Brian Dahl & Mohammad Ovais Data Driven Enforcement Risks of Open Payments and Medicare Part D Data
Brian Dahl & Mohammad Ovais
Data Driven EnforcementRisks of Open Payments and
Medicare Part D Data
Presenters
Mohammad Ovais is the Founder & CEO at qordata and has spent a decade building analytical solutions and applications for Fortune 1000 companies. Prior to this, he served as the Managing Partner/Co-Founder at Streebo. With a Bachelor in Computer Science from Rice University and EMP from MIT, he serves on the board of Entrepreneur Organization as Strategic Alliances Chair.
Mohammad OvaisFounder & CEO qordata
Brian A DahlPrincipal, Dahl Compliance Consulting LLC
Brian A. Dahl is the Principal at Dahl Compliance Consulting LLC., which is a consulting practice focused on assisting life sciences companies with their corporate compliance needs. Over the course of his experience, he has helped structure the corporate compliance programs at two top-tier pharmaceutical companies, Takeda Pharmaceuticals and Teva Pharmaceuticals. He previously practiced health law at a law firm called Baker & Daniels along with the Federal Trade Commission and Collier, Shannon, Rill & Scott.
Agenda• Implications of Transparency of
Spend Data• Case Study: Insys Therapeutics• Using Data Analytics to Identify
Potential Risk
• 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
• Launched 1st Drug (Subsys) in March 2012
• Sublingual Fentanyl Spray for Breakthrough Cancer Pain– Sudden, temporary flares of severe pain– Black box Warning– Risk Evaluation and Mitigation Strategy (REMS)
• Significant Spend on Physicians Reported to CMS
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Multiple instances drawing correlations between Insys spend data and Subsys prescription data
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
Case Study: Insys Therapeutics
$44,100.00 in compensation from Insys for speaking/consulting
$30,700.00 in compensation from Insys for speaking/consulting
Dr Awerbuch
Physician Name State
Total Prescription
Amount Amount 2013 Amount 2014GAVIN AWERBUCH MD PLLC MI $10,137,350.03 $6,443,778.33 $3,693,571.70 MAHMOOD AHMAD AK $3,829,292.10 $3,829,292.10 JOHN COUCH AL $3,316,811.38 $887,855.82 $2,428,955.56 STEVEN CHUN FL $3,275,021.75 $495,399.53 $2,779,622.22 JOHN MILNOR TN $2,761,229.20 $570,868.70 $2,190,360.50 CHRISTOPHER CLOUGH NH $2,566,636.46 $827,086.85 $1,739,549.61 BART GATZ FL $2,539,642.35 $709,095.63 $1,830,546.72 FERNANDO AVILA TX $1,969,125.86 $93,366.37 $1,875,759.49 JEFFREY GOLDSTEIN NY $1,895,679.28 $305,507.34 $1,590,171.94 JEFFREY KESTEN CO $1,894,687.22 $351,987.67 $1,542,699.55
Top Prescribers for Subsys
Dr Awerbuch prescribed 3x more subsys then the next highest prescribing physician
Dr Awerbuch
Dr Gavin IRA Awerbuch
Open Payments with Med Part D
Pres
crip
tions
Spend
Lower Risk
Lower Risk
High Risk
Open Payments with Med Part D
Pres
crip
tions
Spend
Lower Risk
Lower Risk
High Risk
Open Payments with Med Part D
Pres
crip
tions
Spend
Lower Risk
Lower Risk
High Risk
Insys TherapeuticsLower Risk
Lower Risk
High Risk
Dr Judson Somerville – Speaker Programs
Dr Judson Somerville(spend vs prescriptions)
1
2
3
• High percentage of spend from a single company– Generally > 50%
• High percentage of spend on speaker fees/consulting– Generally > 70%
• High proportion of scripts written for that company– Generally > 50%
High risk physicians – common elements
Case Study: Insys Therapeutics
http://sirf-online.org/2015/07/14/the-darkening-world-of-insys-therapeutics/
Case Study: Insys Therapeutics
http://sirf-online.org/2015/07/14/the-darkening-world-of-insys-therapeutics/
Case Study: Insys Therapeutics
Insys TherapeuticsLower Risk
Lower Risk
High Risk
Dr Gordon Freedman – Speaker Programs
Dr Gordon Freedman (spend vs prescriptions)
1
2
3
Case Study: Insys Therapeutics
TRICARE Prescriptions
1/1/13-5/31/14
Insys TherapeuticsLower Risk
Lower Risk
High Risk
Dr John Couch – Speaker Programs
Dr John Couch(spend vs prescriptions)
1
2
3
Dr Ruan Xiulu – Speaker Programs
Dr Ruan Xiulu (spend vs prescriptions)
1
2
3
Dr Madison
Dr Gavin IRA Awerbuch
Dr Madison
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
• Waiting for the Other Shoe to Drop
Statements from the OIG
Statements from the OIG
Recommendation – Know YOUR data!• Data analytics are central to managing risk
• Transparency of spend data increases the risk of data being used against you
• With three years of spend data available, expanded mining of this data is inevitable
• Identify Outliers• Perception of correlation between high spend and high prescriptions• Speaker program payments are an enforcement priority
• Open Payments and Medicare Part D data are a good start but still reactive
• Explore ways to do more real time data analytics• Think about other data sets and data dashboards
Options to get startedInternal Build
Data sets are downloadableEngage internal IT
Volume of dataMerge/match PhysiciansData cleansing
3-6 months project
Pre-built Compliance Analytics platform
Immediate availability
Review data before next spend submission cycle
Time to value: 1-2 weeks
Thank You