,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #dgad  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #c1 #bjaf ,mr4   
,"y ( ,indiana 7= himself & ,mr4 ,pet]s7
 introduc$ ! foll[+ bill2 :i* 0 ref]r$  
to ! ,committee on ,ways & ,means1 & 9  
addition to ! ,committee on ,en]gy &    
,comm]ce1 = 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 ensure ,m$ic>e
 cov]age ( c]ta9 co/s associat$ )       
,,fda-approv$ cl9ical trials4  #a4 ,%ort
 title ,?is ,act may be cit$ z ! ,remov+
 ,b>ri]s to ,cl9ical ,rese>* ,act (     
#bjaf4  #b4 ,m$ic>e cov]age ( c]ta9 co/s
 associat$ ) ,,fda-approv$ cl9ical      
trials  7a7 ,9 g5]al ,section #ahfb7m7 (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #acieg7m77 is am5d$--  7#a7 9 !        
subsection head+-- 7,a7 by /rik+ r\t9e &
 ins]t+ c]ta92 &  7,b7 by /rik+ category
 ,a & ins]t+ m$ical2  7#b7 9 p>agraph   

7#a7--  7,a7 by /rik+ category ,a &     
ins]t+ category ,a or category ,b2 &    
7,b7 by /rik+ paym5t = cov]age ( r\t9e &
 ins]t+ ! foll[+3 8paym5t = cov]age (-- 
7,a7 9 ! case ( category ,a & category  
,b cl9ical trials1 r\t9e  2  7,c7 9     
subp>agraph 7,a71 z add$ by subp>agraph 
7,b7 ( ?is subsection1 by /rik+ ! p]iod 
at ! end & ins]t+ 2 or2 &  7,d7 by add+ 
at ! end ! foll[+ new subp>agraph3  7,b7
 9 ! case ( category ,b cl9ical trials1 
! co/s ( ! devices "u inve/igation4  2 &
  7#c7 by add+ at ! end ! foll[+ new    
p>agraphs3  7#c7 ,category ,b cl9ical   
trial ,= purposes ( p>agraph 7#a71 a    
category ,b cl9ical trial means a trial 
( a m$ical device if--  7,a7 ! trial is 
( a nonexp]iem5tal_/inve/igational      
7category ,b7 m$ical device 7z def9$ 9  
regulations "u section #dje4bja7;b7 (   
title #db1 ,code ( ,f$]al ,regulations  
7z 9 effect z ( ,janu>y #a1 #bjae772 &  
7,b7 ! trial meets crit]ia e/abli%$ by !
 ,secret>y to ensure t ! trial con=ms to
 appropriate sci5tific & e?ical /&>ds4  

7#d7 ,automatic qualification ( c]ta9   
trials ,a trial ( a m$ical device %all  
be deem$ to be meet ! def9ition ( a     
category ,a or category ,b cl9ical trial
 "u p>agraph 7#b7 or 7#c71 respectively1
 z ! case may be1 if ! trial is conduct$
 "u ! inve/igational use exemption "u   
section #ebj7;g7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;j7g774  4  7b7 ,con=m+ am5dm5t     
,p>agraph 7#c7 ( section #gca7;b7 ( !   
,m$ic>e ,prescription ,drug1            
,improvem5t1 & ,mod]nization ,act (     
#bjjc 7#db ,u4,s4,c4 #aciey note7 is    
repeal$4  7c7 ,effective date ,!        
am5dm5ts made by ?is section %all apply 
to co/s incurr$ on or aft] ! date t is  
#ij days aft] ! date ( ! enactm5t ( ?is 
,act4