,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #ddh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,janu>y #aj1 #bjai,mr4 ,cumm+s 7= himself1 ,mr4 ,wel*1 ,mr4 ,doggett1 ,mr4 ,sean ,patrick ,maloney ( ,new ,york1 ,mr4 ,pocan1 ,ms4 ,de,lauro1 ,ms4 ,gabb>d1 ,ms4 ,bonamici1 ,ms4 ,om>1 ,mr4 ,khanna1 ,ms4 ,norton1 ,ms4 ,jayapal1 ,ms4 ,s*ak[sky1 ,mr4 ,higg9s ( ,new ,york1 ,mr4 ,neguse1 ,mr4 ,coh51 ,mr4 ,kri%namoor?i1 & ,ms4 ,tlaib7 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 provide = ! negotiation ( l[] cov]$ "p ,d drug prices on behalf ( ,m$ic>e b5efici>ies & ! e/abli%m5t & application ( a =mul>y by ! ,secret>y ( ,heal? & ,human ,s]vices "u ,m$ic>e "p ,d1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ic>e ,drug ,price ,negotiation ,act4 #b4 ,negotiation ( l[] cov]$ "p ,d drug prices on behalf ( ,m$ic>e b5efici>ies2 ,e/abli%m5t & application ( =mul>y by ! ,secret>y ( ,heal? & ,human ,s]vices "u ,m$ic>e "p ,d 7a7 ,9 g5]al ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by /rik+ subsection 7i7 7relat+ to non9t]f]5ce7 & ins]t+ ! foll[+3 7i7 ,negotiation ( l[] drug prices2 e/abli%m5t & application ( =mul>y 7#a7 ,negotiation 7,a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 subject to subp>agraph 7,b71 ! ,secret>y %all1 ) respect to an applicable p]iod 7z def9$ 9 subp>agraph 7,h77-- 7i7 dur+ ! negotiation ye> 7z def9$ 9 su* subp>agraph7 = su* p]iod1 negotiate ) ph>maceutical manufactur]s ! prices 7includ+ disc\nts1 rebates1 & all o!r price concessions7 t may be *>g$ to ,,pdp sponsors & ,,ma organizations = applicable cov]$ "p ,d drugs 7z def9$ 9 su* subp>agraph7 furni%$ to enrollees dur+ su* p]iod2 & 7ii7 complete su* negotiations n less ?an #cj days be=e ! fir/ day ( ! application review process = ! fir/ plan ye> dur+ ! applicable p]iod = new contracts or exp&+ exi/+ contracts ) ,,pdp sponsors & ,,ma organizations to (f] prescription drug plans or ,,ma-,,pd plans1 respectively4 7,b7 ,use ( fallback if negotiations fail 7i7 ,9 g5]al ,if1 aft] negotiations "u subp>agraph 7,a7 ) respect to an applicable p]iod1 ! ,secret>y is n successful 9 obta9+ an appropriate price = applicable cov]$ "p ,d drugs 9 accordance ) clause 7ii71 ! price t may be *>g$ to ,,pdp sponsors & ,,ma organizations = applicable cov]$ "p ,d drugs furni%$ to enrollees dur+ su* p]iod %all be ! l[e/ ( ! foll[+3 7,i7 ,! contract price appli$ pursuant to section #habf ( title #ch1 ,unit$ ,/ates ,code1 = su* drug = ! contract ye> 7z def9$ 9 su* section #habf74 7,,ii7 ,! av]age ( ! prices available1 dur+ ! mo/ rec5t #ab-mon? p]iod = :i* data is available f ! manufactur] to any :olesal]1 retail]1 provid]1 heal? ma9t5ance organization1 nonpr(it entity1 or gov]nm5tal entity 9 ,canada1 ! ,unit$ ,k+dom1 ,g]many1 ,france1 & ,japan4 7,,iii7 ,! be/ price det]m9$ "u section #aibg7;c77#a77;,c7 = su* drug = ! mo/ rec5t rebate p]iod 7z def9$ 9 section #aibg7k77#h77 applicable to su* fir/ plan ye> ( ! applicable p]iod4 7ii7 ,guidance ,n lat] ?an #f mon?s be=e ! ,secret>y beg9s negotiations "u subp>agraph 7,a7 ) respect to ! fir/ applicable p]iod1 ! ,secret>y %all issue guidance on crit]ia to be consid]$ = purposes ( det]m9+ "u clause 7i7 :e!r or n ! ,secret>y is successful 9 obta9+ an appropriate price = an applicable cov]$ "p ,d drug4 ,su* crit]ia %all include at lea/ ! foll[+3 7,i7 ,! comp>ative cl9ical effectiv5ess & co/ effectiv5ess1 if available1 ( su* cov]$ "p ,d drug4 7,,ii7 ,! budget>y impact ( provid+ cov]age "u ?is "p = su* cov]$ "p ,d drug4 7,,iii7 ,! numb] ( simil>ly effective drug or alt]native treatm5t regim5s = ea* approv$ use ( su* cov]$ "p ,d drug4 7,,iv7 ,associat$ unmet ne$ or sev]ity ( illness4 7,c7 ,id5tification ( applicable cov]$ "p ,d drugs 7i7 ,9 g5]al ,! ,secret>y %all1 = ea* applicable p]iod1 9 accordance ) ! subsequ5t clauses ( ?is subp>agraph1 & pursuant to rulemak+1 id5tify applicable cov]$ "p ,d drugs = :i* negotiations "u subp>agraph 7,a7 %all be conduct$ dur+ ! negotiation ye> = su* p]iod4 ,9 ?is p>agraph1 all su* cov]$ "p ,d drugs s id5tifi$ = an applicable p]iod are collectively ref]r$ to z applicable cov]$ "p ,d drugs ) respect to su* p]iod4 7ii7 ,id5tification ( prioritiz$ drugs ,9 c>ry+ out clause 7i71 except z provid$ "u clause 7iii71 ! ,secret>y may n id5tify a cov]$ "p ,d drug t is n a drug prioritiz$ pursuant to subp>agraph 7,d7 z an applicable cov]$ "p ,d drug until all cov]$ "p ,d drugs t are s prioritiz$ h be5 id5tifi$ z an applicable cov]$ "p ,d drug = ! applicable p]iod or = a previ\s applicable p]iod = :i* ! negotiat$ price ( su* drug has n expir$4 7iii7 ,drug inclusions = price r5egotiations ,9 ! case ( a cov]$ "p ,d drug t is id5tifi$ z an applicable cov]$ "p ,d drug = an applicable p]iod1 su* cov]$ "p ,d drug %all be id5tifi$ z an applicable cov]$ "p ,d drug = ea* subsequ5t ?ird negotiation ye>4 7iv7 ,reasonable notification ,! ,secret>y %all c>ry out ?is subp>agraph 9 su* mann] z to provide = public notification ( applicable cov]$ "p ,d drugs = ! applicable p]iod )9 a reasonable p]iod be=e ! beg9n+ ( ! negotiation ye> = su* p]iod4 7,d7 ,prioritization ( c]ta9 cov]$ "p ,d drugs ,= purposes ( subp>agraph 7,c77ii71 ! ,secret>y %all prioritize cov]$ "p ,d drugs-- 7i7 t are among-- 7,i7 ! #dj cov]$ "p ,d drugs t are utiliz$ by at lea/ #a1jjj ,m$ic>e "p ,d b5efici>ies & ) respect to :i* !re 7 ! highe/ total exp5ditures "u ?is "p dur+ ! mo/ rec5t #ab-mon? p]iod = :i* data is available2 7,,ii7 ! #dj cov]$ "p ,d drugs t are utiliz$ by at lea/ #a1jjj ,m$ic>e "p ,d b5efici>ies ) respect to :om ! total annual sp5d+ p] su* a b5efici>y "u ?is "p = cov]age ( su* a drug is at lea/ #aj1jjj2 or 7,,iii7 ! #bj cov]$ "p ,d drugs t are utiliz$ by at lea/ #a1jjj ,m$ic>e "p ,d b5efici>ies & ) respect to :i* !re are unit co/ increases at or above ! #ie? p]c5tile ( ov]all cov]$ "p ,d drug unit co/ increases dur+ ! mo/ rec5t #ab-mon? p]iod prior to ! beg9n+ ( su* negotiation ye> = :i* data is available2 7ii7 ) respect to :i* ! co/ ( su* a drug to ! "p ,d eligible individual involv$ w\ld exce$ ! annual out-(-pocket ?re%old applicable "u section #ahfj;,d-#b7;b77#d77;,b7 = su* negotiation ye>1 if ! drug 7 prescrib$ to ! individual = ! p]iod ( ! ye> or ) respect to :i* a s+le treatm5t regim5 is pric$ above su* annual out-(-pocket ?re%old applicable "u su* section #ahfj;,d-#b7;b77#d77;,b7 = ! ye>2 or 7iii7 t are s+le-s\rce drugs or biologicals 7z def9$ 9 section #ahdg;,a7c77#f77;,d77 & t satisfy at lea/ "o o!r crit]ion describ$ 9 a previ\s clause ( ?is subp>agraph4 7,e7 ,annual report to ,congress ,n lat] ?an #cj days aft] ! date on :i* ! ,secret>y completes negotiations "u ?is p>agraph = ! fir/ negotiation ye> & ea* ye> !reaft]1 ! ,secret>y %all submit to ,congress & make available to ! public a report describ+ ! negotiations dur+ ! prec$+ negotiation ye>1 includ+-- 7i7 ! numb] ( applicable cov]$ "p ,d drug prices negotiat$2 7ii7 ! magnitude ( sav+s a*iev$ z a result ( su* negotiations2 7iii7 ! numb] ( times price negotiations fail$ 7bas$ on ! crit]ia includ$ 9 ! guidance issu$ pursuant to clause 7ii7 ( subp>agraph 7,b77 & result$ 9 ! use ( fallback prices "u clause 7i7 ( su* subp>agraph1 & ! rationale = any su* decisions2 7iv7 ! progress made t[>d negotiat+ ! prices ( cov]$ "p ,d drugs t are prioritiz$ "u subp>agraph 7,d72 & 7v7 ! b>ri]s1 if any1 to a*iev+ sav+s ?r\gh negotiations4 7,f7 ,,gao report ,n lat] ?an ,decemb] #ca1 #bjbd1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! negotiations conduct$ by ! ,secret>y "u ?is p>agraph1 includ+ a description & analysis (-- 7i7 ! ext5t to :i* su* price negotiations are a*iev+ l[] prices = cov]$ "p ,d drugs = enrollees2 7ii7 ! p>ties b5efitt+ f su* l[] prices1 su* z enrollees1 ! ,f$]al gov]nm5t1 ,/ates1 prescription drug plans & ,,ma-,,pd plans1 or o!r entities2 7iii7 h[ su* price negotiations are affect+-- 7,i7 ! li/ price ( cov]$ "p ,d drugs2 & 7,,ii7 drug prices 9 ! private m>ket2 & 7iv7 recomm5dations = improv+ price negotiations1 if applicable4 7,g7 ,def9itions ,= purposes ( ?is p>agraph3 7i7 ,applicable cov]$ "p ,d drugs ,! t]m applicable cov]$ "p ,d drugs means1 = an applicable p]iod1 cov]$ "p ,d drugs id5tifi$ by ! ,secret>y "u subp>agraph 7,c7 = su* p]iod4 7ii7 ,applicable p]iod ,! t]m applicable p]iod means1 ) respect to a negotiation ye> & applicable cov]$ "p ,d drugs1 ! #c-plan ye> p]iod beg9n+ ) ! fir/ plan ye> beg9n+ aft] ! negotiation ye> = su* cov]$ "p ,d drugs4 7iii7 ,negotiation ye> ,! t]m negotiation ye> means1 ) respect to an applicable p]iod1 a plan ye>1 beg9n+ ) #bjbj1 prior to ! fir/ plan ye> ( ! applicable p]iod4 7#b7 ,e/abli%m5t & application ( =mul>y by ! ,secret>y or *anges 9 =mul>ies to be requir$ by ,secret>y 7,a7 ,9 g5]al ,! ,secret>y %all1 = plan ye>s beg9n+ ) plan ye> #bjbj-- 7i7 subject to subp>agraphs 7,b7 & 7,c71 e/abli% & apply a =mul>y = requir$ use by sponsors ( prescription drug plans & organizations (f]+ ,,ma-,,pd plans "u ?is "p2 or 7ii7 require *anges1 z necess>y1 9 ! cov]$ "p ,d drugs includ$ on =mul>ies ( ,,pdp sponsors ( prescription drug plans 7includ+ *anges1 z necess>y1 9 ! pref]r$ or ti]$ co/-%>+ /atus ( su* a drug7 to take into acc\nt negotiations c>ri$ out by ! ,secret>y pursuant to p>agraph 7#a71 reg>dless ( :e!r su* a cov]$ "p ,d drug is ! subject ( su* negotiations4 7,b7 ,requir$ inclusion ( drugs 9 all !rapeutic categories ,a =mul>y e/abli%$ & appli$ "u subp>agraph 7,a77i7 %all include at lea/ two cov]$ "p ,d drugs 9 ea* category & class ( cov]$ "p ,d drugs z describ$ 9 section #dbc4abj7;b77#b77;i7 ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,janu>y #a1 #bjag74 7,c7 ,application ( developm5t & revision requirem5ts & requir$ inclusion ( all drugs 9 c]ta9 categories & classes ,! requirem5ts describ$ 9 subp>agraphs 7,a7 & 7,b7 ( section #ahfj;,d-#d7;b77#c7 7relat+ to developm5t & revision requirem5ts ( ! =mul>y7 & subp>agraph 7,g7 ( su* section 7relat+ to requir$ inclusion ( all drugs 9 c]ta9 categories & classes7 %all apply to a =mul>y e/abli%$ & appli$ "u subp>agraph 7,a77i7 ( ?is p>agraph4 7#c7 ,plan flexibility to negotiate great] disc\nts ,no?+ 9 ?is subsection %all be con/ru$ z prev5t+ ! sponsor ( a prescription drug plan1 or an organization (f]+ an ,,ma-,,pd plan1 f obta9+ a disc\nt or r$uction ( ! price = a cov]$ "p ,d drug bel[ ! price negotiat$ "u p>agraph 7#a71 if applicable1 includ+ ?r\gh ! use ( pref]r$ or ti]$ co/-%>+ /atus4 7#d7 ,ensur+ b5efici>y access to ne$$ drugs ,beg9n+ ) plan ye> #bjbj1 ea* ,,pdp sponsor ( a prescription drug plan & organization (f]+ an ,,ma-,,pd plan %all h 9 place a process "u :i* an enrollee 9 ! plan may reque/ cov]age "u ! plan = a cov]$ "p ,d drug t is n on ! =mul>y1 or is subject to utilization managem5t controls1 su* z ti]$ pric+1 prior au?orization1 or /ep !rapy4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,9 g5]al ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is am5d$-- 7,a7 9 subsection 7b77#c71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,if a ,,pdp & ins]t+ ,subject to section #ahfj;,d-#aa7;i77#b71 if a ,,pdp2 7,b7 9 subsection 7g7-- 7i7 9 p>agraph 7#a71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 except t ! ,,pdp sponsor ( a prescription drug plan %all treat ! pres5tation ( a prescription to a p>ticipat+ ph>macy1 :i* is transmitt$ to ! plan by ! ph>macy1 z a reque/ = a cov]age det]m9ation 7includ+ ) respect to prior au?orization1 /ep !rapy1 or quantity limits7 &1 9 apply+ su* p>agraphs ( section #aheb7;g71 ! response to su* transmittal %all be treat$ z a det]m9ation by ! sponsor2 & 7ii7 9 p>agraph 7#b71 9 ! fir/ s5t5ce1 by ins]t+ 7or a p>ticipat+ ph>macy1 on behalf ( su* individual1 ?r\gh transmission ( a prescription z describ$ 9 p>agraph 7#a77 aft] a "p ,d eligible individual :o is enroll$ 9 ! plan2 & 7,c7 9 subsection 7h7-- 7i7 9 p>agraph 7#a71 9 ! second s5t5ce1 by ins]t+ 7or a p>ticipat+ ph>macy1 on behalf ( su* individual7 aft] ! "p ,d eligible individual2 & 7ii7 9 p>agraph 7#b71 by ins]t+ 7or a p>ticipat+ ph>macy1 on behalf ( su* individual7 aft] ,a "p ,d eligible individual :o is enroll$ 9 a prescription drug plan (f]$ by a ,,pdp sponsor4 7#b7 ,effective date ,! am5dm5ts made by subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#a7 %all apply to plans ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj4 #c4 ,requir+ drug manufactur]s to provide drug rebates = drugs disp5s$ to l[-income individuals 7a7 ,9 g5]al ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7#a7 9 subsection 7e77#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & subsection 7f7 aft] ?is subsection2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7f7 ,prescription drug rebate agreem5t = rebate eligible individuals 7#a7 ,requirem5t 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj1 9 ?is "p1 ! t]m cov]$ "p ,d drug does n include any drug or biological product t is manufactur$ by a manufactur] t has n ent]$ into & h 9 effect a rebate agreem5t describ$ 9 p>agraph 7#b74 7,b7 #bjbj plan ye> requirem5t ,any drug or biological product manufactur$ by a manufactur] t decl9es to ent] into a rebate agreem5t describ$ 9 p>agraph 7#b7 = ! p]iod beg9n+ on ,janu>y #a1 #bjbj1 & end+ on ,decemb] #ca1 #bjbj1 %all n be includ$ z a cov]$ "p ,d drug = ! subsequ5t plan ye>4 7#b7 ,rebate agreem5t ,a rebate agreem5t "u ?is subsection %all require ! manufactur] to provide to ! ,secret>y a rebate = ea* rebate p]iod 7z def9$ 9 p>agraph 7#f77;,b77 end+ aft] ,decemb] #ca1 #bjai1 9 ! am\nt specifi$ 9 p>agraph 7#c7 = any cov]$ "p ,d drug ( ! manufactur] disp5s$ aft] ,decemb] #ca1 #bjai1 to any rebate eligible individual 7z def9$ 9 p>agraph 7#f77;,a77 = :i* paym5t 0 made by a ,,pdp sponsor or ,,ma organization "u ?is "p = su* p]iod1 includ+ paym5ts pass$ ?r\gh ! l[-income & re9surance subsidies "u sections #ahfj;,d-#ad & #ahfj;,d-#ae7;b71 respectively4 ,su* rebate %all be paid by ! manufactur] to ! ,secret>y n lat] ?an #cj days aft] ! date ( receipt ( ! in=mation describ$ 9 section #ahfj;,d-#ab7;b77#h71 includ+ z su* section is appli$ "u section #aheg7;f77#c71 or #cj days aft] ! receipt ( in=mation "u subp>agraph 7,d7 ( p>agraph 7#c71 z det]m9$ by ! ,secret>y4 ,ins(> z n inconsi/5t ) ?is subsection1 ! ,secret>y %all e/abli% t]ms & conditions ( su* agreem5t relat+ to compliance1 p5alties1 & program evaluations1 inve/igations1 & audits t are simil> to ! t]ms & conditions = rebate agreem5ts "u p>agraphs 7#c7 & 7#d7 ( section #aibg7;b74 7#c7 ,rebate = rebate eligible ,m$ic>e drug plan enrollees 7,a7 ,9 g5]al ,! am\nt ( ! rebate specifi$ "u ?is p>agraph = a manufactur] = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( any cov]$ "p ,d drug provid$ by su* manufactur] & disp5s$ to a rebate eligible individual1 %all be equal to ! product (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? ( ! drug s provid$ & disp5s$ = :i* paym5t 0 made by a ,,pdp sponsor or an ,,ma organization "u ?is "p = ! rebate p]iod1 includ+ paym5ts pass$ ?r\gh ! l[-income & re9surance subsidies "u sections #ahfj;,d-#ad & #ahfj;,d-#ae7;b71 respectively2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! ,m$icaid rebate am\nt 7z def9$ 9 subp>agraph 7,b77 = su* =m1 /r5g?1 & p]iod1 exce$s 7,,ii7 ! av]age ,m$ic>e drug program rebate eligible rebate am\nt 7z def9$ 9 subp>agraph 7,c77 = su* =m1 /r5g?1 & p]iod4 7,b7 ,m$icaid rebate am\nt ,= purposes ( ?is p>agraph1 ! t]m ,m$icaid rebate am\nt means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ "p ,d drug provid$ by ! manufactur] = a rebate p]iod-- 7i7 9 ! case ( a s+le s\rce drug or an innovator multiple s\rce drug1 ! am\nt specifi$ 9 p>agraph 7#a77;,a77ii77,,ii7 or 7#b77;,c7 ( section #aibg7;c7 plus ! am\nt1 if any1 specifi$ 9 subp>agraph 7,a77ii7 ( p>agraph 7#b7 ( su* section1 = su* =m1 /r5g?1 & p]iod2 or 7ii7 9 ! case ( any o!r cov]$ outpati5t drug1 ! am\nt specifi$ 9 p>agraph 7#c77;,a77i7 ( su* section = su* =m1 /r5g?1 & p]iod4 7,c7 ,av]age ,m$ic>e drug program rebate eligible rebate am\nt ,= purposes ( ?is subsection1 ! t]m av]age ,m$ic>e drug program rebate eligible rebate am\nt means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ "p ,d drug provid$ by a manufactur] = a rebate p]iod1 ! sum1 = all ,,pdp sponsors "u "p ,d & ,,ma organizations adm9i/]+ an ,,ma-,,pd plan "u "p ,c1 (-- 7i7 ! product1 = ea* su* sponsor or organization1 (-- 7,i7 ! sum ( all rebates1 disc\nts1 or o!r price concessions 7n tak+ into acc\nt any rebate provid$ "u p>agraph 7#b7 or any disc\nts "u ! program "u section #ahfj;,d-#ad;,a7 = su* dosage =m & /r5g? ( ! drug disp5s$1 calculat$ on a p]-unit basis1 b only to ! ext5t t any su* rebate1 disc\nt1 or o!r price concession applies equally to drugs disp5s$ to rebate eligible ,m$ic>e drug plan enrollees & drugs disp5s$ to ,,pdp & ,,ma-,,pd enrollees :o are n rebate eligible individuals2 & 7,,ii7 ! numb] ( ! units ( su* dosage & /r5g? ( ! drug disp5s$ dur+ ! rebate p]iod to rebate eligible individuals enroll$ 9 ! prescription drug plans adm9i/]$ by ! ,,pdp sponsor or ! ,,ma-,,pd plans adm9i/]$ by ! ,,ma organization2 divid$ by 7ii7 ! total numb] ( units ( su* dosage & /r5g? ( ! drug disp5s$ dur+ ! rebate p]iod to rebate eligible individuals enroll$ 9 all prescription drug plans adm9i/]$ by ,,pdp sponsors & all ,,ma-,,pd plans adm9i/]$ by ,,ma organizations4 7,d7 ,use ( e/imates ,! ,secret>y may e/abli% a me?odology = e/imat+ ! av]age ,m$ic>e drug program rebate eligible rebate am\nts = ea* rebate p]iod bas$ on bid & utilization in=mation "u ?is "p & may use ^! e/imates z ! basis = det]m9+ ! rebates "u ?is section4 ,if ! ,secret>y elects to e/imate ! av]age ,m$ic>e drug program rebate eligible rebate am\nts1 ! ,secret>y %all e/abli% a reconciliation process = adju/+ manufactur] rebate paym5ts n lat] ?an #c mon?s aft] ! date t manufactur]s receive ! in=mation collect$ "u section #ahfj;,d-#ab7;b77#h77;,b74 7#d7 ,l5g? ( agreem5t ,! provisions ( p>agraph 7#d7 ( section #aibg7;b7 7o!r ?an clauses 7iv7 & 7v7 ( subp>agraph 7,b77 %all apply to rebate agreem5ts "u ?is subsection 9 ! same mann] z su* p>agraph applies to a rebate agreem5t "u su* section4 7#e7 ,o!r t]ms & conditions ,! ,secret>y %all e/abli% o!r t]ms & conditions ( ! rebate agreem5t "u ?is subsection1 includ+ t]ms & conditions relat$ to compliance1 t are consi/5t ) ?is subsection4 7#f7 ,def9itions ,9 ?is subsection & section #ahfj;,d-#ab7;b77#h73 7,a7 ,rebate eligible individual ,! t]m rebate eligible individual means-- 7i7 a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77;,a772 7ii7 a ,m$icaid b5efici>y treat$ z a subsidy eligible individual "u clause 7v7 ( section #ahfj;,d-#ad7;a77#c77;,b72 & 7iii7 any "p ,d eligible individual n describ$ 9 clause 7i7 or 7ii7 :o is det]m9$ = purposes ( ! ,/ate plan "u title ,,xix to be eligible = m$ical assi/ance "u clause 7i71 7iii71 or 7iv7 ( section #aijb7;a77#aj77;,e74 7,b7 ,rebate p]iod ,! t]m rebate p]iod has ! mean+ giv5 su* t]m 9 section #aibg7k77#h74 4 7b7 ,report+ requirem5t = ! det]m9ation & paym5t ( rebates by manufactur]s relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees 7#a7 ,requirem5ts = ,,pdp sponsors ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,report+ requirem5t = ! det]m9ation & paym5t ( rebates by manufactur]s relat$ ,to rebate = rebate eligible ,m$ic>e drug plan enrollees 7,a7 ,9 g5]al ,= purposes ( ! rebate "u section #ahfj;,d-#b7;f7 = contract ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj1 ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan %all require t ! sponsor comply ) subp>agraphs 7,b7 & 7,c74 7,b7 ,report =m & cont5ts ,n lat] ?an a date specifi$ by ! ,secret>y1 a ,,pdp sponsor ( a prescription drug plan "u ?is "p %all report to ea* manufactur]-- 7i7 in=mation 7by ,national ,drug ,code numb]7 on ! total numb] ( units ( ea* dosage1 =m1 & /r5g? ( ea* drug ( su* manufactur] disp5s$ to rebate eligible ,m$ic>e drug plan enrollees "u any prescription drug plan op]at$ by ! ,,pdp sponsor dur+ ! rebate p]iod2 7ii7 in=mation on ! price disc\nts1 price concessions1 & rebates = su* drugs = su* =m1 /r5g?1 & p]iod2 7iii7 in=mation on ! ext5t to :i* su* price disc\nts1 price concessions1 & rebates apply equally to rebate eligible ,m$ic>e drug plan enrollees & ,,pdp enrollees :o are n rebate eligible ,m$ic>e drug plan enrollees2 & 7iv7 any additional in=mation t ! ,secret>y det]m9es is necess>y to enable ! ,secret>y to calculate ! av]age ,m$ic>e drug program rebate eligible rebate am\nt 7z def9$ 9 p>agraph 7#c77;,c7 ( su* section71 & to det]m9e ! am\nt ( ! rebate requir$ "u ?is section1 = su* =m1 /r5g?1 & p]iod4 ,su* report %all be 9 a =m consi/5t ) a /&>d report+ =mat e/abli%$ by ! ,secret>y4 7,c7 ,submission to ,secret>y ,ea* ,,pdp sponsor %all promptly transmit a copy ( ! in=mation report$ "u subp>agraph 7,b7 to ! ,secret>y = ! purpose ( audit ov]sight & evaluation4 7,d7 ,confid5tiality ( in=mation ,! provisions ( subp>agraph 7,d7 ( section #aibg7;b77#c71 relat+ to confid5tiality ( in=mation1 %all apply to in=mation report$ by ,,pdp sponsors "u ?is p>agraph 9 ! same mann] t su* provisions apply to in=mation disclos$ by manufactur]s or :olesal]s "u su* section1 except-- 7i7 t any ref]5ce to ?is section 9 clause 7i7 ( su* subp>agraph %all be treat$ z be+ a ref]5ce to ?is section2 7ii7 ! ref]5ce to ! ,director ( ! ,congressional ,budget ,(fice 9 clause 7iii7 ( su* subp>agraph %all be treat$ z includ+ a ref]5ce to ! ,m$ic>e ,paym5t ,advisory ,commission2 & 7iii7 clause 7iv7 ( su* subp>agraph %all n apply4 7,e7 ,ov]sight ,in=mation report$ "u ?is p>agraph may be us$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices = ! /atutorily au?oriz$ purposes ( audit1 inve/igation1 & evaluations4 7,f7 ,p5alties = failure to provide timely in=mation & provision ( false in=mation ,9 ! case ( a ,,pdp sponsor-- 7i7 t fails to provide in=mation requir$ "u subp>agraph 7,b7 on a timely basis1 ! sponsor is subject to a civil money p5alty 9 ! am\nt ( #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$2 or 7ii7 t kn[+ly 7z def9$ 9 section #aabh;,a7i77 provides false in=mation "u su* subp>agraph1 ! sponsor is subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alties are 9 addition to o!r p5alties z may be prescrib$ by law4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 4 7#b7 ,application to ,,ma organizations ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,report+ requirem5t relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees ,section #ahfj;,d-#ab7;b77#h74 4 7c7 ,deposit ( rebates into ,m$ic>e ,prescription ,drug ,acc\nt ,section #ahfj;,d-#af7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaf7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,rebate = rebate eligible ,m$ic>e drug plan enrollees ,am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f7 %all be deposit$ into ! ,acc\nt4 4 7d7 ,exclusion f det]m9ation ( be/ price & av]age manufactur] price "u ,m$icaid 7#a7 ,exclusion f be/ price det]m9ation ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is am5d$ by ins]t+ & am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f7 aft] ?is section4 7#b7 ,exclusion f av]age manufactur] price det]m9ation ,section #aibg7k77#a77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i77 is am5d$-- 7,a7 9 subclause 7,,iv71 by /rik+ & aft] ! semicolon2 7,b7 9 subclause 7,v71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,vi7 am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f74 4