,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #baac  ,,in ,,the ,,house ,,of  
,,representatives  ,april #h1 #bjai,mr4 
,neal 7for himself and ,mr4 ,brady7     
introduced the following bill2 which was
 referred to the ,committee on ,ways and
 ,means1 and in addition to the         
,committee on ,energy and ,commerce1 for
 a period to be subsequently determined 
by the ,speaker1 in each case for       
consideration of such provisions as fall
 within the jurisdiction of the         
committee concerned  ,a ,,bill  ,to     
amend titles ,,xi and ,,xviii of the    
,social ,security ,act to provide for   
drug manufacturer price transparency1 to
 require certain manufacturers to report
 on product samples provided to certain 
health care providers1 and for other    
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,prescription ,drug 
,sunshine1 ,transparency1               
,accountability and ,reporting ,act or  
the ,prescription ,drug ,,star ,act4    
#b4 ,drug manufacturer price            

transparency  7a7 ,in general ,title    
,,xi of the ,social ,security ,act 7#db 
,u4,s4,c4 #acja et seq47 is amended by  
inserting after section #aabh,k the     
following new section3  #aabh,l4 ,drug  
manufacturer price transparency  7a7 ,in
 general ,with respect to each year1    
beginning with #bjba1 the ,secretary    
shall1 at least once during such year1  
determine if there is a triggered       
,,spike increase 7in accordance with    
subsection 7b77 with respect to an      
applicable drug 7as defined in          
subsection 7f77#a774 ,if the ,secretary 
determines1 with respect to a year1     
there is such an increase with respect  
to an applicable drug1 the manufacturer 
of the applicable drug shall submit to  
the ,secretary the justification        
described in subsection 7c71 subject to 
subsection 7b77#d71 for each such       
triggered ,,spike increase in accordance
 with the timing described in subsection
 7d74  7b7 ,triggered ,,spike increase  
7#a7 ,in general ,a triggered ,,spike   

increase occurs1 with respect an        
applicable drug and year 7beginning with
 #bjba and referred to in this paragraph
 as the applicable year71 in any of the 
following cases3  7,a7 ,if there is at  
least a #aj percent 7or #aj1jjj7        
cumulative increase with respect to the 
wholesale acquisition cost 7or          
alternative cost measure specified by   
the ,secretary under paragraph 7#c77 of 
such drug during a calendar-year period 
beginning and ending within the lookback
 period that is the #e-year period      
preceding such applicable year4  7,b7   
,if there is at least a #be percent 7or 
#be1jjj7 cumulative increase with       
respect to the wholesale acquisition    
cost 7or such alternative cost measure7 
of such drug during any                 
three-calendar-year period beginning and
 ending within such lookback period4    
7,c7 ,in the case of such a drug that is
 first covered under title ,,xviii with 
respect to such applicable year1 if the 
estimated cost or spending under such   

title per individual or per user of such
 drug 7as estimated by the ,secretary7  
for such applicable year 7or per course 
of treatment in such applicable year1 as
 defined by the ,secretary7 is at least 
#bf1jjj4  7#b7 ,indexing dollar amounts 
,the dollar amounts applied under       
paragraph 7#a7 for #bjbb and each       
subsequent year shall be the dollar     
amounts specified in such paragraph for 
the previous year increased by the      
annual percentage increase in the       
consumer price index 7all items2 ,u4,s4 
city average7 as of ,september of such  
previous year4 ,if any amount           
established under paragraph 7#a71 after 
application of this paragraph1 for a    
year is not a multiple of #aj1 it shall 
be rounded to the nearest multiple of   
#aj4  7#c7 ,alternative to ,,wac ,the   
,secretary may1 for purposes of making  
determinations under paragraph 7#a71 in 
addition to using the wholesale         
acquisition cost for an applicable drug1
 use alternative cost measures of such  

drug1 or use such alternative cost      
measure if the wholesale acquisition    
cost is not available4  7#d7 ,exception 
,a justification under subsection 7c7   
shall not be required for a triggered   
,,spike increase described in paragraph 
7#a7 of an applicable drug of a         
manufacturer if--  7,a7 there is any    
portion of the lookback period described
 in the respective subparagraph of such 
paragraph for such increase that is     
included within the lookback period for 
another triggered ,,spike increase 7or  
combination of such increases7 for which
 a justification is made under this     
section for such drug by such           
manufacturer2 or  7,b7 such increase is 
less than the wholesale acquisition cost
 7or alternative cost measure specified 
by the ,secretary under paragraph 7#c77 
of such drug during the calendar-year   
period described in paragraph 7#a77;,a7 
or the three-calendar-year period       
described in paragraph 7#a77;,b71 as    
applicable1 for such increase1 increased

 by the percentage increase in the      
consumer price index for all urban      
consumers 7all items2 ,united ,states   
city average7 for the #ab-month period  
ending six months prior to the          
calendar-year period so described and   
for the #cf-month period ending six     
months prior to the three-calendar-year 
period so described1 respectively4  7#e7
 ,unit determination ,for purposes of   
determining the wholesale acquisition   
cost in carrying out this section1 the  
,secretary shall determine a unit 7such 
as a unit size7 to apply4  7#f7 ,public 
posting ,beginning with respect to      
#bjba1 the ,secretary shall publicly    
post on the ,internet website of the    
,department of ,health and ,human       
,services--  7,a7 alternative           
percentages1 dollar amounts1 and        
lookback periods that1 if applied under 
paragraph 7#a71 would be projected to   
increase the number of applicable drugs 
for which a triggered ,,spike increase  
would occur for such year2 and  7,b7 the

 number of applicable drugs for which a 
triggered ,,spike increase would occur  
for such year of such an alternative    
percentage1 dollar amount1 or period    
were applied for such year4  7c7        
,justification described  7#a7 ,in      
general ,the justification described in 
this subsection1 with respect to a      
triggered ,,spike increase described in 
subsection 7b77#a7 of an applicable drug
 of a manufacturer1 is--  7,a7 all of   
the information described in paragraph  
7#b72  7,b7 all of the information and  
supporting documentation described in   
paragraph 7#c71 as applicable to the    
increase and drug2 and  7,c7 a          
certification described in paragraph    
7#d74  7#b7 ,required information ,for  
purposes of paragraph 7#a71 the         
information described in this paragraph 
is the following3  7,a7 ,the individual 
factors that have contributed to the    
increase in the wholesale acquisition   
cost4  7,b7 ,an explanation of the role 
of each factor in contributing to such  

increase4  7#c7 ,information as         
applicable ,for purposes of paragraph   
7#a71 the information and supporting    
documentation described in this         
paragraph is the following1 as          
applicable to the increase of the drug3 
7,a7 ,total expenditures of the         
manufacturer on-- 7i7 materials and     
manufacturing for such drug2  7ii7      
acquiring patents and licensing for each
 drug of the manufacturer2 and  7iii7   
costs to purchase or acquire the drug   
from another company1 if applicable4    
7,b7 ,the percentage of total           
expenditures of the manufacturer on     
research and development for such drug  
that was derived from ,federal funds4   
7,c7 ,the total expenditures of the     
manufacturer on research and development
 for such drug4  7,d7 ,the total revenue
 and net profit generated from the      
applicable drug for each calendar year  
since drug approval4  7,e7 ,the total   
costs associated with marketing and     
advertising for the applicable drug4    

7,f7 ,additional information specific to
 the manufacturer of the applicable     
drug1 such as--  7i7 the total revenue  
and net profit of the manufacturer for  
the period of such increase1 as         
determined by the ,secretary2  7ii7     
metrics used to determine executive     
compensation2  7iii7 total expenditures 
on--  7,i7 drug research and            
development2 or  7,,ii7 clinical trials 
on drugs that failed to receive approval
 by the ,food and ,drug ,administration2
 and  7iv7 any additional information   
related to drug pricing decisions of the
 manufacturer4  7,g7 ,any other relevant
 information and supporting             
documentation necessary to justify the  
triggering ,,spike increase4  7,h7 ,any 
other relevant information and          
supporting documentation1 as specified  
by the ,secretary4  7#d7 ,certification 
,for purposes of paragraph 7#a71 the    
certification described in this         
paragraph is a certification1 that all  
such information and documentation is   

accurate and complete1 by one of the    
following3  7,a7 ,the chief executive   
officer of the manufacturer4  7,b7 ,the 
chief financial officer of the          
manufacturer4  7,c7 ,an individual who  
has delegated authority to sign for1 and
 who reports directly to1 such chief    
executive officer or chief financial    
officer4  7d7 ,timing  7#a7             
,notification ,not later than #fj days  
after the date on which the ,secretary  
makes the determination that there is a 
triggering ,,spike increase with respect
 to an applicable drug1 the ,secretary  
shall notify the manufacturer of the    
applicable drug of such determination4  
7#b7 ,submission of justification ,not  
later than #ij days after the date on   
which a manufacturer receives a         
notification under paragraph 7#a71      
subject to subsection 7b77#d71 the      
manufacturer shall submit to the        
,secretary the justification required   
under subsection 7a71 including a       
summary of such justification1 in a form

 and manner specified by the ,secretary4
 ,in specifying such form1 with respect 
to the summary required under the       
previous sentence1 the ,secretary shall 
provide that such summary shall be in an
 easily understandable format1 as       
specified by the ,secretary1 and shall  
permit the manufacturer to exclude      
proprietary information from such       
summary4  7#c7 ,posting on ,internet    
website ,not later than #cj days after  
receiving the complete justification    
under paragraph 7#b71 the ,secretary    
shall post on the ,internet website of  
the ,centers for ,medicare  ,medicaid   
,services the summary included for such 
justification4  7e7 ,penalties  7#a7    
,failure to submit timely justification 
,if the ,secretary determines that a    
manufacturer has failed to submit a     
justification as required under this    
section1 including in accordance with   
the timing and form required1 with      
respect to an applicable drug1 the      
,secretary shall apply a civil monetary 

penalty in an amount of #aj1jjj for each
 day the manufacturer has failed to     
submit such justification as so         
required4  7#b7 ,false information ,any 
manufacturer that submits a             
justification under this section that   
knowingly provides false information in 
such justification is subject to a civil
 monetary penalty in an amount not to   
exceed #ajj1jjj for each item of false  
information4  7#c7 ,application of      
procedures ,the provisions of section   
#aabh;,a 7other than subsections 7a7 and
 7b77 shall apply to a civil monetary   
penalty under this subsection in the    
same manner as such provisions apply to 
a penalty or proceeding under section   
#aabh;,a7a74 ,civil monetary penalties  
imposed under this subsection are in    
addition to other penalties as may be   
prescribed by law4  7f7 ,definitions ,in
 this section3 7#a7 ,applicable drug    
7,a7 ,in general ,subject to            
subparagraph 7,b71 the term applicable  
drug means1 with respect to a lookback  

period described in subsection 7b77#a71 
a covered outpatient drug 7as defined in
 paragraph 7#b7 of section #aibg7k71    
without application of paragraph 7#c7 of
 such section7 that is covered under    
title ,,xviii and is not a low cost     
drug4  7,b7 ,exclusion of low cost drugs
 ,for purposes of subparagraph 7,a71 not
 later than ,january #a1 #bjba1 the     
,secretary shall specify a threshold    
7such as a cost or spending threshold7  
for identifying 7and shall identify7 low
 cost drugs to be excluded from the     
definition of the term applicable drug1 
such as a drug that has a wholesale     
acquisition cost of less than #aj per   
unit or less than #ajj in average       
estimated expenditures under title      
,,xviii per individual per year or per  
user of such drug per year4 ,for        
purposes of this section1 a drug shall  
not be considered specified as a low    
cost drug for a lookback period         
described in subsection 7b77#a7 with    
respect to a year unless such drug is   

identified as being below the specified 
threshold for the entirety of the       
lookback period4  7#b7 ,manufacturer    
,the term manufacturer has the meaning  
given that term in section              
#ahdg;,a7c77#f77;,a74  7#c7 ,wholesale  
acquisition cost ,the term wholesale    
acquisition cost has the meaning given  
that term in section                    
#ahdg;,a7c77#f77;,b74  4  7b7 ,reporting
 to the ,secretary of the ,treasury     
7#a7 ,in general ,subpart ,a of part    
,,iii of subchapter ,a of chapter #fa of
 the ,internal ,revenue ,code of #aihf  
is amended by inserting after section   
#fjci;,j the following new section3     
#fjci,k4 ,drug price ,,spike increase   
reporting ,each manufacturer 7within the
 meaning of section #aabh,l of the      
,social ,security ,act7 shall file a    
return 7as such time and in such form   
and manner as the ,secretary may        
provide7 showing for each year with     
respect to which such section applies   
all information and supporting          

documentation and the certification     
included within a justification reported
 by the manufacturer under subsection   
7c77#a7 of such section4  4  7#b7       
,clerical amendment ,the table of       
sections for subpart ,a of part ,,iii of
 subchapter ,a of chapter #fa of such   
,code is amended by inserting after the 
item relating to section #fjci;,j the   
following new item3  ,sec4 #fjci,k4     
,drug price ,,spike increase reporting4 
4  #c4 ,requirement for manufacturers of
 certain drugs1 devices1 biologicals1   
and medical supplies to report on       
product samples provided to certain     
health care providers  7a7 ,in general  
,section #aabh;,g7a7 of the ,social     
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;h7a77 is amended by adding at
 the end the following new paragraph3   
7#c7 ,certain product samples  7,a7 ,in 
general ,in addition to the requirements
 under paragraphs 7#a77;,a7 and 7#b71 on
 the #ijth day of each calendar year    
7beginning with #bjbc71 any applicable  

manufacturer that provides a payment or 
other transfer of value that is a       
product sample described in subparagraph
 7,b7 to any covered recipient 7or to an
 entity or individual at the request of1
 or designated on behalf of1 such a     
covered recipient7 shall submit to the  
,secretary1 in such electronic form as  
the ,secretary shall require1 the       
following information 7aggregated per   
each drug1 device1 biological1 or       
medical supply1 as applicable7 with     
respect to the preceding calendar year3 
7i7 ,the total quantity of all such     
payments or other transfers of value    
provided to all covered recipients4     
7ii7 ,the total value of all such       
payments or other transfers of value    
provided to all covered recipients4     
7iii7 ,if applicable1 information       
described in clauses 7vii7 and 7viii7 of
 paragraph 7#a77;,a7 with respect to    
such a payment or other transfer of     
value4  7,b7 ,product sample described  
,for purposes of subparagraph 7,a71 a   

product sample described in this        
subparagraph is a product sample that is
 not intended to be sold and is intended
 for patient use4  4  7b7 ,public       
availability of information ,section    
#aabh;,g7c77#a77;,c77ii7 of the ,social 
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;h7c77#a77;,c77ii77 is        
amended-- 7#a7 by striking 7ii7 contains
 and inserting 7ii77,i7 with respect to 
information that is not information     
submitted under paragraph 7#c7 of       
subsection 7a71 contains2  7#b7 by      
striking 1 as applicable2 and inserting 
1 as applicable2 and2 and  7#c7 by      
adding at the end the following new     
subclause3  7,,ii7 with respect to      
information submitted under paragraph   
7#c7 of subsection 7a71 contains        
information that is presented by the    
name of the applicable manufacturer1 the
 total amount of all payments or other  
transfers of value described in such    
paragraph provided to all covered       
recipients1 the total value of all such 

payments or other transfers of value    
provided to all covered recipients1 and 
the name of the covered drug1 device1   
biological1 or medical supply1 as       
applicable2  4  7c7 ,conforming         
amendment ,section                      
#aabh;,g7e77#aj77;,b77ii7 of the ,social
 ,security ,act 7#db ,u4,s4,c4          
#acbj;a-#g;h7e77#aj77;,b77ii77 is       
amended by striking ,product samples and
 inserting ,except for purposes of      
paragraph 7#c7 of subsection 7a71       
product samples4  7d7 ,reporting to the 
,secretary of the ,treasury  7#a7 ,in   
general ,subpart ,a of part ,,iii of    
subchapter ,a of chapter #fa of the     
,internal ,revenue ,code of #aihf1 as   
amended by section #b1 is further       
amended by inserting after section      
#fjci,k the following new section3      
#fjci,l4 ,product samples of applicable 
manufacturers ,each applicable          
manufacturer 7within the meaning of     
section #aabh;,g7a77#c7 of the ,social  
,security ,act7 shall file a return 7as 

such time and in such form and manner as
 the ,secretary may provide7 showing for
 each year to which such section        
applies--  7#a7 the amount described in 
section #aabh;,g7a77#c77;,a77ii7 of such
 ,act with respect to such year1 and    
7#b7 the portion of such amount for     
which a deduction was claimed under     
section #afb4  4  7#b7 ,clerical        
amendment ,the table of sections for    
subpart ,a of part ,,iii of subchapter  
,a of chapter #fa of such ,code1 as     
amended by section #b1 is further       
amended by inserting after the item     
relating to section #fjci,k the         
following new item3  ,sec4 #fjci,l4     
,product samples of applicable          
manufacturers4  4  #d4 ,analysis and    
report on inpatient hospital drug costs 
7a7 ,analysis ,the ,secretary of ,health
 and ,human ,services shall conduct an  
analysis that1 to the extent            
practicable--  7#a7 focuses on drugs    
that are furnished in the inpatient     
setting2  7#b7 includes data on         

inpatient hospital drug costs1 ,medicare
 spending1 volume1 and spending per     
admission2  7#c7 considers trends in    
inpatient hospital drug costs1 such as  
trends by hospital size1 classification 
of urban or rural1 whether the hospital 
is a teaching hospital1 or other        
categorization2 and  7#d7 examines the  
impact of drug shortages on services    
that are furnished in an inpatient      
hospital setting4  ,in conducting such  
analysis1 the ,secretary may conduct    
hospital surveys1 use data from hospital
 cost reports1 or use other data as     
determined by the ,secretary4  7b7      
,report ,not later than ,january #a1    
#bjba1 the ,secretary shall submit to   
the ,committee on ,ways and ,means of   
the ,house of ,representatives and the  
,finance ,committee of the ,senate a    
report on drug costs in the inpatient   
hospital setting1 including the analyses
 described in paragraphs 7#a7 through   
7#d7 of subsection 7a74  7c7 ,funding   
,for purposes of carrying out this      

section1 there shall be transferred to  
the ,secretary #c1jjj1jjj from the      
,federal ,hospital ,insurance ,trust    
,fund under section #ahag of the ,social
 ,security ,act 7#db ,u4,s4,c4 #acie;i74
  #e4 ,public disclosure of drug        
discounts ,section #aaej;,a of the      
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;b-#bc7 is amended-- 7#a7 in       
subsection 7c71 in the matter preceding 
paragraph 7#a71 by inserting 7other than
 as permitted under subsection 7e77     
after disclosed by the ,secretary2 and  
7#b7 by adding at the end the following 
new subsection3  7e7 ,public            
availability of certain information     
7#a7 ,in general ,in order to allow the 
comparison of ,p,b,ms' ability to       
negotiate rebates1 discounts1 and price 
concessions and the amount of such      
rebates1 discounts1 and price           
concessions that are passed through to  
plan sponsors1 beginning ,january #a1   
#bjbj1 the ,secretary shall make        
available on the ,internet website of   

the ,department of ,health and ,human   
,services the information with respect  
to the second preceding calendar year   
provided to the ,secretary on generic   
dispensing rates 7as described in       
paragraph 7#a7 of subsection 7b77 and   
information provided to the ,secretary  
under paragraphs 7#b7 and 7#c7 of such  
subsection that1 as determined by the   
,secretary1 is with respect to each     
,,pbm4  7#b7 ,availability of data ,in  
carrying out paragraph 7#a71 the        
,secretary shall ensure the following3  
7,a7 ,confidentiality ,the information  
described in such paragraph is displayed
 in a manner that prevents the          
disclosure of information on rebates1   
discounts1 and price concessions1 with  
respect to an individual drug or an     
individual plan4  7,b7 ,class of drug   
,the information described in such      
paragraph is made available by class of 
drug1 using an existing classification  
system1 but only if the class contains  
such number of drugs1 as specified by   

the ,secretary1 to ensure               
confidentiality of proprietary          
information or other information that is
 prevented to be disclosed under        
subparagraph 7,a74  4  #f4 ,requiring   
certain manufacturers to report drug    
pricing information with respect to     
drugs under the ,medicare program  7a7  
,in general ,section #ahdg;,a of the    
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#c;a7 is amended-- 7#a7 in       
subsection 7b7--  7,a7 in paragraph     
7#b77;,a71 by inserting or subsection   
7f77#b71 as applicable before the period
 at the end2  7,b7 in paragraph 7#c71 in
 the matter preceding subparagraph 7,a71
 by inserting or subsection 7f77#b71 as 
applicable1 before determined by2 and   
7,c7 in paragraph 7#f77;,a71 in the     
matter preceding clause 7i71 by         
inserting or subsection 7f77#b71 as     
applicable1 before determined by2 and   
7#b7 in subsection 7f7--  7,a7 by       
striking ,for requirements and inserting
 the following3  7#a7 ,in general ,for  

requirements  2 and  7,b7 by adding at  
the end the following new paragraph3    
7#b7 ,manufacturers without a rebate    
agreement under title ,,xix  7,a7 ,in   
general ,in the case of a manufacturer  
of a drug or biological described in    
subparagraph 7,c71 7,e71 or 7,g7 of     
section #ahdb7o77#a7 or in clause 7ii7  
or 7iii7 of section #ahha7;b77#ad77;,b7 
that does not have a rebate agreement in
 effect under section #aibg1 for        
calendar quarters beginning on or after 
,january #a1 #bjbj1 such manufacturer   
shall report to the ,secretary the      
information described in subsection     
7b77#c77;,a77iii7 of such section #aibg 
with respect to such drug or biological 
in a time and manner specified by the   
,secretary4  7,b7 ,audit ,information   
reported under subparagraph 7,a7 is     
subject to audit by the ,inspector      
,general of the ,department of ,health  
and ,human ,services4  7,c7             
,verification ,the ,secretary may survey
 wholesalers and manufacturers that     

directly distribute drugs described in  
subparagraph 7,a71 when necessary1 to   
verify manufacturer prices and          
manufacturer's average sales prices     
7including wholesale acquisition cost7  
if required to make payment reported    
under subparagraph 7,a74 ,the ,secretary
 may impose a civil monetary penalty in 
an amount not to exceed #ajj1jjj on a   
wholesaler1 manufacturer1 or direct     
seller1 if the wholesaler1 manufacturer1
 or direct seller of such a drug refuses
 a request for information about charges
 or prices by the ,secretary in         
connection with a survey under this     
subparagraph or knowingly provides false
 information4 ,the provisions of section
 #aabh;,a 7other than subsections 7a7   
7with respect to amounts of penalties or
 additional assessments7 and 7b77 shall 
apply to a civil money penalty under    
this subparagraph in the same manner as 
such provisions apply to a penalty or   
proceeding under section #aabh;,a7a74   
7,d7 ,confidentiality ,notwithstanding  

any other provision of law1 information 
disclosed by manufacturers or           
wholesalers under this paragraph 7other 
than the wholesale acquisition cost for 
purposes of carrying out this section7  
is confidential and shall not be        
disclosed by the ,secretary in a form   
which discloses the identity of a       
specific manufacturer or wholesaler or  
prices charged for drugs by such        
manufacturer or wholesaler1 except--    
7i7 as the ,secretary determines to be  
necessary to carry out this section     
7including the determination and        
implementation of the payment amount71  
or to carry out section #ahdg;,b2  7ii7 
to permit the ,comptroller ,general to  
review the information provided2 and    
7iii7 to permit the ,director of the    
,congressional ,budget ,office to review
 the information provided4  4  7b7      
,enforcement ,section #ahdg;,a such ,act
 7#db ,u4,s4,c4 #aciew-#c;a7 is further 
amended-- 7#a7 in subsection 7d77#d7--  
7,a7 in subparagraph 7,a71 by striking  

,in general and inserting               
,misrepresentation2  7,b7 in            
subparagraph 7,b71 by striking          
subparagraph 7,b7 and inserting         
subparagraph 7,a71 7,b71 or 7,c72  7,c7 
by redesignating subparagraph 7,b7 as   
subparagraph 7,d72 and  7,d7 by         
inserting after subparagraph 7,a7 the   
following new subparagraphs3  7,b7      
,failure to provide timely information  
,if the ,secretary determines that a    
manufacturer described in subsection    
7f77#b7 has failed to report on         
information described in section        
#aibg7;b77#c77;,a77iii7 with respect to 
a drug or biological in accordance with 
such subsection1 the ,secretary shall   
apply a civil money penalty in an amount
 of #aj1jjj for each day the            
manufacturer has failed to report such  
information and such amount shall be    
paid to the ,treasury4  7,c7 ,false     
information ,any manufacturer required  
to submit information under subsection  
7f77#b7 that knowingly provides false   

information is subject to a civil money 
penalty in an amount not to exceed      
#ajj1jjj for each item of false         
information4 ,such civil money penalties
 are in addition to other penalties as  
may be prescribed by law4  2 and  7#b7  
in subsection 7c77#f77;,a71 by striking 
the period at the end and inserting 1   
except that1 for purposes of subsection 
7f77#b71 the ,secretary may1 if the     
,secretary determines appropriate1      
exclude repackagers of a drug or        
biological from such term44  7c7 ,report
 ,not later than ,january #a1 #bjba1 the
 ,inspector ,general of the ,department 
of ,health and ,human ,services shall   
assess and submit to ,congress a report 
on the accuracy of average sales price  
information submitted by manufacturers  
under section #ahdg;,a of the ,social   
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a74 ,such report shall include
 any recommendations on how to improve  
the accuracy of such information4