Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
O P D :
PEN  AYMENTS  ATA   
 
 
R A ,
EVIEW OF  CCURACY  
 
 
P ,
RECISION  AND 
   
C R
ONSISTENCY IN  EPORTING  
 
Suzanne Murrin  
Deputy Inspector General 
 
August 2018 
OEI-03-15-00220   
   
Report in Brief 
August 2018  
OEI-03-15-00220   
 
Why OIG Did This Review   Open Payments Data: Review of Accuracy, 
The Open Payments program 
Precision, and Consistency in Reporting  
promotes transparency by making 
available to the public the financial 
What OIG Found 
relationships that physicians and 
Of 11.9 million records published on the Open  Key Takeaway 
teaching hospitals have with 
Payments website for 2015, less than 
applicable manufacturers and group   Although almost all the 
1 percent were missing required data 
purchasing organizations.  Although  2015 data reported in the 
elements.  Although the Open Payments data 
these financial relationships may  Open Payments program 
elements reported to CMS were complete  met requirements, there 
provide important opportunities to 
overall, we did identify records that contained  were several areas where 
increase medical research and 
inaccurate, imprecise, or inconsistent  CMS could improve data 
enhance medical knowledge, they 
information.  These include records  accuracy, precision, and 
also can raise concerns because of 
containing drug and device names that do not  consistency to better help 
their potential to influence the 
consumers use the 
match the definitions of these data elements; 
decision-making of health care  information. 
national drug codes (NDCs) that were not 
providers.    
found in multiple Food and Drug 
The transparency of the Open 
Administration databases or other drug informatio n resources; and 
Payments program reveals the nature 
payment dates from a different reporting year.   
and extent of these relationships and 
has the potential to discourage the  CMS did note that it has conducted outreach to address data concerns 
development of inappropriate  with manufacturers and group purchasing organizations.  CMS also 
financial relationships.  However, the  reported that it is still compiling a list of noncompliant manufacturers and 
program can benefit the public only if  group purchasing organizations for further investigation.  
the data reported are complete and 
What OIG Recommends   
accurate.   
We recommend that CMS take a number of practical steps to improve the 
How OIG Did This Review 
accuracy, precision, and consistency of the data to better help consumers 
To determine the extent to which  use the information: (1) ensure that records contain all required data; 
data reported were missing  (2) strengthen validation rules and revise data-element definitions so that 
elements, or were inaccurate or  actual drug and device names must be reported; (3) revise the definition 
inconsistent, we downloaded data for  of the device-name data element so that the information reported is 
2015 from the Open Payments  required to be more specific; and (4) ensure that manufacturers and 
website in June 2016.  To determine  group purchasing organizations report valid NDCs for drugs.  CMS 
the role of the Centers for Medicare  concurred with all four of our recommendations. 
& Medicaid Services (CMS) in 
 
validating Open Payments data 
received from manufacturers and   
group purchasing organizations, we 
 
reviewed policies and procedures 
and other information that CMS   
provided regarding its oversight.  
 
 
Full report can be found at http://oig.hhs.gov/oei/reports/oei-03-15-00220.asp 
   
   
TABLE OF CONTENTS 
 
Objectives ....................................................................................................1 
Background ..................................................................................................1 
Methodology ................................................................................................4 
Findings........................................................................................................7 
Almost all Open Payments records contained the required data .....7 
A small percentage of Open Payment records contained  
inaccurate, imprecise, or inconsistent information ..........................8 
CMS monitors Open Payments data to detect anomalies and 
addresses specific issues as they arise .............................................9 
Conclusion and Recommendations ............................................................12 
Agency Comments and Office of Inspector General Response .....14 
Appendix ....................................................................................................15 
Agency Comments ...........................................................................15 
Acknowledgments......................................................................................17 
 
   
   
OBJECTIVES  
1.  To assess whether data published on the Open Payments website were 
missing data elements, were inaccurate, or were inconsistent. 
2.  To evaluate the extent to which the Centers for Medicare & Medicaid 
Services (CMS) provides oversight to ensure that data submitted by 
manufacturers and group purchasing organizations (GPOs) is in 
compliance with requirements for reporting Open Payments data.   
BACKGROUND  
Open Payments Program 
Physicians and teaching hospitals sometimes have financial relationships 
with manufacturers and GPOs.  These financial relationships can take the 
form of consulting fees; research payments; ownership or investment 
interests; or other forms of compensation.  Although these relationships 
can provide important opportunities to expand medical research and 
enhance medical knowledge, they also can raise concerns because of their 
potential to influence the decision-making of health care providers. 
The Open Payments program promotes transparency by publishing data on 
financial relationships that physicians and teaching hospitals have with 
applicable manufacturers and GPOs (hereafter referred to as 
manufacturers and GPOs).1  Transparency reveals the nature and 
extent of these relationships and has the potential to discourage the 
development of inappropriate financial relationships.   
To increase the transparency of relationships that providers have with 
manufacturers and GPOs, the Open Payments program requires 
manufacturers that produce at least one covered product to report all 
payments2 and other transfers of value (hereafter referred to collectively as 
payments) that they make to all covered recipients, i.e., physicians and 
 
1 GPOs are entities that leverage the purchasing power of a group of businesses, e.g., 
hospitals, to obtain discounts from manufacturers and vendors. 
2 Manufacturers and GPOs are not required to report payments of less than $10.  
However, they must report these payments when the total annual value of payments 
provided to a covered recipient by a single manufacturer or GPO is more than $100.  
These thresholds are adjusted annually for inflation.  
Open Payments Data: Review of Accuracy, Precision, and Consistency in Reporting  
(OEI-03-15-00220)    1   
   
teaching hospitals.3  A covered product is any drug, device, biological, or 
medical supply that is eligible for payment by Medicare, Medicaid, or the 
Childrens Health Insurance Program, and requires a prescription or 
approval by the Food and Drug Administration (FDA).4   
Manufacturers, as well as GPOs that purchase or negotiate the purchase of 
covered products, also are required to report ownership and investment 
interests (hereafter referred to as ownership interests) held by physicians 
or their immediate family members.  (Manufacturers and GPOs do not 
report ownership interests held by teaching hospitals.)  GPOs are required 
to report payments made to physicians who hold ownership interests in the 
GPO at any point in the reporting year.  CMS makes this information 
publicly available on the website https://openpaymentsdata.cms.gov/.   
Reporting entities, i.e., manufacturers and GPOs, must register with the 
Open Payments system to submit data and must recertify annually.  CMS 
published the first payment data in September 2014 covering the reporting 
period between August and December 2013.  CMS publishes the previous 
years data every June and an update on all years data early in the 
following year.  
 
3 Covered recipients are (1) physicians who are not employees of the manufacturer 
reporting the payment and (2) teaching hospitals that receive payment for Medicare direct 
graduate medical education, inpatient hospital prospective payment system indirect 
medical education, or psychiatric hospital indirect medical education. For the purposes of 
the Open Payments program, a physician is any of the following types of professionals: 
Doctor of Medicine, Doctor of Osteopathy, Doctor of Dentistry, Doctor of Dental 
Surgery, Doctor of Podiatry, Doctor of Optometry, and Doctor of Chiropractic Medicine.  
Residents in these fields are excluded from the definition of physicians for the purpose of 
this program.   
4 A covered product is any drug, device, biological, or medical supply that is eligible for 
payment by Medicare, Medicaid, or the Childrens Health Insurance Program either 
individually or as a part of a bundled payment.  In addition, the covered drug or 
biological must require a prescription to be dispensed and the covered device requires 
premarket approval by, or premarket notification to, FDA. 
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Open Payments Data 
Data Submission.  There are three types of records in the Open Payments 
system: general payments, research payments, and ownership interests.  
Key data elements collected within the Open Payments system include 
information about the following:  
  the covered recipient;  Types of Records 
in the Open 
  the reporting entity;  Payments System 
   
  the covered drug or biological  General payments: Records of all 
payments that were not made in 
related to the payment (hereafter 
connection with research  
referred to as drug);  
 
Research payments: Records of all 
  the device, or medical supply 
payments made in connection with 
related to the payment (hereafter 
research  
referred to as device and   
Ownership interests: Records of the 
includes items such as blood 
ownership interests that physicians or 
glucose meters or replacement 
their immediate family members held 
joints);  in a manufacturer or GPO 
  the form of the payment; 
  the total dollar amount of the payment;  
  the total dollar amount of ownership or investment interests; and 
  the date of payment. 
Manufacturers and GPOs also must report payments assigned to a third 
party by a covered recipient.  Examples of third parties include individuals 
or entities such as contract research organizations, nonteaching hospitals, 
or charities.  
CMS Oversight of Open Payments Program  
CMSs Center for Program Integrity manages the Open Payments 
program.  According to CMS, the Open Payments program does not 
identify which financial relationships are beneficial or which may cause 
conflicts of interest.5   
Data Validation and Matching.  According to the Open Payments User 
Guide, CMS must validate data submitted to the Open Payments system 
before accepting them.  CMS evaluates the data according to its validation 
rules.  Validation helps ensure that all required fields are populated and 
the information in each field meets specific formatting requirements.  For 
 
5 CMS, Open Payments Data in Context.  Accessed at 
https://www.cms.gov/OpenPayments/About/Open-Payments-Data-in-Context.html on 
March 27, 2018. 
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example, the date of payment should be reported and should be in 
a YYYYMMDD format. 
After successful validation, CMS compares the identification information 
for physicians and teaching hospitalse.g., the physician name and the 
teaching hospital address in each recordto the same identification 
information within existing CMS resources.6  After completing this data 
check, CMS notifies manufacturers and GPOs regarding the success or 
failure of their respective submissions and whether any validation or 
matching errors exist.  Manufacturers and GPOs must correct and 
resubmit or delete records flagged for validation or matching errors. 
Data Attestation.  After records pass data element validation and data 
matching, manufacturers and GPOs must attest to the data.  Manufacturers 
and GPOs must attest to the timeliness, accuracy, and completeness of all 
submitted data including any resubmissions of corrected data.   
Manufacturers and GPOs may make what are known as reasonable 
assumptions when compiling and reporting payment data to the Open 
Payments system, and they can add these reasonable assumptions to their 
attestations.  The reasonable assumptions explain the analytical and 
methodological choices that manufacturers and GPOs used when reporting 
payments or ownership interests.  For example, the reasonable 
assumptions may explain why a manufacturer chose to exclude certain 
payments from its reporting.  CMS does not publish these assumptions on 
the Open Payments website. 
According to CMS, it may audit manufacturers and GPOs for compliance 
to ensure the submission of timely, accurate, and complete data.  CMS 
also has the authority to impose civil monetary penalties on manufacturers 
and GPOs that fail to report or knowingly fail to report information 
regarding payments and ownership interests in a timely, accurate, or 
complete manner.7  
METHODOLOGY 
Data Collection 
We collected data (general payments records, research payments records, 
and ownership interests records) for 2015 from the Open Payments 
website in June 2016, soon after the 2015 data were published.  We also 
collected CMSs policies and procedures related to Open Payments data 
 
6 CMS uses information from sources such as hospital cost reports; the National Plan and 
Provider Enumeration System; and the Provider Enrollment, Chain, and Ownership 
System. 
7 42 CFR  403.912. 
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validation.  We requested information from CMS on how it validated the 
2015 data that it received from manufacturers and GPOs; whether CMS 
performs any validation after data are accepted into the Open Payments 
system; and about the data problems that CMS identified through the 
validation process.  We also obtained the reasonable assumptions provided 
by manufacturers and GPOs when reporting 2015 payments or ownership 
interests to CMS.    
Data Analysis 
Data Completeness and Accuracy.  We performed summary analyses on 
the published general payments, research payments, and ownership 
interests records to determine the number of records that (1) were missing 
data from required fields and/or (2) contained inaccurate or inconsistent 
information.  With regard to the second category, we determined the 
number of records that contained: 
  Product names that did not appear to be drugs or devices.   
o  To find such product names, we manually reviewed the 
names of drugs and devices submitted by manufacturers 
and GPOs. 
  Payment dates that were outside 2015.  
  National Drug Codes (NDCs)8 that we did not find in three FDA 
databases or First Databanks National Drug Data File (a national 
drug compendium).  For the NDCs that we did not find in these 
sources, we conducted Internet searches for them using NDCs and 
the associated drug names.9 
o  The three FDA databases we used were the NDC Directory, 
the NDC Structured Product Labeling Data Elements File, 
and the Unfinished Drugs Database File.   
CMS Oversight.  We reviewed the information that CMS gave us in 
response to our request.  We analyzed CMSs policies and procedures as 
well as its responses to our questionnaire to determine whether and how 
CMS audits or performs other activities to ensure that manufacturers and 
GPOs submit data that are in compliance with Open Payments reporting 
requirements.  We also determined whether CMS has taken any action 
against manufacturers or GPOs that submitted data that did not meet the 
reporting requirements under the Open Payments program.  Finally, we 
 
8 An NDC is a numeric code that provides information about the drugs manufacturer, 
product, and package size. Manufacturers and GPOs may provide the NDC of the drug 
reported within the payment record. 
9 We conducted the analysis of NDCs using all three components of the numeric code, 
i.e., the portions representing the manufacturer, product, and package size.   
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reviewed the reasonable assumptions that manufacturers and GPOs 
provided to CMS. 
Limitations 
We reviewed 2015 Open Payments data published by CMS as of 
June 2016.  This first release of 2015 Open Payments data contained 
11.9 million records associated with $7.5 billion in payments and 
ownership interests.  As of the June 2018 update of the 2015 data, there 
were 12.4 million records associated with $8.4 billion in payments and 
ownership interests.  These updated data were not included in our review.    
This review analyzed only financial relationships published on the Open 
Payments website.   We did not determine whether there were 
manufacturers and GPOs that failed to submit all required financial 
relationships for all covered recipients.      
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency. 
   
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FINDINGS 
Almost all Open Payments records contained 
the required data 
Of 11.9 million records published on the Open Payments website, less 
than 1 percent were missing required data elements.  As shown in 
Exhibit 1, only 11,463 records were missing one or more required data 
elements.  The data element most commonly missing from records 
associated with physicians financial interests was the physician 
specialty.10  The types of missing data would not appear to hinder 
consumers ability to obtain information on the financial relationships that 
their health care providers might have with manufacturers and GPOs. 
 
Exhibit 1: Number of Records That Had Missing Data  
Number of Records 
Data Element 
With Missing Values1 
Physician Specialty  8,673 
Third-Party Recipient Equals a Covered Recipient Indicator2  2,423 
Physician License State  170 
Principal Investigator Specialty  107 
Pre-Clinical Research Indicator  35 
Recipient Province (outside United States)3  29 
Name of Covered Drug and/or Device  10 
Name of Research Study  7 
Country of Travel   7 
City of Travel  7 
State of Travel  4 
Third-Party Recipient Name (if an entity)  1 
Principal Investigator City   1 
Total records missing at least one data element   11,463 
Total records reported to Open Payments   11,901,001 
Source:  OIG analysis of records published on the Open Payments website for 2015. 
1 Some records had more than one missing value. 
2 This field indicates whether the third-party recipient who received a general payment on behalf of a 
covered recipient is, itself, a covered recipient. 
3 Recipient province is no longer a required data element. 
 
 
10  According to CMS, when the specialty reported with the physician record is not a 
recognized specialty under Open Payments but the reported provider has been verified as 
meeting the definition of a covered recipient, the specialty information is intentionally 
removed from public display.  
 
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A small percentage of Open Payment records 
contained inaccurate, imprecise, or inconsistent 
information  
We identified inaccurate, imprecise, or inconsistent data in fields within 
Open Payments records that were not addressed by the validation process 
described either by CMS or its Open Payments User Guide in operation 
during 2015.  This includes records that contained imprecise or inaccurate 
product names; NDCs that were not found in FDAs NDC databases or 
other drug information resources; and payment dates outside of the 
reporting year.   
For thousands of records, values within product-name data 
elements did not appear to be names of specific products 
For at least 100,000 records, manufacturers and GPOs entered text for 
drug and device names that were not product names or were not specific 
enough to identify the products.  There were 6,630 records in which 
manufacturers and GPOs indicated that a payment was related to 
a covered drug or device, but in the drug-name field or device-name field, 
they entered text such as no product discussed or no product specified.  
Additionally, some manufacturers and GPOs entered a single digit or 
a disease type within the drug-name field or device-name-field.  
Therapeutic areas and product categories that some manufacturers and 
GPOs reported were overly broad and/or inconsistently reported.  Unlike 
with covered drugsfor which CMS requires actual namesfor covered 
devices, CMS allows manufacturers and GPOs to report a devices 
therapeutic area or its product category, rather than the actual device 
name.  Some manufacturers and GPOs were very specific when reporting 
device names.  However, in hundreds of thousands of records, the 
therapeutic areas and product categories that some manufacturers and 
GPOs used were extremely broad.  For example, approximately 6 percent 
of all device-related records on the Open Payments website included just 
the name of a body part, such as elbow or shoulder, rather than an 
actual device name.  The three devices associated with the highest 
payments ($153 million) were hips, spine, and knees.  The use of 
broad categories rather than actual device names makes it difficult for 
consumers to determine whether any devices used or proposed to be used 
as part of their care were associated with payments received by their 
respective health care providers. 
 
 
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Nine percent of records contained NDCs that were not found in 
multiple FDA databases or other drug information resources 
Approximately 1.1 million records, or 9 percent of all records, contained 
NDCs that were not found in multiple FDA databases or other drug 
information resources.  These records were associated with $302 million 
in payments.  Of the 1,265 NDCs associated with payments published on 
the Open Payments website, 110 NDCs (9 percent) were not found in 
these databases or resources.  Although the Open Payments system 
validates whether the NDC associated with a given payment is in the 
correct submission format, the system does not determine whether 
that NDC is valid.  Requiring valid NDCs would enable researchers to 
perform more thorough analysis of Open Payments data.   
A small number of records were associated with payment 
dates outside the year 2015  
Although the Open Payments system validates whether the payment date 
is in the correct submission format and whether the year reported is the 
same as the program year, we found that 565 records had a payment date 
that was either earlier or later than 2015.  According to CMS, 
manufacturers and GPOs that submitted records with dates outside program 
year 2015 were notified by phone and a followup email and were asked to 
correct the records, resubmit them, and provide re-attestations.  However, 
the corrected records were not reflected in the June 2016 publication of the 
data.   
CMS monitors Open Payments data to detect 
anomalies and addresses specific issues as they arise 
According to CMS, it conducts analyses of Open Payments data to identify 
manufacturers and GPOs that submitted data late, inaccurately reported 
dates, or deleted records from the system.  CMS also reported conducting 
analysis to ensure the integrity of the Open Payments program by looking at 
general statistics, such as the number of registrations, recertifications, data 
submissions, and corrections.  If CMS identifies any data inconsistencies or 
aberrant patterns, it conducts outreach to the manufacturers and GPOs or 
makes adjustments to the system.   
CMS has not yet conducted any audits of manufacturers and GPOs.  At the 
time of our review, CMS was in the process of developing audit strategies 
and audit plans in anticipation of conducting such audits.  Therefore, we did 
not receive any strategies or plans to review.  According to CMS, it is still 
compiling a list of noncompliant manufacturers and GPOs for further 
investigation. 
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CMS reported that it has established a protocol to address 
problems that manufacturers and GPOs have with validating 
recipient information 
Some manufacturers and GPOs were unable to submit all of their records to 
the Open Payments system because certain records did not pass the 
systems matching process.  This means that the recipient data that 
manufacturers and GPOs entered into the Open Payments system did not 
match CMSs data on recipients.  The matching process for information on 
physicians and teaching hospitals ensures that submissions include only 
physicians and teaching hospitals that meet the definition of a covered 
recipient established by Federal regulation and are identified by data 
sources available to CMS.   
To address this difficulty, CMS established a helpdesk protocol.  This 
protocol instructs manufacturers and GPOs to contact the Open Payments 
system helpdesk when data that they believe to be correct cannot get 
through the matching process.  It also instructs them to documentwithin 
the data field that contains reasonable assumptionsany cases in which 
they believe a recipient meets the definition of covered recipient.  CMS also 
advises manufacturers and GPOs to encourage recipients to keep their 
information updated in CMSs systems to minimize the possibility that 
out-of-date recipient information could cause complications in matching.  
CMS reviewed but did not follow up with manufacturers and 
GPOs that submitted reasonable assumptions 
Out of the 1,456 manufacturers and GPOs that reported payments, 
199 submitted reasonable assumptions.11  CMS stated that it reviewed all the 
reasonable assumptions, but did not conduct any followup with these 
reporting entities about their reasonable assumptions.  The reasonable 
assumptions submitted by these reporting entities included the following: 
  The methodologies used to calculate the values of the payments. 
o  For example, one manufacturer did not report the value 
associated with equipment and other materials provided 
during the course of its sponsored research. 
  Explanations as to why certain payments were excluded from being 
reported. 
 
11 When reporting reasonable assumptions, an additional 111 manufacturers and GPOs 
outlined only difficulties in trying to submit payment records, including those that CMS 
flagged as having invalid recipient information and those that were associated with 
students.  Another 11 manufacturers and GPOs stated that their assumptions were to be 
determined or that they would add assumptions at a later time.   
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o  For example, one manufacturer stated that payments made 
to physicians who were not on CMSs approved list of 
physicians were omitted.12  
  Descriptions of how payments were attributed to products. 
o  For example, some manufacturers reported the NDC related 
to the top-selling product in a product line or brand instead 
of the NDC that was associated with the payment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
12 CMS makes available to reporting entities a Validated Physician List that includes 
identifying information for physicians.  This list is meant to be used as a tool to help 
prepare Open Payments records.  CMS states that it is not an exhaustive list of all 
physicians who should be included in Open Payments reporting. 
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CONCLUSION AND RECOMMENDATIONS 
In 2014, manufacturers and GPOs began submitting information regarding 
payments or other transfers of value made to physicians and teaching 
hospitals to the Open Payments system.  The Open Payments program 
promotes transparency by publishing data on financial relationships that 
physicians and teaching hospitals have with manufacturers or GPOs.  
Transparency protects patients by revealing the nature and extent of these 
relationships and has the potential to discourage the development of 
inappropriate relationships.  The Open Payments program can benefit the 
public only if the data reported are complete and accurate.  As such, 
potential issues with these datalike those identified in this reviewmay 
undermine the public benefit of this program.   
CMSs key controls to ensure data integrity are its matching and 
validation processes.  However, our review found issues with the 
validation process, such as its allowing data values that did not match data 
element descriptions, and its allowing text that did not seem to be the 
names of actual products within product name fields.  In addition, CMS 
has yet to take any action against noncompliant reporting entities. 
Although manufacturers and GPOs included most of the required data 
elements in Open Payment records, more accurate and consistent data 
would help consumers better use the information.  To that end, we 
recommend that CMS take a number of practical steps to improve the 
accuracy, precision, and consistency of the data. 
Ensure that records contain all required data 
Even though most records were complete, some were missing required 
elements.  To ensure completeness, CMS should review its current 
validation process to determine why records that were missing required 
data elements were accepted by the Open Payments system and make 
adjustments as necessary.  
Strengthen validation rules and revise data-element definitions 
so that actual drug and device names must be reported 
Data validation rules should be strengthened and data element definitions 
revised so that manufacturers and GPOs cannot enter just a single digit or 
other invalid text in the fields for drug or device names.   
Revise the definition of the device-name data element so that 
the information reported in this field is required to be more 
specific 
CMS allows manufacturers and GPOs to report the therapeutic area or 
product category of devices rather than actual device names.  However, 
the therapeutic areas and product categories that some manufacturers and 
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GPOs reported were both extremely broad and inconsistently reported.  
More specific device names would enable consumers to determine 
whether their providers received payments related to devices that the 
providers used or planned to use as part of the consumers care. 
Ensure that manufacturers and GPOs report valid NDCs for 
drugs 
CMS should implement a validation step that determines whether the 
NDCs provided are valid.  CMS could use FDA data, widely used 
compendia, or its own drug product data to determine whether the NDCs 
that manufacturers and GPOs report are valid and correct.  Requiring valid 
NDCs will enable researchers to perform more thorough analysis of Open 
Payments data.   
 
   
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AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
CMS concurred with all four recommendations.   
CMS concurred with our recommendation to ensure that Open Payments 
records contain all required data.  CMS stated that it will continue to 
implement strategies to improve the completeness of data submissions. 
CMS concurred with our recommendation to strengthen validation rules 
and revise data element definitions so that actual drug and device names 
must be reported.  CMS stated that it is working to strengthen validation 
processes to ensure that actual drug names are reported and are accurate.  
With respect to devices, CMS stated that a unique device identification 
system is necessary to validate reported device names.  CMS is exploring 
various options to incorporate this information. 
CMS concurred with our recommendation to revise the definition of the 
device-name data element.   
Finally, CMS concurred with our recommendation to ensure that valid 
NDCs are reported for drugs. 
We appreciate CMSs efforts to improve the accuracy and consistency of 
Open Payments data and look forward to working with CMS on these 
issues in the future.   
The full text of CMSs comments is provided in the Appendix. 
   
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APPENDIX  
    Agency Comments 
 
 
 
 
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ACKNOWLEDGMENTS 
Tanaz Dutia served as the team leader for this study.  Others in the Office 
of Evaluation and Inspections who conducted the study include  
Nancy J. Molyneaux.  Office of Evaluation and Inspections staff who 
provided support include Joe Chiarenzelli, Kevin Farber, Dave Graf, 
Christine Moritz, and Meghan Riggs.  
This report was prepared under the direction of Linda Ragone, Regional 
Inspector General for Evaluation and Inspections in the Philadelphia 
regional office, and Edward Burley, Deputy Regional Inspector General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov. 
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Office of Inspector General 
https://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.