,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #dijf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,octob] #bi1 #bjai,ms4 ,de,gette 7= h]self & ,mr4 ,re$7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to provide pati5t protections ) respect to ! co/ ( insul94 #a4 ,%ort title ,?is ,act may be cit$ z ! ,insul9 ,price ,r$uction ,act4 #b4 ,insul9 price protections 7a7 ,9 g5]al ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgbi;,a4 ,insul9 price protections 7a7 ,contract+ requirem5ts 7#a7 ,9 g5]al 7,a7 ,requirem5t ,except z provid$ 9 subp>agraph 7,b71 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n1 & %all 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 directly or indirectly1 receive f a manufactur] ( c]tifi$ insul9 a rebate1 r$uction 9 price1 or o!r remun]ation ) respect to su* insul9 receiv$ by an enrollee 9 ! plan or cov]age & cov]$ by ! plan or cov]age4 7,b7 ,exception ,! requirem5t "u subp>agraph 7,a7 %all n apply to-- 7i7 any su* r$uction 9 price t is reflect$ at ! po9t ( sale to ! enrollee2 or 7ii7 any remun]ation t is a flat fee-bas$ s]vice fee t a manufactur] ( su* insul9 pays to a ph>macy b5efit manag] = s]vices r5d]$ to ! manufactur] t relate to arrangem5ts by ! ph>macy b5efit manag] to provide ph>macy b5efit managem5t s]vices to a heal? plan or heal? insurance issu]1 if c]ta9 conditions e/abli%$ by ! ,secret>y are met1 includ+ requirem5ts t ! fees are transp>5t to ! heal? plan or heal? insurance issu]4 7#b7 ,applicability ,! re/riction "u p>agraph 7#a7 %all apply ) respect to insul9 describ$ 9 p>agraph 7#a71 = :i* ! manufactur] has c]tifi$ ! li/ price 9 accordance ) section #e7;b7 ( ! ,insul9 ,price ,r$uction ,act ) respect to-- 7,a7 any plan ye> 9 :i* ! li/ price = insul9 is c]tifi$ "u section #e7;b77#b77;,a7 ( ! ,insul9 ,price ,r$uction ,act2 & 7,b7 ea* subsequ5t plan ye> dur+ :i* ! manufactur] limits any increase 9 ! li/ price to ! price t gave rise to ! re/riction "u p>agraph 7#a71 adju/$ by n m ?an ! price *ange 9 ! m$ical c>e compon5t ( ! consum] price index = all urban consum]s 7,u4,s4 city av]age71 z c]tifi$ "u section #e7;b77#b77;,b7 ( ! ,insul9 ,price ,r$uction ,act4 7b7 ,d$uctible limitation ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n apply any d$uctible am\nt t o!rwise is applicable to prescription drugs ) respect to cov]age ( c]tifi$ insul9 "u su* plan or cov]age1 dur+ ! p]iod describ$ 9 subsection 7a77#b74 7c7 ,hold h>mless ,dur+ ! p]iod beg9n+ on ! date a c]tification is fir/ made "u section #e7;b77#b77;,a7 ( ! ,insul9 ,price ,r$uction ,act & end+ on ! la/ day ( ! second plan ye> beg9n+ on or aft] su* date1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n1 & %all ensure t any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) su* heal? plan or heal? insurance cov]age does n-- 7#a7 re/rict or disadvantage su* insul9 f ! =mul>y applicable to ! plan or cov]age relative to any o!r insul9 or simil> =mulation2 7#b7 impose high] co/-%>+ ) respect to su* insul9 ?an ! co/-%>+ t appli$ ) respect to ! insul9 9 ! ye> 9 :i* ! li/ price r$uction c]tification 0 provid$ "u section #e7;b77#b77;,a7 ( ! ,insul9 ,price ,r$uction ,act2 7#c7 impose any prior au?orization requirem5ts = cov]age ( su* insul9 t 7 n appli$ dur+ ! ye> 9 :i* ! li/ price r$uction c]tification 0 provid$ "u su* section #e7;b77#b77;,a72 or 7#d7 e/abli% a /ep !rapy requirem5t = su* insul9 t 0 n appli$ dur+ ! ye> 9 :i* ! li/ price r$uction c]tification 0 provid$ "u su* section #e7;b77#b77;,a74 7d7 ,def9itions ,9 ?is section-- 7#a7 ! t]m c]tifi$ insul9 means1 ) respect to a ye>1 insul9 t has be5 c]tifi$ "u section #e7;b7 ( ! ,insul9 ,price ,r$uction ,act = ! ye>2 7#b7 ! t]m insul9 means any insul9 product approv$ by ! ,food & ,drug ,adm9i/ration to improve glycemic control 9 pati5ts ) diabetes mellitus2 7#c7 ! t]m li/ price has ! mean+ giv5 ! t]m :olesale acquisition co/ 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act2 & 7#d7 ! t]m rebate means any disc\nt1 price concession1 or fee1 o!r ?an ! fee describ$ 9 section 7a77#a77;,b71 ! t]ms ( :i* are fix$ at ! "t ( ! sale & disclos$1 b :i* is n receiv$ at ! "t ( ! sale4 4 7b7 ,con=m+ am5dm5t ,p>agraph 7#b7 ( section #bbc7;d7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,e7 & by ins]t+ aft] subp>agraph 7,c7 ! foll[+ new subp>agraph3 7,d7 ,safe h>bor = abs5ce ( d$uctible = insul9 ,a plan %all n fail to be treat$ z a high d$uctible heal? plan by reason ( exempt+ insul9 f any d$uctible pursuant to section #bgbi;,a7b7 ( ! ,public ,heal? ,s]vice ,act dur+ ! p]iod describ$ 9 section #bgbi;,a7a77#b7 ( su* ,act4 4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb4 #c4 ,insul9 price protections "u ,m$ic>e "p ,d ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is am5d$-- 7#a7 by r$esignat+ ! subsection 7m7 z add$ by section #fjfc7;c7 ( ! ,,support = ,pati5ts & ,communities ,act 7,public ,law #aae-bga7 z subsection 7n72 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7o7 ,limitation on rebates1 price r$uctions1 or o!r remun]ation = c]tifi$ insul9 7#a7 ,limitation 7,a7 ,9 g5]al ,subject to subp>agraphs 7,b7 & 7,c71 = plan ye> #bjbb & subsequ5t plan ye>s1 a ,,pdp sponsor & a ,m$ic>e ,advantage organization %all ensure t ea* prescription drug plan or ,,ma-,,pd plan (f]$ by ! sponsor or organization1 & any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) ! prescription drug plan or ,,ma-,,pd plan (f]$ by ! sponsor or organization1 does n1 directly or indirectly1 receive f a manufactur] ( c]tifi$ insul9 a rebate1 r$uction 9 price1 or o!r remun]ation ) respect to c]tifi$ insul9 t is cov]$ by ! plan4 7,b7 ,exception ,! requirem5t "u subp>agraph 7,a7 %all n apply to-- 7i7 any su* r$uction 9 price t is reflect$ at ! po9t ( sale to ! b5efici>y2 or 7ii7 any remun]ation t is a flat fee-bas$ s]vice fee t a manufactur] ( su* c]tifi$ insul9 pays to a ph>macy b5efit manag] = s]vices r5d]$ to ! manufactur] t relate to arrangem5ts by ! ph>macy b5efit manag] to provide ph>macy b5efit managem5t s]vices to a prescription drug plan or ,,ma-,,pd plan1 if c]ta9 conditions e/abli%$ by ! ,secret>y are met1 includ+ requirem5ts t ! fees are transp>5t to ! prescription drug plan or ,,ma-,,pd plan4 7,c7 ,hold h>mless = fir/ #b ye>s t an insul9 is c]tifi$ ,9 ! fir/ #b plan ye>s dur+ :i* p>agraph 7#b7 applies ) respect to a c]tifi$ insul91 a ,,pdp sponsor & a ,m$ic>e ,advantage organization %all n1 & %all ensure t any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) su* sponsor or organization does n-- 7i7 remove su* insul9 f ! =mul>y applicable to ! prescription drug plan or ,,ma-,,pd plan2 7ii7 impose high] co/-%>+ ) respect to su* insul9 ?an ! co/-%>+ t appli$ ) respect to ! c]tifi$ insul9 9 ! ye> 9 :i* ! li/ price r$uction c]tification 0 provid$ "u section #e7;b77#b77;,a7 ( ! ,insul9 ,price ,r$uction ,act2 7iii7 impose any prior au?orization requirem5ts = cov]age ( ! c]tifi$ insul9 t 7 n appli$ dur+ ! ye> 9 :i* ! li/ price r$uction c]tification 0 provid$ "u su* section #e7;b77#b77;,a72 or 7iv7 e/abli% a /ep !rapy requirem5t = ! c]tifi$ insul9 t 0 n appli$ dur+ ! ye> 9 :i* ! li/ price r$uction c]tification 0 provid$ "u su* section #e7;b77#b77;,a74 7#b7 ,def9itions ,9 ?is section3 7,a7 ,c]tifi$ insul9 ,! t]m c]tifi$ insul9 means1 ) respect to a ye>1 insul9 t has be5 c]tifi$ "u section #e7;b7 ( ! ,insul9 ,price ,r$uction ,act = ! ye>4 7,b7 ,insul9 ,! t]m insul9 means any insul9 product approv$ by ! ,food & ,drug ,adm9i/ration to improve glycemic control 9 pati5ts ) diabetes mellitus4 7,c7 ,li/ price ,! t]m li/ price has ! mean+ giv5 ! t]m :olesale acquisition co/ 9 section #ahdg;,a7c77#f77;,b74 7,d7 ,rebate ,! t]m rebate means any disc\nt1 price concession1 or fee1 o!r ?an ! fee describ$ 9 p>agraph 7#a77;,b71 ! t]ms ( :i* are fix$ at ! "t ( ! sale & disclos$1 b :i* is n receiv$ at ! "t ( ! sale4 4 #d4 ,applicability ( pre-li/ price r$uction ,,amp to ,m$icaid m9imum rebate am\nts ,section #aibg7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ & p>agraph 7#e7 aft] p>agraph 7#b72 7#b7 9 p>agraph 7#c77;,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ & p>agraph 7#e7 aft] subp>agraph 7,c72 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,special rule = det]m9+ m9imum basic rebates = insul9 7,a7 ,9 g5]al ,9 det]m9+ ! am\nt ( ! rebate specifi$ 9 ?is subsection = a dosage =m & /r5g? ( a cov]$ outpati5t drug describ$ 9 subp>agraph 7,b7 = any rebate p]iod occurr+ aft] ,april #cj1 #bjbj1 p>agraph 7#a77;,a77ii77,,ii7 or p>agraph 7#c77;,a77i7 7z applicable7 %all be appli$ by sub/itut+-- 7i7 ! pre-r$uction av]age manufactur] price 7z def9$ 9 subp>agraph 7,c77 = ! dosage =m & /r5g? ( ! drug = ! rebate p]iod2 = 7ii7 ! av]age manufactur] price = ! dosage =m & /r5g? ( ! drug = ! rebate p]iod4 7,b7 ,drugs describ$ ,a cov]$ outpati5t drug is describ$ 9 ?is subp>agraph = a rebate p]iod if ! drug is insul9 = :i*1 ?r\gh\t su* rebate p]iod1 ! manufactur] has c]tifi$ ! li/ price = ea* dosage =m & /r5g? ( su* drug 9 accordance ) section #e7;b7 ( ! ,insul9 ,price ,r$uction ,act4 7,c7 ,pre-r$uction av]age manufactur] price ,= purposes ( ?is p>agraph1 ! t]m pre-r$uction av]age manufactur] price means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ outpati5t drug describ$ 9 subp>agraph 7,b7 & a rebate p]iod-- 7i7 ! av]age manufactur] price = su* drug = ! cal5d> qu>t] beg9n+ ,july #a1 #bjai2 increas$ by 7ii7 ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! mon? be=e ! mon? 9 :i* ! rebate p]iod beg9s exce$s su* index = ,septemb] #bjai4 4 #e4 ,li/ price data submissions 7a7 ,initial submission 7#a7 ,9 g5]al ,n lat] ?an ,april #cj1 #bjbj1 any manufactur] ( insul9 wi%+ to receive c]tification "u ?is section %all submit to ! ,secret>y-- 7,a7 data on ! li/ price ( any insul9 manufactur$ by ! manufactur] dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjjj 7or ! fir/ date on :i* su* manufactur] beg9s manufactur+ su* insul971 ?r\gh ! li/ price applicable at ! "t ( ! report2 & 7,b7 a c]tification t su* data is accurate4 7#b7 ,lat] submissions ,any manufactur] ( insul9 t does n submit ! in=mation describ$ 9 p>agraph 7#a7 by ! date describ$ 9 su* p>agraph may lat] submit ! in=mation describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 to ! ,secret>y4 ,su* a manufactur] :o submits su* in=mation pursuant to ?is p>agraph is eligible to c]tify its li/ price = ! applicable insul9 "u subsection 7b77#b77;,a77ii7 ) respect to ! fir/ plan ye> t beg9s at lea/ #ae mon?s aft] ! date ( submission "u ?is p>agraph4 7b7 ,annual price c]tification 7#a7 ,9 g5]al ,any manufactur] ( insul9 :o submits in=mation 9 accordance ) subsection 7a7 is eligible = c]tification "u ?is subsection4 7#b7 ,requirem5ts 7,a7 ,fir/ c]tification 7i7 ,initial eligibility = c]tification ,a manufactur] ( insul9 :o submits in=mation "u subsection 7a77#a7 is consid]$ c]tifi$ "u ?is subsection = plan ye> #bjbb if su* manufactur]1 n lat] ?an ,septemb] #cj1 #bjbj1 submits to ! ,secret>y a c]tification t ! manufactur] r$uc$ its li/ price = insul9 to an am\nt t is no great] ?an ! li/ price = ! same insul9 t appli$ z ( ,july #a1 #bjjf4 7ii7 ,lat] c]tification ,a manufactur] ( insul9 t submitt$ in=mation "u subsection 7a77#b7 n lat] ?an ,septemb] #cj ( ! cal5d> ye> t is #b ye>s prior to ! applicable plan ye>1 is consid]$ c]tifi$ "u ?is subsection = ! applicable plan ye> if su* manufactur] submits to ! ,secret>y a c]tification1 n lat] ?an ,septemb] #cj ( su* cal5d> ye>1 t ! manufactur] r$uc$ its li/ price = insul9 to ! am\nt t is no great] ?an ! li/ price = ! same insul9 t appli$ z ( ,july #a1 #bjjf1 increas$ by n m ?an ! rate by :i* ! m$ical c>e compon5t ( ! consum] price index = all urban consum]s 7,u4,s4 city av]age7 increas$ betwe5 ,septemb] #cj1 #bjbj1 & ! date on :i* ! c]tification is submitt$4 7,b7 ,subsequ5t c]tification ,= plan ye> #bjbc & ea* plan ye> !reaft]1 a manufactur] ( insul9 :o previ\sly submitt$ a c]tification "u clause 7i7 or 7ii7 ( subp>agraph 7,a7 is consid]$ c]tifi$ "u ?is subsection = ! applicable plan ye> if su* manufactur] submits1 n lat] ?an ,septemb] #cj ( ! cal5d> ye> t is #b ye>s prior to ! applicable plan ye>1 a c]tification t ! manufactur] did n increase ! li/ price = insul9 previ\sly c]tifi$ "u clause 7i7 or 7ii7 ( subp>agraph 7,a71 by m ?an ! rate by :i* ! m$ical c>e compon5t ( ! consum] price index = all urban consum]s 7,u4,s4 city av]age7 increas$ s9ce ! initial c]tification "u su* clause 7i7 or 7ii74 7#c7 ,special rule = c]ta9 insul9 7,a7 ,9 g5]al ,9 ! case ( a manufactur] ( insul9 t did n manufacture a p>ticul> insul9 9 #bjjf1 su* manufactur] may be c]tifi$ "u ?is subsection ) respect to su* insul9 by submitt+ in=mation "u p>agraph 7#b77;,a7 c]tify+ t ! li/ price ( su* insul9 is no great] ?an ! weight$ av]age li/ price1 9 #bjjf1 (1 z applicable-- 7i7 7,i7 all %ort-act+ insul9s2 7,,ii7 all rapid-act+ insul9s2 or 7,,iii7 all long-act+ insul9s2 or 7ii7 su* o!r insul9 categories1 z ! ,secret>y det]m9es appropriate4 7,b7 ,increase ,! weight$ av]ages "u subp>agraph 7,a7 %all be increas$ 9 accordance ) p>agraph 7#b77;,a77ii71 z applicable4 7#d7 ,application to au?oriz$ g5]ic insul9 ,9 ! case ( an insul9 t is classifi$ z an au?oriz$ g5]ic drug1 z def9$ 9 section #eje7t77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7t77#c771 ! manufactur] ( su* insul9 may be c]tifi$ "u ?is section by submitt+ in=mation "u p>agraph 7#a77;,a7 c]tify+ t ! li/ price ( su* au?oriz$ g5]ic insul9 is no great] ?an ! li/ price1 z ( ,july #a1 #bjjf1 ( ! li/$ drug insul9 product ^u :i* ! au?oriz$ g5]ic drug 0 bas$ "u section #eje7t7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 ,! c]tification pursuant to ?is p>agraph applies only to ! au?oriz$ g5]ic drug insul91 & does n apply ) respect to ! applicable li/$ drug insul94 7c7 ,audits & p5alties ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices may audit ! f9ancial records & o!r relevant records ( any manufactur] submitt+ data "u subsections 7a7 & 7b71 & any manufactur] or (fic]1 director1 ag5t1 or manag+ employee ( su* manufactur] t kn[+ly submits false or incomplete data %all be subject to a civil p5alty = ea* insul9 = :i* false or incomplete data are submitt$ 9 an am\nt n to exce$ ! great] (-- 7#a7 an am\nt equal to #b times ! total am\nt ( rebates paid by ! manufactur] to ,/ate ,m$icaid plans = ! insul9 = rebate p]iods occurr+ 9 cal5d> ye> #bjah "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h72 or 7#b7 an alt]native am\nt to be det]m9$ by ! ,secret>y4 7d7 ,def9itions ,9 ?is section-- 7#a7 ! t]m insul9 means any insul9 product approv$ by ! ,food & ,drug ,adm9i/ration to improve glycemic control 9 pati5ts ) diabetes mellitus2 7#b7 ! t]m li/ price has ! mean+ giv5 ! t]m :olesale acquisition co/ 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 & 7#c7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4