,,ii  #aafth ,,congress  #ast ,session  
,s4 #bfej  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #ba1  
#bjai,mr4 ,durbin 7for himself and ,mr4 
,brown7 introduced the following bill2  
which was read twice and referred to the
 ,committee on ,finance  ,a ,,bill  ,to 
amend part ,d of title ,,xviii of the   
,social ,security ,act to deliver a     
meaningful benefit and lower            
prescription drug prices under the      
,medicare program4  #a4 ,short title    
,this ,act may be cited as the ,medicare
 ,prescription ,drug ,savings and       
,choice ,act of #bjai4  #b4             
,establishment of ,medicare operated    
prescription drug plan option  7a7 ,in  
general ,subpart #b of part ,d of title 
,,xviii of the ,social ,security ,act is
 amended by inserting after section     
#ahfj;,d-#aa 7#db ,u4,s4,c4 #aciew-#aaa7
 the following new section3             
#ahfj;,d-#aa;,a4 ,medicare operated     
prescription drug plan option  7a7 ,in  
general ,notwithstanding any other      

provision of this part1 for each year   
7beginning with #bjba71 in addition to  
any plans offered under section         
#ahfj;,d-#aa1 the ,secretary shall offer
 one or more ,medicare operated         
prescription drug plans 7as defined in  
subsection 7d77 with a service area that
 consists of the entire ,united ,states 
and shall enter into negotiations in    
accordance with subsection 7c7 with     
pharmaceutical manufacturers to reduce  
the purchase cost of covered part ,d    
drugs for eligible part ,d individuals  
who enroll in such a plan4  7b7         
,enrollment ,notwithstanding            
subparagraphs 7,c7 and 7,d7 of section  
#ahfj;,d-#a7;b77#a71 a ,medicare        
operated prescription drug plan offered 
under this section shall serve as the   
default prescription drug plan for all  
part ,d enrollees unless another        
prescription drug plan is selected4  7c7
 ,negotiations ,notwithstanding section 
#ahfj;,d-#aa7;i71 for purposes of       
offering a ,medicare operated           

prescription drug plan under this       
section1 the ,secretary shall negotiate 
with pharmaceutical manufacturers with  
respect to the purchase price of covered
 part ,d drugs in a ,medicare operated  
prescription drug plan and shall        
encourage the use of more affordable    
therapeutic equivalents to the extent   
such practices do not override medical  
necessity as determined by the          
prescribing physician4 ,to the extent   
practicable and consistent with the     
previous sentence1 the ,secretary shall 
implement negotiation and incentive     
strategies similar to those used by     
other ,federal purchasers of            
prescription drugs to reduce the        
purchase cost of covered ,part ,d drugs1
 and other strategies1 as described in  
subsection 7f71 which may include the   
use of a pricing scale based on an      
international price index4  7d7         
,medicare operated prescription drug    
plan defined ,for purposes of this part1
 the term ,medicare operated            

prescription drug plan means a          
comprehensive prescription drug plan    
that offers qualified prescription drug 
coverage and access to negotiated prices
 described in section                   
#ahfj;,d-#b7;a77#a77;,a74 ,such a plan  
may offer supplemental prescription drug
 coverage in the same manner as other   
qualified prescription drug coverage    
offered by other prescription drug      
plans4  7e7 ,monthly beneficiary premium
  7#a7 ,qualified prescription drug     
coverage ,the monthly beneficiary       
premium for qualified prescription drug 
coverage and access to negotiated prices
 described in section                   
#ahfj;,d-#b7;a77#a77;,a7 to be charged  
under a ,medicare operated prescription 
drug plan shall be uniform nationally4  
,such premium for months in #bjba and   
each succeeding year shall be based on  
the average monthly per capita actuarial
 cost of offering the ,medicare operated
 prescription drug plan for the year    
involved1 including administrative      

expenses4  7#b7 ,supplemental           
prescription drug coverage ,insofar as a
 ,medicare operated prescription drug   
plan offers supplemental prescription   
drug coverage1 the ,secretary may adjust
 the amount of the premium charged under
 paragraph 7#a74  7f7 ,use of           
negotiation and benefit design          
incentives  7#a7 ,in general ,with      
respect to the operation of a ,medicare 
operated prescription drug plan and in  
negotiating with respect to the purchase
 price of covered part ,d drugs in such 
plan1 the ,secretary shall reward value1
 increase appropriate use of drugs1 and 
ensure patient safety and access to     
medications4  7#b7 ,role of ,,ahrq ,the 
,director of the ,agency for ,healthcare
 ,research and ,quality1 in coordination
 with the ,administrator of the ,centers
 for ,medicare  ,medicaid ,services1    
shall be responsible for assessing the  
clinical benefit of covered part ,d     
drugs and making recommendations to the 
,secretary regarding the negotiated     

prices of covered drugs and any         
appropriate tiering or incentive        
strategies under the plan4 ,in          
conducting such assessments and making  
such recommendations1 the ,director     
shall carry out the following           
activities3  7,a7 ,consider the         
comparable international price of such  
drugs based upon the median retail list 
price of such drug 7which shall be1 as  
practicable1 the volume-weighted price  
for comparable units and dosage forms7  
among a category of at least the        
following peer reference countries3     
,canada1 the ,united ,kingdom1 ,france1 
,japan1 ,australia1 and ,germany4  7,b7 
,consider safety concerns and           
post-market data1 including those       
identified by the ,food and ,drug       
,administration and from national health
 registries4  7,c7 ,use available data  
and evaluations1 including from research
 supported by the ,national ,institutes 
of ,health1 with priority given to      
randomized controlled trials1 to examine

 clinical effectiveness1 comparative    
effectiveness1 safety1 and enhanced     
compliance with a drug regimen4  7,d7   
,use the same classes of drugs developed
 by ,united ,states ,pharmacopeia for   
this part4  7,e7 ,consider evaluations  
made by--  7i7 the ,director under      
section #ajac of the ,medicare          
,prescription ,drug1 ,improvement1 and  
,modernization ,act of #bjjc2  7ii7     
other ,federal entities1 such as the    
,secretary of ,veterans ,affairs2 and   
7iii7 other private and public entities1
 which may include the ,drug            
,effectiveness ,review ,project and     
,medicaid programs4  7,f7 ,consider     
recommendations made by the advisory    
committee pursuant to paragraph         
7#c77;,f74  7,g7 ,recommend to the      
,secretary those drugs in a class that  
provide a greater clinical benefit1     
including fewer safety concerns or less 
risk of side effects1 than another drug 
in the same class4  7#c7 ,use of        
advisory committee  7,a7 ,in general    

,the ,secretary shall establish and     
appoint an advisory committee 7in this  
paragraph referred to as the advisory   
committee7--  7i7 to review petitions   
from drug manufacturers1 health care    
provider organizations1 patient groups1 
and other entities regarding negotiated 
prices2 and  7ii7 to recommend any      
changes in order to further negotiations
 with respect to such prices4  7,b7     
,composition ,subject to subparagraph   
7,c71 the advisory committee shall be   
composed of #i members and shall include
 representatives of physicians1         
pharmacists1 consumers1 and others with 
expertise in evaluating prescription    
drugs4 ,the ,secretary shall select     
members based on their knowledge of     
pharmaceuticals and the ,medicare       
population4 ,members shall be deemed to 
be special ,government employees for    
purposes of applying the conflict of    
interest provisions under section #bjh  
of title #ah1 ,united ,states ,code1 and
 no waiver of such provisions for such a

 member shall be permitted4  7,c7       
,banned individuals  7i7 ,drug company  
lobbyists ,no former registered drug    
manufacturer lobbyist-- 7,i7 may be     
appointed to the advisory committee2 or 
7,,ii7 may be employed by the advisory  
committee during the #f-year period     
beginning on the date on which the      
registered lobbyist terminates its      
registration in accordance with section 
#d7;d7 of the ,lobbying ,disclosure ,act
 of #aiie 7#b ,u4,s4,c4 #afjc7;d77 or   
the agent terminates its status1 as     
applicable4  7ii7 ,senior executives of 
law-breaking companies ,no former senior
 executive of a covered entity 7as      
defined in clause 7iii77-- 7,i7 may be  
appointed to the ,advisory ,committee2  
or  7,,ii7 may be employed by the       
,advisory ,committee during the #f-year 
period beginning on the later of-- 7aa7 
the date of the settlement described in 
item 7aa7 of clause 7iii77,,ii72 or     
7bb7 the date on which the enforcement  
action described in item 7bb7 of such   

clause has concluded4  7iii7 ,covered   
entity ,the term covered entity means   
any entity that is--  7,i7 a drug       
manufacturer2 and  7,,ii7 7aa7 operating
 under ,federal settlement including a  
,federal consent decree2 or  7bb7 the   
subject of an enforcement action in a   
court of the ,united ,states or by an   
agency4  7,d7 ,consultation ,the        
advisory committee shall consult1 as    
necessary1 with physicians who are      
specialists in treating the disease for 
which a drug is being considered4  7,e7 
,request for studies ,the advisory      
committee may request the ,agency for   
,healthcare ,research and ,quality or an
 academic or research institution to    
study and make a report on a petition   
described in subparagraph 7,a77i7 in    
order to assess cost effectiveness1     
clinical effectiveness1 comparative     
effectiveness1 safety1 and compliance   
with a drug regimen4  7,f7              
,recommendations ,the advisory committee
 shall make recommendations to the      

,director of the ,agency for ,healthcare
 ,research and ,quality regarding the   
appropriate price at which to begin     
negotiations on a part ,d drug pursuant 
to this section4  7,g7 ,limitations on  
review of manufacturer petitions ,the   
advisory committee shall not review a   
petition of a drug manufacturer under   
subparagraph 7,a77i7 with respect to a  
covered part ,d drug unless the petition
 is accompanied by the following3  7i7  
,raw data from clinical trials on the   
safety and effectiveness of the drug4   
7ii7 ,any data from clinical trials     
conducted using active controls on the  
drug or drugs that are the current      
standard of care4  7iii7 ,any available 
data on comparative effectiveness of the
 drug4  7iv7 ,any other information the 
,secretary requires for the advisory    
committee to complete its review4  7g7  
,informing beneficiaries ,the ,secretary
 shall take steps to inform part ,d     
eligible individuals not previously     
enrolled in a ,medicare operated drug   

plan 7including such individuals who are
 newly eligible to enroll under this    
part7 regarding the enrollment of such  
individual in a ,medicare operated drug 
plan in accordance with this section1   
including providing information in the  
annual handbook and adding information  
to the official public ,medicare website
 related to prescription drug coverage  
available through this part4  7h7       
,application of all other requirements  
for prescription drug plans ,except as  
specifically provided in this section1  
any ,medicare operated drug plan shall  
meet the same requirements as apply to  
any other prescription drug plan1       
including the requirements of section   
#ahfj;,d-#d7;b77#a7 relating to assuring
 pharmacy access4  4  7b7 ,conforming   
amendments  7#a7 ,section               
#ahfj;,d-#c7;a7 of the ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#ajc7;a77 is
 amended by adding at the end the       
following new paragraph3  7#d7          
,availability of the medicare operated  

prescription drug plan ,a ,medicare     
operated prescription drug plan 7as     
defined in section #ahfj;,d-#aa;,a7d77  
shall be offered nationally in          
accordance with section #ahfj;,d-#aa;,a4
  4  7#b7 7,a7 ,section #ahfj;,d-#c of  
the ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#ajc7 is amended by    
adding at the end the following new     
subsection3  7c7 ,provisions only       
applicable in #bjjf through #bjbj ,the  
provisions of this section shall only   
apply with respect to #bjjf through     
#bjbj4  4  7,b7 ,section                
#ahfj;,d-#aa7;g7 of such ,act 7#db      
,u4,s4,c4 #aciew-#aaa7;g77 is amended by
 adding at the end the following new    
paragraph3  7#h7 ,no authority for      
fallback plans after #bjbj ,a fallback  
prescription drug plan shall not be     
available after ,december #ca1 #bjbj4  4
  7#c7 ,section #ahfj;,d-#ac7;c77#c7 of 
the ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#aac7;c77#c77 is       
amended--  7,a7 in the heading1 by      

inserting and ,medicare operated        
prescription drug plans after ,fallback 
plans2 and  7,b7 by inserting or a      
,medicare operated prescription drug    
plan after a fallback prescription drug 
plan4  7#d7 ,section                    
#ahfj;,d-#af7;b77#a7 of the ,social     
,security ,act 7#db ,u4,s4,c4           
#aciew-#aaf7;b77#a77 is amended-- 7,a7  
in subparagraph 7,c71 by striking and   
after the semicolon at the end2  7,b7 in
 subparagraph 7,d71 by striking the     
period at the end and inserting 2 and2  
and  7,c7 by adding at the end the      
following new subparagraph3  7,e7       
payments for expenses incurred with     
respect to the operation of ,medicare   
operated prescription drug plans under  
section #ahfj;,d-#aa;,a4  4  7#e7       
,section #ahfj;,d-#da7;a7 of the ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#aea7;a77 is amended by adding at
 the end the following new paragraph3   
7#ai7 ,medicare operated prescription   
drug plan ,the term ,medicare operated  

prescription drug plan has the meaning  
given such term in section              
#ahfj;,d-#aa;,a7d74  4  7c7 ,rule of    
construction ,nothing in this section   
shall be interpreted to supersede any   
other negotiation authority granted to  
the ,secretary under ,federal law with  
respect to prescription drug prices4    
#c4 ,improved appeals process under the 
,medicare operated prescription drug    
plan ,section #ahfj;,d-#d7;h7 of the    
,social ,security ,act 7#db ,u4,s4,c4   
#acjew-#ajd7;h77 is amended by adding at
 the end the following new paragraph3   
7#d7 ,appeals process for ,medicare     
operated prescription drug plan  7,a7   
,in general ,the ,secretary shall       
develop a well-defined process for      
appeals for denials of benefits under   
this part under the ,medicare operated  
prescription drug plan 7as defined in   
section #ahfj;,d-#aa;,a7d774 ,such      
process shall be efficient1 impose      
minimal administrative burdens1 and     
ensure the timely procurement of        

medications4 ,medical necessity shall be
 based on professional medical judgment1
 the medical condition of the           
beneficiary1 and other medical evidence4
  7,b7 ,consultation in development of  
process ,in developing the appeals      
process under subparagraph 7,a71 the    
,secretary shall consult with consumer  
and patient groups1 as well as other key
 stakeholders1 to ensure the goals      
described in subparagraph 7,a7 are      
achieved4  4