,,ii  #aahth ,,congress  #ast ,session  
,s4 #bgfd  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,september #ab1
 #bjbc,mr4 ,barrasso introduced the     
following bill2 which was read twice and
 referred to the ,committee on ,finance 
,a ,,bill  ,to amend title ,,xviii of   
the ,social ,security ,act to provide   
for a rebate by manufacturers for       
selected drugs and biological products  
subject to maximum fair price           
negotiation4  #a4 ,short title ,this    
,act may be cited as the ,protecting    
,patient ,access to ,cancer and ,complex
 ,therapies ,act of #bjbc4  #b4 ,rebate 
by manufacturers for selected drugs and 
biological products subject to maximum  
fair price negotiation  7a7 ,maintaining
 payments under part ,b based on ,,asp#f
 ,section #ahdg;,a7b77#a77;,b7 of the   
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#c;a7b77#a77;,b77 is amended by  
striking or in the case of such a drug  
or biological product that is a selected
 drug and all that follows through the  

semicolon and inserting a semicolon4    
7b7 ,rebate by manufacturers for        
selected drugs and biological products  
subject to maximum fair price           
negotiation  7#a7 ,in general ,section  
#ahdg;,a of the ,social ,security ,act  
7#db ,u4,s4,c4 #aciew-#c;a7 is amended--
 7,a7 by redesignating subsection 7j7 as
 subsection 7k72 and  7,b7 by inserting 
after subsection 7i7 the following new  
subsection3  7j7 ,rebate by             
manufacturers for selected drugs and    
biological products subject to maximum  
fair price negotiation  7#a7            
,requirements  7,a7 ,secretarial        
provision of information ,not later than
 #f months after the end of each        
calendar quarter beginning on or after  
the first day of the initial price      
applicability period 7as defined in     
section #aaia7;b77#b771 the ,secretary  
shall1 for each selected drug 7as       
defined in section #aaib7;c77 of each   
manufacturer with an agreement under    
section #aaic for which a maximum fair  

price is in effect and for which payment
 may be made under this part1 report to 
each manufacturer of such selected drug 
the following for such calendar quarter 
during such price applicability period3 
7i7 ,information on the total number of 
units of the billing and payment code   
for such selected drug furnished under  
this part during such calendar quarter4 
7ii7 ,information on the sum of-- 7,i7  
the amount 7if any7 by which-- 7aa7 the 
,,asp#f payment amount 7as defined in   
paragraph 7#e77 for such drug and       
calendar quarter1 less the ,,asp#f      
coinsurance amount for such drug and    
calendar quarter2 exceeds  7bb7 the     
,,mfp#f payment amount 7as so defined7  
for such drug and calendar quarter1 less
 the ,,mfp#f coinsurance amount for such
 drug and calendar quarter2 and  7,,ii7 
the amount 7if any7 by which-- 7aa7 the 
,,asp#f coinsurance amount 7as defined  
in paragraph 7#e77 for such drug and    
calendar quarter2 exceeds  7bb7 the     
,,mfp#f coinsurance amount 7as so       

defined7 for such drug and calendar     
quarter4  7iii7 ,the rebate amount      
specified under subparagraph 7,b7 for   
such drug and calendar quarter4  7,b7   
,manufacturer requirement ,for each     
calendar quarter beginning on or after  
the first day of the initial price      
applicability period 7as defined in     
section #aaia7;b77#b771 the manufacturer
 of a selected drug shall1 for such     
drug1 not later than #cj days after the 
date of receipt from the ,secretary of  
the information described in            
subparagraph 7,a7 for such calendar     
quarter1 provide to the ,secretary a    
rebate that is equal to the amount      
specified in subparagraph 7,a77ii7      
multiplied by the number of units       
specified in subparagraph 7,a77i7 for   
such drug for such calendar quarter4    
,the rebate required under this         
subparagraph shall be in addition to any
 other rebates required under this title
 or title ,,xix1 including the payments 
required under subsections 7h7 and 7i74 

7#b7 ,calculation of beneficiary        
coinsurance based on mfp#f  7,a7 ,in    
general ,subject to subparagraph 7,b71  
in the case of a selected drug with     
respect to which a rebate is paid under 
this subsection-- 7i7 the amount of any 
coinsurance applicable under this part  
to an individual to whom such drug is   
furnished during a calendar quarter     
shall be equal to the ,,mfp#f           
coinsurance amount2 and  7ii7 the amount
 of such coinsurance for such calendar  
quarter shall be applied as a percent1  
as determined by the ,secretary1 to the 
payment amount that would otherwise     
apply under subsection 7b77#a77;,b74    
7,b7 ,clarification regarding           
application of inflation rebate ,if a   
rebate is required under subsection 7i7 
with respect to a selected drug for a   
calendar quarter1 the lesser of the     
amount of coinsurance computed under    
subparagraph 7,a7 or the coinsurance    
computed under subsection 7i77#e7 shall 
apply for such drug and calendar        

quarter4  7#c7 ,rebate deposits ,amounts
 paid as rebates under paragraph        
7#a77;,b7 shall be deposited into the   
,federal ,supplementary ,medical        
,insurance ,trust ,fund established     
under section #ahda4  7#d7 ,civil money 
penalty ,the civil money penalty        
established under paragraph 7#g7 of     
subsection 7i7 shall apply to the       
failure to comply with this subsection  
in the same manner as such penalty      
applies to failures to comply with the  
requirements under paragraph 7#a77;,b7  
of subsection 7i74  7#e7 ,definitions   
,in this subsection1 with respect to a  
selected drug for a calendar quarter    
during a price applicability period3    
7,a7 ,,asp#f coinsurance amount ,the    
,,asp#f coinsurance amount is equal to  
#bj percent of the ,,asp#f payment      
amount4  7,b7 ,,asp#f payment amount    
,the ,,asp#f payment amount is equal to 
#ajf percent of the amount determined   
under paragraph 7#d7 of subsection 7b7  
for such drug during such calendar      

quarter4  7,c7 ,,mfp#f coinsurance      
amount ,the ,,mfp#f coinsurance amount  
is equal to #bj percent of the ,,mfp#f  
payment amount4  7,d7 ,,mfp#f payment   
amount ,the ,,mfp#f payment amount is   
equal to #ajf percent of the maximum    
fair price 7as defined in section       
#aaia7;c77#b77 applicable for such drug 
during such calendar quarter4  7#f7     
,clarification ,nothing in part ,e of   
title ,,xi or this subsection shall be  
construed to require a manufacturer to  
provide selected drugs at maximum fair  
prices other than through the rebate    
required under this subsection4  4  7#b7
 ,amounts payable2 cost-sharing ,section
 #ahcc7;a77#a7 of the ,social ,security 
,act 7#db ,u4,s4,c4 #aciel7a77#a77 is   
amended-- 7,a7 in subparagraph 7,g71 by 
striking subsection 7i77#i7 and         
inserting paragraphs 7#i7 and 7#aa7 of  
subsection 7i72  7,b7 in subparagraph   
7,s71 by striking subparagraph 7,,ee7   
and inserting subparagraphs 7,,ee7 and  
7,,ii72  7,c7 by striking and 7,,hh7 and

 inserting 7,,hh72 and  7,d7 by         
inserting before the semicolon at the   
end the following3 1 and 7,,ii7 with    
respect to a selected drug 7as defined  
in section #aaib7;c77 that is subject to
 a rebate under section #ahdg;,a7j71 the
 amounts paid shall be equal to the     
percent of the payment amount otherwise 
determined under section                
#ahdg;,a7b77#a77;,b7 that equals the    
difference between 7i7 #ajj percent1 and
 7ii7 the percent applied under section 
#ahdg;,a7j77#b77;,a77ii74  7#c7 ,,asc   
conforming amendments ,section #ahcc7;i7
 of the ,social ,security ,act 7#db     
,u4,s4,c4 #aciel7i77 is amended by      
adding at the end the following new     
paragraph3  7#aa7 ,in the case of a     
selected drug 7as defined in section    
#aaib7;c771 subject to a rebate under   
section #ahdg;,a7j7 for which payment   
under this subsection is not packaged   
into a payment for a service furnished  
on or after the initial price           
applicability year for the selected drug

 under the revised payment system under 
this subsection1 in lieu of calculation 
of coinsurance and the amount of payment
 otherwise applicable under this        
subsection1 the provisions of section   
#ahdg7;j77#b7 and paragraph 7#a77;,,ii7 
of subsection 7a71 shall1 as determined 
appropriate by the ,secretary1 apply    
under this subsection in the same manner
 as such provisions of section          
#ahdg;,a7j77#b7 and subsection 7a7 apply
 under such section and subsection4  4  
7#d7 ,,opps conforming amendment        
,section #ahcc7t77#h7 of the ,social    
,security ,act 7#db ,u4,s4,c4           
#aciel7t77#h77 is amended by adding at  
the end the following new subparagraph3 
7,g7 ,selected drugs subject to rebate  
,in the case of a selected drug 7as     
defined in section #aaib7;c771 subject  
to a rebate under section #ahdg;,a7j7   
for which payment under this subsection 
is not packaged into a payment for a    
covered ,,opd service 7or group of      
services7 furnished on or after the     

initial price applicability year for the
 selected drug1 and the payment for such
 drug is the same as the amount for a   
calendar quarter under section          
#ahdg;,a7b77#a77;,b71 under the system  
under this subsection1 in lieu of the   
calculation of the copayment amount and 
the amount otherwise applicable under   
this subsection 7other than the         
application of the limitation described 
in subparagraph 7,c771 the provisions of
 section #ahdg;,a7j77#b7 and paragraph  
7#a77;,,ii7 of subsection 7a71 shall1 as
 determined by the ,secretary apply     
under this section in the same manner as
 such provisions of section             
#ahdg;,a7j77#b7 and subsection 7a7 apply
 under such section and subsection4  4  
7#e7 ,exclusion of selected drug mfp    
rebates from asp calculation ,section   
#ahdg;,a7c77#c7 of the ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77
 is amended by striking subsection 7i7  
and inserting subsection 7i71 subsection
 7j74  7#f7 ,coordination with medicaid 

rebate information disclosures ,section 
#aibg7;b77#c77;,d77i7 of the ,social    
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;b77#c77;,d77i77 is amended by
 striking and the rebate and inserting  
and the rebates4  7#g7 ,provision of    
rebates ,section #aaic7;a7 of the       
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;f-#b7;a77 is amended-- 7,a7 in    
paragraph 7#a71 by striking subparagraph
 7,b7 and inserting the following3  7,b7
 by paying rebates in accordance with   
section #ahdg;,a7j72  2  7,b7 in        
paragraph 7#b71 by striking subparagraph
 7,b7 and inserting the following3  7,b7
 by paying rebates in accordance with   
section #ahdg;,a7j72  2 and  7,c7 in    
paragraph 7#c71 by striking subparagraph
 7,b7 and inserting the following3  7,b7
 by paying rebates in accordance with   
section #ahdg;,a7j72  4  7c7 ,conforming
 amendments  7#a7 ,section              
#ahdg;,a7i77#e7 of the ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#c;a7i77#e77
 is amended1 in the matter preceding    

subparagraph 7,a7-- 7,a7 by striking ,in
 the case and inserting ,subsection to  
subsection 7j77#b77;,b71 in the case2   
and  7,b7 by striking 7or1 in the case  
of a part ,b rebatable drug that is a   
selected drug 7as defined in section    
#aaib7;c771 the payment amount described
 in subsection 7b77#a77;,b7 for such    
drug74  7#b7 ,section                   
#ahcc7;a77#a77;,,ee7 of the ,social     
,security ,act 7#db ,u4,s4,c4           
#aciel7a77#a77;,,ee77 is amended-- 7,a7 
by striking 7or1 in the case of a part  
,b rebatable drug that is a selected    
drug 7as defined in section #aaib7;c7   
for which1 the payment amount described 
in section #ahdg;,a7b77#a77;,b77 for    
such drug for such quarter2 and  7,b7 by
 striking or section                    
#ahdg;,a7b77#a77;,b71 as applicable14