Managing The Risk of Open Payments - Validate Spend Report Before CMS Submission
Download as PPTX, PDF1 like612 views
The webinar hosted by Qordata focuses on managing the risks associated with open payments reporting in the pharmaceutical sector, emphasizing the importance of evaluating spending before submissions to the CMS. Key speakers highlighted compliance challenges, potential penalties for inaccurate reporting, and demonstrated analytical tools designed to mitigate these risks. Participants were informed of the necessity for robust data management to prevent enforcement actions from federal agencies due to non-compliance with open payments requirements.
Managing The Risk of Open Payments - Validate Spend Report Before CMS Submission
- 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 www.qordata.com
- 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 www.qordata.com
- 3. • This webinar is being recorded. Recording will be provided after today’s presentation. • This is an hour long webinar. Plug in headsets or turn up your speakers. • You can connect via VoIP and Phone. • Your lines are muted. • Please ask your Questions via Panel on GoToWebinar. • We will address questions at the end of the webinar. • A copy of the presentation slide will be sent to you. • Please note all slides are copyrighted and maybe used with attribution to the copyright holder. • For anything related to webinar support, please call 832 772 6000 x 501 Webinar Housekeeping Rules www.qordata.com
- 5. • Introduction • Implications of Transparency – Case Study • Evaluation of Spend Before CMS Submission • Platform Demonstration • Q&A Agenda www.qordata.com
- 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.” www.qordata.com
- 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 www.qordata.com
- 9. Implications of Transparency Brain A. Dahl www.qordata.com
- 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 www.qordata.com
- 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 www.qordata.com
- 13. Case Study: Insys Therapeutics
- 14. Case Study: Insys Therapeutics www.qordata.com
- 15. Case Study: Insys Therapeutics www.qordata.com
- 16. Case Study: Insys Therapeutics www.qordata.com
- 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 www.qordata.com
- 18. Case Study: Insys Therapeutics www.qordata.com
- 19. Case Study: Insys Therapeutics www.qordata.com
- 20. Case Study: Insys Therapeutics www.qordata.com
- 21. Case Study: Insys Therapeutics http://sirf-online.org www.qordata.com
- 22. Case Study: Insys Therapeutics http://sirf-online.org/2015/07/14/the- darkening-world-of-insys-therapeutics/ www.qordata.com
- 23. Case Study: Insys Therapeutics http://sirf-online.org/2015/07/14/the- darkening-world-of-insys-therapeutics/ www.qordata.com
- 24. Case Study: Insys Therapeutics www.qordata.com
- 25. Case Study: Insys Therapeutics TRICARE Prescriptions 1/1/13-5/31/14 www.qordata.com
- 26. Case Study: Insys Therapeutics www.qordata.com
- 27. Dr. Awerbuch Criminal Complaint www.qordata.com
- 28. Dr. Awerbuch Criminal Complaint • $46,600.00 in compensation from Insys for speaking/consulting www.qordata.com
- 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 www.qordata.com
- 30. Learnings from the OIG www.qordata.com
- 31. Evaluation of Spend Before CMS Submission Ned Mumtaz www.qordata.com
- 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) www.qordata.com
- 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: www.qordata.com 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: www.qordata.com
- 35. Platform Demonstration Mohammad Ovais Context & Ease of Use www.qordata.com
- 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: www.qordata.com
- 37. Platform Demonstration Mohammad Ovais Manage Exceptions www.qordata.com
- 38. Platform Demonstration Mohammad Ovais Engage Stakeholders www.qordata.com
- 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. www.qordata.com
- 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 www.qordata.com
- 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 www.qordata.com
- 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 www.qordata.com
- 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 www.qordata.com
- 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