,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #ceba  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #bj1 #bjbe,mr4   
,ruiz 7= himself & ,mr4 ,pflug]7        
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 mod]nize cl9ical trials &  
remove b>ri]s = p>ticipation 9 cl9ical  
trials1 & = o!r purposes4  #a4 ,%ort    
title  ,?is ,act may be cit$ z !        
,cl9ical ,trial ,mod]nization ,act4  #b4
 ,def9ition ,= purposes ( ?is ,act1 !   
t]m und]repres5t$ population has ! mean+
 giv5 su* t]m by ! ,national ,in/itutes 
( ,heal? = purposes ( ! ,toolkit =      
,pati5t-,focus$ ,!rapy ,developm5t 7z   
publi%$ on ,april #a1 #bjbd71 9 addition
 to su* populations recogniz$ by ! ,food
 & ,drug ,adm9i/ration4  #c4 ,grants to 
enc\rage cl9ical trial enrollm5t by     

und]repres5t$ populations  7a7 ,9 g5]al 
,! ,secret>y may issue grants to & ent] 
into contracts ) entities to support    
community education1 outrea*1 &         
recruitm5t activities = cl9ical trials )
 respect to devices & drugs1 includ+    
vacc9es1 = diseases or conditions t h a 
disproportionate impact on und]repres5t$
 populations4 ,su* activities may       
include--  7#a7 work+ ) community       
cl9ical trial sites1 includ+ community  
heal? c5t]s1 academic heal? c5t]s1 sites
 9 rural communities1 & o!r facilities2 
7#b7 tra9+ heal? c>e p]sonnel1 includ+  
pot5tial cl9ical trial inve/igators1 ) a
 focus on significantly increas+ ! numb]
 ( und]repres5t$ populations ( heal? c>e
 p]sonnel :o are cl9ical trial          
inve/igators at ! community sites =     
ongo+ cl9ical trials2  7#c7 engag+      
community /akehold]s to enc\rage        
p>ticipation 9 cl9ical trials1          
especially 9 und]repres5t$ populations2 
&  7#d7 fo/]+ p>tn]%ips ) community-bas$
 organizations s]v+ und]repres5t$       

populations1 includ+ employee unions &  
frontl9e heal? c>e work]s4  7b7         
,priority = grant & contract aw>ds ,9   
aw>d+ grants & contracts "u ?is section1
 ! ,secret>y %all prioritize entities   
t-- 7#a7 develop educational1           
recruitm5t1 & tra9+ mat]ials 9 multiple 
languages2 or  7#b7 und]take cl9ical    
trial outrea* ef=ts 9 communities t are 
traditionally und]repres5t$ 9 cl9ical   
trials1 su* z tribal areas4  7c7        
,au?orization ( appropriations ,!re is  
au?oriz$ to be appropriat$ = fiscal ye>s
 #bjbe & #bjbf su* sums z may be        
necess>y to c>ry out ?is section4  #d4  
,enc\ragem5t ( cl9ical trial            
p>ticipation by und]repres5t$           
populations ?r\gh paym5t ( /udy         
p>ticipant cl9ical trial exp5ses &      
provision ( digital heal? te*nologies   
7a7 ,9 g5]al ,section                   
#aabh;,a7i77#f77;,f7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;a7i77#f77;,f77 is am5d$ by   
/rik+ "u regulations72 & ins]t+ !       

foll[+3 8"u regulations1 includ+--  7i7 
remun]ation (f]$ or transf]r$ to an     
individual :ile p>ticipat+ 9 a cl9ical  
trial1 z def9$ 9 subsection 7d7 ( ! fir/
 section #bgji ( ! ,public ,heal?       
,s]vice ,act = exp5ses incurr$ z "p ( ! 
trial1 o!r ?an pati5t co/-%>+           
obligations1 includ+ )\t limitation     
travel1 transportation1 & meal exp5ses1 
s long z su* remun]ation is made        
available to all /udy p>ticipants &     
facilitates inclusion ( pati5ts f all   
relevant demographic & socioeconomic    
populations & geographies includ+ rural 
communities2 &  7ii7 ! free provision to
 an individual ( digital heal?          
te*nologies :]e-- 7,i7 ! use ( ! digital
 heal? te*nologies is int5d$ to         
facilitate ! p>ticipation (             
und]repres5t$ pati5t populations2 &     
7,,ii7 ! digital heal? te*nologies are  
necess>y = p>ticipation 9 su* trial2  4 
7b7 ,con=m+ am5dm5t to ! anti-,kickback 
/atute ,section #aabh;,b7b77#c7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   

#acbj;a-#g;b7b77#c77 is am5d$--  7#a7 by
 /rik+ & at ! end ( subp>agraph 7,k72   
7#b7 by /rik+ ! p]iod at ! end (        
subp>agraph 7,l7 & ins]t+ 2 &2  7#c7 by 
align+ ! left m>g9 ( ea* ( subp>agraphs 
7,j7 & 7,k7 ) ! left m>g9 ( subp>agraph 
7,i72 &  7#d7 by ins]t+ aft] subp>agraph
 7,l7 ! foll[+ new subp>agraphs3  7,m7  
any remun]ation (f]$ or transf]r$ to an 
individual :ile p>ticipat+ 9 a cl9ical  
trial 7z def9$ 9 subsection 7d7 ( ! fir/
 section #bgji ( ! ,public ,heal?       
,s]vice ,act7 = exp5ses incurr$ z "p ( !
 trial1 o!r ?an pati5t co/-%>+          
obligations1 includ+ )\t limitation     
travel1 transportation1 & meal exp5ses1 
s long z su* remun]ation is made        
available to all /udy p>ticipants &     
facilitates inclusion ( pati5ts f all   
relevant demographic & socioeconomic    
populations & geographies1 includ+ rural
 communities2 &  7,n7 ! free provision  
to an individual ( digital heal?        
te*nologies :]e--  7i7 ! use ( ! digital
 heal? te*nologies is int5d$ to         

facilitate 9 any phase ( a cl9ical trial
 7z s def9$7 ! p>ticipation (           
und]repres5t$ pati5t populations2 &     
7ii7 ! digital heal? te*nologies are    
necess>y to su* p>ticipation4  4  7c7   
,effective date ,! am5dm5ts made by ?is 
section %all apply to remun]ation       
provid$ on or aft] ! date ( enactm5t (  
?is ,act4  #e4 ,enc\ragem5t ( cl9ical   
trial accessibility ?r\gh support (     
cl9ical trial co/-%>+ ,! paym5t ( pati5t
 co/-%>+ obligations associat$ )        
p>ticipation 9 a cl9ical trial 7z def9$ 
9 subsection 7d7 ( ! fir/ section #bgji 
( ! ,public ,heal? ,s]vice ,act7 or =   
:i* a div]sity action plan is requir$   
pursuant to sections #eje7z7 or         
#ebj7;g77#i7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act by drug or device        
manufactur]s or _! ag5ts = _! cl9ical   
trial p>ticipants %all n be consid]$ a  
violation ( section #aabh;,a ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#acbj;a-#g;a7 7commonly kn[n z ! ,civil 
,monet>y ,p5alties ,law71 section       

#aabh;,b ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #acbj;a-#g;b71 or sections   
#cgbi ?r\gh #cgcc ( title #ca1 ,unit$   
,/ates ,code 7commonly kn[n z ! ,false  
,claims ,act71 provid$ t ! foll[+       
requirem5ts are met3  7#a7 ,! trial &   
any cov]age ( items or s]vices provid$ 9
 ! trial is consi/5t ) all applicable   
cov]age rules by any ,f$]al heal? c>e   
programs provid+ cov]age & reimbursem5t 
= b5efici>ies p>ticipat+ 9 ! trial z    
/udy subjects1 includ+ b n limit$ to1   
any exi/+ trial qualification           
requirem5ts impos$ by ! ,c5t]s = ,m$ic>e
  ,m$icaid ,s]vices = ,m$ic>e cov]age ( 
! trial4  7#b7 ,! propos$ arrangem5t = !
 paym5t ( pati5t co/-%>+ obligations is 
a reasonable means ( facilitat+         
enrollm5t ( an und]repres5t$ set (      
subjects or r$uc+ ! likelihood (        
attrition 9 ! trial by remov+ a pot5tial
 f9ancial b>ri] to p>ticipation 9 !     
trial4  7#c7 ,any sponsor paym5ts (     
p>ticipat+ pati5t co/-%>+ obligations   
mu/ be available ?r\gh\t ! entirety ( ! 

cl9ical trial4  7#d7 ,any sponsor       
paym5ts ( p>ticipat+ pati5t co/-%>+     
obligations are n cont+5t on ! future   
use or pur*ase ( any product or s]vice4 
7#e7 ,any sponsor paym5ts ( p>ticipat+  
pati5t co/-%>+ obligations w n be       
provid$ 9 excess ( ! pati5t's co/-%>+   
obligations "u relevant ,f$]al heal? c>e
 programs4  7#f7 ,a p>ticipat+ pati5t   
receiv+ co/-%>+ assi/ance f a sponsor w 
be requir$ to agree n to accept o!r     
f9ancial assi/ance to cov] ! pati5t's   
co/-%>+ obligations4  7#g7 ,any sponsor 
paym5ts ( p>ticipat+ pati5t co/-%>+     
obligations w cease ^u ! pati5t's       
dis5rollm5t f ! cl9ical trial or !      
conclusion ( ! cl9ical trial1 :i*ev] is 
fir/4  7#h7 ,! propos$ arrangem5t = !   
paym5t ( pati5t co/-%>+ obligations     
includes ! foll[+ elem5ts to protect    
aga9/ improp] increas$ co/s or          
inappropriate utilization ( items &     
s]vices reimburs$ 9 :ole or 9 "p "u     
,f$]al heal? c>e programs3  7,a7 ,!     
availability ( co/-%>+ subsidies w n be 

adv]tis$1 b may be disclos$ z requir$ or
 p]mitt$ by law 9 ! in=m$ cons5t =ms1   
protocol1 or o!r docum5tation associat$ 
) ! /udy4  7,b7 ,p>ticipat+ ,f$]al heal?
 c>e program b5efici>ies mu/ satisfy    
=mal1 objective1 & pr$et]m9$ enrollm5t  
crit]ia & execute an in=m$ cons5t       
docum5t4  7,c7 ,! sponsor mu/ ent] into 
a writt5 agreem5t ) inve/igators t      
requires ! inve/igators to comply ) !   
writt5 protocol = ! /udy & to be subject
 to ov]sight & monitor+ by an           
in/itutional review bo>d or o!r simil>  
body provid+ indep5d5t ov]sight = !     
trial4  7,d7 ,total enrollm5t = ! trial 
is capp$4  #f4 ,exclusion f gross income
 = remun]ation provid$ by sponsors (    
approv$ cl9ical trials to p>ticipants   
7a7 ,9 g5]al ,"p ,,iii ( sub*apt] ,b (  
*apt] #a ( ! ,int]nal ,rev5ue ,code (   
#aihf is am5d$ by ins]t+ be=e section   
#adj ! foll[+ new section3  #aci;,j4    
,remun]ation provid$ by sponsors (      
approv$ cl9ical trials to p>ticipants   
7a7 ,9 g5]al ,gross income %all n       

include ! value ( any paym5t receiv$ by 
an individual f p>ticipation 9 an       
approv$ cl9ical trial 7z def9$ 9        
subsection 7d7 ( ! fir/ section #bgji ( 
! ,public ,heal? ,s]vice ,act74  7b7    
,limitation ,! am\nt exclud$ f gross    
income "u subsection 7a7 = any taxable  
ye> %all n exce$ #b1jjj4  4  7b7        
,cl]ical am5dm5t ,! table ( sections =  
"p ,,iii ( sub*apt] ,b ( *apt] #a ( !   
,int]nal ,rev5ue ,code ( #aihf is am5d$ 
by ins]t+ be=e ! item relat+ to section 
#adj ! foll[+ new item3  ,sec4 #aci;,j4 
,remun]ation provid$ by sponsors (      
approv$ cl9ical trials to p>ticipants4  
4  7c7 ,effective date ,! am5dm5ts made 
by ?is section %all apply to taxable    
ye>s beg9n+ aft] ! date ( enactm5t ( ?is
 ,act4  #g4 ,rule ( con/ruction ,no?+ 9 
section #d or section #e ( ?is ,act %all
 be con/ru$ to limit or n>r[ 9 any way  
any o!r protections f liability "u      
section #aabh;,a or #aabh;,b ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#acbj;a-#g;a2 #acbj;a-#g;b7 or sections 

#cgbi ?r\gh #cgcc ( title #ca1 ,unit$   
,/ates ,code1 :e!r su* o!r protections  
are set =? 9 /atute1 regulation1 or any 
=m ( guidance1 t may apply to any       
practice or arrangem5t enc\rag+         
p>ticipation 9 or accessibility (       
cl9ical trials4