,i #aad? ,,congress #a/ ,session ,h4 ,r4 #bdeb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #ai1 #bjae ,mr4 ,long 7= himself1 ,mr4 ,s*rad]1 & ,mr4 ,burgess7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to facilitat+ dissem9ation ( heal? c>e economic in=mation4 #a4 ,facilitat+ dissem9ation ( heal? c>e economic in=mation ,section #ejb7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 is am5d$-- 7#a7 by /rik+ 7a7 ,if its & ins]t+ 7a77#a7 ,if its2 7#b7 by /rik+ a =mul>y committee1 or o!r simil> entity1 9 ! c\rse ( ! committee or ! entity c>ry+ out its responsibilities = ! selection ( drugs = manag$ c>e or o!r simil> organizations & ins]t+ a payor1 =mul>y committee1 or o!r simil> entity ) k & exp]tise 9 ! area ( heal? c>e economic analysis1 c>ry+ out its responsibilities = ! selection ( drugs = cov]age or reimbursem5t2 7#c7 by /rik+ directly relates & ins]t+ relates2 7#d7 by /rik+ & is bas$ on compet5t & reliable sci5tific evid5ce4 ,! requirem5ts set =? 9 section #eje7;a7 or 9 section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act %all n apply to heal? c>e economic in=mation provid$ to su* a committee or entity 9 accordance ) ?is p>agraph & ins]t+ 1 is bas$ on compet5t & reliable sci5tific evid5ce1 & includes1 :]e applicable1 a conspicu\s & prom95t /atem5t describ+ any mat]ial diff]5ces betwe5 ! heal? c>e economic in=mation & ! label+ approv$ = ! drug "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act4 ,! requirem5ts set =? 9 section #eje7;a7 or 9 subsections 7a7 & 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act %all n apply to heal? c>e economic in=mation provid$ to su* a payor1 committee1 or entity 9 accordance ) ?is p>agraph2 & 7#e7 by /rik+ ,9 ?is p>agraph1 ! t]m & all t foll[s & ins]t+ ! foll[+3 7#b7 7,a7 ,= purposes ( ?is p>agraph1 ! t]m heal? c>e economic in=mation means any analysis 7includ+ ! cl9ical data1 inputs1 cl9ical or o!r assumptions1 me?ods1 results1 & o!r compon5ts und]ly+ or compris+ ! analysis7 t id5tifies1 measures1 or describes ! economic consequ5ces1 :i* may be bas$ on ! sep>ate or aggregat$ cl9ical consequ5ces ( ! repres5t$ heal? outcomes1 ( ! use ( a drug4 ,su* analyses may be comp>ative to ! use ( ano!r drug1 to ano!r heal? c>e int]v5tion1 or to no int]v5tion4 7,b7 ,su* t]m does n include any analysis t relates only to an indication t is n approv$ "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act = su* drug4 4