1 ! foll[+3 7#a7 ,) respect to ea* su* plan1 an id5tification ( ea* drug = :i* b5efits 7 available "u su* plan only :5 adm9i/]$ by a heal? c>e provid] t acquir$ su* drug f an affiliat$ ph>macy4 7#b7 ,an evaluation ( ! diff]5ce betwe5 ! total numb] ( drugs adm9i/]$ by a heal? c>e provid] t 7 acquir$ f affiliat$ ph>macies comp>$ to ! numb] ( su* drugs s adm9i/]$ t 7 acquir$ f ph>macies o!r ?an affiliat$ ph>macies1 & an evaluation ( ! diff]5ce 9 paym5ts = su* drugs s adm9i/]$ :5 acquir$ f a specifi$ ph>macy & :5 acquir$ f a ph>macy t is n a specifi$ ph>macy4 7#c7 ,an evaluation ( ! doll> value ( all su* drugs t 7 n s adm9i/]$ because ( a delay attributable to an affiliat$ ph>macy comp>$ to ! doll> value ( all su* drugs t 7 n s adm9i/]$ because ( a delay attributable to ph>macy t is n an affiliat$ ph>macy4 7#d7 ,! numb] ( enrollees adm9i/]$ su* a drug t 0 acquir$ f an affiliat$ ph>macy4 7#e7 ,! numb] ( enrollees furni%$ su* a drug t 0 acquir$ f a ph>macy t is n an affiliat$ ph>macy4 7e7 ,id5tifications ,= purposes ( subsection 7a77#d71 ! id5tifications describ$ 9 ?is subsection are1 ) respect to an applicable ye>1 id5tifications ( ea* heal? c>e entity p>ticipat+ "u ! ,m$ic>e program ) respect to :i* ano!r heal? c>e entity s p>ticipat+ is a p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c774 7f7 ,def9itions ,9 ?is section3 7#a7 ,affiliat$ ph>macy ,! t]m affiliat$ ph>macy means1 ) respect to a ,m$ic>e ,advantage plan (f]$ by a ,m$ic>e ,advantage organization1 a ph>macy ) respect to :i* su* organization 7or any p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c77 9 su* organization7 is a p]son ) an own]%ip or control int]e/ 7z s def9$74 7#b7 ,applicable ye> ,! t]m applicable ye> means1 ) respect to a report submitt$ "u subsection 7a71 ! fir/ cal5d> ye> beg9n+ at lea/ #d ye>s prior to ! date ( ! submission ( su* report4 7#c7 ,cov]$ "p ,d drug ,! t]m cov]$ "p ,d drug has ! mean+ giv5 su* t]m 9 section #ahfj;,d-#b7;e74 7#d7 ,direct & indirect remun]ation ,! t]m direct & indirect remun]ation has ! mean+ giv5 su* t]m 9 section #dbc4cjh ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#e7 ,qualify+ diagnosis ,! t]m qualify+ diagnosis means1 ) respect to an enrollee ( a ,m$ic>e ,advantage plan1 a diagnosis t is tak5 into acc\nt 9 calculat+ a risk score = su* enrollee "u ! risk adju/m5t me?odology e/abli%$ by ! ,secret>y pursuant to section #ahec7;a77#c74 7#f7 ,risk score ,! t]m risk score means1 ) respect to an enrollee ( a ,m$ic>e ,advantage plan1 ! score calculat$ = su* individual us+ ! me?odology describ$ 9 p>agraph 7#e74 7#g7 ,physician-adm9i/]$ drug ,! t]m physician-adm9i/]$ drug means a drug furni%$ to an individual t1 _h su* individual be5 enroll$ "u "p ,b & n enroll$ "u "p ,c1 w\ld h be5 payable "u section #ahdb7o74 7#h7 ,specifi$ heal? c>e provid] ,! t]m specifi$ heal? c>e provid] means1 ) respect to a ,m$ic>e ,advantage plan (f]$ by a ,m$ic>e ,advantage organization1 a heal? c>e provid] ) respect to :i* su* organization 7or any p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c77 9 su* organization7 is a p]son ) an own]%ip or control int]e/ 7z s def9$74 7#i7 ,specifi$ ph>macy ,! t]m specifi$ ph>macy means1 ) respect to a prescription drug plan (f]$ by a prescription drug plan sponsor1 a ph>macy ) respect to :i*-- 7,a7 su* sponsor 7or any p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c77 9 su* sponsor7 is a p]son ) an own]%ip or control int]e/ 7z s def9$72 or 7,b7 a ph>macy b5efit manag] (f]+ s]vices "u su* plan 7or any p]son ) an own]%ip or control int]e/ 7z s def9$7 9 su* sponsor7 is a p]son ) an own]%ip or control int]e/ 7z s def9$74 7#aj7 ,specifi$ ph>macy b5efit manag] ,! t]m specifi$ ph>macy b5efit manag] means1 ) respect to a prescription drug plan (f]$ by a prescription drug plan sponsor1 a ph>macy b5efit manag] ) respect to :i* su* sponsor 7or any p]son ) an own]%ip or control int]e/ 7z def9$ 9 section #aabd7;a77#c77 9 su* sponsor7 is a p]son ) an own]%ip or control int]e/ 7z s def9$74 4 #aji4 ,advisory ,committee 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbe1 ! ,secret>y ( ,labor1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all jo9tly conv5e an advisory committee 79 ?is section ref]r$ to z ! committee7 consi/+ ( #i memb]s to advise ! ,secret>ies on h[ to improve ! usefulness1 accessibility1 & usability ( in=mation made available 9 accordance ! am5dm5ts made by sections #aje & #ajf1 & by section #bjd ( division ,,bb ( ! ,consolidat$ ,appropriation ,act1 #bjba 7,public ,law #aaf-bfj71 /reaml9e ! report+ ( su* in=mation1 & ensure t-- 7#a7 su* in=mation is accurate1 accessible1 & is deliv]$ 9 a =m & mann] consi/5t ) ! requirem5ts ( su* section2 7#b7 ! =m & mann] 9 :i* su* in=mation is deliv]$ is r\t9ely updat$ 9 accordance ) widely-us$ practices 9 ord] to ensure accessibility2 & 7#c7 su* in=mation is available = audit 7includ+ by mak+ recomm5dations relat+ to h[ ,f$]al & ,/ate actors may conduct su* audits74 7b7 ,memb]%ip ,! ,secret>ies %all jo9tly appo9t memb]s repres5t+ end-us]s ( ! in=mation describ$ 9 subsection 7a74 ,vacancies on ! committee %all be fill$ by appo9tm5t consi/5t ) ?is subsection n lat] ?an #c mon?s aft] ! vacancy arises4 7c7 ,t]m9ation ,! committee %all t]m9ate on ,janu>y #a1 #bjbh4 7d7 ,nonapplicaiton ( ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all n apply to ! committee4 #aaj4 ,report on impact ( ,m$ic>e regulations on provid] & pay] consolidation 7a7 ,annual report on ! impact ( c]ta9 ,m$ic>e regulations on provid] & pay] consolidation2 public comm5t on provid] & pay] consolidation = c]ta9 propos$ rules 7#a7 ,annual report ,n lat] ?an ,decemb] #cj1 #bjbf1 & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all submit to ,congress a report on ! impact 9 ! aggregate on provid] & pay] consolidation ) respect to regulations = p>ts ,a1 ,b1 ,c1 & ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 implem5t$ 9 ! cal5d> ye> imm$iately prior to su* report4 ,su* report %all include regulations t-- 7,a7 implem5t a *ange to an applicable paym5t sy/em1 a rate s*$ule1 or ano!r paym5t sy/em "u "p ,a1 ,b1 ,c1 or ,d ( su* title2 or 7,b7 result 9 a significant rule effect+ provid] or pay] consolidation4 7#b7 ,public comm5t on impact to provid] & pay] consolidation ,beg9n+ = #bjbe1 z "p ( any notice & comm5t rulemak+ process t w result 9 a significant rule effect+ provid] or pay] consolidation ) respect to a propos$ rule = p>ts ,a1 ,b1 ,c1 & ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 ! ,secret>y %all seek public comm5t on ! project$ impact ( su* propos$ rule on provid] & pay] consolidation 9 ! aggregate4 7#c7 ,def9itions ,9 ?is section3 7,a7 ,provid] & pay] consolidation ,! t]m provid] & pay] consolidation includes ! v]tical or horizontal integration among provid]s ( s]vices 7z def9$ 9 subsection 7u7 ( section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex771 suppli]s 7z def9$ 9 subsection 7d7 ( su* section71 acc\ntable c>e organizations "u section #ahii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj71 ,m$ic>e ,advantage organizations1 ,,pdp sponsors1 ph>macy b5efit manag]s1 ph>macies1 & integrat$ deliv]y sy/ems4 7,b7 ,applicable paym5t sy/em ,! t]m applicable paym5t sy/em includes-- 7i7 ) respect to outpati5t hospital s]vices1 ! prospective paym5t sy/em = cov]$ ,,opd s]vices e/abli%$ "u section #ahcc7t7 ( su* ,act 7#db ,u4,s4,c4 #acie7l772 & 7ii7 ) respect to physicians' s]vices1 ! physician fee s*$ules e/abli%$ "u section #ahdh ( su* ,act 7#db ,u4,s4,c4 #aciew-#d74 7b7 ,consid]ation ( effects on provid] & pay] consolidation ) respect to ,,cmi models 7#a7 ,9 g5]al ,section #aaae;,a7b77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#d77;,a77 is am5d$-- 7,a7 9 clause 7i71 by /rik+ at ! end &2 7,b7 9 clause 7ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7iii7 ! ext5t to :i*1 & h[1 ! model has effect$ & c\ld effect provid] & pay] consolidation1 :i* includes ! v]tical or horizontal integration among provid]s ( s]vices 7z def9$ 9 subsection 7u7 ( section #ahfa71 suppli]s 7z def9$ 9 subsection 7d7 ( su* section71 & acc\ntable c>e organizations "u section #ahii4 4 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply ) respect to models te/$ on or aft] ,janu>y #a1 #bjbe4 #aaa4 ,implem5tation fund+ 7a7 ,9 g5]al ,= ! purposes describ$ 9 subsection 7b71 !re are appropriat$1 9 addition to am\nts o!rwise available1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 to ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 #fe1jjj1jjj = fiscal ye> #bjbd1 to rema9 available ?r\gh fiscal ye> #bjbi4 7b7 ,p]mitt$ purposes ,! purposes describ$ 9 ?is subsection are ! foll[+ purposes1 ins(> z su* purposes are to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is title3 7#a7 ,prep>+1 draft+1 & issu+ propos$ & f9al regulations or int]im regulations4 7#b7 ,prep>+1 draft+1 & issu+ guidance & public in=mation4 7#c7 ,prep>+1 draft+1 & publi%+ reports4 7#d7 ,en=cem5t ( su* provisions4 7#e7 ,report+1 collection1 & analysis ( data4 7#f7 ,o!r adm9i/rative duties necess>y = implem5tation ( su* provisions4 7c7 ,transp>5cy ( implem5tation funds ,ea* ,secret>y describ$ 9 subsection 7a7 %all annually submit1 no lat] ?an ,septemb] #a/ ( ea* ye>1 to ! ,committees on ,en]gy & ,comm]ce1 on ,ways & ,means1 on ,education & ,work=ce1 & on ,appropriations ( ! ,h\se ( ,repres5tatives & on ! ,committees on ,heal?1 ,education1 ,labor1 & ,p5sions & on ,appropriations ( ! ,s5ate a report on funds exp5d$ pursuant to funds appropriat$ "u ?is section4 ,,ii ,r$uc+ ,heal? ,c>e ,co/s = ,pati5ts #bja4 ,increas+ transp>5cy 9 g5]ic drug applications 7a7 ,9 g5]al ,section #eje7;j77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#c77 is am5d$ by add+ at ! end ! foll[+3 7,h7 7i7 ,^u reque/ 79 controll$ correspond5ce or an analog\s process7 by a p]son t has submitt$ or int5ds to submit an abbreviat$ application "u ?is subsection = a drug t is requir$ by regulation to conta9 "o or m ( ! same inactive +r$i5ts 9 ! same conc5trations z ! li/$ drug ref]r$ to1 or = :i* ! ,secret>y det]m9es !re is a sci5tific ju/ification = an approa* t is 9 vitro 9 :ole or 9 "p to be us$ to demon/rate bioequival5ce = a drug if su* a drug conta9s "o or m ( ! same inactive +r$i5ts 9 ! same conc5trations z ! li/$ drug1 ! ,secret>y %all in=m ! p]son :e!r su* drug is qualitatively & quantitatively ! same z ! li/$ drug4 ,! ,secret>y may also provide su* in=mation to su* a p]son on ! ,secret>y's own initiative dur+ ! review ( an abbreviat$ application "u ?is subsection = su* drug4 7ii7 ,not)/&+ section #cja7;j71 if ! ,secret>y det]m9es t su* drug is n qualitatively or quantitatively ! same z ! li/$ drug1 ! ,secret>y %all id5tify & disclose to ! p]son-- 7,i7 ! +r$i5t or +r$i5ts t cause su* drug n to be qualitatively or quantitatively ! same z ! li/$ drug2 & 7,,ii7 = any +r$i5t = :i* !re is an id5tifi$ quantitative deviation1 ! am\nt ( su* deviation4 7iii7 ,if ! ,secret>y det]m9es t su* drug is qualitatively & quantitatively ! same z ! li/$ drug1 ! ,secret>y %all n *ange or resc9d su* det]m9ation aft] ! submission ( an abbreviat$ application = su* drug "u ?is subsection unless-- 7,i7 ! =mulation ( ! li/$ drug has be5 *ang$ & ! ,secret>y has det]m9$ t ! prior li/$ drug =mulation 0 )drawn = reasons ( safety or effectiv5ess2 or 7,,ii7 ! ,secret>y makes a writt5 det]m9ation t ! prior det]m9ation mu/ be *ang$ because an error has be5 id5tifi$4 7iv7 ,if ! ,secret>y makes a writt5 det]m9ation describ$ 9 clause 7iii77,,ii71 ! ,secret>y %all provide notice & a copy ( ! writt5 det]m9ation to ! p]son mak+ ! reque/ "u clause 7i74 7v7 ,! disclosures requir$ by ?is subp>agraph are disclosures au?oriz$ by law1 includ+ = purposes ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7b7 ,guidance 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue draft guidance1 or update guidance1 describ+ h[ ! ,secret>y w det]m9e :e!r a drug is qualitatively & quantitatively ! same z ! li/$ drug 7z su* t]ms are us$ 9 section #eje7;j77#c77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a771 includ+ ) respect to assess+ p,h adju/]s4 7#b7 ,process ,9 issu+ guidance "u ?is subsection1 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7,a7 publi% draft guidance2 7,b7 provide a p]iod ( at lea/ #fj days = comm5t on ! draft guidance2 & 7,c7 aft] consid]+ any comm5ts receiv$ & n lat] ?an "o ye> aft] ! close ( ! comm5t p]iod on ! draft guidance1 publi% f9al guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 applies beg9n+ on ! date ( enactm5t ( ?is ,act1 irrespective ( ! date on :i* ! guidance requir$ by subsection 7b7 is f9aliz$4 #bjb4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid 7a7 ,spread pric+ 7#a7 ,9 g5]al ,section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,ph>macy price reimbursem5t requir$ 7,a7 ,9 g5]al ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 79 ?is p>agraph ref]r$ to z a ,,pbm71 or a contract betwe5 ! ,/ate & a designat$ entity 7z def9$ 9 subp>agraph 7,c77 t includes provisions mak+ ! designat$ entity responsible = ! adm9i/ration ( m$ical assi/ance consi/+ ( cov]$ outpati5t drugs = individuals enroll$ ) ! designat$ entity1 %all require t paym5t = su* drugs & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or designat$ entity1 is bas$ on a ph>macy price reimbursem5t model "u :i*-- 7i7 any paym5t made by ! designat$ entity or ! ,,pbm 7z applicable7 = su* a drug-- 7,i7 is limit$ to-- 7aa7 +r$i5t co/2 & 7bb7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate plan or waiv] w\ld pay if ! plan or waiv] 0 mak+ ! paym5t directly2 7,,ii7 is pass$ ?r\gh 9 its entirety by ! designat$ entity or ,,pbm to ! ph>macy or provid] t disp5ses ! drug & is n retroactively d5i$ or r$uc$ except z p]mitt$ or requir$ "u ,f$]al or ,/ate law or regulation2 & 7,,iii7 is made 9 a mann] t is consi/5t ) sections #ddg4ejb1 #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 z if su* requirem5ts appli$ directly to ! designat$ entity or ! ,,pbm1 except t any paym5t by ! designat$ entity or ! ,,pbm = ! +r$i5t co/ ( su* a drug pur*as$ by a cov]$ entity 7z def9$ 9 subsection 7a77#e77;,b77 may exce$ ! actual acquisition co/ 7z def9$ 9 section #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation77 = su* drug if-- 7aa7 su* drug 0 subject to an agreem5t "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 7bb7 su* paym5t = su* co/ ( su* drug does n exce$ ! maximum paym5t t w\ld h be5 made by ! designat$ entity or ! ,,pbm = ! +r$i5t co/ ( su* drug _h su* drug n be5 pur*as$ by su* a cov]$ entity2 & 7cc7 su* cov]$ entity reports to ! ,secret>y1 on an annual basis 79 a =m & mann] specifi$ by ! ,secret>y7 & ) respect to paym5ts = su* co/s ( su* drugs s pur*as$ by su* cov]$ entity t are 9 excess ( ! actual acquisition co/s = su* drugs1 ! aggregate am\nt ( su* excess2 7ii7 paym5t to ! designat$ entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! designat$ entity or ,,pbm is limit$ to an adm9i/rative fee t reflects ! fair m>ket value ( provid+ su* s]vices2 7iii7 ! designat$ entity or ! ,,pbm 7z applicable7 makes available to ! ,/ate1 & ! ,secret>y ^u reque/1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices incurr$1 receiv$1 or made by ! designat$ entity or ! ,,pbm1 includ+ +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees1 po/-sale & po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all o!r remun]ation2 & 7iv7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! designat$ entity or ! ,,pbm 7z applicable7 is 9 excess ( ! am\nt paid to ! ph>macies by ! designat$ entity or ! ,,pbm1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts 7aft] all[+ = a fair m>ket adm9i/rative fee z describ$ 9 clause 7ii771 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 7,b7 ,mak+ c]ta9 in=mation available ,! ,secret>y %all publi%1 n less frequ5tly ?an on an annual basis1 in=mation receiv$ by ! ,secret>y pursuant to subp>agraph 7,a77i77,,iii77cc74 ,su* in=mation %all be s publi%$ 9 an electronic & se>*able =mat1 su* z ?r\gh ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor sy/em74 7,c7 ,def9itions ,9 ?is p>agraph3 7i7 ,designat$ entity ,! t]m designat$ entity means a manag$ c>e entity or o!r specifi$ entity4 7ii7 ,manag$ c>e entity2 o!r specifi$ entity ,! t]ms manag$ c>e entity & o!r specifi$ entity h ! mean+ giv5 su* t]ms 9 section #aijc7m77#i77;,d74 4 7#b7 ,con=m+ am5dm5ts ,section #aijc7m7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$-- 7,a7 9 p>agraph 7#b77;,a77xiii7-- 7i7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 7ii7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,,iv7 ) respect to cov]$ outpati5t drugs & relat$ adm9i/rative s]vices 7z applicable7 provid$ by ! entity 7or by a ph>macy b5efit manag] on behalf ( ! entity "u a contract or o!r arrangem5t ) ! entity71 t paym5t = su* drugs & relat$ adm9i/rative s]vices is bas$ on a ph>macy price reimbursem5t model describ$ 9 section #aibg7;e77#f77;,a72 & 7iii7 by mov+ ! m>g9 #b ems to ! left2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,no paym5t %all be made "u ?is title to a ,/ate ) respect to exp5ditures incurr$ by x = paym5t = s]vices provid$ by an o!r specifi$ entity 7z def9$ 9 p>agraph 7#i77;,d77 unless ! contract betwe5 ! ,/ate & ! entity = ! provision ( su* s]vices provides1 ) respect to cov]$ outpati5t drugs & relat$ adm9i/rative s]vices 7z applicable7 provid$ by ! entity 7or by a ph>macy b5efit manag] on behalf ( ! entity "u a contract or o!r arrangem5t ) ! entity71 t paym5t = su* drugs & relat$ adm9i/rative s]vices is bas$ on a ph>macy price reimbursem5t model describ$ 9 section #aibg7;e77#f77;,a74 4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection apply to contracts betwe5 ,/ates & ph>macy b5efit manag]s & designat$ entities 7z def9$ 9 section #aibg7;e77#f7 ( ! ,social ,security ,act1 z add$ by p>agraph 7#a77 t h an effective date beg9n+ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7b7 ,ensur+ accurate paym5ts to ph>macies "u ,m$icaid 7#a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7,a7 by /rik+ & aft] ! semicolon at ! end ( p>agraph 7#a77;,a77i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,det]m9+ ph>macy actual acquisition co/s ,! ,secret>y %all conduct a survey ( retail community ph>macy drug prices to det]m9e ! national av]age drug acquisition co/ z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs bas$ on a mon?ly survey ( su* ph>macies2 & 2 7,b7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,a ,/ate %all require t any retail community ph>macy 9 ! ,/ate t receives any paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 or rebate relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 or rebate is receiv$ f ! ,/ate or a designat$ entity 7z def9$ 9 subsection 7e77#f77;,c77 directly or f a ph>macy b5efit manag] t has a contract ) ! ,/ate or a designat$ entity1 %all respond to surveys ( retail prices conduct$ "u ?is subsection4 7,g7 ,survey in=mation ,in=mation on national drug acquisition prices obta9$ "u ?is p>agraph %all be made publicly available 9 a timely mann] foll[+ ! collection ( su* in=mation & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate to ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ frame & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,in=mation on price concessions to ! ph>macy1 includ+ disc\nts1 rebates1 & o!r price concessions1 to ! ext5t t su* in=mation may be publicly releas$ & is available dur+ ! survey p]iod4 7,h7 ,report on specialty ph>macies ,n lat] ?an #a ye> aft] ! date t ?is subp>agraph takes effect1 ! ,secret>y %all submit to ,congress a report exam9+ specialty drug cov]age & reimbursem5t "u ?is title1 includ+-- 7i7 a description ( h[ ,/ate ,m$icaid programs def9e specialty drugs & specialty ph>macies2 7ii7 ! am\nt ,/ate ,m$icaid programs pay = specialty drugs2 7iii7 h[ ,/ates & designat$ entities 7z def9$ 9 subsection 7e77#f77;,c77 det]m9e paym5t = specialty drugs2 7iv7 ! sett+s 9 :i* specialty drugs are disp5s$ to individuals receiv+ b5efits "u ?is title 7su* z retail community ph>macies or specialty ph>macies72 7v7 ! ext5t to :i* specialty drugs 7z def9$ by ! respective ,/ates7 are captur$ 9 ! national av]age drug acquisition co/ survey 7or ?r\gh ano!r process72 7vi7 examples ( specialty drug disp5s+ fees to support ! s]vices associat$ ) disp5s+ su* specialty drugs2 & 7vii7 recomm5dations z to :e!r specialty ph>macies %\ld be includ$ 9 ! survey ( retail prices to ensure national av]age drug acquisition co/s capture drugs sold at specialty ph>macies1 & h[ su* specialty ph>macies %\ld be def9$4 7,i7 ,en=cem5t ,at ! discretion ( ! ,secret>y1 ! ,secret>y 7act+ ?r\gh ! ,inspector ,g5]al & 9 collaboration ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices7 may en=ce non-compliance ) ?is p>agraph by a ph>macy ?r\gh ! e/abli%m5t ( p5alties until compliance ) ?is p>agraph has be5 complet$4 2 & 7,c7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 7includ+ paym5t rates "u manag$ c>e organization z def9$ 9 section #aicb7;a77#a77;,b77i7 & ,p,i,h,ps & ,p,a,h,ps z def9$ 9 section #aijc7m77#i77;,d77iii77,i7 & 7,,ii71 respectively7 aft] "u ?is title2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 & ! basis = su* disp5s+ fees be=e ! semicolon at ! end4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 #bjc4 ,p>ity 9 ,m$ic>e paym5ts = hospital outpati5t dep>tm5t s]vices furni%$ (f-campus 7a7 ,9 g5]al ,section #ahcc7t77#af7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#af77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,h7 ,p>ity 9 fee s*$ule am\nt = c]ta9 s]vices furni%$ by an (f-campus outpati5t dep>tm5t ( a provid] 7i7 ,9 g5]al ,subject to clause 7iii71 9 ! case ( specifi$ ,,opd s]vices 7z def9$ 9 clause 7v77 t are furni%$ dur+ #bjbe or a subsequ5t ye> by an (f-campus outpati5t dep>tm5t ( a provid] 7z def9$ 9 clause 7iv77 7or1 9 ! case ( an (f-campus outpati5t dep>tm5t ( a provid] t is a hospital describ$ 9 section #ahhf7;d77#a77;,b77v71 or is locat$ 9 a rural area or a heal? pr(essional %ortage area1 su* s]vices t are furni%$ dur+ #bjbf or a subsequ5t ye>71 !re %all be sub/itut$ = ! am\nt o!rwise det]m9$ "u ?is subsection = su* s]vice & ye> an am\nt equal to ! paym5t am\nt t w\ld h be5 payable "u ! applicable paym5t sy/em "u ?is "p 7o!r ?an "u ?is subsection7 _h su* s]vices be5 furni%$ by su* a dep>tm5t subject to su* paym5t sy/em pursuant to p>agraph 7#ba77;,c74 7ii7 ,n budget neutral implem5tation ,9 mak+ any budget neutrality adju/m5ts "u ?is subsection = #bjbe or a subsequ5t ye>1 ! ,secret>y %all n take into acc\nt ! r$uc$ exp5ditures t result f ! application ( ?is subp>agraph4 7iii7 ,transition ,! ,secret>y %all provide = a #d-ye> phase-9 ( ! application ( clause 7i71 ) clause 7i7 be+ fully applicable = specifi$ ,,opd s]vices beg9n+ ) #bjbh 7or 9 ! case ( an (f-campus outpati5t dep>tm5t ( a provid] t is a hospital describ$ 9 section #ahhf7;d77#a77;,b77v71 or is locat$ 9 a rural area or a heal? pr(essional %ortage area1 beg9n+ ) #bjbi74 7iv7 ,(f-campus dep>tm5t ( a provid] ,= purposes ( ?is subp>agraph1 ! t]m (f-campus outpati5t dep>tm5t ( a provid] means a dep>tm5t ( a provid] 7z def9$ 9 section #dac4fe7;a77#b7 ( title #db1 ,code ( ,f$]al ,regulations7 t is n locat$-- 7,i7 on ! campus 7z su* t]m is def9$ 9 su* section7 ( su* provid]2 or 7,,ii7 )9 ! di/ance 7describ$ 9 su* def9ition ( campus7 f a remote location ( a hospital facility 7z def9$ 9 su* section74 7v7 ,o!r def9itions ,= purposes ( ?is subp>agraph3 7,i7 ,designat$ ambulatory paym5t classification gr\p ,! t]m designat$ ambulatory paym5t classification gr\p means an ambulatory paym5t classification gr\p = drug adm9i/ration s]vices4 7,,ii7 ,heal? pr(essional %ortage area ,! t]m heal? pr(essional %ortage area has ! mean+ giv5 su* t]m 9 section #ccb7;a77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act4 7,,iii7 ,rural area ,! t]m rural area has ! mean+ giv5 su* t]m 9 section #ahhf7;d77#b77;,d74 7,,iv7 ,specifi$ ,,opd s]vices ,! t]m specifi$ ,,opd s]vices means cov]$ ,,opd s]vices assign$ to a designat$ ambulatory paym5t classification gr\p4 4 7b7 ,implem5tation ,section #ahcc7t77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ab77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ! det]m9ation ( any paym5t am\nt "u p>agraph 7#af77;,h71 includ+ ! transition "u clause 7iii7 ( su* p>agraph4 4 #bjd4 ,requir+ a sep>ate id5tification numb] & an atte/ation = ea* (f-campus outpati5t dep>tm5t ( a provid] 7a7 ,9 g5]al ,section #ahcc7t7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#bc7 ,use ( unique heal? id5tifi]s2 atte/ation 7,a7 ,9 g5]al ,no paym5t may be made "u ?is subsection 7or "u an applicable paym5t sy/em pursuant to p>agraph 7#ba77 = items & s]vices furni%$ on or aft] ,janu>y #a1 #bjbf1 by an (f-campus outpati5t dep>tm5t ( a provid] 7z def9$ 9 subp>agraph 7,c77 unless-- 7i7 su* dep>tm5t has obta9$1 & su* items & s]vices are bill$ "u1 a /&>d unique heal? id5tifi] = heal? c>e provid]s 7z describ$ 9 section #aagc7;b77 t is sep>ate f su* id5tifi] = su* provid]2 & 7ii7 su* provid] has submitt$ to ! ,secret>y1 dur+ ! #b-ye> p]iod end+ on ! date su* items & s]vices are s furni%$1 an atte/ation t su* dep>tm5t is compliant ) ! requirem5ts describ$ 9 section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation74 7,b7 ,process = submission & review ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 e/abli% a process = ea* provid] ) an (f-campus outpati5t dep>tm5t ( a provid] to submit an atte/ation pursuant to subp>agraph 7,a77ii71 & = ! ,secret>y to review ea* su* atte/ation & det]m9e1 ?r\gh site visits1 remote audits1 or o!r means 7z det]m9$ appropriate by ! ,secret>y71 :e!r su* dep>tm5t is compliant ) ! requirem5ts describ$ 9 su* subp>agraph4 7,c7 ,(f-campus outpati5t dep>tm5t ( a provid] def9$ ,= purposes ( ?is p>agraph1 ! t]m (f-campus outpati5t dep>tm5t ( a provid] means a dep>tm5t ( a provid] 7z def9$ 9 section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation7 t is n locat$-- 7i7 on ! campus 7z def9$ 9 su* section7 ( su* provid]2 or 7ii7 )9 ! di/ance 7describ$ 9 su* def9ition ( campus7 f a remote location ( a hospital facility 7z def9$ 9 su* section74 4 7b7 ,,hhs ,,oig analysis ,n lat] ?an ,janu>y #a1 #bjcj1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all submit to ,congress-- 7#a7 an analysis ( ! process e/abli%$ by ! ,secret>y ( ,heal? & ,human ,s]vices to conduct ! reviews & det]m9ations describ$ 9 section #ahcc7t77#bc77;,b7 ( ! ,social ,security ,act1 z add$ by subsection 7a7 ( ?is section2 & 7#b7 recomm5dations bas$ on su* analysis1 z ! ,inspector ,g5]al det]m9es appropriate4 ,,iii ,support+ ,pati5ts1 ,heal? ,c>e ,work]s1 ,community ,heal? ,c5t]s1 & ,hospitals #cja4 ,ext5sion = community heal? c5t]s1 ! national heal? s]vice corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs 7a7 ,tea*+ heal? c5t]s t op]ate graduate m$ical education programs 7#a7 ,addition to capp$ am\nts = fiscal ye>s #bjbd & #bjbe ,p>agraph 7#b7 ( section #cdj;,h7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;h7b77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,addition ,not)/&+ any provision ( ?is section1 = ea* ( fiscal ye>s #bjbd & #bjbe1 ! ,secret>y may use any am\nts made available 9 any fiscal ye> to c>ry out ?is section 7includ+ am\nts rec\p$ "u subsection 7f77 to make paym5ts describ$ 9 p>agraphs 7#a77;,a7 & 7#a77;,b71 9 addition to ! total am\nt ( funds appropriat$ "u subsection 7g74 4 7#b7 ,reconciliation ,section #cdj;,h7f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;h7f77 is am5d$-- 7,a7 by /rik+ ,! ,secret>y %all det]m9e & ins]t+ ! foll[+3 7#a7 ,det]m9ation ,! ,secret>y %all det]m9e 2 & 7,b7 by add+ at ! end ! foll[+3 7#b7 ,annual report to ,congress ,= ea* fiscal ye>1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report specify+-- 7,a7 ! total am\nt ( funds rec\p$ "u p>agraph 7#a72 7,b7 ! rationale = ! funds be+ rec\p$2 & 7,c7 9 ! case ( ! reports = ea* ( fiscal ye>s #bjbd & #bjbe1 ! total am\nt ( funds rec\p$ "u p>agraph 7#a7 t 7 us$ pursuant to subsection 7b77#b77;,c7 to adju/ total paym5t am\nts above ! total am\nts appropriat$ "u subsection 7g74 4 7#c7 ,fund+ ,section #cdj;,h7g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;h7g77 is am5d$-- 7,a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,9 g5]al ,to c>ry out ?is section1 !re are appropriat$ su* sums z may be necess>y1 n to exce$-- 7,a7 #bcj1jjj1jjj1 = ! p]iod ( fiscal ye>s #bjaa ?r\gh #bjae2 7,b7 #fj1jjj1jjj = ea* ( fiscal ye>s #bjaf & #bjag2 7,c7 #abf1ejj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbc2 7,d7 #af1fce1faf = ! p]iod beg9n+ on ,octob] #a1 #bjbc1 & end+ on ,novemb] #ag1 #bjbc2 7,e7 #ba1hcd1bdg = ! p]iod beg9n+ on ,novemb] #ah1 #bjbc1 & end+ on ,janu>y #ai1 #bjbd2 7,f7 #acf1ecj1acg = ! p]iod beg9n+ on ,janu>y #bj1 #bjbd1 & end+ on ,septemb] #cj1 #bjbd2 7,g7 #age1jjj1jjj = fiscal ye> #bjbe2 7,h7 #bbe1jjj1jjj = ea* ( fiscal ye>s #bjbf & #bjbg2 & 7,i7 #cjj1jjj1jjj = ea* ( fiscal ye>s #bjbh1 #bjbi1 & #bjcj4 2 & 7,b7 by add+ at ! end ! foll[+3 7#c7 ,availability ,! am\nts made available "u p>agraph 7#a7 %all rema9 available until exp5d$4 4 7b7 ,ext5sion = community heal? c5t]s ,section #ajejc7;b77#a77;,f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is am5d$-- 7#a7 by /rik+ & be=e #fij1daj1iei2 & 7#b7 by ins]t+ 1 #c1ahc1efa1fdd = ! p]iod beg9n+ on ,janu>y #bj1 #bjbd1 & end+ on ,septemb] #cj1 #bjbd1 #d1djj1jjj1jjj = fiscal ye> #bjbe1 & #a1aji1jjj1jjj = ! p]iod beg9n+ ,octob] #a1 #bjbe1 & end+ ,decemb] #ca1 #bjbe be=e ! semicolon at ! end4 7c7 ,ext5sion = ! ,national ,heal? ,s]vice ,corps ,section #ajejc7;b77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,h71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,i71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,j7 #bee1gbf1jbh = ! p]iod beg9n+ on ,janu>y #bj1 #bjbd1 & end+ on ,septemb] #cj1 #bjbd1 #cej1jjj1jjj = fiscal ye> #bjbe1 & #hh1bai1agh = ! p]iod beg9n+ ,octob] #a1 #bjbe1 & end+ ,decemb] #ca1 #bjbe4 4 7d7 ,gov]nm5t ,acc\ntability ,(fice report 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report assess+ ! effectiv5ess ( ! ,national ,heal? ,s]vice ,corps at attract+ heal? c>e pr(essionals to ,h,p,s,as1 includ+ by-- 7,a7 assess+ ! metrics us$ by ! ,heal? ,res\rces & ,s]vices ,adm9i/ration 9 evaluat+ ! program2 7,b7 comp>+ ! ret5tion rates ( ,,nhsc p>ticipants 9 ! ,h,p,s,as :]e !y complet$ _! p]iod ( obligat$ s]vice to ! ret5tion rate ( non-,,nhsc p>ticipants 9 ! correspond+ ,h,p,s,as2 7,c7 comp>+ ! ret5tion rates ( ,,nhsc p>ticipants 9 ! ,h,p,s,as :]e !y complet$ _! p]iod ( obligat$ s]vice to ! ret5tion rates ( ,,nhsc p>ticipants 9 ,h,p,s,as o!r ?an ^? :]e !y complet$ _! p]iod ( obligat$ s]vice2 7,d7 id5tify+ factors t influ5ce a ,,nhsc p>ticipant's decision to practice 9 a ,,hpsa o!r ?an ! ,,hpsa :]e !y complet$ _! p]iod ( obligat$ s]vice2 7,e7 id5tify+ factors o!r ?an p>ticipation 9 ! ,national ,heal? ,s]vice ,corps ,s*ol>%ip & ,loan ,repaym5t ,programs t attract heal? c>e pr(essionals to a ,,hpsa2 7,f7 assess+ ! impact ! ,national ,heal? ,s]vice ,corps has on wages = heal? c>e pr(essionals 9 a ,,hpsa2 & 7,g7 comp>+ ! di/ribution ( ,,nhsc p>ticipants across ,h,p,s,as1 includ+ a comp>ison ( rural v]sus non-rural ,h,p,s,as4 7#b7 ,def9ition ,9 ?is section3 7,a7 ,! t]m ,,hpsa means a heal? pr(essional %ortage area designat$ "u section #ccb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;e74 7,b7 ,! t]m ,,nhsc p>ticipant means a ,national ,heal? ,s]vice ,corps memb] p>ticipat+ 9 ! ,national ,heal? ,s]vice ,corps ,s*ol>%ip or ,loan ,repaym5t ,program4 7e7 ,application ( provisions ,am\nts appropriat$ pursuant to ! am5dm5ts made by ?is section %all be subject to ! requirem5ts conta9$ 9 ,public ,law #aag-cbh = funds = programs au?oriz$ "u sections #ccj ?r\gh #cdj ( ! ,public ,heal? ,s]vice ,act4 7f7 ,con=m+ am5dm5t ,p>agraph 7#d7 ( section #cjad7;h7 ( title #ah1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ & section #bcba7;d7 ( ! ,cont9u+ ,appropriations ,act1 #bjbd & ,o!r ,ext5sions ,act & ins]t+ section #bcba7;d7 ( ! ,cont9u+ ,appropriations ,act1 #bjbd & ,o!r ,ext5sions ,act1 & section #cja7;e7 ( ! ,l[] ,co/s1 ,m ,transp>5cy ,act4 #cjb4 ,ext5sion ( special diabetes programs 7a7 ,ext5sion ( special diabetes programs = type i diabetes ,section #ccj;,b7b77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 #abd1chc1efb = ! p]iod beg9n+ on ,janu>y #bj1 #bjbd1 & end+ on ,septemb] #cj1 #bjbd1 to rema9 available until exp5d$2 7,g7 #agj1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$2 & 7,h7 #db1hdi1cae = ! p]iod beg9n+ ,octob] #a1 #bjbe1 & end+ ,decemb] #ca1 #bjbe1 to rema9 available until exp5d$4 4 7b7 ,ext5d+ fund+ = special diabetes programs = ,indians ,section #ccj;,c7c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 #abd1chc1efb = ! p]iod beg9n+ on ,janu>y #bj1 #bjbd1 & end+ on ,septemb] #cj1 #bjbd1 to rema9 available until exp5d$2 7,g7 #agj1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$2 & 7,h7 #db1hdi1cae = ! p]iod beg9n+ ,octob] #a1 #bjbe1 & end+ ,decemb] #ca1 #bjbe1 to rema9 available until exp5d$4 4 #cjc4 ,delay+ c]ta9 disproportionate %>e paym5t cuts ,section #aibc7;f77#g77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;f77#g77;,a77 is am5d$-- 7#a7 9 clause 7i7-- 7,a7 by /rik+ ,= ! p]iod beg9n+ ,janu>y #bj1 #bjbd1 & end+ ,septemb] #cj1 #bjbd1 & = ea* ( fiscal ye>s #bjbe & ins]t+ ,= ea* ( fiscal ye>s #bjbf2 & 7,b7 by /rik+ or p]iod ea* place su* t]m appe>s2 & 7#b7 9 clause 7ii71 by /rik+ = ! p]iod beg9n+ ,janu>y #bj1 #bjbd1 & end+ ,septemb] #cj1 #bjbd1 & = ea* ( fiscal ye>s #bjbe & ins]t+ = ea* ( fiscal ye>s #bjbf4 #cjd4 ,m$icaid improvem5t fund ,section #aida7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifw-#a7;b77#c77;,a77 is am5d$ by /rik+ #f1ceg1aag1haj & ins]t+ #j4 ,,iv ,increas+ access to quality heal? data & l[]+ hidd5 fees #dja4 ,increas+ ,plan ,fiduci>ies' ,access to ,heal? ,data 7a7 ,plan fiduci>y access to in=mation 7#a7 ,9 g5]al ,p>agraph 7#b7 ( section #djh7;b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,no contract or arrangem5t = s]vices betwe5 a gr\p heal? plan & any o!r entity1 includ+ a heal? c>e provid] 7includ+ a heal? c>e facility71 network or association ( provid]s1 s]vice provid] (f]+ access to a network ( provid]s1 ?ird-p>ty adm9i/rator1 or ph>macy b5efit manag]1 is reasonable )9 ! mean+ ( ?is p>agraph unless su* contract or arrangem5t-- 7i7 all[s ! responsible plan fiduci>y 7z def9$ 9 subp>agraph 7,b77ii77,i77ee77 to audit or review all de-id5tifi$ claims & enc\nt] in=mation or data describ$ 9 section #gbd7;a77#a77;,b7 to-- 7,i7 ensure t su* entity complies ) ! t]ms ( ! plan & any applicable law2 & 7,,ii7 det]m9e ! reasonabl5ess ( comp5sation receiv$ by su* entity2 & 7ii7 does n-- 7,i7 unreasonably limit ! numb] ( audits p]mitt$ dur+ a giv5 p]iod ( "t2 7,,ii7 limit ! numb] ( de-id5tifi$ claims & enc\nt] in=mation or data t ! responsible plan fiduci>y may access dur+ an audit2 7,,iii7 limit ! disclosure ( pric+ t]ms = value-bas$ paym5t arrangem5ts or capitat$ paym5t arrangem5ts1 includ+-- 7aa7 paym5t calculations & =mulas2 7bb7 quality measures2 7cc7 contract t]ms2 7dd7 paym5t am\nts2 7ee7 measurem5t p]iods = all inc5tives2 & 7ff7 o!r paym5t me?odologies us$ by an entity1 includ+ a heal? c>e provid] 7includ+ a heal? c>e facility71 network or association ( provid]s1 s]vice provid] (f]+ access to a network ( provid]s1 ?ird-p>ty adm9i/rator1 or ph>macy b5efit manag]2 7,,iv7 limit ! disclosure ( ov]paym5ts & ov]paym5t recov]y t]ms2 7,v7 limit ! "r ( ! responsible plan fiduci>y to select an auditor2 7,,vi7 o!rwise limit or unduly delay by great] ?an #fj cal5d> days aft] ! date ( reque/ ! responsible plan fiduci>y f audit+ all de-id5tifi$ claims & enc\nt] in=mation or data2 or 7,,vii7 p]mit ! entity to *>ge a fee beyond ! reasonable direct co/s to provide ! requir$ in=mation & o!rwise comply & assi/ ) an audit reque/4 4 7#b7 ,civil en=cem5t 7,a7 ,9 g5]al ,subsection 7c7 ( section #ejb ( su* ,act 7#bi ,u4,s4,c4 #aacb7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ac7 ,9 ! case ( an agreem5t betwe5 a gr\p heal? plan & a heal? c>e provid] 7includ+ a heal? c>e facility71 network or association ( provid]s1 s]vice provid] (f]+ access to a network ( provid]s1 ?ird-p>ty adm9i/rator1 or ph>macy b5efit manag]1 t violates ! provisions ( section #gbd1 ! ,secret>y may assess a civil p5alty aga9/ su* provid]1 network or association1 s]vice provid] (f]+ access to a network ( provid]s1 ?ird-p>ty adm9i/rator1 ph>macy b5efit manag]1 or o!r s]vice provid] 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues4 ,su* p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 4 7,b7 ,con=m+ am5dm5t ,p>agraph 7#f7 ( section #ejb7;a7 ( su* ,act is am5d$ by /rik+ or 7#i7 & ins]t+ 7#i71 or 7#ac74 7#c7 ,exi/+ provisions void ,section #daj ( su* ,act is am5d$ by add+ at ! end ! foll[+ new subsection3 7c7 ,any provision 9 an agreem5t or in/rum5t %all be void z aga9/ public policy if su* provision-- 7#a7 unduly delays or limits a plan fiduci>y f access+ ! de-id5tifi$ claims & enc\nt] in=mation or data describ$ 9 section #gbd7;a77#a77;,b72 or 7#b7 violates ! requirem5ts ( section #djh7;b77#b77;,c74 4 7b7 ,updat$ atte/ation = price & quality in=mation ,section #gbd7;a77#c7 ( ! ,employee ,retirem5t ,income ,security ,act 7#bi ,u4,s4,c4 #aahem7a77#c77 is am5d$ to read z foll[s3 7#c7 ,atte/ation 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! plan fiduci>y ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all annually submit to ! ,secret>y an atte/ation t su* plan or issu] ( su* cov]age is 9 compliance ) ! requirem5ts ( ?is subsection4 ,su* atte/ation %all also include a /atem5t v]ify+ t-- 7i7 ! in=mation or data describ$ "u subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 is available ^u reque/ & provid$ to ! plan fiduci>y1 ! plan adm9i/rator1 or ! issu] 9 a timely mann]2 & 7ii7 !re are no t]ms 9 ! agreem5t "u su* p>agraph 7#a7 t directly or indirectly re/rict or unduly delay a plan fiduci>y1 ! plan adm9i/rator1 or ! issu] f audit+1 review+1 or o!rwise access+ su* in=mation1 except z p]mitt$ "u section #djh7;b77#b77;,c74 7,b7 ,limitation on submission ,subject to clause 7ii71 a gr\p heal? plan or issu] (f]+ gr\p heal? insurance cov]age may n ent] into an agreem5t ) a ?ird-p>ty adm9i/rator or o!r s]vice provid] to submit ! atte/ation requir$ "u subp>agraph 7,a74 7,c7 ,exception ,9 ! case ( a gr\p heal? plan or issu] (f]+ gr\p heal? insurance cov]age t is unable to obta9 ! in=mation or data ne$$ to submit ! atte/ation requir$ "u subp>agraph 7,a71 su* plan or issu] may submit a writt5 /atem5t 9 lieu ( su* atte/ation t includes-- 7i7 an explanation ( :y su* plan or issu] 0 unsuccessful 9 obta9+ su* in=mation or data1 includ+ :e!r su* plan or issu] 0 limit$ or prev5t$ f audit+1 review+1 or o!rwise access+ su* in=mation or data2 7ii7 a description ( ! ef=ts made by ! plan fiduci>y to remove any gag clause provisions f ! agreem5t "u p>agraph 7#a72 & 7iii7 a description ( any response by ! ?ird-p>ty adm9i/rator or o!r s]vice provid] ) respect to ef=ts to comply ) ! atte/ation requirem5t "u subp>agraph 7,a74 4 7c7 ,report on plan assets ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,labor %all submit to ! ,committee on ,education & ! ,work=ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! /atus ( de-id5tifi$ claims & enc\nt] in=mation or data describ$ 9 section #gbd7;a77#a77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahem71 includ+ in=mation on ! foll[+3 7#a7 ,:e!r *anges to regulations or guidance w\ld p]mit su* in=mation or data to be deem$ a gr\p heal? plan asset 7z def9$ "u section #c7db7 ( su* ,act74 7#b7 ,:e!r re/rictions on ! ability ( a plan fiduci>y to access su* in=mation or data violates a requirem5t ( curr5t law4 7#c7 ,! exi/+ regulatory au?ority ( ! ,secret>y to cl>ify :e!r su* in=mation or data is ! prop]ty ( a gr\p heal? plan1 r ?an a s]vice provid]4 7#d7 ,legislative recomm5dations to e/abli% t su* in=mation or data relat$ to a plan belongs to a gr\p heal? plan & is h&l$ 9 ! be/ int]e/s ( plan p>ticipants & b5efici>ies4 7d7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply ) respect to a plan beg9n+ ) ! fir/ plan ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #djb4 ,hidd5 ,fees ,disclosure ,requirem5ts 7a7 ,cl>ification ( ! application ( fee disclosure requirem5ts to cov]$ s]vice provid]s 7#a7 ,s]vices ,clause 7ii77,i77bb7 ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$-- 7,a7 9 subitem 7,,aa7 by /rik+ ,brok]age s]vices1 & ins]t+ ,s]vices 7includ+ brok]age s]vices712 & 7,b7 9 subitem 7,,bb7-- 7i7 by /rik+ ,consult+1 & ins]t+ ,o!r s]vices12 & 7ii7 by ins]t+ any ( ! foll[+3 be=e plan design4 7#b7 ,disclosures ,clause 7iii77,,iii7 ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$ by /rik+ 1 ei!r 9 ! aggregate or by s]vice1 & ins]t+ by s]vice4 7b7 ,/r5g!n+ disclosure requirem5ts ) respect to ph>macy b5efit manag]s & ?ird p>ty adm9i/rators = gr\p heal? plans 7#a7 ,c]ta9 arrangem5ts = ph>macy b5efit manag] s]vices consid]$ z indirect 7,a7 ,9 g5]al ,clause 7i7 ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$-- 7i7 by /rik+ requirem5ts ( ?is clause & ins]t+ requirem5ts ( ?is subp>agraph2 & 7ii7 by add+ at ! end ! foll[+3 ,= purposes ( apply+ section #djf7;a77#a77;,c7 ) respect to a transaction describ$ "u ?is subp>agraph1 a contract or arrangem5t = s]vices betwe5 a cov]$ plan & a heal? insurance issu] provid+ heal? insurance cov]age 9 connection ) ! cov]$ plan 9 :i* ! heal? insurance issu] contracts1 9 connection ) su* plan1 ) a s]vice provid] = ph>macy b5efit managem5t s]vices %all be consid]$ to con/itute an indirect furni%+ ( goods1 s]vices1 or facilities betwe5 ! plan & ! s]vice provid] act+ z ! p>ty 9 int]e/44 7,b7 ,heal? insurance issu] & heal? insurance cov]age def9$ ,clause 7ii77,i77aa7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$ by ins]t+ be=e ! p]iod at ! end & ! t]ms heal? insurance cov]age & heal? insurance issu] h ! mean+s giv5 su* t]ms 9 section #gcc7;b74 7,c7 ,te*nical am5dm5t ,clause 7ii77,i77aa7 ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is fur!r am5d$ by ins]t+ 9 aft] def9$4 7#b7 ,specific disclosure requirem5ts ) respect to ph>macy b5efit managem5t s]vices 7,a7 ,9 g5]al ,clause 7iii7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$ by add+ at ! end ! foll[+3 7,,vii7 ,) respect to a contract or arrangem5t ) ! cov]$ plan 9 connection ) ! provision ( ph>macy b5efit managem5t s]vices1 z "p ( ! description requir$ "u subclauses 7,,iii7 & 7,,iv7-- 7aa7 all comp5sation describ$ 9 clause 7ii77,i77dd77,,aa71 includ+ fees1 rebates1 alt]native disc\nts1 co-paym5t (fsets1 & o!r remun]ation expect$ to be receiv$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor f a ph>maceutical manufactur]1 di/ributor1 rebate aggregator1 accumulator1 & maximiz]1 gr\p pur*as+ organization1 or any o!r ?ird p>ty2 7bb7 ! am\nt & =m ( any rebates1 disc\nts1 or price concessions1 includ+ ! am\nt expect$ to be pass$ ?r\gh to ! plan sponsor or ! p>ticipants & b5efici>ies "u ! cov]$ plan2 7cc7 all comp5sation expect$ to be receiv$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor z a result ( pay+ a l[] am\nt = ! drug ?an ! am\nt *>g$ z a copaym5t1 co9surance am\nt1 or d$uctible2 7dd7 all comp5sation expect$ to be receiv$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor z a result ( pay+ ph>macies less ?an :at is *>g$ ! heal? plan1 plan sponsor1 or p>ticipants & b5efici>ies "u ! cov]$ plan2 & 7ee7 all comp5sation expect$ to be receiv$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor f drug manufactur]s & any o!r ?ird p>ty 9 ex*ange =-- 7,,aa7 adm9i/]+1 invoic+1 allocat+1 or collect+ rebates relat$ to ! cov]$ plan2 7,,bb7 provid+ bus9ess s]vices & activities1 includ+ provid+ access to drug utilization data2 7,,cc7 keep+ a p]c5tage ( ! li/ price ( a drug2 or 7,,dd7 any o!r reason relat$ to ! role ( a cov]$ s]vice provid] z a conduit betwe5 ! drug manufactur]s or any o!r ?ird p>ty & ! cov]$ plan4 4 7,b7 ,annual disclosure ,clause 7v7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$ by add+ at ! end ! foll[+3 7,,iii7 ,a cov]$ s]vice provid]1 ) respect to a contract or arrangem5t ) ! cov]$ plan 9 connection ) provid+ ph>macy b5efit managem5t s]vices1 %all disclose1 on an annual basis n lat] ?an #fj days aft] ! beg9n+ ( ! curr5t plan ye>1 to a responsible plan fiduci>y1 9 writ+1 ! foll[+ ) respect to ! twelve mon?s prec$+ ! curr5t plan ye>3 7aa7 ,all direct comp5sation describ$ 9 subclause 7,,iii7 ( clause 7iii7 & indirect comp5sation describ$ 9 subclause 7,,iv7 ( clause 7iii7 receiv$ by ! cov]$ s]vice provid] 7includ+ su* comp5sation describ$ 9 subclause 7,,vii7 ( clause 7iii774 7bb7 ,! total gross sp5d+ by ! cov]$ plan on drugs 7exclud+ rebates1 disc\nts1 or o!r price concessions74 7cc7 ,! total net sp5d+ by ! cov]$ plan on drugs4 7dd7 ,! total gross sp5d+ at all ph>macies :olly or p>tially own$ by ! cov]$ s]vice provid] or any entity affiliat$ ) ! cov]$ s]vice provid]1 includ+ mail-ord]1 specialty & retail ph>macies1 ) a breakd[n by individual ph>macy location4 7ee7 ,! aggregate am\nt ( clawback f su* ph>macies1 includ+ mail-ord]1 specialty1 & retail ph>macies4 7,,aa7 categorical explanations 7gr\p$ by ! reason = clawback1 su* z contractual true-up provisions1 ov]paym5ts1 or non-cov]$ m$ication disp5s$1 & includ+ in=mation on ! am\nt 9 ea* category t 0 pass$ ?r\gh to ! cov]$ plan & to p>ticipants & b5efici>ies ( ! cov]$ plan72 or 7,,bb7 individual explanations = su* clawbacks4 7ff7 ,total aggregate am\nts ( fees collect$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor 9 connection ) ! provision ( ph>macy b5efit managem5t s]vices to ! cov]$ plan4 7gg7 ,any o!r in=mation specifi$ by ! ,secret>y ?r\gh regulations or guidance t may be necess>y = a responsible plan fiduci>y to consid] ! m]its ( ! contract or arrangem5t ) ! cov]$ s]vice provid] & any conflicts ( int]e/ t may exi/4 4 7,c7 ,ph>macy b5efit managem5t s]vices def9$ ,clause 7ii77,i7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 is am5d$ by add+ at ! end ! foll[+3 7gg7 ,! t]m ph>macy b5efit managem5t s]vices includes any s]vices provid$ by a cov]$ s]vice provid] to a cov]$ plan ) respect to ! adm9i/ration ( prescription drug b5efits "u ! cov]$ plan1 includ+-- 7,,aa7 process+ & paym5t ( claims2 7,,bb7 design ( ph>macy networks2 7,,cc7 negotiation1 aggregation1 & di/ribution ( rebates1 disc\nts1 & o!r price concessions2 7,,dd7 =mul>y design & ma9t5ance2 7,,ee7 op]ation ( ph>macies 7:e!r retail1 mail ord]1 specialty drug1 or o!rwise72 7,,ff7 recordkeep+2 7,,gg7 utilization review2 7,,hh7 adjudication ( claims2 & 7,,ii7 any o!r s]vices specifi$ by ! ,secret>y ?r\gh guidance or rulemak+4 4 7,d7 ,clawback def9$ ,clause 7ii77,i7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b771 z am5d$ by subp>agraph 7,c71 is am5d$ by add+ at ! end ! foll[+3 7hh7 ,! t]m clawback means am\nts collect$ by a provid] ( ph>macy b5efit managem5t s]vices f a ph>macy = copaym5ts collect$ f a p>ticipant or b5efici>y 9 excess ( ! contract$ rate4 4 7#c7 ,specific disclosure requirem5ts ) respect to ?ird p>ty adm9i/ration s]vices = gr\p heal? plans 7,a7 ,9 g5]al ,clause 7iii7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b771 z am5d$ by p>agraph 7#b77;,a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,,viii7 ,) respect to a contract or arrangem5t ) ! cov]$ plan 9 connection ) ! provision ( ?ird p>ty adm9i/ration s]vices = gr\p heal? plans1 z "p ( ! description requir$ "u subclauses 7,,iii7 & 7,,iv7-- 7aa7 ! am\nt & =m ( any rebates1 disc\nts1 sav+s fees1 refunds1 or am\nts receiv$ f provid]s & facilities1 includ+ ! am\nts t w be reta9$ by ! cov]$ s]vice provid] z a fee2 7bb7 ! am\nt & =m ( fees expect$ to be receiv$ f o!r s]vice provid]s 9 relation to ! cov]$ plan1 includ+ ! am\nts t w be reta9$ by ! cov]$ s]vice provid] z a fee2 & 7cc7 ! am\nt & =m ( expect$ recov]ies by ! cov]$ s]vice provid]1 includ+ ! am\nts t w be reta9$ by ! cov]$ s]vice provid] z a fee 7disaggregat$ by category71 z a result (-- 7,,aa7 ov]paym5ts2 7,,bb7 errone\s paym5ts2 7,,cc7 unca%$ *ecks or incomplete paym5ts2 7,,dd7 bill+ errors2 7,,ee7 subrogation2 7,,ff7 fraud2 or 7,,gg7 any o!r reason on behalf ( ! cov]$ plan4 4 7,b7 ,annual disclosure ,clause 7v7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b771 z am5d$ by p>agraph 7#b77;,b71 is am5d$ by add+ at ! end ! foll[+3 7,,iv7 ,a cov]$ s]vice provid]1 ) respect to a contract or arrangem5t ) ! cov]$ plan 9 connection ) provid+ ?ird p>ty adm9i/ration s]vices = gr\p heal? plans1 %all disclose1 on an annual basis n lat] ?an #fj days aft] ! beg9n+ ( ! curr5t plan ye>1 to a responsible plan fiduci>y1 9 writ+1 ! foll[+ ) respect to ! twelve mon?s prec$+ ! curr5t plan ye>3 7aa7 ,all direct comp5sation describ$ 9 subclause 7,,iii7 ( clause 7iii74 7bb7 ,all indirect comp5sation describ$ 9 subclause 7,,iv7 ( clause 7iii7 receiv$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor 7includ+ su* comp5sation describ$ 9 subclause 7,,viii7 ( clause 7iii774 7cc7 ,! aggregate am\nt = :i* ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor receiv$ indirect comp5sation & ! e/imat$ am\nt ( co/-%>+ incurr$ by plan p>ticipants & b5efici>ies z a result4 7dd7 ,! total gross sp5d+ by ! cov]$ plan on all co/s & fees aris+ "u or paid "u ! adm9i/rative s]vices agreem5t ) ! cov]$ s]vice provid] 7n includ+ any am\nts describ$ 9 items 7aa7 ?r\gh 7cc7 ( clause 7iii77,,viii774 7ee7 ,! total net sp5d+ by ! cov]$ plan on all co/s & fees aris+ "u or paid "u ! adm9i/rative s]vices agreem5t ) ! cov]$ s]vice provid]4 7ff7 ,! aggregate fees collect$ by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor4 7gg7 ,any o!r in=mation specifi$ by ! ,secret>y ?r\gh regulations or guidance t may be necess>y = a responsible plan fiduci>y to consid] ! m]its ( ! contract or arrangem5t ) ! cov]$ s]vice provid] & any conflicts ( int]e/ t may exi/4 4 7,c7 ,?ird p>ty adm9i/ration s]vices = gr\p heal? plans def9$ ,clause 7ii77,i7 ( section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b771 z am5d$ by p>agraph 7#b77;,c71 is am5d$ by add+ at ! end ! foll[+3 7ii7 ,! t]m ?ird p>ty adm9i/ration s]vices = gr\p heal? plans includes any s]vices provid$ by a cov]$ s]vice provid]1 an affiliate1 or a subcontractor to a cov]$ plan ) respect to ! adm9i/ration ( heal? b5efits "u ! cov]$ plan1 includ+-- 7,,aa7 ! process+1 repric+1 & paym5t ( claims2 7,,bb7 design1 creation1 & ma9t5ance ( provid] networks2 7,,cc7 negotiation ( disc\nts (f gross rates2 7,,dd7 b5efit & plan design2 7,,ee7 negotiation ( paym5t rates2 7,,ff7 recordkeep+2 7,,gg7 utilization review2 7,,hh7 adjudication ( claims2 7,,ii7 regulatory compliance2 & 7,,jj7 any o!r s]vices set =? 9 an adm9i/rative s]vices agreem5t or simil> agreem5t or specifi$ by ! ,secret>y ?r\gh rulemak+4 4 7#d7 ,rule ( con/ruction ,no?+ 9 ! am5dm5ts made by ?is section %all be con/ru$ to imply t a practice 9 relation to :i* a cov]$ s]vice provid] is requir$ to provide in=mation z a result ( su* am5dm5ts is p]missible "u ,f$]al law4 7#e7 ,effective date ,no contract or arrangem5t ent]$ into prior to ,janu>y #a1 #bjbe1 %all be subject to ! requirem5ts ( subsection 7b74 7c7 ,privacy requirem5ts ,section #djh7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b771 z am5d$ by section #dja1 is fur!r am5d$ by add+ at ! end ! foll[+3 7,d7 ,privacy requirem5ts ,cov]$ s]vice provid]s %all provide in=mation "u subp>agraph 7,b7 9 a mann] consi/5t ) ! privacy1 security1 & brea* notification regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a771 & consi/5t ) ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy1 security1 & brea* notification regulations & su* ,,hipaa privacy regulations4 7,e7 ,disclosure & r$isclosure 7i7 ,limitation to bus9ess associates ,a responsible plan fiduci>y receiv+ in=mation disclos$ "u subp>agraph 7,b7 may disclose su* in=mation only to ! entity f :i* ! in=mation 0 receiv$1 ! gr\p heal? plan = :i* ! in=mation p]ta9s1 or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa ,privacy ,rule 7#de ,,cfr p>ts #afj & #afd1 subp>ts ,a & ,e74 7ii7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or a cov]$ s]vice provid]1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation describ$ 9 ?is subp>agraph1 except t su* plan1 issu]1 or entity may n re/rict disclosure ( su* in=mation to ! ,dep>tm5t ( ,labor4 7,f7 ,additional privacy requirem5ts 7i7 ,9 g5]al ,cov]$ s]vice provid]s %all ensure t in=mation provid$ "u subp>agraph 7,b7 conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,a gr\p heal? plan mu/ comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations & a responsible plan adm9i/rator :o is a plan sponsor mu/ act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations 7z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act74 4 7d7 ,implem5tation ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,labor %all issue notice & comm5t rulemak+ z necess>y to implem5t ! provisions ( ?is section4 ,! ,secret>y %all ensure t su* rulemak+-- 7#a7 acc\nts = ! v>i$ comp5sation practices ( cov]$ s]vice provid]s 7z def9$ "u section #djh7;b77#b77;,b72 & 7#b7 e/abli%es /&>ds = ! disclosure ( expect$ comp5sation by su* cov]$ s]vice provid]s4 #djc4 ,prescription drug price in=mation requirem5t 7a7 ,,phsa 7#a7 ,9 g5]al ,"p ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act1 z am5d$ by section #ajf1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #bgii;,a-#ab4 ,in=mation on prescription drugs 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all-- 7#a7 n re/rict1 directly or indirectly1 any ph>macy t disp5ses a prescription drug to an enrollee 9 ! plan or cov]age f in=m+ 7or p5alize su* ph>macy = in=m+7 an enrollee ( any diff]5tial betwe5 ! enrollee's out-(-pocket co/ "u ! plan or cov]age ) respect to acquisition ( ! drug & ! am\nt an individual w\ld pay = acquisition ( ! drug )\t us+ any gr\p heal? plan or heal? insurance cov]age2 & 7#b7 ensure t any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) any su* heal? plan or heal? insurance cov]age does n1 ) respect to su* plan or cov]age1 re/rict1 directly or indirectly1 a ph>macy t disp5ses a prescription drug f in=m+ 7or p5alize su* ph>macy = in=m+7 an enrollee ( any diff]5tial betwe5 ! enrollee's out-(-pocket co/ "u su* plan or cov]age ) respect to acquisition ( ! drug & ! am\nt an individual w\ld pay = acquisition ( ! drug )\t us+ any gr\p heal? plan or heal? insurance cov]age4 7b7 ,def9ition ,= purposes ( ?is section1 ! t]m out-(-pocket co/1 ) respect to acquisition ( a drug1 means ! am\nt to be paid by ! enrollee "u ! plan or cov]age1 includ+ any co/-%>+ 7includ+ any d$uctible1 copaym5t1 or co9surance7 &1 z det]m9$ by ! ,secret>y1 any o!r exp5diture4 4 7#b7 ,con=m+ am5dm5t ,section #bgbi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bi7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7c7 ,sunset ,! prec$+ provisions ( ?is section %all n apply beg9n+ on ! date ( ! enactm5t ( ?is subsection4 4 7b7 ,,erisa 7#a7 ,9 g5]al ,subp>t ,b ( "p #g ( ,subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe et seq471 z am5d$ by section #ajf1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #gbg4 ,in=mation on prescription drugs 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all-- 7#a7 n re/rict1 directly or indirectly1 any ph>macy t disp5ses a prescription drug to a p>ticipant or b5efici>y 9 ! plan or cov]age f in=m+ 7or p5alize su* ph>macy = in=m+7 a p>ticipant or b5efici>y ( any diff]5tial betwe5 ! p>ticipant's or b5efici>y's out-(-pocket co/ "u ! plan or cov]age ) respect to acquisition ( ! drug & ! am\nt an individual w\ld pay = acquisition ( ! drug )\t us+ any gr\p heal? plan or heal? insurance cov]age2 & 7#b7 ensure t any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) any su* heal? plan or heal? insurance cov]age does n1 ) respect to su* plan or cov]age1 re/rict1 directly or indirectly1 a ph>macy t disp5ses a prescription drug f in=m+ 7or p5alize su* ph>macy = in=m+7 a p>ticipant or b5efici>y ( any diff]5tial betwe5 ! p>ticipant's or b5efici>y's out-(-pocket co/ "u su* plan or cov]age ) respect to acquisition ( ! drug & ! am\nt an individual w\ld pay = acquisition ( ! drug )\t us+ any gr\p heal? plan or heal? insurance cov]age4 7b7 ,def9ition ,= purposes ( ?is section1 ! t]m out-(-pocket co/1 ) respect to acquisition ( a drug1 means ! am\nt to be paid by ! p>ticipant or b5efici>y "u ! plan or cov]age1 includ+ any co/-%>+ 7includ+ any d$uctible1 copaym5t1 or co9surance7 &1 z det]m9$ by ! ,secret>y1 any o!r exp5diture4 4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq471 z am5d$ by section #ajf1 is fur!r am5d$ by ins]t+ aft] ! item relat+ to section #gbf ! foll[+ new item3 ,sec4 #gbg4 ,in=mation on prescription drugs4 4 7c7 ,,irc 7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #ajf1 is fur!r am5d$ by add+ at ! end ! foll[+3 #ihbg4 ,in=mation on prescription drugs 7a7 ,9 g5]al ,a gr\p heal? plan %all-- 7#a7 n re/rict1 directly or indirectly1 any ph>macy t disp5ses a prescription drug to a p>ticipant or b5efici>y 9 ! plan f in=m+ 7or p5alize su* ph>macy = in=m+7 a p>ticipant or b5efici>y ( any diff]5tial betwe5 ! p>ticipant's or b5efici>y's out-(-pocket co/ "u ! plan ) respect to acquisition ( ! drug & ! am\nt an individual w\ld pay = acquisition ( ! drug )\t us+ any gr\p heal? plan or heal? insurance cov]age2 & 7#b7 ensure t any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) any su* plan does n1 ) respect to su* plan or cov]age1 re/rict1 directly or indirectly1 a ph>macy t disp5ses a prescription drug f in=m+ 7or p5alize su* ph>macy = in=m+7 a p>ticipant or b5efici>y ( any diff]5tial betwe5 ! p>ticipant's or b5efici>y's out-(-pocket co/ "u ! plan ) respect to acquisition ( ! drug & ! am\nt an individual w\ld pay = acquisition ( ! drug )\t us+ any gr\p heal? plan or heal? insurance cov]age4 7b7 ,def9ition ,= purposes ( ?is section1 ! t]m out-(-pocket co/1 ) respect to acquisition ( a drug1 means ! am\nt to be paid by ! p>ticipant or b5efici>y "u ! plan1 includ+ any co/-%>+ 7includ+ any d$uctible1 copaym5t1 or co9surance7 &1 z det]m9$ by ! ,secret>y1 any o!r exp5diture4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #ajf1 is fur!r am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbg4 ,in=mation on prescription drugs4 4 #djd4 ,implem5tation fund+ 7a7 ,9 g5]al ,= ! purposes describ$ 9 subsection 7b71 & 9 addition to am\nts o!rwise available = su* purposes !re are appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 to ! ,secret>y ( ,labor #ce1jjj1jjj1 = fiscal ye> #bjbd1 to rema9 available ?r\gh fiscal ye> #bjbi4 7b7 ,p]mitt$ purposes ,! purposes describ$ 9 ?is subsection are limit$ to ! foll[+ purposes1 ins(> z su* purposes are to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 title ,i & ,,iv3 7#a7 ,prep>+1 draft+1 & issu+ propos$ & f9al regulations or int]im regulations4 7#b7 ,prep>+1 draft+1 & issu+ guidance & public in=mation4 7#c7 ,prep>+1 draft+1 & publi%+ reports4 7#d7 ,en=cem5t ( su* provisions4 7#e7 ,report+1 collection1 & analysis ( data4 7#f7 ,o!r adm9i/rative duties necess>y = implem5tation ( su* provisions4 7c7 ,transp>5cy ( implem5tation funds ,! ,secret>y ( ,labor %all annually submit1 no lat] ?an ,septemb] #a/ ( ea* ye>1 to ! ,committees on ,education & ,work=ce & on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committees on ,heal?1 ,education1 ,labor1 & ,p5sions & on ,appropriations ( ! ,s5ate a report on funds exp5d$ pursuant to funds appropriat$ "u ?is section4 ,pass$ ! ,h\se ( ,repres5tatives ,decemb] #aa1 #bjbc4;,cl]k4