,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #iahd  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #cj1 #bjbd,mr4  
,gu?rie 7= himself & ,ms4 ,b>ragn7      
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 ,,xi ( ! ,social
 ,security ,act to exclude f            
antikickback & o!r sanctions c]ta9      
travel & lodg+ arrangem5ts betwe5       
manufactur]s ( drugs & individuals be+  
adm9i/]$ su* drugs1 & = o!r purposes4   
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,pati5t ,access ,act ( #bjbd4  #b4    
,exclud+ f antikickback & o!r sanctions 
c]ta9 travel & lodg+ arrangem5ts betwe5 
manufactur]s ( drugs & individuals be+  
adm9i/]$ su* drugs  7a7 ,9 g5]al        
,section #aabh;,b ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acbj;a-#g;b7 is    

am5d$--  7#a7 9 subsection 7b77#c7--    
7,a7 9 subp>agraph 7,k71 by /rik+ at !  
end &2  7,b7 9 subp>agraph 7,l77iii71 by
 /rik+ at ! end ! p]iod & ins]t+ 2 &2 & 
7,c7 by add+ at ! end ! foll[+ new      
subp>agraph3  7,m7 an arrangem5t        
describ$ 9 subsection 7i7 betwe5 a      
manufactur] ( a drug & an individual :o 
is prescrib$ su* drug4  2 &  7#b7 by    
add+ at ! end ! foll[+ new subsection3  
7i7 ,= purposes ( subsection            
7b77#c77,m71 an arrangem5t describ$ 9   
?is subsection betwe5 a manufactur] ( a 
drug & an individual :o is prescrib$ su*
 drug is an arrangem5t ent]$ into on or 
aft] ,janu>y #a1 #bjbe1 t satisfies ea* 
( ! foll[+3 7#a7 ,! arrangem5t provides 
= paym5t or reimbursem5t by !           
manufactur] = transportation1 lodg+1    
meals1 or o!r incid5tal exp5ses specifi$
 by ! ,secret>y connect$ ) !            
adm9i/ration ( su* drug & relat+ to     
travel to & f ! facility at :i* su* drug
 is to be adm9i/]$1 = ! individual & up 
to two c>egiv]s ( ! individual 7z       

det]m9$ appropriate by ! manufactur]1   
tak+ into acc\nt ! individual's age &   
m$ical ne$s7 dur+ any portion ( ! p]iod 
dur+ :i* su* individual is be+ adm9i/]$ 
su* drug 7includ+ initial visits to su* 
facility be=e su* adm9i/ration1 &       
foll[up visits to su* facility aft] su* 
adm9i/ration1 relat+ to ! adm9i/ration (
 su* drug74  7#b7 ,! arrangem5t does n  
provide = paym5t or reimbursem5t by !   
manufactur] = transportation1 lodg+1    
meals1 or o!r incid5tal exp5ses describ$
 9 p>agraph 7#a7 if ! manufactur] kn[s t
 ! individual is eligible to receive at 
no co/1 su* transportation1 lodg+1      
meals1 or o!r out-(-pocket exp5ses1 z   
applicable1 f ! facility at :i* ! drug  
is adm9i/]$ to ! individual4  7#c7 ,!   
manufactur] does n adv]tise ! arrangem5t
 & makes good-fai? ef=ts to ensure t !  
availability ( su* arrangem5t is n      
disclos$ to su* individual until aft]   
su* drug is prescrib$ to su* individual1
 provid$ t su* manufactur] does n       
int]f]e ) a heal? c>e provid]'s ability 

to furni% su* individual ) any in=mation
 det]m9$ appropriate by ! provid]4  7#d7
 ,if ! arrangem5t provides = paym5t or  
reimbursem5t by ! manufactur] =         
transportation describ$ 9 p>agraph 7#a71
 su* paym5t or reimbursem5t is only =-- 
7,a7 travel t is practical & conv5i5t1  
tak+ into acc\nt ! individual's mobility
 or m$ical ne$s1 :i* may include gr\nd  
transportation1 air transportation1 or  
transportation by tra92  7,b7 ! co/s    
directly associat$ ) ! travel = !       
individual & c>egiv]s z describ$ 9      
p>agraph 7#a71 su* z airf>e1 taxes1     
tolls1 gas1 or o!r fees2 &  7,c7 travel 
betwe5 ! individual's resid5ce & !      
close/ facility t is available to       
adm9i/] su* drug 9 a mann] t is m$ically
 appropriate 7z det]m9$ by !            
individual's heal? c>e provid]7 = !     
individual 7or betwe5 any lodg+ :]e su* 
individual is /ay+ 9 relation to su*    
adm9i/ration & su* facility74  7#e7 ,if 
! arrangem5t provides = paym5t or       
reimbursem5t by ! manufactur] = lodg+   

describ$ 9 p>agraph 7#a71 su* lodg+ is--
 7,a7 reasonable bas$ on ! individual's 
age & m$ical ne$s2  7,b7 ne> ! facility 
at :i* su* individual is to be adm9i/]$ 
su* drug2 &  7,c7 only provid$ dur+ !   
p]iod describ$ 9 p>agraph 7#a74  7#f7   
,if ! arrangem5t provides = paym5t or   
reimbursem5t by ! manufactur] = meals or
 o!r incid5tal exp5ses describ$ 9       
p>agraph 7#a71 ! am\nt ( su* paym5t or  
reimbursem5t does n exce$ ! p] diem rate
 9 effect = meals & incid5tal exp5ses 9 
! geographic area 9 :i* su* facility is 
locat$ 7z e/abli%$ by ! ,g5]al ,s]vices 
,adm9i/ration7 = ! individual & = ea*   
c>egiv] all[$ "u ! arrangem5t pursuant  
to p>agraph 7#a74  7#g7 ,! individual-- 
7,a7 is det]m9$ to h income t does n    
exce$ ! m$ian income applicable to a    
family ( ! size involv$ 9 ! geographic  
region 7z specifi$ by ! ,secret>y7 9 :i*
 su* individual resides2 &  7,b7 lives m
 ?an #a h\r ( driv+ di/ance 7or #ej     
miles7 f ! ne>e/ facility t adm9i/]s su*
 drug & is accept+ pati5ts4  7#h7 ,su*  

an arrangem5t is (f]$ by ! manufactur]  
to individuals reg>dless ( ! facility   
involv$ 9 ! adm9i/ration ( ! drug &     
reg>dless ( ! insurance /atus ( !       
individual4  7#i7 ,! arrangem5t requires
 ! individual to agree to n reque/      
reimbursem5t f any ,f$]al heal? c>e     
program = any co/s = :i* paym5t or      
reimbursem5t is made by ! manufactur] "u
 ! arrangem5t4  7#aj7 ,! manufactur]    
c]tifies t ! manufactur] does n bill or 
%ift ! co/s ( ! arrangem5t to any ( !   
,f$]al heal? c>e programs4  4  7b7 ,,gao
 /udy & report ,n lat] ?an #c ye>s aft] 
! date ( ! enactm5t ( ?is section1 !    
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all submit to ,congress a report on    
arrangem5ts betwe5 a manufactur] ( a    
drug & an individual :o is prescrib$ su*
 drug describ$ 9 subsection 7i7 (       
section #aabh;,b ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #acbj;a-#g;b71 z    
add$ by subsection 7a74 ,su* report %all
 include--  7#a7 an analysis ( ! impact 
( su* arrangem5ts on-- 7,a7 access to   

trans=mative !rapies1 includ+ r>e       
disease g5e !rapies2  7,b7 access to    
drugs t are ! subject ( su* arrangem5ts1
 includ+ socioeconomic disp>ities )     
respect to su* access2 &  7,c7 !        
utilization by su* individuals (--  7i7 
biosimil> biological products t are !   
subject to su* arrangem5ts1 z comp>$ to 
! utilization ( ! biological products t 
are ! ref]5ce products = su* biosimil>  
biological products2 &  7ii7 g5]ic drugs
 t are ! subject to su* arrangem5ts1 z  
comp>$ to ! utilization ( ! drugs t are 
! ref]5ce drugs = su* g5]ic drugs2  7#b7
 a description ( any tax b5efits obta9$ 
9 connection ) su* arrangem5ts by       
manufactur]s (f]+ su* arrangem5ts2  7#c7
 a li/ ( ! drugs = :i* a manufactur] (  
su* drug (f]s su* an arrangem5t2  7#d7 )
 respect to ea* drug t is ! subject (   
su* an agreem5t-- 7,a7 ! av]age co/     
directly associat$ ) ! travel to & f !  
facility at :i* su* drug is to be       
adm9i/]$1 = ! individual adm9i/]$ su*   
drug "u su* an arrangem5t & c>egiv]s ( !

 individual1 z describ$ 9 subsection    
7i77#a7 ( section #aabh;,b ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;b71 z add$ by subsection 7a72
  7,b7 ! av]age di/ance s travel$ by su*
 individuals & c>egiv]s2  7,c7 ! av]age 
family annual income ( su* individuals2 
7,d7 ! av]age l5g? ( /ay at ! facility  
at :i* ! drug is adm9i/]$ = su*         
individuals2  7,e7 ! total numb] ( su*  
individuals ) :om su* an arrangem5t has 
be5 made2 &  7,f7 ! p]c5tage (          
prescriptions = su* drug t are fill$ :5 
su* an arrangem5t is available to !     
individual be+ adm9i/]$ su* drug comp>$ 
to ! p]c5tage ( prescriptions = su* drug
 t are fill$ :5 su* an arrangem5t is n s
 available2 &  7#e7 an analysis ( !     
efficacy ( any ov]sight conduct$ to     
ensure t su* arrangem5ts adh]e to any   
applicable guidance f ! ,(fice ( !      
,inspector ,g5]al ( ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices on avoid+ wa/e1      
fraud1 & abuse4