,i #aae? ,,congress #b;d ,session ,h4 ,r4 #eggc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #aa1 #bjah,mr4 ,roskam 7= himself1 ,ms4 ,sewell ( ,alabama1 ,mr4 ,knight1 & ,ms4 ,s9ema7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to require ,m$ic>e prescription drug plans to e/abli% drug managem5t programs = at-risk b5efici>ies1 require electronic prior au?orization = cov]$ "p ,d drugs1 & to provide = o!r program integrity measures "u p>ts ,c & ,d ( ! ,m$ic>e program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prev5t+ ,addiction = ,susceptible ,s5iors ,act ( #bjah or ! ,,pass ,act ( #bjah 4 #b4 ,requir+ prescription drug plan sponsors "u ,m$ic>e to e/abli% drug managem5t programs = at-risk b5efici>ies ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 ,) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 a drug managem5t program = at-risk b5efici>ies describ$ 9 p>agraph 7#e74 2 & 7#b7 9 p>agraph 7#e77;,a71 by ins]t+ 7& = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 a ,,pdp sponsor %all7 aft] ,a ,,pdp sponsor may4 #c4 ,electronic prior au?orization = cov]$ "p ,d drugs 7a7 ,inclusion 9 electronic prescription program ,section #ahfj;,d-#d7;e77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,electronic prior au?orization 7i7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! program %all provide = ! secure electronic transmittal (-- 7,i7 a prior au?orization reque/ f ! prescrib+ heal? c>e pr(essional = cov]age ( a cov]$ "p ,d drug = a "p ,d eligible individual enroll$ 9 a "p ,d plan 7z def9$ 9 section #ahfj;,d-#bc7;a77#e77 to ! ,,pdp sponsor or ,m$ic>e ,advantage organization (f]+ su* plan2 & 7,,ii7 a response1 9 accordance ) ?is subp>agraph1 f su* ,,pdp sponsor or ,m$ic>e ,advantage organization1 respectively1 to su* pr(essional4 7ii7 ,electronic transmission 7,i7 ,exclusions ,= purposes ( ?is subp>agraph1 a facsimile1 a propriet>y pay] portal t does n meet /&>ds specifi$ by ! ,secret>y1 or an electronic =m %all n be treat$ z an electronic transmission describ$ 9 clause 7i74 7,,ii7 ,/&>ds ,9 ord] to be treat$1 = purposes ( ?is subp>agraph1 z an electronic transmission describ$ 9 clause 7i71 su* transmission %all comply ) te*nical /&>ds adopt$ by ! ,secret>y 9 consultation ) ! ,national ,c\ncil = ,prescription ,drug ,programs1 o!r /&>d sett+ organizations det]m9$ appropriate by ! ,secret>y1 & /akehold]s includ+ ,,pdp sponsors1 ,m$ic>e ,advantage organizations1 heal? c>e pr(essionals1 & heal? in=mation te*nology s(tw>e v5dors4 4 7b7 ,s5se ( ,congress reg>d+ electronic prior au?orization ,x is ! s5se ( ! ,congress t-- 7#a7 !re %\ld be increas$ use ( electronic prior au?orizations = cov]age ( cov]$ "p ,d drugs = "p ,d eligible individuals enroll$ 9 prescription drug plans "u "p ,d ( title ,,xviii ( ! ,social ,security ,act & ,,ma-,,pd plans "u "p ,c ( su* title to r$uce access delays by resolv+ cov]age issues be=e prescriptions = su* drugs are transmitt$2 & 7#b7 great] priority %\ld be plac$ on increas+ ! adoption ( use ( su* electronic prior au?orizations among prescrib]s ( su* drugs1 ph>macies1 ,,pdp sponsors1 & ,m$ic>e ,advantage organizations4 #d4 ,program integrity transp>5cy measures "u ,m$ic>e p>ts ,c & ,d 7a7 ,9 g5]al ,section #ahei ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bh7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,program integrity transp>5cy measures 7#a7 ,program integrity portal 7,a7 ,9 g5]al ,n lat] ?an two ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all1 aft] consultation ) /akehold]s1 e/abli% a secure ,int]net website portal 7or o!r successor te*nology7 t w\ld all[ a secure pa? = communication betwe5 ! ,secret>y1 ,,ma plans "u ?is "p1 prescription drug plans "u "p ,d1 & an eligible entity ) a contract "u section #ahic 7su* z a ,m$ic>e drug integrity contractor or an entity responsible = c>ry+ out program integrity activities "u ?is "p & "p ,d7 = ! purpose ( enabl+ ?r\gh su* portal 7or o!r successor te*nology7-- 7i7 ! ref]ral by su* plans ( sub/antiat$ fraud1 wa/e1 & abuse = initiat+ or assi/+ inve/igations conduct$ by ! eligible entity2 & 7ii7 data %>+ among su* ,,ma plans1 prescription drug plans1 & ! ,secret>y4 7,b7 ,requir$ uses ( portal ,! ,secret>y %all dissem9ate ! foll[+ in=mation to ,,ma plans "u ?is "p & prescription drug plans "u "p ,d ?r\gh ! secure ,int]net website portal 7or o!r successor te*nology7 e/abli%$ "u subp>agraph 7,a73 7i7 ,provid]s ( s]vices & suppli]s t h be5 ref]r$ pursuant to subp>agraph 7,a77i7 dur+ ! previ\s #ab-mon? p]iod4 7ii7 ,provid]s ( s]vices & suppli]s :o are ! subject ( an active exclusion "u section #aabh or :o are subject to a susp5sion ( paym5t "u ?is title pursuant to section #ahfb7o7 or o!rwise4 7iii7 ,provid]s ( s]vices & suppli]s :o are ! subject ( an active revocation ( p>ticipation "u ?is title1 includ+ = n satisfy+ conditions ( p>ticipation4 7iv7 ,9 ! case ( su* a plan t makes a ref]ral "u subp>agraph 7,a77i7 ?r\gh ! portal 7or o!r successor te*nology7 ) respect to activities ( sub/antiat$ fraud1 wa/e1 or abuse ( a provid] ( s]vices or suppli]1 if su* provid] or suppli] has be5 ! subject ( an adm9i/rative action "u ?is title or title ,,xi ) respect to simil> activities1 a notification to su* plan ( su* action s tak54 7,c7 ,rulemak+ ,= purposes ( ?is p>agraph1 ! ,secret>y %all1 ?r\gh rulemak+1 specify :at con/itutes sub/antiat$ fraud1 wa/e1 & abuse1 us+ guidance su* z :at is provid$ 9 ! ,m$ic>e ,program ,integrity ,manual #d4g4a4 ,9 c>ry+ out ?is subsection1 a fraud hotl9e tip 7z def9$ by ! ,secret>y7 )\t fur!r evid5ce %all n be treat$ z suffici5t evid5ce = sub/antiat$ fraud1 wa/e1 or abuse4 7,d7 ,,hipaa compliant in=mation only ,= purposes ( ?is subsection1 communications may only occur if ! communications are p]mitt$ "u ! ,f$]al regulations 7conc]n+ ! privacy ( individually id5tifiable heal? in=mation7 promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif4 7#b7 ,qu>t]ly reports ,beg9n+ two ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all make available to ,,ma plans "u ?is "p & prescription drug plans "u "p ,d 9 a timely mann] 7b no less frequ5tly ?an qu>t]ly7 & us+ in=mation submitt$ to an entity describ$ 9 p>agraph 7#a7 ?r\gh ! portal 7or o!r successor te*nology7 describ$ 9 su* p>agraph or pursuant to section #ahic1 in=mation on fraud1 wa/e1 & abuse s*emes & tr5ds 9 id5tify+ suspici\s activity4 ,in=mation includ$ 9 ea* su* report %all-- 7,a7 include adm9i/rative actions1 p]t95t in=mation relat$ to opioid ov]prescrib+1 & o!r data det]m9$ appropriate by ! ,secret>y 9 consultation ) /akehold]s2 & 7,b7 be anonymiz$ in=mation submitt$ by plans )\t id5tify+ ! s\rce ( su* in=mation4 7#c7 ,cl>ification ,no?+ 9 ?is subsection %all be con/ru$ z preclud+ or o!rwise affect+ ref]rals describ$ 9 subp>agraph 7,a7 t may o!rwise be made to law en=cem5t entities or to ! ,secret>y4 4 7b7 ,contract requirem5t ,to communicate plan corrective actions aga9/ opioid ov]-,prescrib]s ,section #aheg7;e77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77#d77;,c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,communicat+ plan corrective actions aga9/ opioids ov]-prescrib]s 7,a7 ,9 g5]al ,beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 a contract "u ?is section ) an ,,ma organization %all require ! organization to submit to ! ,secret>y1 ?r\gh ! process e/abli%$ "u subp>agraph 7,b71 in=mation on ! inve/igations & o!r actions tak5 by su* plans relat$ to provid]s ( s]vices :o prescribe a high volume ( opioids4 7,b7 ,process ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all1 9 consultation ) /akehold]s1 e/abli% a process "u :i* ,,ma plans & prescription drug plans %all submit to ! ,secret>y in=mation describ$ 9 subp>agraph 7,a74 7,c7 ,regulations ,= purposes ( ?is p>agraph1 includ+ z appli$ "u section #ahfj;,d-#ab7;b77#c77;,d71 ! ,secret>y %all1 pursuant to rulemak+-- 7i7 specify a def9ition = ! t]m high volume ( opioids & a me?od = det]m9+ if a provid] ( s]vices prescribes su* a high volume2 & 7ii7 e/abli% ! process describ$ 9 subp>agraph 7,b7 & ! types ( in=mation t %all be submitt$ ?r\gh su* process4 4 7c7 ,ref]5ce "u "p ,d to program integrity transp>5cy measures ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7m7 ,program integrity transp>5cy measures ,= program integrity transp>5cy measures appli$ ) respect to prescription drug plan & ,,ma plans1 see section #ahei7;i74 4 #e4 ,exp&+ eligibility = m$ication !rapy managem5t programs "u "p ,d ,section #ahfj;,d-#d7;c77#b77;,a77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#b77;,a77ii77 is am5d$-- 7#a7 by r$esignat+ subclauses 7,i7 ?r\gh 7,,iii7 z items 7aa7 ?r\gh 7cc71 respectively1 & adju/+ ! m>g9s accord+ly2 7#b7 by /rik+ are "p ,d eligible individuals :o-- & ins]t+ are ! foll[+3 7,i7 ,"p ,d eligible individuals :o-- 2 & 7#c7 by add+ at ! end ! foll[+ new subclause3 7,,ii7 ,beg9n+ ,janu>y #a1 #bjba1 at-risk b5efici>ies = prescription drug abuse 7z def9$ 9 p>agraph 7#e77;,c774 4 #f4 ,m$ic>e notifications to outli] prescrib]s ( opioids ,section #ahfj;,d-#d7;c77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#d77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7,d7 ,outli] prescrib] notification 7i7 ,notification ,beg9n+ n lat] ?an two ye>s aft] ! date ( ! enactm5t ( ?is subp>agraph1 ! ,secret>y %all1 9 ! case ( a prescrib] id5tifi$ by ! ,secret>y "u clause 7ii7 to be an outli] prescrib] ( opioids1 provide1 subject to clause 7iv71 an annual notification to su* prescrib] t su* prescrib] has be5 s id5tifi$ & t includes res\rces on prop] prescrib+ me?ods & o!r in=mation specifi$ 9 accordance ) clause 7iii74 7ii7 ,id5tification ( outli] prescrib]s ( opioids 7,i7 ,9 g5]al ,! ,secret>y %all1 subject to subclause 7,,iii71 us+ ! valid prescrib] ,national ,provid] ,id5tifi]s includ$ pursuant to subp>agraph 7,a7 on claims = cov]$ "p ,d drugs = "p ,d eligible individuals enroll$ 9 prescription drug plans "u ?is "p or ,,ma-,,pd plans "u "p ,c & bas$ on ! ?re%old e/abli%$ "u subclause 7,,ii71 conduct an analysis to id5tify prescrib]s t are outli] opioid prescrib]s = a p]iod specifi$ by ! ,secret>y4 7,,ii7 ,e/abli%m5t ( ?re%old ,= purposes ( subclause 7,i7 & subject to subclause 7,,iii71 ! ,secret>y %all1 aft] consultation ) /akehold]s1 e/abli% a ?re%old1 bas$ on prescrib] specialty & geographic area1 = id5tify+ :e!r a prescrib] 9 a specialty & geographic area is an outli] prescrib] ( opioids z comp>$ to o!r prescrib]s ( opioids )9 su* specialty & area4 7,,iii7 ,exclusions ,! ,secret>y may exclude ! foll[+ individuals & prescrib]s f ! analysis "u ?is clause3 7aa7 ,individuals receiv+ hospice s]vices4 7bb7 ,individuals ) a canc] diagnosis4 7cc7 ,prescrib]s :o are ! subject ( an inve/igation by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices or ! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7iii7 ,cont5ts ( notification ,! ,secret>y %all1 bas$ on input f /akehold]s1 specify ! res\rces & o!r in=mation to be includ$ 9 notifications provid$ "u clause 7i74 7iv7 ,modifications & expansions 7,i7 ,frequ5cy ,beg9n+ #e ye>s aft] ! date ( ! enactm5t ( ?is subp>agraph1 ! ,secret>y may *ange ! frequ5cy ( ! notifications describ$ 9 clause 7i7 bas$ on /akehold] input4 7,,ii7 ,expansion to o!r prescriptions ,! ,secret>y may exp& notifications "u ?is subp>agraph to include id5tifications & notifications ) respect to concurr5t prescriptions ( cov]$ ,"p ,d drugs us$ 9 comb9ation ) opioids t are consid]$ to h adv]se side effects :5 s us$ 9 su* comb9ation1 z det]m9$ by ! ,secret>y4 7v7 ,opioids def9$ ,= purposes ( ?is subp>agraph1 ! t]m opioids has su* mean+ z specifi$ by ! ,secret>y ?r\gh program in/ruction or o!rwise4 4