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

Q&A

Mohammad Ovaismohammad.ovais@qordata.comT: +1 832 860 3334

Brian Dahldahlcomplianceconsulting@gmail.comT: + 913-897-6790

Thank You