,i #aae? ,,congress #b;d ,session ,h4 ,r4 #fjga ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #ab1 #bjah,ms4 ,matsui 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 ! ,public ,heal? ,s]vice ,act to cl>ify ! int5t ( ! #cdj;,b program & provide = enhanc$ #cdj;,b program integrity1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/ret*+ ,entity ,res\rces = ,vuln]able ,communities ,act or ! ,,s]v ,communities ,act4 #b4 ,s5se ( ,congress relat$ to purpose ( ! #cdj;,b ,program ,x is ! s5se ( ,congress t-- 7#a7 ! program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 79 ?is section ref]r$ to z ! #cdj;,b program7 enables cov]$ entities to /ret* sc>ce res\rces z f> z possible1 rea*+ m pati5ts & provid+ m compreh5sive s]vices ?an )\t su* program2 7#b7 ! #cdj;,b program provides heal? c>e sett+s t s]ve a disproportionate %>e ( und]s]v$ pati5t populations 7ref]r$ to z cov]$ entities7 a disc\nt f drug manufactur]s on ! cov]$ outpati5t drugs !y pur*ase to meet heal? c>e ne$s ( ! community2 7#c7 cov]$ entities t qualify = p>ticipation "u ! #cdj;,b program meet rigor\s eligibility crit]ia1 prov+ !y are safety net heal? c>e provid]s = _m und]s]v$ pati5ts2 7#d7 su* disc\nts are provid$ to su* cov]$ entities on ! basis ( meet+ eligibility crit]ia "u ! #cdj;,b program1 & n directly to individual pati5ts2 7#e7 ! #cdj;,b ,program enables cov]$ entities to provide compreh5sive s]vices to ! communities !y s]ve1 :i* may include provid+ free or disc\nt$ drugs to vuln]able populations1 b provid+ free or disc\nt$ drugs to pati5ts is n ! sole purpose ( ! program2 7#f7 ! #cdj;,b ,program is design$ to help cov]$ entities promote heal? = und]s]v$ communities & pati5ts1 reg>dless ( a p>ticul> pati5t's insurance /atus or inability to pay2 7#g7 sav+s f ! #cdj;,b program are us$ by cov]$ entities to rea* m pati5ts & provide m compreh5sive s]vices1 & cov]$ entities are 9 ! be/ position to assess ! use ( _! sav+s = community ne$s2 & 7#h7 drugs pur*as$ "u ! #cdj;,b program acc\nt = a small proportion ( ov]all drug sp5d+ & ! disc\nts describ$ 9 p>agraph 7#b7 provid$ ?r\gh ! #cdj;,b program are n fund$ by taxpay]s4 #c4 ,codify+ def9ition ( pati5t "u #cdj;,b program ,section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,pati5t 7,a7 ,9 g5]al ,= purposes ( c>ry+ out ?is section1 ! t]m pati5t %all h ! def9ition giv5 to su* t]m on pages #eeaef ?r\gh #eeaeh ( title #fa ( ! ,f$]al ,regi/] publi%$ on ,octob] #bd1 #aiif4 7,b7 ,cl>ification ,= purposes ( ?is section1 ! ,secret>y %all n implem5t ! def9ition "u subp>agraph 7,a7 m n>r[ly ?an ! def9ition specifi$ 9 subp>agraph 7,a71 includ+ by limit+ ! application ( ! def9ition to p>ticul> individuals bas$ on _! insurance /atus4 4 #d4 ,non-discrim9ation ) respect to cov]$ entities ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,non-,discrim9ation ) respect to cov]$ entities 7#a7 ,t]ms ( agreem5t ,subject to p>agraph 7#c71 no entity t reimburses a cov]$ entity or its contract ph>macy = drugs t are subject to an agreem5t "u ?is section may discrim9ate aga9/ su* cov]$ entity ) respect to ! t]ms ( su* reimbursem5t1 includ+ t]ms relat+ to ! level & am\nt ( reimbursem5t1 on ! basis t ! cov]$ entity p>ticipates 9 ! program "u ?is section4 7#b7 ,pati5t's *oice ,) respect to a pati5t eligible to receive drugs t are subject to an agreem5t "u ?is section f a cov]$ entity or its contract ph>macy1 no entity t makes paym5t = su* drugs %all discrim9ate aga9/ ! cov]$ entity or its contract ph>macy 9 a mann] t prev5ts or int]f]es ) ! pati5t's *oice to receive su* drugs f ! cov]$ entity or contract ph>macy4 7#c7 ,exception ,p>agraph 7#a7 %all n apply to ,/ates ) respect to retail drugs t are reimburs$ by ! ,/ate on a fee-=-s]vice basis pursuant to a ,/ate plan approv$ "u title ,,xix ( ! ,social ,security ,act4 4 #e4 ,program integrity 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,9 response to f9d+s by ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices t ne>ly #ajj p]c5t ( cov]$ entities 7 ov]*>g$ by manufactur]s = at lea/ "o ( ! drugs review$1 ,congress direct$ ! ,secret>y ( ,heal? & ,human ,s]vices 9 #bjaj to publi% ! ceil+ prices "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 79 ?is section ref]r$ to z ! #cdj;,b ceil+ price7 via ,int]net website s t cov]$ entities c\ld v]ify !y 7 be+ *>g$ ! correct price1 h[ev] ?is website has n yet be5 e/abli%$1 leav+ cov]$ entities vuln]able to cont9u+ manufactur] ov]*>ges4 7#b7 ,9 response to f9d+s by ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ( widespread ov]*>ges by manufactur]s & a lack ( ov]sight & au?ority by ! ,secret>y ( ,heal? & ,human ,s]vices to ensure t cov]$ entities paid no m ?an ! #cdj;,b ceil+ price1 ,congress direct$ ! ,secret>y to develop /&>ds = calculat+ #cdj;,b ceil+ prices & civil monet>y p5alties to apply to manufactur]s t violate ^! rules1 h[ev] ^? /&>ds & p5alties h n yet be5 develop$1 significantly limit+ ! ,secret>y's ability to ov]see manufactur] compliance ) su* section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b74 7#c7 ,!re is no public transp>5cy on drug manufactur]s' av]age manufactur] price1 be/ price 9 ! m>ketplace1 or h[ mu* ! av]age manufactur] price ( a drug has increas$ relative to ! rate ( inflation4 7#d7 ,in=mation on ! av]age manufactur] price & be/ price are report$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 b r>ely does ! ,f$]al ,gov]nm5t audit ! raw data und]ly+ ^? calculations4 7#e7 ,su* data is n submitt$ & review$ by ! ,heal? ,res\rces & ,s]vices ,adm9i/ration z "p ( a #cdj;,b program audit4 7#f7 ,fur!rmore1 ! ,(fice ( ,ph>macy ,affairs has conduct$ only #aa total audits ( manufactur]s4 7b7 ,p>ity 9 audits betwe5 manufactur] & hospital audits ,section #cdj;,b7d77#a77;,b77v7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b77v77 is am5d$ to read z foll[s3 7v7 ,selective audit+ ( manufactur]s & :olesal]s to ensure ! integrity ( ! drug disc\nt program "u ?is section1 consi/5t ) ! foll[+3 7,i7 ,su* audits %all be conduct$ 9 a =m & mann] t1 to ! greate/ ext5t practicable1 results 9 p>ity betwe5 su* audits & audits "u subsection 7a77#e77;,c7 ( cov]$ entities1 z measur$ by comp>+ ! p]c5tage ( total manufactur] audits "u ?is clause to ! p]c5tage ( total audits conduct$ "u su* subsection ( cov]$ entities describ$ 9 subsection 7a77#d77,l74 7,,ii7 ,su* audits %all include review ( av]age manufactur] price1 be/ price1 & ! inflation>y p5alty to ensure t manufactur]s are calculat+ ! ceil+ price accurately4 4 7c7 ,deadl9e = ,int]net ,website ) applicable ceil+ prices = cov]$ outpati5t drugs ,section #cdj;,b7d77#a77;,b77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b77iii77 is am5d$ by /rik+ ,! provision & ins]t+ ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ! ,/ret*+ ,entity ,res\rces = ,vuln]able ,community ,act1 ! provision4 7d7 ,civil monet>y p5alty 7#a7 ,9 g5]al ,clause 7vi77,,ii7 ( section #cdj;,b7d77#a77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b77 is am5d$ to read z foll[s3 7,,ii7 %all n exce$1 = ea* in/ance ( ov]*>g+ a cov]$ entity t may h occurr$1 ! great] (-- 7aa7 #e1jjj2 or 7bb7 #bjj p]c5t ( ! am\nt ( su* ov]*>ge2 & 4 7#b7 ,cl>ifications ,section #cdj;,b7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,cl>ifications ,= purposes ( subp>agraph 7,b77vi7-- 7i7 an in/ance ( ov]*>g+ describ$ 9 subclause 7,,ii7 ( su* subp>agraph %all-- 7,i7 apply to ea* unit ( a national drug code )9 an ord]1 :e!r plac$ directly ) a manufactur] or ?r\gh a :olesal]1 au?oriz$ di/ributor1 or ag5t1 & may n be (fset by o!r disc\nts provid$ on any o!r ,national ,drug ,code or disc\nts provid$ on ! same ,national ,drug ,code on o!r transactions1 ord]s or pur*ases2 & 7,,ii7 include a manufactur]'s failure1 su* z ?r\gh a limit$ di/ribution network1 to (f] a cov]$ outpati5t drug to a cov]$ entity at ! #cdj;,b ceil+ price to ! same ext5t ! manufactur] makes ! drug available to non-#cdj;,b provid]s1 unless su* action is tak5 to n>r[ly address an actual or imm95t %ortage & has be5 approv$ 9 advance by ! ,secret>y pursuant to /&>ds issu$ ?r\gh an appropriate policy or regulatory issuance2 & 7ii7 9 apply+ subclause 7,,iii7 ( su* subp>agraph-- 7,i7 ! t]m kn[+ly %all h ! mean+ giv5 ! t]m %\ld "k 9 section #ajjc4aja ( title #db ( ! ,code ( ,f$]al ,regulations 7or any successor regulation72 & 7,,ii7 ! t]m int5tionally means1 ) respect to an ov]*>ge1 t su* ov]*>ge is n due to inadv]t5t error4 4 7#c7 ,non-application ( #cdj;,b ceil+ price & ,,cmp regulation ,! ,secret>y ( ,heal? & ,human ,s]vices %all n take any action to implem5t1 adm9i/]1 or en=ce ! provision ( ! f9al regulation titl$ #cdj;,b ,drug ,pric+ ,program ,ceil+ ,price & ,manufactur] ,civil ,monet>y ,p5alties ,regulation publi%$ on ,june #e1 #bjah 7#hc ,f$4 ,reg4 #beidc et seq471 t *anges ! effective date ( ! #cdj;,b ,drug ,pric+ ,program ,ceil+ ,price & ,manufactur] ,civil ,monet>y ,p5alties ,regulation f ,july #a1 #bjah to ,july #a1 #bjai4 ,! effective date %all be det]m9$ z if su* f9al regulation publi%$ on ,june #e1 #bjah1 did n apply4 7#d7 ,implem5tation ,! ,secret>y ( ,heal? & ,human ,s]vices %all implem5t ! am5dm5ts made by p>agraphs 7#a7 & 7#b7 by program in/ruction or o!rwise su* t su* am5dm5t applies to in/ances ( ov]*>ges occurr+ on or aft] ! date t is #fj days aft] ! date ( ! enactm5t ( ?is ,act4 7#e7 ,,gao report ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report evaluat+ ! ext5t to :i* ! ,secret>y ( ,heal? & ,human ,s]vices is c>ry+ out ! provisions ( clause 7vi7 ( section #cdj;,b7d77#a77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b771 z am5d$ by ?is subsection4 7e7 ,manufactur] transp>5cy ,section #cdj;,b7d77#a77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b77 is am5d$ by add+ at ! end ! foll[+ new clauses3 7vii7 ,! requirem5t t ! applicable ceil+ price describ$ 9 clause 7iii7 = a cov]$ outpati5t drug1 ) respect to a cal5d> qu>t]1 %all be equal to ! av]age manufactur] price "u section #aibg7k77#a7 ( ! ,social ,security ,act f ! prec$+ cal5d> qu>t] = ! smalle/ unit ( measure m9us ! unit rebate am\nt & w be calculat$ us+ six decimal places & w be publi%$ by ! ,secret>y r\nd$ to two decimal places1 9 accordance ) ! foll[+3 7,i7 ,9 ! case t ! ceil+ price calculation results 9 an am\nt less ?an #j4ja1 ! ceil+ price w be #j4ja4 7,,ii7 ,= a new cov]$ outpati5t drug-- 7aa7 manufactur]s %all e/imate ! ceil+ price z ( ! date ! new drug is fir/ available = sale2 7bb7 ! e/imation %all be calculat$ z :olesale acquisition co/ m9us ! appropriate rebate p]c5tage until an av]age manufactur] price is available1 :i* %all occur no lat] ?an ! #d? qu>t] t ! drug is available = sale2 & 7cc7 manufactur]s %all calculate ! actual ceil+ price & %all (f] to refund or cr$it ! cov]$ entity ! diff]5ce betwe5 ! e/imat$ ceil+ price & ! actual ceil+ price )9 #abj days ( ! det]m9ation by ! manufactur] involv$ t an ov]*>ge occurr$4 7viii7 ,! prohibition aga9/ discrim9atory di/ribution ( drugs1 consi/5t ) ! foll[+3 7,i7 ,a manufactur] %all make available ea* cov]$ outpati5t drug to cov]$ entities on ! same t]ms & conditions t ! cov]$ outpati5t drug is (f]$ to pur*as]s t are n cov]$ entities except t ! manufactur] w *>ge ! cov]$ entity = ! cov]$ outpati5t drug at or bel[ ! ceil+ price4 7,,ii7 ,if ! ,secret>y f9ds1 aft] audit z describ$ 9 subp>agraph 7,b77v7 & aft] notice & he>+1 t a manufactur] is 9 violation ( ! requirem5t describ$ 9 subclause 7,i71 ! manufactur] %all be liable to ! cov]$ entity t 0 n able to pur*ase ! cov]$ outpati5t drug involv$ at a disc\nt$ price 9 an am\nt equal to ! r$uction 9 ! price ( ! drug provid$ "u ! agreem5t betwe5 ! entity & ! manufactur] "u ?is section4 4 #f4 ,includ+ programs fund$ "u ! ,community ,m5tal ,heal? ,s]vices ,block ,grant or ! ,sub/ance ,abuse ,prev5tion & ,treatm5t ,block ,grant z cov]$ entities 7a7 ,9 g5]al ,section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,p7 ,a program c>ri$ out ?r\gh funds receiv$ "u a grant "u ! ,community ,m5tal ,heal? ,s]vices ,block ,grant or ! ,sub/ance ,abuse ,prev5tion & ,treatm5t ,block ,grant "u "p ,b ( title ,,xix4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply beg9n+ on ! date ( ! enactm5t ( ?is ,act4 #g4 ,prev5t+ ,m$ic>e ,hospital ,outpati5t ,paym5t ,cuts = ,hospitals t ,pur*ase ,drugs "u #cdj;,b ,program 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all n take any action to implem5t1 adm9i/]1 or en=ce ! provision ( ! f9al regulation titl$ ! ,m$ic>e ,program3 ,hospital ,outpati5t ,prospective ,paym5t & ,ambulatory ,surgical ,c5t] ,paym5t ,sy/ems & ,quality ,report+ ,programs publi%$ on ,novemb] #ac1 #bjag 7#hb ,f$4 ,reg4 #ebcef et seq471 t *anges ! paym5t am\nt "u ! ,prospective ,paym5t ,sy/em = ,hospital ,outpati5t ,dep>tm5t ,s]vices "u section #ahcc7t7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 = sep>ately payable1 nonpass-?r\gh drugs & biologicals pur*as$ "u ! #cdj;,b drug pric+ program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b74 ,! paym5t am\nt "u su* paym5t sy/em "u su* section #ahcc7t7 = su* a drug or biological provid$ on or aft] ,janu>y #a1 #bjah1 %all be det]m9$ 7or 9 ! case ( claims already process$1 r$et]m9$7 ?r\gh ! same me?odology z if su* f9al regulation did n apply4 7b7 ,,opps budget neutrality adju/m5t ,! fir/ s5t5ce ( section #ahcc7t77#i77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#i77;,b77 is am5d$ by /rik+ "p ea* place su* t]m appe>s & ins]t+ subsection ea* su* place4