,,ii  #aai? ,,congress  #b;d ,session   
,s4 #ebeh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #e1 #bjbf,mr4   
,cassidy 7= himself & ,ms4 ,murk[ski7   
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to am5d title ,,xi 
( ! ,social ,security ,act to e/abli% a 
paym5t model to reimburse provid]s =    
furni%+ compreh5sive brea/ canc] risk   
assessm5ts & develop+ p]sonaliz$ scre5+ 
& risk-r$uction plans1 & = o!r purposes4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,p]sonaliz$ ,risk ,evaluation ,=    
,effective ,risk ,r$uction & ,e>ly      
,detection ,scre5+ ,act or ! ,,pref]r$  
,scre5+ ,act4  #b4 ,,cmi model to te/   
reimburs+ eligible provid]s = furni%+   
compreh5sive brea/ canc] risk assessm5ts
 & develop+ p]sonaliz$ scre5+ & risk    
r$uction plans ,section #aaae;,a ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#acae;a7 is am5d$-- 7#a7 9 subsection   
7b77#b77;,a71 by add+ at ! end ! foll[+ 
new s5t5ce3 ,! models select$ "u ?is    

subp>agraph %all include ! model        
describ$ 9 subsection 7h742 &  7#b7 by  
add+ at ! end ! foll[+ new subsection3  
7h7 ,te/+ reimburs+ provid]s = furni%+  
compreh5sive brea/ canc] risk assessm5ts
 & develop+ p]sonaliz$ scre5+ & risk    
r$uction plans  7#a7 ,purpose &         
e/abli%m5t  7,a7 ,9 g5]al ,n lat] ?an #b
 ye>s aft] ! date ( enactm5t ( ?is      
subsection1 ! ,secret>y %all implem5t a 
paym5t model 7ref]r$ to 9 ?is subsection
 z ! ,model7 to reimburse eligible      
provid]s 7z def9$ 9 p>agraph 7#aa77 =   
furni%+ compreh5sive brea/ canc] risk   
assessm5ts to eligible individuals 7z   
def9$ 9 su* p>agraph71 & = develop+     
p]sonaliz$ scre5+ & risk-r$uction plans 
bas$ on su* assessm5ts4  7,b7 ,purpose  
,! purpose ( ! ,model is to te/ :e!r    
reimburs+ eligible provid]s = furni%+   
compreh5sive brea/ canc] risk assessm5ts
 & develop+ p]sonaliz$ scre5+ &         
risk-r$uction plans *anges ! furni%+ (  
brea/ canc] scre5+ & risk-r$uction      
s]vices to eligible individuals4  7,c7  

,beg9n+ ( ,model ,= purposes ( ?is      
subsection1 ! ,model %all be treat$ z   
hav+ begun on ! date on :i* ! fir/      
eligible individual receives a          
compreh5sive brea/ canc] risk assessm5t 
furni%$ "u ! ,model4  7,d7 ,notification
 requirem5t if !re is a delay ,if !     
,model has n begun by ! date t is #b    
ye>s aft] ! date ( enactm5t ( ?is       
subsection1 ! ,secret>y %all notify !   
relevant committees ( ! reasons = !     
delay & ( ! expect$ date on :i* ! ,model
 w beg94  7,e7 ,rule ( con/ruction ,no?+
 9 ?is subsection %all be con/ru$ to    
require ! ,secret>y to e/abli% ! cl9ical
 efficacy ( risk-/ratifi$ brea/ canc]   
scre5+4  7#b7 ,compreh5sive brea/ canc] 
risk assessm5ts & p]sonaliz$ scre5+ &   
risk-r$uction plans  7,a7 ,compreh5sive 
brea/ canc] risk assessm5ts  7i7 ,9     
g5]al ,a compreh5sive brea/ canc] risk  
assessm5t describ$ 9 p>agraph 7#a7      
%all-- 7,i7 collect ! in=mation describ$
 9 clause 7ii72  7,,ii7 us+ a validat$  
risk model1 produce an e/imate ( an     

eligible individual's #e-ye> risk (     
develop+ brea/ canc]1 supplem5t$ by !   
results ( multig5e panel te/+ & a       
polyg5ic risk score2 &  7,,iii7 on !    
basis ( su* e/imate & ! results (       
multig5e panel te/+1 assign su* eligible
 individual to a risk category4 ,su*    
risk categories %all include at m9imum a
 high-risk category & an elevat$-risk   
category & be e/abli%$ by ! ,secret>y4  
7ii7 ,in=mation collect$ ,! in=mation   
describ$ 9 ?is clause1 ) respect to an  
eligible individual1 is-- 7,i7 ! results
 ( g5etic te/+1 includ+ multig5e panel  
te/+ = ! ,,brca#a1 ,,brca#b1 ,,palb#b1  
,,cdh#a1 ,,tp#ec1 ,,pt51 ,,/k#aa1 ,,atm1
 & ,,*ek#b g5es & su* o!r brea/ canc]   
susceptibility g5es z ! ,secret>y       
det]m9es appropriate2  7,,ii7 a polyg5ic
 risk score2  7,,iii7 ! family hi/ory ( 
! eligible individual ) respect to brea/
 canc] & relat$ canc]s2  7,,iv7 brea/   
d5sity1 z det]m9$ "u mammographic imag+2
  7,v7 cl9ical & life/yle risk factors2 
&  7,,vi7 su* o!r in=mation z !         

,secret>y det]m9es appropriate4  7,b7   
,p]sonaliz$ scre5+ & risk-r$uction plan 
,a p]sonaliz$ scre5+ & risk r$uction    
plan describ$ 9 p>agraph 7#a7 %all      
include-- 7i7 recomm5dations reg>d+--   
7,i7 adju/$ canc] scre5+ frequ5cy &     
modality 7su* z mammography1 magnetic   
resonance imag+ 7ref]r$ to 9 ?is        
subsection z ,,mri71 & ultras\nds7 bas$ 
on an individual's risk level2  7,,ii7  
ref]rals = enhanc$ surveillance imag+1  
includ+ brea/ ,m,r,is1 = high-risk      
individuals 7z def9$ 9 p>agraph 7#aa772 
7,,iii7 risk r$uction c\nsel+ on        
modifiable factors1 su* z weight        
managem5t1 physical activity1 & alcohol 
consumption2  7,,iv7 c\nsel+ = a        
high-risk individual reg>d+ endocr9e    
risk-r$uc+ m$ications1 su* z tamoxif51  
raloxif5e1 & aromatase inhibitors2  7,v7
 ref]rals = g5etic c\nsel+ foll[+       
pa?og5ic1 likely pa?og5ic1 or unc]ta9   
significance f9d+s bas$ on te/ results2 
&  7,,vi7 :5 su* individual %\ld be     
reassess$ bas$ on *anges 9 risk factors1

 updat$ risk models1 or reclassification
 ( g5etic v>iants2  7ii7 notify+        
fir/-degree relatives :o may b5efit f   
g5etic te/+2 &  7iii7 communicat+ !     
p]sonaliz$ scre5+ & risk-r$uction plan  
to ! individual's prim>y c>e provid] &  
integrat+ su* plan into ! individual's  
m$ical record4  7#c7 ,deliv]y approa*es 
,! ,secret>y %all ensure t ! ,model     
all[s eligible provid]s to furni%       
compreh5sive brea/ canc] risk assessm5ts
 ?r\gh-- 7,a7 traditional 9-p]son (fice 
visits2 &  7,b7 remote means1 includ+   
all[+ su* provid]s to collect g5etic    
te/+ specim5s ?r\gh kits mail$ to an    
eligible individual's home4  7#d7 ,site 
selection  7,a7 ,9 g5]al ,! ,secret>y   
%all ensure t ! eligible provid]s       
p>ticipat+ 9 ! ,model include a mix (   
academic m$ical c5t]s1 community-bas$   
practices1 & facilities s]v+ rural      
populations4  7,b7 ,application ,an     
eligible provid] seek+ to enroll 9 !    
,model %all submit to ! ,secret>y an    
application = enrollm5t conta9+ su*     

requirem5ts1 at su* "t1 & 9 su* mann]1 z
 specifi$ by ! ,secret>y4  7,c7         
,selection ( eligible provid]s ,9       
select+ eligible provid]s to p>ticipate 
9 ! ,model1 ! ,secret>y %all prioritize 
su* provid]s-- 7i7 locat$ 9 ! #aj ,/ates
 ) ! highe/ brea/ canc] mortality rate  
among wom52  7ii7 locat$ 9 an area      
designat$ z a heal? pr(essional %ortage 
area "u section #ccb7;a77#a77;,a7 ( !   
,public ,heal? ,s]vice ,act2  7iii7     
locat$ 9 a m$ically und]s]v$ area or t  
s]ve m$ically und]s]v$ populations 7z   
def9$ 9 section #ccj7;b77#c7 ( su*      
,act72 or  7iv7 locat$ 9 a rural area 7z
 def9$ 9 section #ahhf7;d77#b77;,d77 ^: 
population has limit$ access to g5etic  
c\nsel+ s]vices or compreh5sive brea/   
canc] risk assessm5ts4  7,d7 ,data %>+  
,9 select+ eligible provid]s to         
p>ticipate 9 ! ,model1 ! ,secret>y may  
give pref]5ce to eligible provid]s :o   
use laboratories t submit de-id5tifi$   
v>iant data1 includ+ v>iants ( unc]ta9  
significance1 to ! ,clin,var public     

database ma9ta9$ by ! ,national ,c5t] = 
,biote*nology ,in=mation4  7#e7 ,paym5t 
7,a7 ,9 g5]al ,! ,secret>y %all e/abli% 
a paym5t am\nt = ! furni%+ ( a          
compreh5sive brea/ canc] risk assessm5t 
& p]sonaliz$ scre5+ & risk r$uction plan
 "u ! ,model4  7,b7 ,consid]ations ,9   
det]m9+ ! paym5t am\nt describ$ 9       
subp>agraph 7,a71 ! ,secret>y %all      
consid]-- 7i7 ! cl9ical "t & complexity 
( ! s]vices furni%$2  7ii7 !            
int]pretation ( g5etic te/+ results1    
polyg5ic risk scores1 & brea/ d5sity    
data2  7iii7 ! "t requir$ = ! developm5t
 ( p]sonaliz$ scre5+ & risk r$uction    
plans2 &  7iv7 comp>able compreh5sive   
assessm5t & prev5tion-plann+ s]vices "u 
! physician fee s*$ule "u title ,,xviii4
  7,c7 ,adju/m5t ,! ,secret>y may adju/ 
! paym5t am\nt e/abli%$ "u subp>agraph  
7,a7 dur+ ! p]iod ( ! ,model on ! basis 
( ! evaluation describ$ 9 p>agraph      
7#f77;,a77vi74  7#f7 ,evaluation ,!     
,secret>y %all evaluate ! ,model f      
claims data & f ! p]sonaliz$ scre5+ &   

risk-r$uction plans develop$ "u ! ,model
 by ! foll[+ measures t ! ,secret>y %all
 /ratify by age b&3 7,a7 ,prim>y        
measures ,! ,secret>y %all evaluate--   
7i7 ! proportion ( eligible individuals 
:o receive a compreh5sive brea/ canc]   
risk assessm5t "u ! ,model2  7ii7 :e!r !
 s]vices recomm5d$ 9 an eligible        
individual's p]sonaliz$ scre5+ &        
risk-r$uction plan h be5 furni%$ to su* 
individual2  7iii7 ! ext5t to :i* scre5+
 mammography frequ5cy & modality v>y    
across ! risk categories e/abli%$ "u    
p>agraph 7#b77;,a77i77,,iii72  7iv7     
brea/ ,,mri utilization among high-risk 
individuals2  7v7 utilization ( endocr9e
 risk-r$uc+ m$ications1 su* z tamoxif51 
raloxif5e1 & aromatase inhibitors1 among
 high-risk individuals & individuals    
assign$ to an elevat$ risk category2    
7vi7 :e!r ! paym5t am\nt is suffici5t to
 su/a9 eligible provid] p>ticipation 9 !
 ,model2 &  7vii7 ! numb] ( eligible    
provid]s :o cont9ue to p>ticipate 9 !   
,model4  7,b7 ,second>y measures ,!     

,secret>y %all evaluate-- 7i7 ! total   
co/ ( c>e = brea/ canc] scre5+ &        
treatm5t episodes among p>ticipat+      
eligible individuals1 b5*m>k$ aga9/     
national utilization & sp5d+ =          
individuals comp>able to eligible       
individuals2  7ii7 ! project$           
co/-effectiv5ess ( ! ,model ov] a       
#aj-ye> & #bj-ye> horizon1 includ+ !    
e/imat$ value ( canc]s prev5t$1 canc]s  
detect$ at e>li] /ages1 & scre5+        
proc$ures avoid$2  7iii7 ! proportion ( 
compreh5sive brea/ canc] risk assessm5ts
 t integrate ea* item ( in=mation       
describ$ 9 p>agraph 7#b77;,a77ii72  7iv7
 ! rate at :i* p]sonaliz$ scre5+ & risk 
r$uction plans are develop$ &           
communicat$ to ! prim>y c>e provid]s (  
eligible individuals2  7v7 ! av]age "t f
 :5 an eligible individual fir/ receives
 a compreh5sive brea/ canc] risk        
assessm5t to ! "t su* individual        
receives a p]sonaliz$ scre5+ & risk     
r$uction plan2  7vi7 ! rate at :i*      
eligible individuals adh]e to !         

recomm5dations 9 _! p]sonaliz$ scre5+ & 
risk r$uction plan2  7vii7 :e!r !re are 
any diff]5ces 9 ! measures describ$ 9   
?is subp>agraph betwe5 diff]5t deliv]y  
approa*es & eligible provid]s2 &  7viii7
 report$ outcomes ( eligible            
individuals1 includ+ ! satisfaction (   
eligible individuals ) ! p]sonaliz$     
scre5+ & risk r$uction plan furni%$ to  
su* individuals1 ! und]/&+ ( ! p]sonal  
risk level ( eligible individuals1 & !  
anxiety & decisional conflict ( eligible
 individuals1 measur$ us+ validat$      
pati5t-report$ outcome in/rum5ts4  7,c7 
,exploratory measures ,! ,secret>y %all 
evaluate1 among p>ticipat+ eligible     
individuals-- 7i7 ! rate (-- 7,i7 /age  
,,iib or high] brea/ canc]s2 &  7,,ii7  
/age ,,iia brea/ canc]s2  7ii7 ! rate ( 
ductal c>c9oma 9 situ 7,,dcis7          
detection2 &  7iii7 ! proportion ( brea/
 canc]s detect$ ?r\gh scre5+ comp>$ to !
 numb] ( brea/ canc]s detect$ ?r\gh     
symptomatic pres5tation4  7#g7          
,additional au?ority ,if ! ,secret>y    

det]m9es t additional /atutory au?ority 
is requir$ to te/ or exp& ! ,model1 n   
lat] ?an #ahj days aft] mak+ su*        
det]m9ation1 ! ,secret>y %all notify !  
,committee on ,f9ance ( ! ,s5ate & !    
,committee on ,ways & ,means ( ! ,h\se (
 ,repres5tatives4  7#h7 ,t]m9ation  7,a7
 ,9 g5]al ,! ,model %all t]m9ate on !   
date t is #g ye>s aft] ! date on :i* !  
,model beg9s1 unless ! ,secret>y        
det]m9es t expansion ( ! ,model is      
appropriate "u subsection 7c74  7,b7    
,au?ority ,! ,secret>y may n t]m9ate !  
,model "u subsection 7b77#c77;,b7 until 
aft] ! date on :i* ! ,secret>y submits !
 int]im report describ$ 9 p>agraph      
7#i77;,a74  7#i7 ,reports  7,a7 ,int]im 
report ,n lat] ?an ! date t is #c ye>s  
aft] ! comm5cem5t ( ! ,model1 !         
,secret>y %all submit to ! relevant     
committees1 ! ,director ( ! ,ag5cy =    
,heal?c>e ,rese>* & ,quality1 & ! ,unit$
 ,/ates ,prev5tive ,s]vices ,task ,=ce  
an int]im report describ+-- 7i7 !       
measures us$ to evaluate ! ,model "u    

p>agraph 7#f72 &  7ii7 ! rate (         
laboratories us$ by eligible provid]s t 
submit de-id5tifi$ v>iant data to !     
,clin,var public database ma9ta9$ by !  
,national ,c5t] = ,biote*nology         
,in=mation4  7,b7 ,f9al ,report ,n lat] 
?an ! date t is #g ye>s aft] !          
comm5cem5t ( ! ,model1 ! ,secret>y %all 
submit to ! relevant committees1 !      
,director ( ! ,ag5cy = ,heal?c>e ,rese>*
 & ,quality1 & ! ,unit$ ,/ates          
,prev5tive ,s]vices ,task ,=ce a f9al   
report-- 7i7 describ+ ! measures us$ to 
evaluate ! ,model "u p>agraph 7#f72     
7ii7 ! rate ( laboratories us$ by       
eligible provid]s t submit de-id5tifi$  
v>iant data to ! ,clin,var public       
database ma9ta9$ by ! ,national ,c5t] = 
,biote*nology ,in=mation2 &  7iii7 )    
recomm5dations reg>d+ :e!r ! model %\ld 
be exp&$ or made p]man5t1 includ+ :e!r !
 ,model %\ld be exp&$ to individuals    
enroll$ 9 a ,m$ic>e ,advantage plan "u  
"p ,c ( title ,,xviii4  7,c7 ,unit$     
,/ates ,prev5tive ,s]vices ,task ,=ce   

,if1 aft] ! date ( enactm5t ( ?is ,act1 
! ,unit$ ,/ates ,prev5tive ,s]vices     
,task ,=ce issues an updat$             
recomm5dation address+ brea/ canc] risk 
assessm5t or g]ml9e g5etic te/+1 !      
,secret>y %all-- 7i7 evaluate ! effect  
on su* recomm5dation on ! design &      
evaluation ( ! ,model1 includ+ :e!r any 
modification ( ! ,model is w>rant$2 &   
7ii7 n lat] ?an #ahj days aft] ! ,unit$ 
,/ates ,prev5tive ,s]vices ,task ,=ce   
issues su* recomm5dation1 submit to !   
relevant committees a report describ+   
su* evaluation4  7#aj7 ,fund+ ,no       
additional funds are au?oriz$ to be     
appropriat$ to c>ry out ?is subsection4 
,! ,secret>y %all c>ry out ! ,model us+ 
funds o!rwise available "u subsection   
7f74  7#aa7 ,def9itions ,9 ?is          
subsection3 7,a7 ,eligible individual ,!
 t]m eligible individual means an       
individual-- 7i7 entitl$ to1 or enroll$ 
=1 b5efits "u "p ,a ( title ,,xviii1 or 
enroll$ = b5efits "u "p ,b ( su* title1 
b n enroll$ 9 a plan "u "p ,c ( su*     

title2  7ii7 :o has atta9$ #dj ye>s (   
age b has n atta9$ #ge ye>s ( age2      
7iii7 :o does n h end-/age r5al disease2
 &  7iv7 :o is n receiv+ hospice c>e "u 
title ,,xviii4  7,b7 ,eligible provid]  
7i7 ,9 g5]al ,! t]m eligible provid]    
means-- 7,i7 a physician 7z def9$ 9     
section #ahfa7r77#a772  7,,ii7 a c]tifi$
 nurse-midwife 7z def9$ 9 section       
#ahfa7;gg772  7,,iii7 a nurse           
practition] 7z def9$ 9 section          
#ahfa7;aa77#e77;,a772  7,,iv7 a         
physician assi/ant 7z def9$ 9 su*       
section72  7,v7 a g5etic c\nselor :o is 
c]tifi$ by ! ,am]ican ,bo>d ( ,g5etic   
,c\nsel+ or ! ,am]ican ,bo>d ( ,m$ical  
,g5etics & ,g5omics2 or  7,,vi7 any o!r 
qualifi$ heal? pr(essional det]m9$      
appropriate by ! ,secret>y4  7ii7       
,cl>ification ,an individual describ$ 9 
clause 7i7 %all be consid]$ an eligible 
provid] )\t reg>d to :e!r su* individual
 is o!rwise recogniz$ z a suppli] "u    
title ,,xviii4  7,c7 ,high-p5etrance g5e
 ,! t]m high-p5etrance g5e means !      

,,brca#a1 ,,brca#b1 ,,palb#b1 ,,cdh#a1  
,,tp#ec1 ,,pt51 or ,,/k#aa g5e1 & any   
su* o!r g5e z ! ,secret>y det]m9es to   
conf] comp>able risk4  7,d7 ,high-risk  
individual ,! t]m high-risk individual  
means an individual-- 7i7 ^: #e-ye> risk
 ( develop+ brea/ canc]1 z e/imat$ by a 
validat$ risk model1 is #f p]c5t or     
great]2  7ii7 :o has a pa?og5ic v>iant 9
 a high-p5etrance g5e2 or  7iii7 :o     
possesses su* o!r crit]ia t ! ,secret>y 
det]m9es to be appropriate1 consi/5t )  
applicable cl9ical practice guidel9es4  
7,e7 ,relevant committees ,! t]m        
relevant committees means ! ,committee  
on ,f9ance & ! ,committee on ,heal?1    
,education1 ,labor1 & ,p5sions ( !      
,s5ate1 ! ,committee on ,ways & ,means &
 ! ,committee on ,en]gy & ,comm]ce ( !  
,h\se ( ,repres5tatives4  7,f7 ,validat$
 risk model ,! t]m validat$ risk model  
means a model t-- 7i7 produces an       
e/imate ( an individual's #e-ye> risk ( 
develop+ brea/ canc]2 &  7ii7 !         
,secret>y det]m9es has be5 validat$ 9 a 

population comp>able to eligible        
individuals4  4