This presentation is meant to help you understand how you, as a pharmaceutical company, can protect yourself from risks of audit and fines even before you submit your final report to CMS.

1. By Ned Mumtaz, Brian A. Dahl & Mohammad Ovais
Session Moderator: Thomas Sullivan
Webinar: Managing the Risks of Open Payments – Validate Spend
Report Before CMS Submission
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2. qordata is a data analytics and integration company
specializing in pharmaceutical, biotech and medical
device industries. With a DNA in data integration and
analytics, qordata provides software and tools to
extract insights for decision making from a variety of
publicly available data sets. Our consulting services
enable pharma, biotech and device companies to
operationalize the use of data based decision making
across business functions such as compliance and
marketing.
About qordata
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4. Speaker
Presentations
Demonstration
of Compliance
Scenarios
Q&A
Webinar Flow
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5. • Introduction
• Implications of Transparency – Case Study
• Evaluation of Spend Before CMS Submission
• Platform Demonstration
• Q&A
Agenda
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6. Thomas Sullivan
Editor-in-Chief – Policy and Medicine
Editor/author of popular website Policy and Medicine, ranked #1 by Google for five years, which
covers important compliance and regulatory issues effecting the pharmaceutical and device industry.
Brian A. Dahl
Principal - Dahl Compliance Consulting LLC
Architect of the Corporate Compliance Programs at two top tier pharmaceutical companies.
Independent compliance consultant, author and a frequent speaker on compliance-related topics.
Ned Mumtaz
Practice Lead, Life sciences – qordata
Leads the qordata transparency directive program in the US & EU and has over 15 years of
pharmaceutical industry experience as IT Director for several manufacturers.
Mohammad Ovais
CEO – qordata
Leads the Information Management Practice at qordata (formarly a division of Streebo). He is an
expert in data management and analytics. Prior to launching Streebo in 2008 he held various
positions at Kalido Inc., IBM, and Bowstreet.
Speakers Profile

7. Data Mining and Transparency
Gold Mining the FCA and the Emergence of the
Data Driven Whistle Blower (LSCU 1/16)
Using Open Payments Data to Support Corporate
Liability (LSCU 1/16)
Using the Open Payments System as Compliance
Tool (P&M 11/11/15)
• “Pharmaceutical and device companies can
expect federal agencies to begin pursuing
enforcement actions against companies that fail
to comply with Open Payment reporting
requirements within the next year.”
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8. Objective:
To give Compliance Teams analytical tools and techniques to utilize for
evaluating spend before CMS submission
Expected Result / Key Take-away:
At least one analytical tool or method to utilize to reduce compliance
program risks for 2015 spend submission
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9. Implications of Transparency
Brain A. Dahl
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10. Open Payments Data
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11. • Penalties for What is Not Reported
– $1,000-$10,000/transaction up to $150,000
– $10,000-$100,000/transaction up to $1 million
• Penalties for What Is Reported
– Kickbacks
– False Claims
Implications of Transparency
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12. • Launched Subsys in March 2012
• Sublingual Fentanyl Spray for Breakthrough Cancer Pain
– Sudden, temporary flares of severe pain
• Blackbox Warning and Subject to Risk Evaluation and
Mitigation Strategy (REMS)
Case Study: Insys Therapeutics
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13. Case Study: Insys Therapeutics

14. Case Study: Insys Therapeutics
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15. Case Study: Insys Therapeutics
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16. Case Study: Insys Therapeutics
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17. Case Study: Insys Therapeutics
1. $64,315
2. $61,232
3. $53,085
4. $46,452
5. $43,513
6. $43,154
7. $41,400
8. $41,225
9. $37,382
10. $36,448
Top 10 Physicians for Speaker / Consulting Fees
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18. Case Study: Insys Therapeutics
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19. Case Study: Insys Therapeutics
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20. Case Study: Insys Therapeutics
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21. Case Study: Insys Therapeutics
http://sirf-online.org
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22. Case Study: Insys Therapeutics
http://sirf-online.org/2015/07/14/the-
darkening-world-of-insys-therapeutics/
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23. Case Study: Insys Therapeutics
http://sirf-online.org/2015/07/14/the-
darkening-world-of-insys-therapeutics/
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24. Case Study: Insys Therapeutics
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25. Case Study: Insys Therapeutics
TRICARE
Prescriptions
1/1/13-5/31/14
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26. Case Study: Insys Therapeutics
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27. Dr. Awerbuch Criminal Complaint
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28. Dr. Awerbuch Criminal Complaint
• $46,600.00 in compensation from Insys
for speaking/consulting
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29. Case Study: Insys Therapeutics
• Company Announced Subpoenas
• December 2013 from OIG requesting documents relating to
commercialization of Subsys
• September 2014 U.S. Attorney District of MA requesting
documents relating to sales and marketing practices for
Subsys
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30. Learnings from the OIG
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31. Evaluation of Spend Before CMS Submission
Ned Mumtaz
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32. Typical Spend ReportingRisks
Incomplete
Spend report
• Missing spend
transactions
Incorrect
Spend report
• Spend amounts
are incorrect
• Improper
classification
Suspect
Spend
• False claim
• Fraud
• Questionable
spend (excessive
for a category)
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33. Challenges in Monitoring Spend Data for Completeness and Accuracy:
Aggregated transactions require context and ease of use.
Too many individual spend transactions to monitor.
Engage multiple stakeholders to verify spend.Accuracy:
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Too many individual spend transactions to monitor.
Aggregated transactions require context and ease of use.Volume:
Method:
Too much effort to chase individual exceptions.
Need systematic plan to regularly monitor.

34. Method:
Challenges in Monitoring Spend Data for Completeness and Accuracy:
Aggregated transactions require context and ease of use.
Too many individual spend transactions to monitor.
Too much effort to chase individual exceptions.
Need systematic plan to regularly monitor.
Volume:
Engage multiple stakeholders to verify spend.Accuracy:
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35. Platform Demonstration
Mohammad Ovais
Context & Ease of Use
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36. Challenges in Monitoring Spend Data for Completeness and Accuracy:
Too many individual spend transactions to monitor.
Aggregated transactions require context and ease of use.
Too much effort to chase individual exceptions.
Need systematic plan to regularly monitor.
Volume:
Method:
Engage multiple stakeholders to verify spend.Accuracy:
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37. Platform Demonstration
Mohammad Ovais
Manage Exceptions
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38. Platform Demonstration
Mohammad Ovais
Engage Stakeholders
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39. Ready platform to manage risk before submission40
Pharma/Device
Companies
Utilizing the Platform
Ready built SaaS solution
(SaaS: Software as a Service)
2013/2014 CMS data pre-loaded
Readily add 2015 company data
Prebuilt monitoring dashboards
Easy to use and track
Enterprise wide access to
Shared reports and notifications
+ Manufacturers current year spend.
- History, Industry, Competitors, etc.
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40. Published Data
2013
2014
2015 (when available)
Internal Data
Current Year
From Agg Spend
System
2015
Other Data
(Medicare Part D,
EFPIA when
available)
Overview
Trends
Comparisons
Management Reports
Compliance Dashboards
Outliers
New Physicians
Peer comparison
Ad-Hoc Analysis
For Analysts
Access to all
Data
Compliance Data Flow
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41. “Open Payments Analytics provides new
insight into the reams of physician
payment data that, due to the shear file
size, has so far been near impossible to
achieve.” –
Policy and Medicine
“qordata comes in with a portal that
organizes the data by physician,
specialty, originating payer, geography
and time…. qordata offers customized
analytics solutions on top of the data”–
Pharmaceutical Commerce
Recognition – In the media
“Pioneering Business Intelligence for the
Pharma Sector”
CIO Review
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42. Next Steps …
Utilize Open Payments Analytics Vital to audit your 2015 spend before submission
• Get up and running in a week (cloud software requires no installation)
• One year subscription will provide two year spend review (2015 and 2016)
• Risk-Free 100% refund policy
• Compatible with all leading aggregate spend tools
• Webinar specific special pricing –
if it saves you one penalty, it will pay for itself for a decade!
Compatible
with all
Aggregate
Spend tools
Risk Free
Subscripti
on Cancel
Anytime
100%
Money Back
Guarantee
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43. Q&A
Come meet us next week at
13th Annual Pharmaceutical Compliance Congress
Venue: THE RITZ-CARLTON - Washington, DC
Date: January 26-27, 2016
For more information and scheduling, contact:
Ned Mumtaz
Life Sciences Practice Leader
Ned.mumtaz@qordata.com
Tel: 201-753-1734
www.qordata.com

44. Takeaways
• Prosecutors and Qui Tam Attorneys Will Utilize Sophisticated Data
Analytics
• Monitoring and Reviewing your Ag Spend Data During the Year Is
Important
• There are Tools Available To Review Your Data
• Important to Look for Outliers and Perhaps Merge/Compare with
Other Data Sources for Analytics
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45. Thank You
Thomas Sullivan
Editor-in-Chief – Policy and Medicine
tsullivan@rockpointe.com
Brian A. Dahl
Principal - Dahl Compliance Consulting LLC
dahlcomplianceconsulting@gmail.com
Ned Mumtaz
Practice Lead, Life sciences – qordata
ned.mumtaz@qordata.com
Mohammad Ovais
CEO – qordata
mohammad.ovais@qordata.com
www.qordata.com