,i #aag? ,,congress #a/ ,session ,h4 ,r4 #ecid ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #bh1 #bjba,mr4 ,buc%on 7= himself & ,ms4 ,s*ri]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 require ! ,secret>y ( ,heal? & ,human ,s]vices to e/abli% a new program :i* ensures mean+ful access to claims data by cl9ician-l$ cl9ical data regi/ries1 & = o!r purposes4 #a4 ,%ort title ,?is "p may be cit$ z ! ,mean+ful ,access to ,f$]al ,heal? ,plan ,claims ,data ,act ( #bjba4 #b4 ,f9d+s ,congress f9ds z foll[s3 7#a7 ,cl9ician-l$ cl9ical data regi/ries s]ve an important role 9 promot+1 facilitat+1 & conduct+ m$ical rese>* & improv+ quality ( heal?c>e by provid+ timely & actionable fe$back to practition]s on _! p]=mance 9 relation to o!r practition]s & be/ cl9ical practices4 7#b7 ,cl9ician-l$ cl9ical data regi/ries are h9d]$ 9 _! ability to promote m$ical rese>* & quality improvem5t by _! lack ( mean+ful access to claims data4 7#c7 ,:ile ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices has e/abli%$ programs = provid+ access to claims data1 ^? programs fail to provide cl9ician-l$ cl9ical data regi/ries ) mean+ful access to su* data4 7#d7 ,ensur+ cl9ician-l$ cl9ical data regi/ries mean+ful access to claims data w enable su* entities to bett] track pati5t outcomes ov] "t1 exp& _! ability to assess ! safety & effectiv5ess ( m$ical treatm5ts1 & provide !m ) ! in=mation necess>y to assess ! co/-effectiv5ess ( !rapies4 #c4 ,ensur+ mean+ful access to claims data by cl9ician-l$ cl9ical data regi/ries 7a7 ,ensur+ mean+ful access to claims data 7#a7 ,e/abli%m5t ( a new program 7#b7 ,e/abli%m5t ( a new program ,! ,secret>y %all e/abli% a new program 7sep>ate f any exi/+ data access programs1 includ+1 )\t limitation1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,qualifi$ ,entity 79 ?is section1 ref]r$ to z ,,qe7 ,program 7#db ,u4,s4,c4 #aciekk7e71 #aciekk-#b7 79 ?is section1 ref]r$ to z ! ,m$ic>e ,data ,%>+ = ,p]=mance ,measurem5t ,program7 & ! ,rese>* ,data ,assi/ance ,c5t] 79 ?is section1 ref]r$ to z ! ,res,d,a,c7 process7 "u :i* ! ,secret>y %all1 at ! reque/ ( a cl9ician-l$ cl9ical data regi/ry1 provide timely1 broad1 & cont9u\s access to a database ( claims data to su* cl9ician-l$ cl9ical data regi/ry = purposes ( rese>*1 quality ( c>e measurem5t & report+ to heal? c>e provid]s1 l9k+ su* data ) cl9ical data & p]=m+ risk-adju/$1 sci5tifically valid analyses & rese>* to support quality improvem5t or pati5t safety1 & o!r purposes & uses describ$ h]e9 or approv$ by ! ,secret>y4 ,access to a database ( claims data pursuant to ?is subsection %all n be m re/rictive ?an access to data provid$ "u ! ,,qe ,program or ! ,res,d,a,c process4 7#c7 ,/reaml9$ application process 7,a7 ,initial & rec]tification application ,prior to ga9+ access to a database ( claims data "u ! program e/abli%$ 9 subsection 7a71 a cl9ician-l$ cl9ical data regi/ry %all submit to ! ,secret>y an application demon/rat+ t x is qualifi$ 7z det]m9$ by ! ,secret>y7 to use claims data4 ,^u ! ,secret>y's approval ( a cl9ician-l$ cl9ical data regi/ry's application describ$ 9 ?is subp>agraph1 ! ,secret>y %all provide access to a database ( claims data to su* cl9ician-l$ cl9ical data regi/ry = a p]iod ( at lea/ #e ye>s4 ,aft] ! expiration ( ! "t p]iod describ$ 9 ?is subp>agraph1 ! cl9ician-l$ cl9ical data regi/ry %all reapply to access ! database ( claims data "u ! program e/abli%$ 9 subsection 7a74 7,b7 ,process ,! ,secret>y %all e/abli% a /reaml9$ initial application & rec]tification application process "u :i* ! ,secret>y %all approve or d5y ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 subp>agraph 7#b77;,a7 )9 #fj cal5d> days aft] receiv+ ! application unless ! ,secret>y demon/rates a compell+ reason = ne$+ additional "t to complete ! process4 ,if ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 subp>agraph 7#b77;,a7 is d5i$1 ! ,secret>y %all provide ! reason7s7 = d5ial4 7#d7 ,appeal rights 7,a7 ,opportunity to appeal ,! ,secret>y %all develop & ma9ta9 a process by :i* cl9ician-l$ cl9ical data regi/ries may appeal-- 7i7 ! ,secret>y's decision to d5y ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 subp>agraph 7#b77;,a72 & 7ii7 ! ,secret>y's failure to approve or d5y ! cl9ician-l$ cl9ical data regi/ry's application describ$ 9 subp>agraph 7#b77;,a7 )9 a reasonable timeframe e/abli%$ by ! ,secret>y4 7,b7 ,deadl9e = decision ,! ,secret>y %all r5d] a decision ) respect to an appeal fil$ by a cl9ician-l$ cl9ical data regi/ry pursuant to subp>agraph 7,a7 9 a timely mann]1 n to exce$ #fj cal5d> days aft] ! ,secret>y receives ! cl9ician-l$ cl9ical data regi/ry's reque/ = an appeal4 ,notice ( su* decision %all be provid$ to ! cl9ician-l$ cl9ical data regi/ry fil+ ! appeal be=e ! conclusion ( su* #fj-;day p]iod4 7#e7 ,broad & timely access to data ,! ,secret>y %all /ructure its database ( claims data to all[ = v>i\s data set qu]ies1 includ+1 b n limit$ to1 provid]-specific claims data1 cl9ical specialty-specific claims data1 /ate-specific claims data1 & nationwide claims data4 ,! ,secret>y %all promptly make available to a cl9ician-l$ cl9ical data regi/ry access to claims data reque/$ by su* cl9ician-l$ cl9ical data regi/ry )9 a reasonable timeframe1 n to exce$ #cj cal5d> days1 aft] ! ,secret>y approves ! reque/ f ! cl9ician-l$ cl9ical data regi/ry4 7b7 ,p]missible uses ( claims data ,cl9ician-l$ cl9ical data regi/ries may-- 7#a7 make available to ! public reports evaluat+ ! p]=mance ( provid]s ( s]vices & suppli]s us+ ! claims data provid$ to su* cl9ician-l$ cl9ical data regi/ry "u subsection 7a7 9 comb9ation ) regi/ry data2 7#b7 use claims data receiv$ "u subsection 7a7 comb9$ ) regi/ry data to conduct additional non-public analyses & provide or *>ge an access fee = su* analyses to au?oriz$ us]s = non-public use2 7#c7 provide or *>ge an access fee = data sets t l9k claims data receiv$ "u subsection 7a7 ) regi/ry data to au?oriz$ us]s = non-public use2 & 7#d7 provide or *>ge an access fee = claims data receiv$ "u subsection 7a7 to au?oriz$ us]s = non-public use4 7c7 ,fees 7#a7 ,claims data provid$ to cl9ician-l$ cl9ical data regi/ries ,claims data %all be provid$ to a cl9ician-l$ cl9ical data regi/ry "u subsection 7a7 at a reasonable fee bas$ on ! co/ ( provid+ su* data to ! cl9ician-l$ cl9ical data regi/ry4 ,su* fee %all be bas$ at lea/ 9 "p on ! numb] ( pati5ts includ$ 9 ! claims data provid$ to su* cl9ician-l$ cl9ical data regi/ry4 ,any fee collect$ pursuant to ! prec$+ s5t5ce %all be deposit$ 9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt4 7#b7 ,analyses & data provid$ to au?oriz$ us]s ,cl9ician-l$ cl9ical data regi/ries may *>ge a reasonable1 co/-bas$ fee = provid+ to au?oriz$ us]s claims data1 data sets l9k+ claims data ) regi/ry data1 or analyses describ$ 9 subsection 7b74 7d7 ,protection ( in=mation 7#a7 ,privacy1 security1 & disclosure laws ,! ,secret>y %all provide access to a database ( claims data pursuant to subsection 7a7 9 accordance ) applicable in=mation1 privacy1 security1 & disclosure laws1 includ+1 )\t limitation1 ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 ,public ,law #ajd-aia1 z am5d$ by ! ,privacy & ,security provisions set =? 9 ,section #acdjj ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act1 ,public ,law #aaa-e1 ! regulations promulgat$ !reund] codifi$ at #de ,,cfr ,p>ts #afj & #afd1 & subp>agraphs 7,a7 ?r\gh 7,b7 ( section #aje7;a77#c7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#c774 7#b7 ,prohibition on us+ analyses or data = m>ket+ purposes ,an au?oriz$ us] %all n use analyses or data provid$ or sold "u p>agraphs 7#b7 ?r\gh 7#d7 ( subsection 7b7 = m>ket+ purposes4 7#c7 ,no r$isclosure ( analyses or data ,an au?oriz$ us] 9 receipt ( an analysis or datum provid$ or sold "u p>agraphs 7#b7 ?r\gh 7#d7 ( subsection 7b7 %all comply ) section #aje7;a77#e7 ( ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#e774 7#d7 ,opportunity = provid]s ( s]vices & suppli]s to review ,prior to a cl9ician-l$ cl9ical data regi/ry us+1 provid+1 or *>g+ an access fee = claims data1 data sets l9k+ claims data ) regi/ry data1 or analyses describ$ 9 subsection 7b71 to ! ext5t t su* data1 data sets1 or analyses w\ld individually id5tify a provid] ( s]vices or suppli] :o is n be+ provid$ or sold su* data1 data sets1 or analyses1 su* cl9ician-l$ cl9ical data regi/ry %all confid5tially make available su* data1 data sets1 or analyses to su* provid] ( s]vices or suppli] & provide su* provid] ( s]vices or suppli] ) ! opportunity to appeal & correct errors4 7e7 ,data use agreem5t ,a cl9ician-l$ cl9ical data regi/ry & an au?oriz$ us] %all ent] into a data use agreem5t reg>d+ ! use or disclosure ( any claims data or data sets t l9k claims data ) regi/ry data t ! cl9ician-l$ cl9ical data regi/ry is provid+ or *>g+ an access fee to ! au?oriz$ us] "u p>agraphs 7#c7 ?r\gh 7#d7 ( subsection 7b74 ,su* agreem5t %all include ! requirem5ts & prohibitions describ$ 9 section #aje7;a77#d7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#d774 7f7 ,assessm5t = a brea* 7#a7 ,9 g5]al ,9 ! case ( a brea* ( a data use agreem5t1 ! ,secret>y %all impose an assessm5t on ! cl9ician-l$ cl9ical data regi/ry & ! au?oriz$ us]4 7#b7 ,assessm5t ,! assessm5t "u subsection 7f77#a7 %all be 9 an am\nt up to #ajj = ea* individual entitl$ to1 or enroll$ =1 b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act or enroll$ = b5efits "u "p ,b ( su* title = :om ! cl9ician-l$ cl9ical data regi/ry provid$ data on to ! au?oriz$ us]4 7#c7 ,deposit ( am\nts collect$ ,any am\nts collect$ pursuant to ?is subsection %all be deposit$ 9 ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet74 7g7 ,discov]y or admission z evid5ce ,claims data releas$ to a cl9ician-l$ cl9ical data regi/ry "u subsection 7a7 %all n be subject to discov]y or admission z evid5ce 9 judicial or adm9i/rative proce$+s )\t cons5t ( ! applicable provid] ( s]vices or suppli]4 #d4 ,report to congress ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,secret>y %all submit to ,congress a report on ! ext5t to :i* cl9ician-l$ cl9ical data regi/ries are af=d$ mean+ful access to claims data4 #e4 ,def9itions ,9 ?is ,act3 7#a7 ,au?oriz$ us] ,! t]m au?oriz$ us] %all h ! mean+ ascrib$ to x 9 section #aje7;a77#i77;,a7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#i77;,a771 z well z a gov]nm5t ag5cy or o!r gov]nm5tal entity1 rese>*]s1 entities t seek data = purposes ( comply+ ) regulations or o!r requirem5ts ( ! ,f$]al ,food & ,drug ,adm9i/ration1 & o!r entities approv$ by ! ,secret>y4 7#b7 ,claims data ,! t]m claims data %all h ! mean+ ascrib$ to ! t]m data 9 section #aje7;b77#a77;,b7 ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7#db ,u4,s4,c4 #aciekk-#b7;b77#a77;,b774 7#c7 ,cl9ician-l$ cl9ical data regi/ry ,! t]m cl9ician-l$ cl9ical data regi/ry %all h ! mean+ ascrib$ to x 9 section #djje7;b7 ( ! #ba/ ,c5tury ,cures ,act4 7#d7 ,data use agreem5t ,! t]m data use agreem5t means an agreem5t describ$ 9 subsection 7e7 ( section #c4 7#e7 ,non-public use ,! t]m non-public use means = ! purposes (-- 7,a7 promot+1 facilitat+1 & conduct+ m$ical rese>*2 assi/+ provid]s ( s]vices & suppli]s to improve pati5t safety & to develop & p>ticipate 9 quality & pati5t c>e improvem5t activities1 includ+ develop+ new models ( c>e2 7,b7 assi/+ cl9ician-l$ cl9ical data regi/ries 9 develop+ & report+ quality measures to heal? c>e provid]s quality measures2 7,c7 educat+ a gov]nm5t ag5cy or o!r gov]nm5tal entity2 & 7,d7 support+ cl9ical trials & o!r activities necess>y to comply ) pre- or po/-m>ket approval or adv]se ev5t report+ requirem5ts or conditions impos$ by ! ,f$]al ,food & ,drug ,adm9i/ration2 & o!r purposes approv$ by ! ,secret>y4 7#f7 ,provid] ( s]vices ,! t]m provid] ( s]vices %all h ! mean+ ascrib$ to x 9 section #ahfa7u7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7u774 7#g7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,humans ,s]vices4 7#h7 ,suppli] ,! t]m suppli] %all h ! mean+ ascrib$ to x 9 section #ahfa7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7d774 #f4 ,regulations ,! ,secret>y %all promulgate n lat] ?an #a ye> aft] ! enactm5t ( ?is ,act1 f9al regulations to implem5t ! provisions ( ! prec$+ sections ( ?is ,act4 #g4 ,cov]age ( promis+ new te*nologies "u ! m$ic>e program 7a7 ,non-,exclusion ( items & s]vices furni%$ "u access ) data collection ,section #ahfb7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a77 is am5d$-- 7#a7 9 subp>agraph 7,o71 by /rik+ at ! end &2 7#b7 9 subp>agraph 7,p71 by /rik+ ! semicolon at ! end & ins]t+ 1 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,q7 7i7 9 ! case ( items & s]vices = :i* evid5ce is promis+ b n def9itive to det]m9e t ! items & s]vices are reasonable & necess>y = ! diagnosis or treatm5t ( illness ( injury or to improve ! function+ ( a mal=m$ body memb]1 :i* are n reasonable & necess>y = evid5ce collection to det]m9e t ! reasonable & necess>y /&>d 9 subp>agraph 7,a7 is met2 & 7ii7 = purposes ( ?is subp>agraph1 evid5ce collection may include-- 7,i7 evid5ce ( appropriat5ess1 impact on quality ( life1 effectiv5ess1 safety or o!r outcomes z det]m9$ by ! ,secret>y2 & 7,,ii7 evid5ce d]iv$ f real _w data repositories1 pati5t regi/ries1 cohort /udies1 r&omiz$ controll$ trials1 or o!r /udies z det]m9$ by ! ,secret>y2 7iii7 ! evid5ce collection describ$ 9 clause 7ii7 %all be evid5ce collection approv$ by ! ,secret>y act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 9 collaboration ) ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality z meet+ ! priorities ( ?is title z set =? "u ,section #aadb2 7iv7 su* evid5ce collection %all be "t-limit$ to a p]iod ( no m ?an #e ye>s1 unless ! ,secret>y deems t ext5sion is ne$$ to address rema9+ gaps 9 evid5ce2 7v7 su* evid5ce collection %all be accessible1 include outcomes relevant to pati5ts1 & h transp>5t gov]nance2 & 7vi7 su* evid5ce collection %all be ref]r$ to z ,access ) ,data ,collection4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply to items & s]vices furni%$ aft] ,decemb] #ca1 #bjba4