,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fege ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #aj1 #bjbe ,mrs4 ,kiggans ( ,virg9ia 7= h]self1 ,mr4 ,got!im]1 ,mr4 ,lawl]1 ,mr4 ,cuell>1 ,mr4 ,bresnahan1 ,mr4 ,suozzi1 ,mr4 ,mack5zie1 ,ms4 ,lee ( ,nevada1 ,ms4 ,salaz>1 ,mr4 ,l&sman1 ,mr4 ,van ,drew1 ,mr4 ,case1 ,mr4 ,ciscomani1 ,mr4 ,co/a1 ,mr4 ,valadao1 ,mr4 ,riley ( ,new ,york1 ,mr4 ,hurd ( ,colorado1 ,ms4 ,s*olt51 ,mr4 ,bacon1 ,ms4 ,wilson ( ,florida1 ,mr4 ,gim5ez1 ,ms4 ,goodl&]1 ,ms4 ,de ,la ,cruz1 ,mr4 ,soto1 ,mr4 ,la,lota1 ,mr4 ,gray1 ,mr4 ,kiley ( ,cali=nia1 ,mr4 ,vic5te ,gonzalez ( ,texas1 ,mr4 ,kean1 ,mr4 ,figures1 ,mr4 ,fitzpatrick1 ,mr4 ,pappas1 ,mr4 ,licc>do1 ,mr4 ,davis ( ,nor? ,c>ol9a1 ,mr4 ,mosk[itz1 ,mr4 ,panetta1 ,mr4 ,pet]s1 & ,mr4 ,gold5 ( ,ma9e7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ,rules1 = 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 ! ,int]nal ,rev5ue ,code ( #aihf to ext5d & modify ! enhanc$ premium tax cr$it1 to am5d ! ,pati5t ,protection & ,af=dable ,c>e ,act to make c]ta9 adju/m5ts to ! op]ation ( ! ,ex*anges e/abli%$ "u su* ,act1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,common,ground = ,af=dable ,heal? ,c>e ,act4 #b4 ,ext5sion & modification ( enhanc$ premium tax cr$it 7a7 ,ext5sion & modification ( rules to increase premium assi/ance am\nts ,section #cf;,b7b77#c77;,a77iii7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 by r$esignat+ subclauses 7,i7 & 7,,ii7 z items 7aa7 & 7bb71 respectively1 & adju/+ ! m>g9s accord+ly1 7#b7 by /rik+ ,tempor>y p]c5tages = #bjba ?r\gh #bjbe4--;,9 ! case ( & ins]t+ ,tempor>y p]c5tages = c]ta9 ye>s4-- 7,i7 ,be=e #bjbf ,9 ! case ( 1 & 7#c7 by add+ at ! end ! foll[+3 7,,ii7 #bjbf ,9 ! case ( a taxable ye> beg9n+ aft] ,decemb] #ca1 #bjbe1 & be=e ,janu>y #a1 #bjbg-- 7aa7 clause 7ii7 %all n apply = purposes ( adju/+ premium p]c5tages "u ?is subp>agraph1 & 7bb7 ! foll[+ table %all be appli$ 9 lieu ( ! table conta9$ 9 clause 7i73 ,9 ! case ( h\sehold income 7express$ z a p]c5t ( pov]ty l9e7 )9 ! foll[+ income ti]3,! initial premium p]c5tage is-,! f9al premium p]c5tage is- ,up to #aejj4jj4j #aej up to #bjjj4jb4j #bjj up to #bejb4jd4j #bej up to #cjjd4jf4j #cjj up to #djjf4jh4e #djj up to #fjjh4eh4e #fjj up to #ijjh4ei4be #ijj up to #ajjji4beaj4j 4 7b7 ,ext5sion & modification ( rule to all[ cr$it to taxpay]s ^: h\sehold income exce$s #djj p]c5t ( pov]ty l9e ,section #cf;,b7c77#a77;,e7 ( su* ,code is am5d$-- 7#a7 by /rik+ ,tempor>y rule = #bjba ?r\gh #bjbe4--;,9 ! case ( & ins]t+ ,tempor>y rule = c]ta9 ye>s4-- 7i7 ,be=e #bjbf ,9 ! case ( 1 & 7#b7 by add+ at ! end ! foll[+3 7ii7 #bjbf ,9 ! case ( a taxable ye> beg9n+ aft] ,decemb] #ca1 #bjbe1 & be=e ,janu>y #a1 #bjbg1 subp>agraph 7,a7 %all be appli$ by sub/itut+ b does n exce$ #ajjj p]c5t = b does n exce$ #djj p]c5t4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjbe4 #c4 ,gu>drails to prev5t fraud 9 ,ex*anges 7a7 ,r$uction ( fraudul5t enrollm5t 9 qualifi$ heal? plans 7#a7 ,p5alties = ag5ts & brok]s ,section #adaa7;h77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjha7;h77#a77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by r$esignat+ clause 7ii7 z clause 7iv72 7ii7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by /rik+ ,if-- & all t foll[s ?r\gh ! su* p]son 9 ! matt] foll[+ subclause 7,,ii7 & ins]t+ ! foll[+3 ,if any p]son 7o!r ?an an ag5t or brok]7 fails to provide correct in=mation "u subsection 7b7 & su* failure is attributable to neglig5ce or disreg>d ( any rules or regulations ( ! ,secret>y1 su* p]son2 & 7,,ii7 9 ! second s5t5ce1 by /rik+ ,= purposes & ins]t+ ! foll[+3 7iii7 ,def9itions ( neglig5ce1 disreg>d ,= purposes 2 7iii7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 ,civil p5alties = c]ta9 violations by ag5ts or brok]s ,if any ag5t or brok] fails to provide correct in=mation "u subsection 7b7 or section #acaa7;c77#h7 or o!r in=mation1 z specifi$ by ! ,secret>y1 & su* failure is attributable to neglig5ce or disreg>d ( any rules or regulations ( ! ,secret>y1 su* ag5t or brok] %all be subject1 9 addition to any o!r p5alties t may be prescrib$ by law1 includ+ subp>agraph 7,c71 to a civil p5alty ( n less ?an #aj1jjj & n m ?an #ej1jjj ) respect to ea* individual :o is ! subject ( an application = :i* su* incorrect in=mation is provid$4 2 & 7iv7 9 clause 7iv7 7z s r$esignat$71 by ins]t+ or 7ii7 aft] clause 7i72 7,b7 9 subp>agraph 7,b7-- 7i7 by ins]t+ includ+ subp>agraph 7,c71 aft] law12 7ii7 by /rik+ ,any p]son & ins]t+ ! foll[+3 7i7 ,9 g5]al ,any p]son 2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 ,civil p5alties = kn[+ violations by ag5ts or brok]s 7,i7 ,9 g5]al ,any ag5t or brok] :o kn[+ly provides false or fraudul5t in=mation "u subsection 7b7 or section #acaa7;c77#h71 or o!r false or fraudul5t in=mation z "p ( an application = enrollm5t 9 a qualifi$ heal? plan (f]$ ?r\gh an ,ex*ange1 z specifi$ by ! ,secret>y1 %all be subject1 9 addition to any o!r p5alties t may be prescrib$ by law1 includ+ subp>agraph 7,c71 to a civil p5alty ( n m ?an #bjj1jjj ) respect to ea* individual :o is ! subject ( an application = :i* su* false or fraudul5t in=mation is provid$4 7,,ii7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty "u subclause 7,i7 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 2 & 7,c7 by add+ at ! end ! foll[+3 7,c7 ,crim9al p5alties ,any ag5t or brok] :o kn[+ly & willfully provides false or fraudul5t in=mation "u subsection 7b7 or section #acaa7;c77#h71 or o!r false or fraudul5t in=mation z "p ( an application = enrollm5t 9 a qualifi$ heal? plan (f]$ ?r\gh an ,ex*ange1 z specifi$ by ! ,secret>y1 %all be f9$ "u title #ah1 ,unit$ ,/ates ,code1 imprison$ = n m ?an #aj ye>s1 or bo?4 4 7#b7 ,consum] protections 7,a7 ,9 g5]al ,section #acaa7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,ag5t- or brok]-assi/$ enrollm5t 9 qualifi$ heal? plans 9 c]ta9 ex*anges 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] su* date specifi$ by ! ,secret>y1 b n lat] ?an ,janu>y #a1 #bjbi1 9 ! case ( an ,ex*ange t ! ,secret>y op]ates pursuant to section #acba7;c77#a71 ! ,secret>y %all e/abli% a v]ification process = new enrollm5ts ( individuals 91 & *anges 9 cov]age = individuals "u1 a qualifi$ heal? plan (f]$ ?r\gh su* ,ex*ange1 :i* are submitt$ by an ag5t or brok] 9 accordance ) section #acab7;e7 & = :i* ! ag5t or brok] is eligible to receive a commission4 7,b7 ,requirem5ts ,! enrollm5t v]ification process "u subp>agraph 7,a7 %all include-- 7i7 a requirem5t t ! ag5t or brok] provide ) ! new enrollm5t or cov]age *ange su* docum5tation or evid5ce 7su* z a /&>diz$ cons5t =m7 or o!r s\rces z ! ,secret>y det]m9es necess>y to e/abli% t ! ag5t or brok] has ! cons5t ( ! individual = ! new enrollm5t or cov]age *ange2 7ii7 a requirem5t t any commissions due to a brok] or ag5t = su* new enrollm5t or cov]age *ange are paid aft] ! enrollee has resolv$ all inconsi/5cies 9 accordance ) p>agraphs 7#c7 & 7#d7 ( section #adaa7;e72 7iii7 a requirem5t t ! in=mation requir$ "u clause 7i7 &1 z applicable1 ! date on :i* inconsi/5cies are resolv$ z describ$ 9 clause 7ii71 is accessible to ! applicable qualifi$ heal? plan ?r\gh a database or o!r res\rce1 z det]m9$ by ! ,secret>y1 s t any commissions due to a brok] or ag5t = su* enrollm5t c be effectuat$ at ! appropriate "t2 7iv7 a requirem5t t individuals are notifi$ ( any *anges to enrollm5t1 cov]age1 ! ag5t ( record1 or premium tax cr$its 9 a timely mann] & t su* notice provides pla9 language in/ructions on h[ individuals c cancel unau?oriz$ activity2 7v7 a requirem5t t individuals be able to access _! acc\nt in=mation on a website or o!r te*nology plat=m1 z def9$ by ! ,secret>y1 :5 us$ to submit an enrollm5t or plan *ange1 9 lieu ( ! ,ex*ange website describ$ 9 subsection 7d77#d77;,c71 includ+ in=mation on ! ag5t ( record1 ! qualifi$ heal? plan1 & :5 any *anges are made to ! ag5t ( record or ! qualifi$ heal? plan1 on a consum]-fac+ website or ?r\gh a toll-free telephone hotl9e2 & 7vi7 a requirem5t t ! ag5t or brok] report to ! ,secret>y any ?ird-p>ty m>ket+ organization or field m>ket+ organization 7z su* t]ms are def9$ 9 section #acab7;e77 involv$ 9 ! *a9 ( enrollm5t 7z s def9$7 ) respect to su* new enrollm5t or cov]age *ange4 7,c7 ,consum] protection ,! ,secret>y %all ensure t ! enrollm5t v]ification process "u subp>agraph 7,a7 prioritizes cont9uity ( cov]age & c>e = individuals1 includ+ by n dis5roll+ individuals f a qualifi$ heal? plan )\t ! cons5t ( ! individual1 reg>dless ( :e!r ! brok]1 ag5t1 or qualifi$ heal? plan is 9 violation ( any requirem5t "u ?is p>agraph4 4 7,b7 ,requir$ report+ ,section #acaa7;c77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c77#a77 is am5d$-- 7i7 9 subp>agraph 7,h71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,i71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,j7 report to ! ,secret>y ! t]m9ation 7z def9$ 9 section #acab7;e77#a77;,c77 ( an issu]4 4 7#c7 ,au?ority to regulate field m>ket+ organizations & ?ird-p>ty m>ket+ organizations ,section #acab7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb7;e77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z subclauses 7,i7 & 7,,ii71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 9 subclause 7,,ii7 7z s r$esignat$71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 7,c7 by /rik+ ! subsection designation & head+ & all t foll[s ?r\gh brok]s-- & ins]t+ ! foll[+3 7e7 ,regulation ( ag5ts1 brok]s1 & c]ta9 m>ket+ organizations 7#a7 ,ag5ts1 brok]s1 & c]ta9 m>ket+ organizations 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% proc$ures "u :i* a ,/ate may all[-- 7i7 ag5ts or brok]s-- 2 & 7,d7 by add+ at ! end ! foll[+3 7ii7 field m>ket+ organizations & ?ird-p>ty m>ket+ organizations to p>ticipate 9 ! *a9 ( enrollm5t = an individual ) respect to qualifi$ heal? plans (f]$ ?r\gh an ,ex*ange4 7,b7 ,crit]ia ,= plan ye>s beg9n+ on or aft] su* date specifi$ by ! ,secret>y1 b n lat] ?an ,janu>y #a1 #bjbi1 ! ,secret>y1 by regulation1 %all e/abli% crit]ia = ,/ates to use 9 det]m9+ :e!r to all[ ag5ts & brok]s to enroll individuals & employ]s 9 qualifi$ heal? plans z describ$ 9 subclause 7,i7 ( subp>agraph 7,a77i7 & to assi/ individuals z describ$ 9 subclause 7,,ii7 ( su* subp>agraph & field m>ket+ organizations & ?ird-p>ty m>ket+ organizations to p>ticipate 9 ! *a9 ( enrollm5t z describ$ 9 subp>agraph 7,a77ii74 ,su* crit]ia %all1 at a m9imum1 require t-- 7i7 an ag5t or brok] act 9 accordance ) a /&>d ( conduct t includes a duty ( su* ag5t or brok] to act 9 ! be/ int]e/s ( ! enrollee2 7ii7 a field m>ket+ organization or ?ird-p>ty m>ket+ organization agree to report ! t]m9ation ( an ag5t or brok] to ! applicable ,/ate & ! ,secret>y1 includ+ ! reason = t]m9ation2 & 7iii7 an ag5t1 brok]1 field m>ket+ organization1 or ?ird-p>ty m>ket+ organization-- 7,i7 meet su* m>ket+ requirem5ts z are requir$ by ! ,secret>y2 7,,ii7 meet m>ket+ requirem5ts 9 accordance ) o!r applicable ,f$]al or ,/ate law2 7,,iii7 does n employ practices t are confus+ or mislead+1 z det]m9$ by ! ,secret>y2 7,,iv7 submit all m>ket+ mat]ials to ! ,secret>y =1 z det]m9$ appropriate by ! ,secret>y1 review & approval2 7,v7 is a lic5s$ ag5t or brok] or meets o!r lic5sure requirem5ts1 z requir$ by ! ,/ate2 7,,vi7 regi/] ) ! ,secret>y2 & 7,,vii7 does n comp5sate any individual or organization = ref]rals or any o!r s]vice relat+ to ! sale (1 m>ket+ =1 or enrollm5t 9 qualifi$ heal? plans unless su* individual or organization meets ! crit]ia describ$ 9 subclauses 7,i7 ?r\gh 7,,vi74 7,c7 ,def9itions ,9 ?is p>agraph3 7i7 ,*a9 ( enrollm5t ,! t]m *a9 ( enrollm5t1 ) respect to enrollm5t ( an individual 9 a qualifi$ heal? plan (f]$ ?r\gh an ,ex*ange1 means any /eps tak5 f m>ket+ to su* individual1 to su* individual mak+ an enrollm5t decision ) respect to su* a plan4 7ii7 ,field m>ket+ organization ,! t]m field m>ket+ organization means an organization or individual t directly employs or contracts ) ag5ts & brok]s1 or contracts ) c>ri]s1 to provide functions relat+ to enrollm5t ( individuals 9 qualifi$ heal? plans (f]$ ?r\gh an ,ex*ange z "p ( ! *a9 ( enrollm5t4 7iii7 ,m>ket+ ,! t]m m>ket+ means ! use ( m>ket+ mat]ials to provide in=mation to curr5t & prospective enrollees 9 a qualifi$ heal? plan (f]$ ?r\gh an ,ex*ange4 7iv7 ,m>ket+ mat]ials ,! t]m m>ket+ mat]ials means mat]ials relat+ to a qualifi$ heal? plan (f]$ ?r\gh an ,ex*ange or b5efits (f]$ ?r\gh an ,ex*ange t-- 7,i7 are int5d$-- 7aa7 to draw an individual's att5tion to su* plan or ! premium tax cr$its or co/-%>+ r$uctions = su* plan or plans (f]$ ?r\gh an ,ex*ange2 7bb7 to influ5ce an individual's decision-mak+ process :5 select+ a qualifi$ heal? plan 9 :i* to enroll2 or 7cc7 to influ5ce an enrollee's decision to /ay enroll$ 9 su* plan2 & 7,,ii7 include or address cont5t reg>d+ ! b5efits1 b5efit /ructure1 premiums1 or co/ %>+ ( su* plan4 7v7 ,t]m9ation ,! t]m t]m9ation1 ) respect to a contract or bus9ess arrangem5t betwe5 an ag5t or brok] & a field m>ket+ organization1 ?ird-p>ty m>ket+ organization1 or heal? insurance issu]1 means-- 7,i7 ! end+ ( su* contract or bus9ess arrangem5t1 ei!r unilat]ally by "o ( ! p>ties or on mutual agreem5t2 or 7,,ii7 ! expiration ( su* contract or bus9ess arrangem5t t is n replac$ by a sub/antially simil> agreem5t4 7vi7 ,?ird-p>ty m>ket+ organization ,! t]m ?ird-p>ty m>ket+ organization means an organization or individual t is comp5sat$ to p]=m lead g5]ation1 m>ket+1 or sales relat+ to enrollm5t ( individuals 9 qualifi$ heal? plans (f]$ ?r\gh an ,ex*ange z "p ( ! *a9 ( enrollm5t4 4 7#d7 ,transp>5cy ,section #acab7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb7;e771 z am5d$ by p>agraph 7#c71 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraphs3 7#b7 ,audits 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] su* date specifi$ by ! ,secret>y1 b n lat] ?an ,janu>y #a1 #bjbi1 ! ,secret>y1 9 coord9ation ) ! ,/ates & 9 consultation ) ! ,national ,association ( ,insurance ,commission]s1 %all implem5t a process = ! ov]sight & en=cem5t ( ag5t & brok] compliance ) ?is section & o!r applicable ,f$]al & ,/ate law 7includ+ regulations7 t %all include-- 7i7 p]iodic audits ( ag5ts & brok]s bas$ on-- 7,i7 compla9ts fil$ ) ! ,secret>y by individuals enroll$ by su* an ag5t or brok] 9 a qualifi$ heal? plan (f]$ ?r\gh an ,ex*ange2 7,,ii7 an incid5t or enrollm5t patt]n t sugge/s fraud2 & 7,,iii7 o!r factors det]m9$ by ! ,secret>y2 & 7ii7 a process "u :i* ! ,secret>y %all %>e audit results & ref] pot5tial cases ( fraud to ! relevant ,/ate dep>tm5t ( insurance4 7,b7 ,effect ,no?+ 9 ?is p>agraph limits or re/ricts any ref]rals made "u section #acaa7;i77#c7 or any en=cem5t actions "u section #adaa7;h74 7#c7 ,li/ ,! ,secret>y %all develop a process to regul>ly provide to qualifi$ heal? plans1 ,ex*anges1 & ,/ates a li/ ( susp5d$ & t]m9at$ ag5ts & brok]s4 4 7b7 ,removal ( deceas$ individuals f ,ex*ange plans ,section #acaa7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,removal ( deceas$ individuals f ,ex*ange plans 7,a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is p>agraph1 & on a qu>t]ly basis !reaft]1 ! ,secret>y %all conduct a *eck ( ! ,dea? ,ma/] ,file 7z su* t]m is def9$ 9 section #bjc7;d7 ( ! ,bip>tisan ,budget ,act ( #bjac7 = purposes ( id5tify+ individuals enroll$ 9 a qualifi$ heal? plan ?r\gh an ,ex*ange :o are deceas$4 7,b7 ,process ,! ,secret>y %all-- 7i7 e/abli% a process to v]ify t an individual id5tifi$ pursuant to a *eck describ$ 9 subp>agraph 7,a7 is deceas$2 & 7ii7 require an ,ex*ange to t]m9ate su* individual's enrollm5t "u a qualifi$ heal? plan4 4 7c7 ,/&>d ( pro( = t]m9at+ ag5ts & brok]s ,section #acab7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb7;e771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,/&>d = t]m9ation = c]ta9 ,ex*anges ,9 ! case ( an ag5t or brok] ) an agreem5t 9 effect ) an ,ex*ange op]at$ by ! ,secret>y pursuant to section #acba7;c7 to p]=m activities describ$ 9 p>agraph 7#a77;,a77i7 ) respect to su* ,ex*ange1 ! ,secret>y may t]m9ate su* agreem5t if ! ,secret>y f9ds1 bas$ on a prepond]ance ( ! evid5ce1 t su* ag5t or brok] has violat$ su* agreem5t1 o!rwise applicable law1 or any o!r requirem5t applicable to su* ag5t or brok]4 4 7d7 ,requirem5t = ,ex*ange to notify individuals ( value ( premium tax cr$its ,section #adab7;c77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjhb7;c77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,ex*ange responsibilities ,beg9n+ ,janu>y #a1 #bjbg1 if an ,ex*ange is notifi$ "u p>agraph 7#a7 ( an advance det]m9ation "u section #adaa ) respect to ! eligibility ( an individual = a premium tax cr$it "u section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf1 ! ,ex*ange %all1 prior to enroll+ su* individual 9 a qualifi$ heal? plan1 cle>ly notify su* individual ( ! am\nt ( su* tax cr$it4 4 #d4 ,ext5d+ annual op5 enrollm5t p]iod = ,ex*anges = plan ye> #bjbf 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all revise section #aee4daj7;e7 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulation7 to provide t ! annual op5 enrollm5t p]iod det]m9$ = plan ye> #bjbf pursuant to section #acaa7;c77#f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c77#f77 %all beg9 on ,novemb] #a1 #bjbe1 & end on ,m>* #ai1 #bjbf4 7b7 ,notification ( op5 enrollm5t ext5sion ,! ,secret>y ( ,heal? & ,human ,s]vices %all p]=m su* outrea* activities z are necess>y to in=m qualifi$ individuals 7z def9$ 9 section #acab7;f77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb7;f77#a777 ( ! ext5d$ op5 enrollm5t p]iod provid$ = "u subsection 7a74 #e4 ,mod]niz+ & ,ensur+ ,,pbm ,acc\ntability 7a7 ,9 g5]al 7#a7 ,prescription drug plans ,section #ahfj;,d-#ab ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,requirem5ts relat+ to ph>macy b5efit manag]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbi3 7#a7 ,agreem5ts ) ph>macy b5efit manag]s ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all provide t any ph>macy b5efit manag] act+ on behalf ( su* sponsor has a writt5 agreem5t ) ! ,,pdp sponsor "u :i* ! ph>macy b5efit manag]1 & any affiliates ( su* ph>macy b5efit manag]1 z applicable1 agree to meet ! foll[+ requirem5ts3 7,a7 ,no income o!r ?an bona fide s]vice fees 7i7 ,9 g5]al ,! ph>macy b5efit manag] & any affiliate ( su* ph>macy b5efit manag] %all n d]ive any remun]ation ) respect to any s]vices provid$ on behalf ( any entity or individual1 9 connection ) ! utilization ( cov]$ "p ,d drugs1 f any su* entity or individual o!r ?an bona fide s]vice fees1 subject to clauses 7ii7 & 7iii74 7ii7 ,inc5tive paym5ts ,= ! purposes ( ?is subsection1 an inc5tive paym5t 7z det]m9$ by ! ,secret>y7 paid by a ,,pdp sponsor to a ph>macy b5efit manag] t is p]=m+ s]vices on behalf ( su* sponsor %all be deem$ a bona fide s]vice fee 7ev5 if su* paym5t does n o!rwise meet ! def9ition ( su* t]m "u p>agraph 7#g77;,b77 if su* paym5t is a flat doll> am\nt1 is consi/5t ) fair m>ket value 7z specifi$ by ! ,secret>y71 is relat$ to s]vices actually p]=m$ by ! ph>macy b5efit manag] or affiliate ( su* ph>macy b5efit manag]1 on behalf ( ! ,,pdp sponsor mak+ su* paym5t1 9 connection ) ! utilization ( cov]$ "p ,d drugs1 & meets additional requirem5ts1 if any1 z det]m9$ appropriate by ! ,secret>y4 7iii7 ,cl>ification on rebates & disc\nts us$ to l[] co/s = cov]$ "p d drugs ,rebates1 disc\nts1 & o!r price concessions receiv$ by a ph>macy b5efit manag] or an affiliate ( a ph>macy b5efit manag] f manufactur]s1 ev5 if su* price concessions are calculat$ z a p]c5tage ( a drug's price1 %all n be consid]$ a violation ( ! requirem5ts ( clause 7i7 if !y are fully pass$ ?r\gh to a ,,pdp sponsor & are compliant ) all regulatory & subregulatory requirem5ts relat$ to direct & indirect remun]ation = manufactur] rebates "u ?is "p1 includ+ 9 cases :]e a ,,pdp sponsor is act+ z a ph>macy b5efit manag] on behalf ( a prescription drug plan (f]$ by su* ,,pdp sponsor4 7iv7 ,evaluation ( remun]ation arrangem5ts ,compon5ts ( subsets ( remun]ation arrangem5ts 7su* z fees or o!r =ms ( comp5sation paid to or reta9$ by ! ph>macy b5efit manag] or affiliate ( su* ph>macy b5efit manag]71 z det]m9$ appropriate by ! ,secret>y1 betwe5 ph>macy b5efit manag]s or affiliates ( su* ph>macy b5efit manag]s1 z applicable1 & o!r entities involv$ 9 ! disp5s+ or utilization ( cov]$ "p ,d drugs 7includ+ ,,pdp sponsors1 manufactur]s1 ph>macies1 & o!r entities z det]m9$ appropriate by ! ,secret>y7 %all be subject to review by ! ,secret>y1 9 consultation ) ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 z det]m9$ appropriate by ! ,secret>y4 ,! ,secret>y1 9 consultation ) ! ,(fice ( ! ,inspector ,g5]al1 %all review :e!r remun]ation "u su* arrangem5ts is consi/5t ) fair m>ket value 7z specifi$ by ! ,secret>y7 ?r\gh reviews & assessm5ts ( su* remun]ation1 z det]m9$ appropriate4 7v7 ,disgorgem5t ,! ph>macy b5efit manag] %all disgorge any remun]ation paid to su* ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] 9 violation ( ?is subp>agraph to ! ,,pdp sponsor4 7vi7 ,additional requirem5ts ,! ph>macy b5efit manag] %all-- 7,i7 ent] into a writt5 agreem5t ) any affiliate ( su* ph>macy b5efit manag]1 "u :i* ! affiliate %all id5tify & disgorge any remun]ation describ$ 9 clause 7v7 to ! ph>macy b5efit manag]2 & 7,,ii7 atte/1 subject to any requirem5ts det]m9$ appropriate by ! ,secret>y1 t ! ph>macy b5efit manag] has ent]$ into a writt5 agreem5t describ$ 9 subclause 7,i7 ) any relevant affiliate ( ! ph>macy b5efit manag]4 7,b7 ,transp>5cy reg>d+ gu>antees & co/ p]=mance evaluations ,! ph>macy b5efit manag] %all-- 7i7 def9e1 int]pret1 & apply1 9 a fully transp>5t & consi/5t mann] = purposes ( calculat+ or o!rwise evaluat+ ph>macy b5efit manag] p]=mance aga9/ pric+ gu>antees or simil> co/ p]=mance measurem5ts relat$ to rebates1 disc\nts1 price concessions1 or net co/s1 t]ms su* z-- 7,i7 g5]ic drug1 9 a mann] consi/5t ) ! def9ition ( ! t]m "u section #dbc4d ( title #db1 ,code ( ,f$]al ,regulations1 or a successor regulation2 7,,ii7 br& "n drug1 9 a mann] consi/5t ) ! def9ition ( ! t]m "u section #dbc4d ( title #db1 ,code ( ,f$]al ,regulations1 or a successor regulation2 7,,iii7 specialty drug2 7,,iv7 rebate2 & 7,v7 disc\nt2 7ii7 id5tify any drugs1 claims1 or price concessions exclud$ f any pric+ gu>antee or o!r co/ p]=mance measure 9 a cle> & consi/5t mann]2 & 7iii7 :]e a pric+ gu>antee or o!r co/ p]=mance measure is bas$ on a pric+ b5*m>k o!r ?an ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 ( a drug1 calculate & provide a :olesale acquisition co/-bas$ equival5t to ! pric+ gu>antee or o!r co/ p]=mance measure4 7,c7 ,provision ( in=mation 7i7 ,9 g5]al ,n lat] ?an ,july #a ( ea* ye>1 beg9n+ 9 #bjbi1 ! ph>macy b5efit manag] %all submit to ! ,,pdp sponsor1 & to ! ,secret>y1 a report1 9 accordance ) ?is subp>agraph1 & %all make su* report available to su* sponsor at no co/ to su* sponsor 9 a =mat specifi$ by ! ,secret>y "u p>agraph 7#e74 ,ea* su* report %all include1 ) respect to su* ,,pdp sponsor & ea* plan (f]$ by su* sponsor1 ! foll[+ in=mation ) respect to ! previ\s plan ye>3 7,i7 ,a li/ ( all drugs cov]$ by ! plan t 7 disp5s$ includ+1 ) respect to ea* su* drug-- 7aa7 ! br& "n1 g5]ic or non-propriet>y "n1 & ,national ,drug ,code2 7bb7 ! numb] ( plan enrollees = :om ! drug 0 disp5s$1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills1 c\nt$ z sep>ate claims71 & ! total numb] ( dosage units ( ! drug disp5s$2 7cc7 ! numb] ( prescription claims describ$ 9 item 7bb7 by ea* type ( disp5s+ *annel ?r\gh :i* ! drug 0 disp5s$1 includ+ retail1 mail ord]1 specialty ph>macy1 long t]m c>e ph>macy1 home infusion ph>macy1 or o!r types ( ph>macies or provid]s2 7dd7 ! av]age :olesale acquisition co/1 li/$ z co/ p] day's supply1 co/ p] dosage unit1 & co/ p] typical c\rse ( treatm5t 7z applicable72 7ee7 ! av]age :olesale price = ! drug1 li/$ z price p] day's supply1 price p] dosage unit1 & price p] typical c\rse ( treatm5t 7z applicable72 7ff7 ! total out-(-pocket sp5d+ by plan enrollees on su* drug aft] application ( any b5efits "u ! plan1 includ+ plan enrollee sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7gg7 total rebates paid by ! manufactur] on ! drug z report$ "u ! ,detail$ ,,dir ,report 7or any successor report7 submitt$ by su* sponsor to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7hh7 all o!r direct or indirect remun]ation on ! drug z report$ "u ! ,detail$ ,,dir ,report 7or any successor report7 submitt$ by su* sponsor to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7ii7 ! av]age ph>macy reimbursem5t am\nt paid by ! plan = ! drug 9 ! aggregate & disaggregat$ by disp5s+ *annel id5tifi$ 9 item 7cc72 7jj7 ! av]age ,national ,av]age ,drug ,acquisition ,co/ 7,,nadac72 & 7kk7 total manufactur]-d]iv$ rev5ue1 inclusive ( bona fide s]vice fees1 attributable to ! drug & reta9$ by ! ph>macy b5efit manag] & any affiliate ( su* ph>macy b5efit manag]4 7,,ii7 ,9 ! case ( a ph>macy b5efit manag] t has an affiliate t is a retail1 mail ord]1 or specialty ph>macy1 ) respect to drugs cov]$ by su* plan t 7 disp5s$1 ! foll[+ in=mation3 7aa7 ,! p]c5tage ( total prescriptions t 7 disp5s$ by ph>macies t are an affiliate ( ! ph>macy b5efit manag] = ea* drug4 7bb7 ,! int]qu>tile range ( ! total comb9$ co/s paid by ! plan & plan enrollees1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply = ea* drug disp5s$ by ph>macies t are n an affiliate ( ! ph>macy b5efit manag] & t are includ$ 9 ! ph>macy network ( su* plan4 7cc7 ,! int]qu>tile range ( ! total comb9$ co/s paid by ! plan & plan enrollees1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply = ea* drug disp5s$ by ph>macies t are an affiliate ( ! ph>macy b5efit manag] & t are includ$ 9 ! ph>macy network ( su* plan4 7dd7 ,! l[e/ total comb9$ co/ paid by ! plan & plan enrollees1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 = ea* drug t is available f any ph>macy includ$ 9 ! ph>macy network ( su* plan4 7ee7 ,! diff]5ce betwe5 ! av]age acquisition co/ ( ! affiliate1 su* z a ph>macy or o!r entity t acquires prescription drugs1 t initially acquires ! drug & ! am\nt report$ "u subclause 7,i77jj7 = ea* drug4 7ff7 ,a li/ inclusive ( ! br& "n1 g5]ic or non-propriet>y "n1 & ,national ,drug ,code ( cov]$ "p ,d drugs subject to an agreem5t ) a cov]$ entity "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act = :i* ! ph>macy b5efit manag] or an affiliate ( ! ph>macy b5efit manag] _h a contract or o!r arrangem5t ) su* a cov]$ entity 9 ! s]vice area ( su* plan4 7,,iii7 ,:]e a drug approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7ref]r$ to 9 ?is subclause z ! li/$ drug7 is cov]$ by ! plan1 ! foll[+ in=mation3 7aa7 ,a li/ ( curr5tly m>ket$ g5]ic drugs approv$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act pursuant to an application t ref]5ces su* li/$ drug t are n cov]$ by ! plan1 are cov]$ on ! same =mul>y ti] or a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! li/$ drug1 or are subject to utilization managem5t t ! li/$ drug is n subject to4 7bb7 ,! e/imat$ av]age b5efici>y co/-%>+ "u ! plan = a #cj-;day supply ( ! li/$ drug4 7cc7 ,:]e a g5]ic drug li/$ "u item 7aa7 is on a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! li/$ drug1 ! e/imat$ av]age co/-%>+ t a b5efici>y w\ld h paid = a #cj-;day supply ( ea* ( ! g5]ic drugs describ$ 9 item 7aa71 _h ! plan provid$ cov]age = su* drugs on ! same =mul>y ti] z ! li/$ drug4 7dd7 ,a writt5 ju/ification = provid+ m favorable cov]age ( ! li/$ drug ?an ! g5]ic drugs describ$ 9 item 7aa74 7ee7 ,! numb] ( curr5tly m>ket$ g5]ic drugs approv$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act pursuant to an application t ref]5ces su* li/$ drug4 7,,iv7 ,:]e a ref]5ce product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act7 is cov]$ by ! plan1 ! foll[+ in=mation3 7aa7 ,a li/ ( curr5tly m>ket$ biosimil> biological products lic5s$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act pursuant to an application t ref]s to su* ref]5ce product t are n cov]$ by ! plan1 are cov]$ on ! same =mul>y ti] or a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! ref]5ce product1 or are subject to utilization managem5t t ! ref]5ce product is n subject to4 7bb7 ,! e/imat$ av]age b5efici>y co/-%>+ "u ! plan = a #cj-;day supply ( ! ref]5ce product4 7cc7 ,:]e a biosimil> biological product li/$ "u item 7aa7 is on a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! ref]5ce product1 ! e/imat$ av]age co/-%>+ t a b5efici>y w\ld h paid = a #cj-;day supply ( ea* ( ! biosimil> biological products describ$ 9 item 7aa71 _h ! plan provid$ cov]age = su* products on ! same =mul>y ti] z ! ref]5ce product4 7dd7 ,a writt5 ju/ification = provid+ m favorable cov]age ( ! ref]5ce product ?an ! biosimil> biological product describ$ 9 item 7aa74 7ee7 ,! numb] ( curr5tly m>ket$ biosimil> biological products lic5s$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 pursuant to an application t ref]s to su* ref]5ce product4 7,v7 ,total gross sp5d+ on cov]$ "p ,d drugs by ! plan1 n net ( rebates1 fees1 disc\nts1 or o!r direct or indirect remun]ation4 7,,vi7 ,! total am\nt reta9$ by ! ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] 9 rev5ue relat$ to utilization ( cov]$ "p ,d drugs "u t plan1 inclusive ( bona fide s]vice fees4 7,,vii7 ,! total sp5d+ on cov]$ "p ,d drugs net ( rebates1 fees1 disc\nts1 or o!r direct & indirect remun]ation by ! plan4 7,,viii7 ,an explanation ( any b5efit design p>amet]s "u su* plan t enc\rage plan enrollees to fill prescriptions at ph>macies t are an affiliate ( su* ph>macy b5efit manag]1 su* z mail & specialty home deliv]y programs1 & retail & mail auto-refill programs4 7,,ix7 ,! foll[+ in=mation3 7aa7 ,a li/ ( all brok]s1 consultants1 advisors1 & auditors t receive comp5sation f ! ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] = ref]rals1 consult+1 audit+1 or o!r s]vices (f]$ to ,,pdp sponsors relat$ to ph>macy b5efit managem5t s]vices4 7bb7 ,! am\nt ( comp5sation provid$ by su* ph>macy b5efit manag] or affiliate to ea* su* brok]1 consultant1 advisor1 & auditor4 7cc7 ,! me?odology = calculat+ ! am\nt ( comp5sation provid$ by su* ph>macy b5efit manag] or affiliate1 = ea* su* brok]1 consultant1 advisor1 & auditor4 7,x7 ,a li/ ( all affiliates ( ! ph>macy b5efit manag]4 7,,xi7 ,a summ>y docum5t submitt$ 9 a /&>diz$ template develop$ by ! ,secret>y t includes su* in=mation describ$ 9 subclauses 7,i7 ?r\gh 7,x74 7ii7 ,writt5 explanation ( contracts or agreem5ts ) drug manufactur]s 7,i7 ,9 g5]al ,! ph>macy b5efit manag] %all1 n lat] ?an #cj days aft] ! f9alization ( any contract or agreem5t betwe5 su* ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] & a drug manufactur] 7or subsidi>y1 ag5t1 or entity affiliat$ ) su* drug manufactur]7 t makes rebates1 disc\nts1 paym5ts1 or o!r f9ancial inc5tives relat$ to "o or m cov]$ "p ,d drugs or o!r prescription drugs1 z applicable1 ( ! manufactur] directly or indirectly cont+5t ^u cov]age1 =mul>y placem5t1 or utilization managem5t conditions on any o!r cov]$ "p ,d drugs or o!r prescription drugs1 z applicable1 submit to ! ,,pdp sponsor a writt5 explanation ( su* contract or agreem5t4 7,,ii7 ,requirem5ts ,a writt5 explanation "u subclause 7,i7 %all-- 7aa7 include ! manufactur] subject to ! contract or agreem5t1 all cov]$ "p ,d drugs & o!r prescription drugs1 z applicable1 subject to ! contract or agreem5t & ! manufactur]s ( su* drugs1 & a high-level description ( ! t]ms ( su* contract or agreem5t & h[ su* t]ms apply to su* drugs2 & 7bb7 be c]tifi$ by ! ,*ief ,executive ,(fic]1 ,*ief ,f9ancial ,(fic]1 or ,g5]al ,c\nsel ( su* ph>macy b5efit manag]1 or affiliate ( su* ph>macy b5efit manag]1 z applicable1 or an individual delegat$ ) ! au?ority to sign on behalf ( "o ( ^! (fic]s1 :o reports directly to ! (fic]4 7,,iii7 ,def9ition ( o!r prescription drugs ,= purposes ( ?is clause1 ! t]m o!r prescription drugs means prescription drugs cov]$ z supplem5tal b5efits "u ?is "p or prescription drugs paid outside ( ?is "p4 7,d7 ,audit rights 7i7 ,9 g5]al ,n less ?an once a ye>1 at ! reque/ ( ! ,,pdp sponsor1 ! ph>macy b5efit manag] %all all[ = an audit ( ! ph>macy b5efit manag] to ensure compliance ) all t]ms & conditions "u ! writt5 agreem5t describ$ 9 ?is p>agraph & ! accuracy ( in=mation report$ "u subp>agraph 7,c74 7ii7 ,auditor ,! ,,pdp sponsor %all h ! "r to select an auditor4 ,! ph>macy b5efit manag] %all n impose any limitations on ! selection ( su* auditor4 7iii7 ,provision ( in=mation ,! ph>macy b5efit manag] %all make available to su* auditor all records1 data1 contracts1 & o!r in=mation necess>y to confirm ! accuracy ( in=mation provid$ "u subp>agraph 7,c71 subject to reasonable re/rictions on h[ su* in=mation mu/ be report$ to prev5t r$isclosure ( su* in=mation4 7iv7 ,tim+ ,! ph>macy b5efit manag] mu/ provide in=mation "u clause 7iii7 & o!r in=mation1 data1 & records relevant to ! audit to su* auditor )9 #f mon?s ( ! initiation ( ! audit & respond to reque/s = additional in=mation f su* auditor )9 #cj days aft] ! reque/ = additional in=mation4 7v7 ,in=mation f affiliates ,! ph>macy b5efit manag] %all be responsible = provid+ to su* auditor in=mation requir$ to be report$ "u subp>agraph 7,c7 or "u clause 7iii7 ( ?is subp>agraph t is own$ or held by an affiliate ( su* ph>macy b5efit manag]4 7#b7 ,en=cem5t 7,a7 ,9 g5]al ,ea* ,,pdp sponsor %all-- 7i7 disgorge to ! ,secret>y any am\nts disgorg$ to ! ,,pdp sponsor by a ph>macy b5efit manag] "u p>agraph 7#a77;,a77v72 7ii7 require1 9 a writt5 agreem5t ) any ph>macy b5efit manag] act+ on behalf ( su* sponsor or affiliate ( su* ph>macy b5efit manag]1 t su* ph>macy b5efit manag] or affiliate reimburse ! ,,pdp sponsor = any civil money p5alty impos$ on ! ,,pdp sponsor z a result ( ! failure ( ! ph>macy b5efit manag] or affiliate to meet ! requirem5ts ( p>agraph 7#a7 t are applicable to ! ph>macy b5efit manag] or affiliate "u ! agreem5t2 & 7iii7 require1 9 a writt5 agreem5t ) any su* ph>macy b5efit manag] act+ on behalf ( su* sponsor or affiliate ( su* ph>macy b5efit manag]1 t su* ph>macy b5efit manag] or affiliate be subject to punitive rem$ies = brea* ( contract = failure to comply ) ! requirem5ts applicable "u p>agraph 7#a74 7,b7 ,report+ ( alleg$ violations ,! ,secret>y %all make available & ma9ta9 a me*anism = manufactur]s1 ,,pdp sponsors1 ph>macies1 & o!r entities t h contractual relation%ips ) ph>macy b5efit manag]s or affiliates ( su* ph>macy b5efit manag]s to report1 on a confid5tial basis1 alleg$ violations ( p>agraph 7#a77;,a7 or subp>agraph 7,c74 7,c7 ,anti-retaliation & anti-co]cion ,consi/5t ) applicable ,f$]al or ,/ate law1 a ,,pdp sponsor %all n-- 7i7 retaliate aga9/ an individual or entity = report+ an alleg$ violation "u subp>agraph 7,b72 or 7ii7 co]ce1 intimidate1 ?reat51 or int]f]e ) ! ability ( an individual or entity to report any su* alleg$ violations4 7#c7 ,c]tification ( compliance 7,a7 ,9 g5]al ,ea* ,,pdp sponsor %all furni% to ! ,secret>y 7at a "t & 9 a mann] specifi$ by ! ,secret>y7 an annual c]tification ( compliance ) ?is subsection1 z well z su* in=mation z ! ,secret>y det]m9es necess>y to c>ry out ?is subsection4 7,b7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is p>agraph by program in/ruction or o!rwise4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ z-- 7,a7 prohibit+ flat disp5s+ fees or reimbursem5t or paym5t = +r$i5t co/s 7includ+ cu/om>y1 indu/ry-/&>d disc\nts directly relat$ to drug acquisition t are reta9$ by ph>macies or :olesal]s7 to entities t acquire or disp5se prescription drugs2 or 7,b7 modify+ regulatory requirem5ts or sub-regulatory program in/ruction or guidance relat$ to ph>macy paym5t1 reimbursem5t1 or disp5s+ fees4 7#e7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbh1 ! ,secret>y %all specify /&>d1 ma*9e-readable =mats = ph>macy b5efit manag]s to submit annual reports requir$ "u p>agraph 7#a77;,c77i74 7,b7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is p>agraph by program in/ruction or o!rwise4 7#f7 ,confid5tiality 7,a7 ,9 g5]al ,in=mation disclos$ by a ph>macy b5efit manag]1 an affiliate ( a ph>macy b5efit manag]1 a ,,pdp sponsor1 or a ph>macy "u ?is subsection t is n o!rwise publicly available or available = pur*ase %all n be disclos$ by ! ,secret>y or a ,,pdp sponsor receiv+ ! in=mation1 except t ! ,secret>y may disclose ! in=mation = ! foll[+ purposes3 7i7 ,z ! ,secret>y det]m9es necess>y to c>ry out ?is "p4 7ii7 ,to p]mit ! ,comptroll] ,g5]al to review ! in=mation provid$4 7iii7 ,to p]mit ! ,director ( ! ,congressional ,budget ,(fice to review ! in=mation provid$4 7iv7 ,to p]mit ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission to review ! in=mation provid$4 7v7 ,to ! ,attorney ,g5]al = ! purposes ( conduct+ ov]sight & en=cem5t "u ?is title4 7vi7 ,to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 accordance ) its au?orities "u ! ,inspector ,g5]al ,act ( #aigh 7section #djf ( title #e1 ,unit$ ,/ates ,code71 & o!r applicable /atutes4 7,b7 ,re/riction on use ( in=mation ,! ,secret>y1 ! ,comptroll] ,g5]al1 ! ,director ( ! ,congressional ,budget ,(fice1 & ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission %all n report on or disclose in=mation disclos$ pursuant to subp>agraph 7,a7 to ! public 9 a mann] t w\ld id5tify-- 7i7 a specific ph>macy b5efit manag]1 affiliate1 ph>macy1 manufactur]1 :olesal]1 ,,pdp sponsor1 or plan2 or 7ii7 contract prices1 rebates1 disc\nts1 or o!r remun]ation = specific drugs 9 a mann] t may all[ ! id5tification ( specific contract+ p>ties or ( su* specific drugs4 7#g7 ,def9itions ,= purposes ( ?is subsection3 7,a7 ,affiliate ,! t]m affiliate means1 ) respect to any ph>macy b5efit manag] or ,,pdp sponsor1 any entity t1 directly or indirectly-- 7i7 owns or is own$ by1 controls or is controll$ by1 or is o!rwise relat$ 9 any own]%ip /ructure to su* ph>macy b5efit manag] or ,,pdp sponsor2 or 7ii7 acts z a contractor1 pr9cipal1 or ag5t to su* ph>macy b5efit manag] or ,,pdp sponsor1 ins(> z su* contractor1 pr9cipal1 or ag5t p]=ms any ( ! functions describ$ "u subp>agraph 7,c74 7,b7 ,bona fide s]vice fee ,! t]m bona fide s]vice fee means a fee t is reflective ( ! fair m>ket value 7z specifi$ by ! ,secret>y1 ?r\gh notice & comm5t rulemak+7 = a bona fide1 itemiz$ s]vice actually p]=m$ on behalf ( an entity1 t ! entity w\ld o!rwise p]=m 7or contract =7 9 ! abs5ce ( ! s]vice arrangem5t & t is n pass$ on 9 :ole or 9 "p to a cli5t or cu/om]1 :e!r or n ! entity takes title to ! drug4 ,su* fee mu/ be a flat doll> am\nt & %all n be directly or indirectly bas$ on1 or cont+5t ^u-- 7i7 drug price1 su* z :olesale acquisition co/ or drug b5*m>k price 7su* z av]age :olesale price72 7ii7 ! am\nt ( disc\nts1 rebates1 fees1 or o!r direct or indirect remun]ation ) respect to cov]$ "p ,d drugs disp5s$ to enrollees 9 a prescription drug plan1 except z p]mitt$ pursuant to p>agraph 7#a77;,a77ii72 7iii7 cov]age or =mul>y placem5t decisions or ! volume or value ( any ref]rals or bus9ess g5]at$ betwe5 ! p>ties to ! arrangem5t2 or 7iv7 any o!r am\nts or me?odologies prohibit$ by ! ,secret>y4 7,c7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any p]son or entity t1 ei!r directly or ?r\gh an int]m$i>y1 acts z a price negotiator or gr\p pur*as] on behalf ( a ,,pdp sponsor or prescription drug plan1 or manages ! prescription drug b5efits provid$ by su* sponsor or plan1 includ+ ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! adjudication ( appeals or grievances relat$ to ! prescription drug b5efit1 contract+ ) network ph>macies1 controll+ ! co/ ( cov]$ "p ,d drugs1 or ! provision ( relat$ s]vices4 ,su* t]m includes any p]son or entity t c>ries out "o or m ( ! activities describ$ 9 ! prec$+ s5t5ce1 irrespective ( :e!r su* p]son or entity calls itself a ph>macy b5efit manag]4 4 7#b7 ,,ma-,,pd plans ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,requirem5ts relat+ to ph>macy b5efit manag]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbi1 section #ahfj;,d-#ab7;h74 4 7#c7 ,nonapplication ( ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! implem5tation ( ?is subsection4 7#d7 ,fund+ 7,a7 ,secret>y ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #aac1jjj1jjj = fiscal ye> #bjbf1 to rema9 available until exp5d$1 to c>ry out ?is subsection4 7,b7 ,,oig ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #bj1jjj1jjj = fiscal ye> #bjbf1 to rema9 available until exp5d$1 to c>ry out ?is subsection4 7b7 ,,gao ,/udy & ,report on ,price-,relat$ ,comp5sation ,across ! ,supply ,*a9 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is subsection ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy describ+ ! use ( comp5sation & paym5t /ructures relat$ to a prescription drug's price )9 ! retail prescription drug supply *a9 9 "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 ,su* /udy %all summ>ize in=mation f ,f$]al ag5cies & indu/ry exp]ts1 to ! ext5t available1 ) respect to ! foll[+3 7,a7 ,! type1 magnitude1 o!r features 7su* z ! pric+ b5*m>ks us$71 & preval5ce ( comp5sation & paym5t /ructures relat$ to a prescription drug's price1 su* z calculat+ fee am\nts z a p]c5tage ( a prescription drug's price1 betwe5 int]m$i>ies 9 ! prescription drug supply *a91 includ+-- 7i7 ph>macy b5efit manag]s2 7ii7 ,,pdp sponsors (f]+ prescription drug plans & ,m$ic>e ,advantage organizations (f]+ ,,ma-,,pd plans2 7iii7 drug :olesal]s2 7iv7 ph>macies2 7v7 manufactur]s2 7vi7 ph>macy s]vices adm9i/rative organizations2 7vii7 brok]s1 auditors1 consultants1 & o!r entities t-- 7,i7 advise ,,pdp sponsors (f]+ prescription drug plans & ,m$ic>e ,advantage organizations (f]+ ,,ma-,,pd plans reg>d+ ph>macy b5efits2 or 7,,ii7 review ,,pdp sponsor & ,m$ic>e ,advantage organization contracts ) ph>macy b5efit manag]s2 & 7viii7 o!r s]vice provid]s t contract ) any ( ! entities describ$ 9 clauses 7i7 ?r\gh 7vii7 t may use price-relat$ comp5sation & paym5t /ructures1 su* z rebate aggregators 7or o!r entities t negotiate or process price concessions on behalf ( ph>macy b5efit manag]s1 plan sponsors1 or ph>macies74 7,b7 ,! prim>y bus9ess models & comp5sation /ructures = ea* category ( int]m$i>y describ$ 9 subp>agraph 7,a74 7,c7 ,v>iation 9 price-relat$ comp5sation /ructures betwe5 affiliat$ entities 7su* z entities ) common own]%ip1 ei!r full or p>tial1 & subsidi>y relation%ips7 & unaffiliat$ entities4 7,d7 ,pot5tial conflicts ( int]e/ among contract+ entities relat$ to ! use ( prescription drug price-relat$ comp5sation /ructures1 su* z ! pot5tial = fees or o!r paym5ts set z a p]c5tage ( a prescription drug's price to advantage =mul>y selection1 di/ribution1 or pur*as+ ( prescription drugs ) high] prices4 7,e7 ,notable diff]5ces1 if any1 9 ! use & level ( price-bas$ comp5sation /ructures ov] "t & betwe5 diff]5t m>ket segm5ts1 su* z "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 & ! ,m$icaid program "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq474 7,f7 ,! effects ( drug price-relat$ comp5sation /ructures & alt]native comp5sation /ructures on ,f$]al heal? c>e programs & program b5efici>ies1 includ+ ) respect to co/-%>+1 premiums1 ,f$]al outlays1 biosimil> & g5]ic drug adoption & utilization1 drug %ortage risks1 & ! pot5tial = fees set z a p]c5tage ( a drug's price to advantage ! =mul>y selection1 di/ribution1 or pur*as+ ( drugs ) high] prices4 7,g7 ,o!r issues det]m9$ to be relevant & appropriate by ! ,comptroll] ,g5]al4 7#b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 ! ,comptroll] ,g5]al %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u p>agraph 7#a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 7c7 ,med,p,a,c reports on agreem5ts ) ph>macy b5efit manag]s ) respect to prescription drug plans & ,,ma-,,pd plans 7#a7 ,9 g5]al ,! ,m$ic>e ,paym5t ,advisory ,commission %all submit to ,congress ! foll[+ reports3 7,a7 ,initial report ,n lat] ?an ! fir/ ,m>* #ae occurr+ aft] ! date t is #b ye>s aft] ! date on :i* ! ,secret>y makes ! data available to ! ,commission1 a report reg>d+ agreem5ts ) ph>macy b5efit manag]s ) respect to prescription drug plans & ,,ma-,,pd plans4 ,su* report %all include1 to ! ext5t practicable-- 7i7 a description ( tr5ds & patt]ns1 includ+ relevant av]ages1 totals1 & o!r figures = ! types ( in=mation submitt$2 7ii7 an analysis ( any diff]5ces 9 agreem5ts & _! effects on plan enrollee out-(-pocket sp5d+ & av]age ph>macy reimbursem5t1 & o!r impacts2 & 7iii7 any recomm5dations ! ,commission det]m9es appropriate4 7,b7 ,f9al report ,n lat] ?an #b ye>s aft] ! date on :i* ! ,commission submits ! initial report "u subp>agraph 7,a71 a report describ+ any *anges ) respect to ! in=mation describ$ 9 subp>agraph 7,a7 ov] "t1 toge!r ) any recomm5dations ! ,commission det]m9es appropriate4 7#b7 ,fund+ ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,m$ic>e ,paym5t ,advisory ,commission1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #a1jjj1jjj = fiscal ye> #bjbf1 to rema9 available until exp5d$1 to c>ry out ?is subsection4 #f4 ,exp$it$ consid]ation ( enhanc$ premium tax cr$it re=m bill 7a7 ,qualify+ legislation 7#a7 ,9 g5]al ,only an enhanc$ premium tax cr$it re=m bill %all be entitl$ to exp$it$ consid]ation "u ?is section4 7#b7 ,def9ition ,9 ?is section1 ! t]m enhanc$ premium tax cr$it re=m bill means a bill or jo9t resolution :i* consi/s solely ( legislative language ) respect to cont9u$ heal? insurance premium sav+s1 includ+ m significant re=ms1 t has accumulat$ at lea/ #aj cosponsors f ea* ( ! majority p>ty & ! m9ority p>ty at ! "t x is (f]$4 7b7 ,consid]ation 9 ! ,h\se ( ,repres5tatives 7#a7 ,ref]ral & report+ ,any committee ( ! ,h\se ( ,repres5tatives to :i* an enhanc$ premium tax cr$it re=m bill is ref]r$ %all report ! enhanc$ premium tax cr$it re=m bill to ! ,h\se ( ,repres5tatives )\t am5dm5t n lat] ?an #e legislative days aft] ! date on :i* ! enhanc$ premium tax cr$it re=m bill 0 s ref]r$4 ,if a committee ( ! ,h\se ( ,repres5tatives fails to report an enhanc$ premium tax cr$it re=m bill )9 t p]iod1 t committee %all be automatically dis*>g$ f consid]ation ( ! enhanc$ premium tax cr$it re=m bill1 & ! enhanc$ premium tax cr$it re=m bill %all be plac$ on ! appropriate cal5d>4 7#b7 ,proce$+ to consid]ation ,aft] ! la/ committee au?oriz$ to consid] an enhanc$ premium tax cr$it re=m bill reports x to ! ,h\se ( ,repres5tatives or has be5 dis*>g$ f its consid]ation1 x %all be 9 ord] to move to proce$ to consid] ! enhanc$ premium tax cr$it re=m bill 9 ! ,h\se ( ,repres5tatives4 ,su* a motion %all n be 9 ord] aft] ! ,h\se ( ,repres5tatives has dispos$ ( a motion to proce$ ) respect to ! enhanc$ premium tax cr$it re=m bill4 ,! previ\s "q %all be consid]$ z ord]$ on ! motion to its adoption )\t int]v5+ motion4 ,! motion %all n be debatable4 ,a motion to reconsid] ! vote by :i* ! motion is dispos$ ( %all n be 9 ord]4 7#c7 ,vote on passage ,! vote on passage ( ! enhanc$ premium tax cr$it re=m bill %all occur n lat] ?an #c legislative days aft] ! date on :i* ! la/ committee au?oriz$ to consid] ! enhanc$ premium tax cr$it re=m bill reports x to ! ,h\se ( ,repres5tatives or is dis*>g$4 7c7 ,exp$it$ proc$ure 9 ! ,s5ate 7#a7 ,committee consid]ation ,an enhanc$ premium tax cr$it re=m bill introduc$ 9 ! ,s5ate %all be jo9tly ref]r$ to ! committee or committees ( jurisdiction1 :i* committees %all report ! enhanc$ premium tax cr$it re=m bill )\t any revision & ) a favorable recomm5dation1 an unfavorable recomm5dation1 or )\t recomm5dation1 n lat] ?an #e session days aft] ! date on :i* ! enhanc$ premium tax cr$it re=m bill 0 s ref]r$4 ,if any committee to :i* an enhanc$ premium tax cr$it re=m bill is ref]r$ fails to report ! enhanc$ premium tax cr$it re=m bill )9 t p]iod1 t committee %all be automatically dis*>g$ f consid]ation ( ! enhanc$ premium tax cr$it re=m bill1 & ! enhanc$ premium tax cr$it re=m bill %all be plac$ on ! appropriate cal5d>4 7#b7 ,proce$+ ,not)/&+ rule ,,xxii ( ! ,/&+ ,rules ( ! ,s5ate1 x is 9 ord]1 n lat] ?an #b days ( session aft] ! date on :i* an enhanc$ premium tax cr$it re=m bill is report$ or dis*>g$ f all committees to :i* ! enhanc$ premium tax cr$it re=m bill 0 ref]r$1 = ! majority lead] ( ! ,s5ate or ! designee ( ! majority lead] to move to proce$ to ! consid]ation ( ! enhanc$ premium tax cr$it re=m bill4 ,x %all also be 9 ord] = any ,memb] ( ! ,s5ate to move to proce$ to ! consid]ation ( ! enhanc$ premium tax cr$it re=m bill at any "t aft] ! conclusion ( su* #b-;day p]iod4 ,a motion to proce$ is 9 ord] ev5 ?\gh a previ\s motion to ! same effect has be5 disagre$ to4 ,all po9ts ( ord] aga9/ ! motion to proce$ to ! enhanc$ premium tax cr$it re=m bill are waiv$4 ,! motion to proce$ is n debatable4 ,! motion is n subject to a motion to po/pone4 ,a motion to reconsid] ! vote by :i* ! motion is agre$ to or disagre$ to %all n be 9 ord]4 ,if a motion to proce$ to ! consid]ation ( ! enhanc$ premium tax cr$it re=m bill is agre$ to1 ! enhanc$ premium tax cr$it re=m bill %all rema9 ! unf9i%$ bus9ess until dispos$ (4 ,all po9ts ( ord] aga9/ an enhanc$ premium tax cr$it re=m bill & aga9/ consid]ation ( ! enhanc$ premium tax cr$it re=m bill are waiv$4 7d7 ,consid]ation by ! o!r ,h\se 7#a7 ,9 g5]al ,if1 be=e pass+ an enhanc$ premium tax cr$it re=m bill1 a ,h\se receives f ! o!r ,h\se an enhanc$ premium tax cr$it re=m bill ( ! o!r ,h\se-- 7,a7 ! enhanc$ premium tax cr$it re=m bill ( ! o!r ,h\se %all n be ref]r$ to a committee2 & 7,b7 ! proc$ure 9 ! receiv+ ,h\se %all be ! same z if no enhanc$ premium tax cr$it re=m bill _h be5 receiv$ f ! o!r ,h\se until ! vote on passage1 :5 ! enhanc$ premium tax cr$it re=m bill receiv$ f ! o!r ,h\se %all supplant ! enhanc$ premium tax cr$it re=m bill ( ! receiv+ ,h\se4 7#b7 ,rev5ue measures ,?is subsection %all n apply to ! ,h\se ( ,repres5tatives if an enhanc$ premium tax cr$it re=m bill receiv$ f ! ,s5ate is a rev5ue measure4 7e7 ,rules to coord9ate action ) o!r ,h\se 7#a7 ,treatm5t ( enhanc$ premium tax cr$it re=m bill ( o!r ,h\se ,if an enhanc$ premium tax cr$it re=m bill is n introduc$ 9 ! ,s5ate or ! ,s5ate fails to consid] an enhanc$ premium tax cr$it re=m bill "u ?is section1 ! enhanc$ premium tax cr$it re=m bill ( ! ,h\se ( ,repres5tatives %all be entitl$ to exp$it$ floor proc$ures "u ?is section4 7#b7 ,treatm5t ( companion measures 9 ! ,s5ate ,if1 foll[+ passage ( an enhanc$ premium tax cr$it re=m bill 9 ! ,s5ate1 ! ,s5ate !n receives f ! ,h\se ( ,repres5tatives an enhanc$ premium tax cr$it re=m bill1 ! ,h\se-pass$ enhanc$ premium tax cr$it re=m bill %all n be debatable4 ,! vote on passage ( ! enhanc$ premium tax cr$it re=m bill 9 ! ,s5ate %all be consid]$ to be ! vote on passage ( ! enhanc$ premium tax cr$it re=m bill receiv$ f ! ,h\se ( ,repres5tatives4 7#c7 ,vetoes ,if ! ,presid5t vetoes an enhanc$ premium tax cr$it re=m bill1 consid]ation ( a veto message 9 ! ,s5ate "u ?is p>agraph %all be #aj h\rs equally divid$ betwe5 ! majority & m9ority lead]s ( ! ,s5ate or ! designees ( ! majority & m9ority lead]s ( ! ,s5ate4 7f7 ,vote on passage ,! vote on f9al passage 9 ! ,h\se ( ,repres5tatives & ! ,s5ate ( ! enhanc$ premium tax cr$it re=m bill %all occur n lat] ?an ,july #a1 #bjbf4 7g7 ,ex]cise ( rulemak+ p[] ,?is section is enact$ by ,congress-- 7#a7 z an ex]cise ( ! rulemak+ p[] ( ! ,s5ate & ,h\se ( ,repres5tatives1 respectively1 & z su* x is deem$ a "p ( ! rules ( ea* ,h\se1 respectively1 b applicable only ) respect to ! proc$ure to be foll[$ 9 t ,h\se 9 ! case ( an enhanc$ premium tax cr$it re=m bill1 & x sup]s$es o!r rules only to ! ext5t t x is inconsi/5t ) su* rules2 & 7#b7 ) full recognition ( ! con/itutional "r ( ei!r ,h\se to *ange ! rules 7s f> z relat+ to ! proc$ure ( t ,h\se7 at any "t1 9 ! same mann]1 & to ! same ext5t z 9 ! case ( any o!r rule ( t ,h\se4