,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cfha  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #i1 #bjac,mr4
 ,pauls5 7= himself1 ,mr4 ,ma!son1 ,mr4 
,%imkus1 & ,mr4 ,b>r[ ( ,georgia7       
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 promote heal? 
c>e te*nology innovation & access to    
m$ical devices & s]vices = :i* pati5ts  
*oose to self-pay "u ! ,m$ic>e program1 
& = o!r purposes4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,accel]at+         
,innovation 9 ,m$ic9e ,act ( #bjac or ! 
,,aim ,act ( #bjac4  #b4 ,f9d+s         
,congress f9ds z foll[s3 7#a7           
,innovation 9 heal? c>e te*nology is    
necess>y to improve heal? outcomes &    
dep5ds 9 "p on ! ability ( m$ical       

te*nology develop]s1 includ+ sci5ti/s1  
physicians1 eng9e]s1 & pati5t advocates1
 to introduce m$ical devices into !     
m>ketplace4  7#b7 ,ev5 aft] meet+       
requirem5ts = m>ket+ set by ! ,food &   
,drug ,adm9i/ration1 !re may be         
unc]ta9ties ab\t pati5t access ?r\gh    
gov]nm5t heal? c>e programs1 caus+      
significant delays 9 br++ innovative    
m$ical devices to pati5ts or caus+      
m$ical te*nology develop]s to ab&on     
pot5tial heal? c>e solutions4  7#c7     
,pati5ts cov]$ by ! ,m$ic>e program are 
(t5 will+ to ent] into self-pay         
arrangem5ts ) physicians & o!r provid]s 
to pur*ase items or s]vices1 yet "u     
curr5t laws re/rict+ su* fre$om ( *oice1
 ! self-pay arrangem5ts may be associat$
 ) regulatory imp$im5ts or a risk (     
civil p5alties4  7#d7 ,enabl+ heal? c>e 
te*nology manufactur]s to designate     
products to be directly available to    
self-pay pati5ts & exclud$ f gov]nm5t   
heal? program paym5ts at an e>ly /age ( 
product developm5t w promote innovation 

& result 9 increas$ pati5t access to    
desir$ products & s]vices1 save taxpay] 
doll>s1 & r$uce adm9i/rative burd5s on  
physicians & ! gov]nm5t4  7#e7 ,enabl+  
heal? c>e te*nology manufactur]s to     
designate _! devices z available to     
self-pay pati5ts w\ld p]mit a w9d[ ( "t 
dur+ :i* additional data may be obta9$  
on outcomes1 comp>ative cl9ical         
effectiv5ess or o!r data elem5ts =      
possible future cov]age by ! ,m$ic>e    
program4  #c4 ,e/abli%m5t ( manufactur] 
opt-out program = m$ical devices  7a7 ,9
 g5]al ,section #ahfb ( ! ,social       
,security ,act 7#db ,u4,s4,c4 #aciey7 is
 am5d$ add+ at ! end ! foll[+ new       
subsection3  7p7 ,e/abli%m5t ( accel]at+
 innovation 9 m$ic9e 7,,aim7 li/ (      
m$ical devices volunt>ily exclud$ f     
cov]age  7#a7 ,9 g5]al ,n lat] ?an #ij  
days aft] ! date ( ! enactm5t ( ?is     
subsection1 ! ,secret>y %all develop &  
ma9ta9 a li/+ 79 ?is section ref]r$ to z
 ! ,,aim li/7 ( m$ical devices = :i*1   
because ( _! inclusion 9 su* li/+1 no   

insurance b5efit & no paym5t may be made
 = su* a device "u ?is title ei!r       
directly or on a capitat$ basis su* t no
 claim = paym5t may be submitt$ "u ?is  
title = su* a device & an individual :o 
cons5ts to receive su* a device is      
responsible = paym5t = ! device &       
s]vices relat$ to furni%+ ! device4     
7#b7 ,proc$ures = inclusion 9 ,,aim li/ 
7,a7 ,requirem5t = writt5 cons5t (      
manufactur] ,no m$ical device may be    
includ$ 9 ! ,,aim li/ )\t ! writt5      
cons5t ( ! manufactur] ( ! device4  7,b7
 ,submission process ,a manufactur]     
seek+ to h a m$ical device includ$ 9 !  
,,aim li/ %all submit to ! ,secret>y a  
reque/ = inclusion ( ! device 9 ! ,,aim 
li/4 ,9 ! case ( su* a device = :i*--   
7i7 !re is a reque/ = approval or       
cle>ance = m>ket+ & sale ( ! device by !
 ,food & ,drug ,adm9i/ration pursuant to
 au?ority grant$ by ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cja et seq471 includ+ pursuant to      
section #eaj7k7 or #eae7;c7 ( su* ,act  

7#ba ,u4,s4,c4 #cfj7k71 #cfj;e7c771 !   
reque/ = inclusion ( ! device 9 ! ,,aim 
li/ may n be submitt$ e>li] ?an ! date (
 ! reque/ = su* approval or cle>ance &  
no lat] ?an ! fir/ bus9ess day ( ! mon? 
beg9n+ at lea/ #cj days aft] ! date (   
su* approval or cle>ance2 or  7ii7 !    
device is exempt f su* approval &       
cle>ance requirem5ts1 ! reque/ may be   
submitt$ at a "t t is n lat] ?an ! fir/ 
bus9ess day ( ! mon? beg9n+ at lea/ #cj 
days aft] ! date ( ! fir/ sale ( !      
device by its manufactur]4  7#c7 ,li/+  
p]iods2 removal f li/  7,a7 #c-ye> li/+ 
p]iods ,a m$ical device includ$ 9 !     
,,aim li/ %all be initially li/$ = a    
p]iod ( #c ye>s & %all rema9 s li/$ =   
subsequ5t #c-ye> p]iods subject to      
subp>agraphs 7,b7 & 7,c74  7,b7 ,removal
 at reque/ ( manufactur] ,at any "t a   
device ( a manufactur] includ$ 9 ! ,,aim
 li/ %all be remov$ f ! ,,aim li/ ^u !  
writt5 reque/ ( ! manufactur]4 ,subject 
to subp>agraph 7,c71 su* a device ( a   
manufactur] may n be remov$ f ! ,,aim   

li/ except ^u ! writt5 reque/ ( !       
manufactur]4  7,c7 ,provision ( data on 
cl9ical /udies z a condition = cont9u$  
li/+ ,z a condition = ! cont9u$         
inclusion ( ! device ( a manufactur] 9 !
 ,,aim li/ = a subsequ5t #c-ye> li/+    
p]iod "u subp>agraph 7,a71 ! manufactur]
 %all provide ! ,secret>y ) publi%$ or  
publicly available data on cl9ical      
/udies complet$ = ! device at ! end ( ! 
previ\s #c-ye> li/+ p]iod4 ,if !        
,secret>y det]m9es t a manufactur] ( a  
device has mat]ially fail$ to provide   
su* data = ! device1 ! ,secret>y may    
remove ! device f ! ,,aim li/ or n r5ew 
! li/+ = ! device or bo?4  7#d7 ,m$ical 
device def9$ ,9 ?is subsection1 ! t]m   
m$ical device has ! mean+ giv5 ! t]m    
device 9 section #bja7;h7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7;h774  7#e7 ,po/+ ( li/$ 
devices on website ,! ,secret>y %all po/
 on a public website ( ! ,dep>tm5t (    
,heal? & ,human ,s]vices or o!r publicly
 accessible mann] a li/ ( ! m$ical      

devices includ$ 9 ! ,,aim li/ & %all    
provide = updat+ ! website on a real-"t 
basis 7b no less frequ5tly ?an mon?ly7  
to reflect *anges 9 ! m$ical devices 9 !
 ,,aim li/4  7#f7 ,regulations n requir$
 ,no?+ 9 ?is subsection %all be con/ru$ 
z requir+ ! ,secret>y to promulgate     
regulations to c>ry out ?is subsection4 
7#g7 ,requirem5t = in=m$ cons5t 9 ord] =
 provid] to *>ge = device ,if a         
physician or o!r entity furni%es a      
m$ical device includ$ 9 ! ,,aim li/ to  
an individual "u ?is title & fail$ to   
obta91 be=e furni%+ ! device1 an        
appropriate in=m$ cons5t "u :i* !       
individual is in=m$ ( & accepts         
liability "u p>agraph 7#a7 = paym5t = ! 
device 7& relat$ s]vices71 ! physician  
or o!r entity is deem$ to h agre$ n to  
impose any *>ge "u ?is title = su*      
device 7& = s]vices relat$ to furni%+ ! 
device74  4  7b7 ,con=m+ am5dm5t        
,section #ahfb7;a7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #aciey7a77 is      
am5d$-- 7#a7 9 p>agraph 7#bd71 by /rik+ 

or at ! end2  7#b7 9 p>agraph 7#be71 by 
/rik+ ! p]iod at ! end & ins]t+ 2 or2 & 
7#c7 by ins]t+ aft] p>agraph 7#be7 !    
foll[+ new p>agraph3  7#bf7 :]e su*     
exp5ses are = a m$ical device includ$ 9 
! ,,aim li/ "u section #ahfb7p7 or =    
items & s]vices relat$ to furni%+ su*   
device4  4