Persius/hicric huggingface dataset:
May (cid:20)(cid:23), 2020 
TO:  Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
SUZANNE Digitally signed by 
FROM:   Suzanne Murrin   SUZANNE MURRIN 
Deputy Inspector GeMnerUal RRIN  Date: 2020.05.14 
   for Evaluation and Inspections   11:17:38 -04'00' 
SUBJECT:  Comparison of Average Sales Prices and Average Manufacturer Prices: Results 
for the Fourth Quarter of 2019, OEI-03-20-00050  
This memorandum summarizes the results of the Office of  Inspector Generals (OIGs) 
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the 
fourth quarter of 2019.  By law, OIG must notify the Secretary of Health and Human Services if 
the ASP for a particular  drug exceeds the drugs AMP by 5 percent or more.  If that threshold is 
met, the Secretary may disregard the drugs ASP when setting the reimbursement amount and 
shall substitute the payment amount with the lesser of either the widely available market price or 
103 percent of the AMP.  
In  April 2013, the Centers for Medicare & Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug 
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters.  CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price substitutions be  
implemented for drugs that the Food and Drug Administration identifies as being in short supply. 
OIG found that in the fourth quarter of 2019, nine drug codes met CMSs price substitution 
criteria by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters, based on complete AMP data.  OIG found one additional drug code that, based on 
complete AMP data, exceeded the 5-percent threshold.  However,  at the time of our analysis, the   Page 2Seema Verma, M.P.H. 
Food and Drug Administration identified these drug codes as being in short supply.  Another 
eight drug codes had ASPs that exceeded the AMPs by at least 5 percent in the fourth quarter of 
2019, based on complete AMP data, but these drug codes did not meet other CMS 
price-substitution criteria. 
We will provide you with the results of our pricing comparison for the fourth quarter of 2019, as 
well as the results for the 3 previous quarters.  This information will be transmitted via our  
secure file transfer system.
February 11, 2020 
TO:  Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
Digitally signed by ANN 
FROM:  (cid:73)(cid:82)(cid:85)  Suzanne Murrin  ANN MAXWELL MAXWELL 
Date: 2020.02.12 11:34:26 
Deputy Inspector General  -05'00' 
for Evaluation and Inspections 
SUBJECT:  Comparison of Average Sales Prices and Average Manufacturer Prices: Results 
for the Third Quarter of 2019, OEI-03-20-00040 
This memorandum summarizes the results of the Office of Inspector Generals (OIGs) 
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the third 
quarter of 2019.  By law, OIG must notify the Secretary of Health and Human Services if the 
ASP for a particular drug exceeds the drugs AMP by 5 percent or more.  If that threshold is met, 
the Secretary may disregard the drugs ASP when setting the reimbursement amount and shall 
substitute the payment amount with the lesser of either the widely available market price or 
103 percent of the AMP.  
In April 2013, the Centers for Medicare & Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug 
code that exceeds the 5-percent threshold for two consecutive quarters or three of the previous 
four quarters.  CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price substitutions be 
implemented for drugs that the Food and Drug Administration identifies as being in short supply. 
OIG found that in the third quarter of 2019, 11 drug codes met CMSs price substitution criteria 
by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters, 
based on complete AMP data.  Another seven drug codes had ASPs that exceeded the AMPs by 
at least 5 percent in the third quarter of 2019, based on complete AMP data, but these drug codes  Page 2Seema Verma, M.P.H. 
did not meet other CMS price-substitution criteria.    
 
We will provide you with the results of our pricing comparison for the third quarter of 2019, as 
well as the results for the three previous quarters.  This information will be transmitted via our 
secure file transfer system.  
 
 
Attachment
TO:  Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
FROM: 
SUBJECT:  <;omparison ofA verage Sales Prices and Average Manufacturer Prices: Results 
for the Second Quarter of2 019, OEl-03-20-00070 
This memorandum summarizes the results of the Office oflnspector General's (OIG) 
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the 
second quarter of 2019.  By law, OIG must notify the Secretary of Health and Human Services if 
the ASP for a particular drug exceeds the drug's AMP by 5 percent or more.  If that threshold is 
met, the Secretary may disregard the drug's ASP when setting the reimbursement amount and 
shall substitute the payment amount with the lesser of either the widely available market price or 
103 percent of the AMP. 
In April 2013, the Centers for Medicare & Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug 
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters. CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price substitutions be 
implemented for drugs that the Food and Drug Administration (FDA) identifies as being in short 
supply. 
OIG found that in the second quarter of 2019, 11 drug codes met CMS's price substitution 
criteria by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous  Page 2-Seema Verma, M.P.H. 
4 quarters, based on complete AMP data.  Another 11 drug codes had ASPs that exceeded the 
AMPs by at least 5 percent in the second quarter of 2019, based on complete AMP data, but 
these drug codes did not meet other CMS price-substitution criteria. 
We will provide you with the results of our pricing comparison for the second quarter of 2019, as 
well as the results for the 3 previous quarters.  This information will be transmitted via our 
secure file transfer system.
TO:  Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
~ 
FROM: 
Suzanne Mur~r11 
Deputy Inspector  a  ~ 
for Evaluati  and lnsp  tions 
SUBJECT:  Comparison ofA verage Sales Prices and Average Manufacturer Prices: Results 
for the First Quarter of2 019, OEI-03-19-00050 
This memorandum summarizes the results of the Office of Inspector General's (OIG) 
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the first 
quarter of 2019.  By law, OIG must notify the Secretary of Health and Human Services if the 
ASP for a particular drug exceeds the drug's AMP by 5 percent or more.  If that threshold is met, 
the Secretary may disregard the drug's ASP when setting the reimbursement amount and shall 
substitute the payment amount with the lesser of either the widely available market price or 
I 03 percent of the AMP. 
In April 2013, the Centers for Medicare & Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug 
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters.  CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price substitutions be 
implemented for drugs that the Food and Drug Administration (FDA) identifies as being in short 
supply. 
OIG found that in the first quarter of 2019, 11 drug codes met CMS's price substitution criteria 
by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters,  Page 2-Seema Verma, M.P.H. 
based on complete AMP data.  OIG found one additional drug code that, based on complete 
AMP data, exceeded the 5-percent threshold.  However, at the time of our analysis, FDA 
identified this drug code as being in short supply.  Another three drug codes had ASPs that 
exceeded the AMPs by at least 5 percent in the first quarter of 2019, based on complete AMP 
data, but these drug codes did not meet other CMS price-substitution criteria. 
We will provide you with the results of our pricing comparison for the first quarter of 2019, as 
well as the results for the 3 previous quarters.  This information will be transmitted via our 
secure file transfer system.
May 10, 2019 
TO:   Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
SUZANNE  Digitally signed by
FROM:   Suzanne Murrin  SUZANNE MURRIN
MURRIN  Date: 2019.05.09 
Deputy Inspector General   18:13:36 -04'00' 
for Evaluation and Inspections  
SUBJECT:   Comparison of Average Sales Prices and Average Manufacturer Prices: Results 
for the Fourth Quarter of 2018, OEI-03-19-00040 
This memorandum summarizes the results of the Office of Inspector Generals (OIG)  
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the  
fourth quarter of 2018.  By law, OIG must notify the Secretary of Health and Human Services if  
the ASP for a particular drug exceeds the drugs AMP by 5 percent or more.  If that threshold is  
met, the Secretary may disregard the drugs ASP when setting the reimbursement amount and  
shall substitute the payment amount with the lesser of either the widely available market price or  
103 percent of the AMP.   
In April 2013, the Centers for Medicare  & Medicaid Services (CMS) began making price  
substitutions in accordance with the November 2012 final rule specifying the circumstances  
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes  
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug  
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters. CMS lowers reimbursement amounts only when ASP and AMP comparisons are  
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS  
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be  
implemented if the substituted amount would exceed the ASP-based payment amount for the  
quarter in which the price substitution would take effect.  Nor shall price substitutions be  
implemented for drugs that the Food and Drug Administration (FDA) identifies as being in short  
supply. 
OIG found that in the fourth quarter of 2018, 10 drug codes met CMSs price substitution criteria  
by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters,  Page 2Seema Verma, M.P.H.(cid:3)
(cid:3) 
based on complete AMP data. OIG found one additional drug code that, based on complete  
AMP data, exceeded the 5-percent threshold. However, at the time of our analysis, FDA  
identified these drug codes as being in short supply.  Another five drug codes had ASPs that  
exceeded the AMPs by at least 5 percent in the fourth quarter of 2018, based on complete AMP  
data, but these drug codes did not meet other CMS price-substitution criteria. 
We will provide you with the results of our pricing comparison for the fourth quarter of 2018, as  
well as the results for the 3 previous quarters.  This information will be transmitted via our  
secure file transfer system.
(cid:3)
(cid:3)
DEPAR11v1ENT Of HE \LTH AND HUJVL  SERVICES 
OFFICE OF INSPECTOR GENERAL 
WA  HINGTO 1, DC  2020 I 
February 14, 2019 
TO:  Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
FROM: 
SUBJECT:  Comparison ofA verage Sales Prices and Average Manufacturer Prices: Results 
for the Third Quarter of2 018, OEI-03-19-00030 
This memorandum summarizes the results of the Office of Inspector General's (OIG) 
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the third 
quarter of 2018.  By law, OIG must notify the Secretary of Health and Human Services if the 
ASP for a particular drug exceeds the drug's AMP by 5 percent or more.  If that threshold is met, 
the Secretary may disregard the drug's ASP when setting the reimbursement amount and shall 
substitute the payment amount with the lesser of either the widely available market price or 
103 percent of the AMP. 
In April 2013, the Centers for Medicare & Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug 
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters.  CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price substitutions be 
implemented for drugs that the Food and Drug Administration (FDA) identifies as being in short 
supply.  Page 2-Seema Verma, M.P.H. 
OIG found that in the third quarter of 2018, nine drug codes met CMS's price substitution 
criteria by exceeding the 5-percent threshold for 2 consecutive quarters or 3 ofthe previous 
4 quarters, based on complete AMP data.  OIG found two additional drug codes that, based on 
complete AMP data, exceeded the 5-percent threshold.  However, at the time of our analysis, 
FDA identified these drug codes as being in short supply.  Another ten drug codes had ASPs that 
exceeded the AMPs by at least 5 percent in the third quarter of 2018, based on complete AMP 
data, but these drug codes did not meet other CMS price-substitution criteria. 
We will provide you with the results of our pricing comparison for the third quarter of2018, as 
well as the results for the 3 previous quarters.  This information will be transmitted via our 
secure file transfer system.
DEPARTME  T OF HEALTH AND HUMAN SERVICES 
OFFICE OF INSPECTOR GENERAL 
WA J-IL~GTON  DC  20201 
TO:   Seema Verma, M.P.H. 
Administrator 
Centers for Medicare & Medicaid Services 
SUZANNE  Digitally signed by
FROM:   Suzanne Murrin  SUZANNE MURRIN
MURRIN  Date: 2018.11.15 13:45:44 
Deputy Inspector General   -05'00' 
for Evaluation and Inspections 
SUBJECT:   Comparison of Average Sales Prices and Average Manufacturer Prices: Results 
for the Second Quarter of 2018, OEI-03-19-00020 
This memorandum summarizes the results of the Office of  Inspector Generals (OIG) 
comparison of average sales prices (ASPs) and average manufacturer prices (AMPs) for the 
second quarter of 2018.  By law, OIG must notify  the Secretary of Health and Human Services if 
the ASP  for a particular  drug  exceeds the drugs AMP by 5 percent or more.  If that threshold is 
met, the Secretary  may  disregard the drugs ASP when setting  the reimbursement amount and 
shall substitute the payment amount with the lesser of either the widely available market price or 
103 percent of the AMP.  
In  April 2013, the Centers for Medicare &  Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG  identifies  a  drug  
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters. CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug  products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price  substitutions be  
implemented for drugs that the Food and Drug Administration (FDA) identifies as being in short 
supply.  Page 2Seema Verma, M.P.H.  
 
OIG found that in the second quarter of 2018, nine drug  codes met CMSs price  substitution 
criteria by  exceeding  the 5-percent  threshold for 2 consecutive quarters or 3 of the previous 
4 quarters, based on complete AMP data. OIG  found two additional drug  codes that, based on 
complete AMP data, exceeded the 5-percent threshold.  However, at the time of our analysis, 
FDA identified these drug codes as being  in short supply. Another five drug codes had ASPs 
that exceeded the AMPs by  at least 5 percent in the second quarter of 2018, based on complete 
AMP data, but these drug codes did not meet other CMS price-substitution criteria. 
We will provide you with the results of our pricing  comparison for the second quarter of 2018, as 
well as the results for the  3 previous quarters.  This information will be transmitted via our 
secure file transfer system.
DEPART?vIE  T Of HE \LTH  ND HUl'vli\  SER\ ICES 
-------- - --
OFFICE OF INSPECTOR GENERAL 
\\. \ 'HL'\/GTON  D .  20201 
FEB  15 2018 
TO:  Seema Verma 
Administrator 
Centers for Medic[a& Medicajid (Serv~ices   
t 
\A 
V/  ,  :::\  -
~  ~ 
FROM:  Suzanne Murrin 
Deputy Inspector General  - ~t ~-r___, .\ f-.v\ (  \  \(/-..{YI V') 
for Evaluation and Inspections 
SUBJECT:  Comparison ofA  verage Sales Prices and Average Manufacturer Prices: Results 
for the Third Quarter of2 017, OEI-03-18-00150 
This memorandum provides the results of the Office oflnspector General's (OIG) comparison of 
average sales prices (ASPs) and average manufacturer prices (AMPs) for the third quarter 
of 2017. By law, OIG must notify the Secretary of Health and Human Services if the ASP for a 
particular drug exceeds the drug's AMP by 5 percent or more.  If that threshold is met, the 
Secretary may disregard the drug's ASP when setting the reimbursement amount and shall 
substitute the payment amount with the lesser of either the widely available market price or 
103 percent of the AMP. 
In April 2013, the Centers for Medicare & Medicaid Services (CMS) began making price 
substitutions in accordance with the November 2012 final rule specifying the circumstances 
under which AMP-based price substitutions shall occur.  Pursuant to the rule, CMS substitutes 
103 percent of the AMP for the ASP-based reimbursement amount when OIG identifies a drug 
code that exceeds the 5-percent threshold for 2 consecutive quarters or 3 of the previous 
4 quarters.  CMS lowers reimbursement amounts only when ASP and AMP comparisons are 
based on the same set of drug products (i.e., based on complete AMP data).  To prevent CMS 
from inadvertently raising the Medicare reimbursement amount, a price substitution shall not be 
implemented if the substituted amount would exceed the ASP-based payment amount for the 
quarter in which the price substitution would take effect.  Nor shall price substitutions be 
implemented for drugs that the Food and Drug Administration (FDA) identifies as being in short 
supply.  Page 2-Seema Verma 
OIG found that in the third quarter of 2017, 11 drug codes met CMS's price substitution criteria 
by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters, 
based on complete AMP data.  OIG found one additional drug code that, based on complete 
AMP data, exceeded the 5-percent threshold.  However, at the time of our analysis, FDA 
identified this drug code as being in short supply.  Another ten drug codes had ASPs that 
exceeded the AMPs by at least 5 percent in the third quarter of 2017, based on complete AMP 
data, but these drug codes did not meet other CMS price substitution criteria. 
We will provide you with the results of our pricing comparison for the third quarter of 201 7, as 
well as the results for the 3 previous quarters.  This information will be transmitted via our 
secure file transfer system.