By Ned Mumtaz, Brian A. Dahl & Mohammad OvaisSession Moderator: Thomas Sullivan

Webinar: Managing the Risks of Open Payments – Validate Spend Report Before CMS Submission

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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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Speaker

Presentations

Demonstration of Complia

nce Scenario

s

Q&A

Webinar Flow

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• Introduction• Implications of Transparency – Case Study• Evaluation of Spend Before CMS Submission• Platform Demonstration• Q&A

Agenda

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Thomas SullivanEditor-in-Chief – Policy and MedicineEditor/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. DahlPrincipal - 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 MumtazPractice Lead, Life sciences – qordataLeads 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 OvaisCEO – qordataLeads 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

Data Mining and TransparencyGold 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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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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Implications of Transparency Brain A. Dahl

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Open Payments Data

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• 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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• 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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Case Study: Insys Therapeutics

Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

1. $64,3152. $61,2323. $53,0854. $46,4525. $43,513

6. $43,1547. $41,4008. $41,2259. $37,38210. $36,448

Top 10 Physicians for Speaker /

Consulting Fees

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Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

http://sirf-online.org

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Case Study: Insys Therapeutics

http://sirf-online.org/2015/07/14/the-darkening-world-of-insys-therapeutics/

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Case Study: Insys Therapeutics

http://sirf-online.org/2015/07/14/the-darkening-world-of-insys-therapeutics/

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Case Study: Insys Therapeutics

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Case Study: Insys Therapeutics

TRICARE Prescriptions

1/1/13-5/31/14

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Case Study: Insys Therapeutics

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Dr. Awerbuch Criminal Complaint

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Dr. Awerbuch Criminal Complaint

• $46,600.00 in compensation from Insys for speaking/consulting

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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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Learnings from the OIG

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Evaluation of Spend Before CMS SubmissionNed Mumtaz

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Typical Spend Reporting Risks

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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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.

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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Platform Demonstration

Mohammad Ovais

Context & Ease of Usewww.qordata.com

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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Platform Demonstration

Mohammad Ovais

Manage Exceptionswww.qordata.com

Platform Demonstration

Mohammad Ovais

Engage Stakeholderswww.qordata.com

Ready platform to manage risk before submission

40Pharma/Device

CompaniesUtilizing the

Platform

Ready built SaaS solution(SaaS: Software as a Service)

2013/2014 CMS data pre-loadedReadily add 2015 company data

Prebuilt monitoring dashboardsEasy to use and track

Enterprise wide access toShared reports and notifications

+ Manufacturers current year spend.- History, Industry, Competitors, etc.

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Published Data201320142015 (when available)

Internal DataCurrent YearFrom Agg Spend System2015

Other Data (Medicare Part D,EFPIA whenavailable) Overview

TrendsComparisons

Management Reports

Compliance Dashboards

OutliersNew PhysiciansPeer comparison

Ad-Hoc Analysis

For AnalystsAccess to all Data

Compliance Data Flow

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“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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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 Subscription Cancel Anytime

100% Money Back Guarantee

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Q&A

Come meet us next week at 13th Annual Pharmaceutical Compliance Congress Venue: THE RITZ-CARLTON - Washington, DCDate: January 26-27, 2016For more information and scheduling, contact:

Ned Mumtaz Life Sciences Practice Leader Ned.mumtaz@qordata.com Tel: 201-753-1734

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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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Thank You

Thomas Sullivan Editor-in-Chief – Policy and Medicine tsullivan@rockpointe.com

Brian A. DahlPrincipal - Dahl Compliance Consulting LLC

dahlcomplianceconsulting@gmail.com

Ned MumtazPractice Lead, Life sciences – qordata

ned.mumtaz@qordata.com

Mohammad Ovais CEO – qordata mohammad.ovais@qordata.com

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