Next Generation Compliance

Using Analytics to Reduce Compliance Risk

Benjamin YaoDirector Transparency Global Ethics & Complianceat Astellas Pharmaceuticals

Mohammad OvaisFounder & CEO qordata

Kelly TopeDirector of Compliance Zimmer Biomet

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address them in the Q&A section

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Compliance Directors were asked ….

what I don’t know missing data & outliers outliersyou had the data, why you did not know?

What keeps you up at night?

Inquiring Minds — How to Use Data Analytics to Assess Compliance Risks - CBI Conference, Washington, DC 2016

PANELISTS: Chad Morin, Director, ARIAD Pharm., Inc.

Timothy M. Roberts, Director, Daiichi Sankyo.

Paul Steele, Director, Sunovion Pharm., Inc. Heather McCollum, Director, Shionogi Inc.

Agenda Introduction Mohammad Ovais

Kelly Tope

Find non-compliantpayments.Identify outliers based on benchmarks and businessrules.Competitor bench-markingand analysis.

General complianceAuditing and monitoring.“Advanced” monitoringusing Open Paymentsdata.Future analytics

Benjamin Yao Mohammad Ovais

qordata’s OpenPayments Analytics toanalyze spendingpatterns and covercompliance risks

Benjamin Yao is responsible for US transparency activities at Astellas Pharmaceuticals, a top 20 international pharmaceutical organization. He is a member of the PhRMA Sunshine Act Reporting Work Group and Chicagoland Transparency Roundtable. Ben received his MBA from Emory’s Goizueta Business School.

Benjamin YaoDirector Transparency Global Ethics & ComplianceAstellas Pharmaceuticals

Kelly Tope, Esq., MBA is the Director of Compliance and Transparency Reporting, US & Canada for Zimmer Biomet. Kelly’s primarily responsibilities include HCP arrangements, transparency reporting, compliance training, and IT systems relating to compliance (e.g. aggregate spend, HCP contracting, LMS, policy management).  Kelly previously held the role of Director – Global Compliance Operations at Biomet.  Prior to Biomet, Kelly practiced corporate law at Lewis & Kappes in Indianapolis, specializing in health care, tax, and technology.  Before becoming an attorney, Kelly worked as a consultant for Deloitte (Chicago office) specializing in electronic medical records systems implementations and revenue cycle redesign.

Kelly TopeDirector of Compliance Zimmer Biomet

Our speakers today

Benjamin YaoDirector Transparency Global Ethics & Complianceat Astellas Pharmaceuticals

o General compliance auditing and monitoring

o Advanced monitoring using Open Payments data

o Future analytics

Disclaimer

The views and opinions expressed in this presentation are those of the speaker, and do not reflect the official policy or position of Astellas Pharmaceuticals or any of

its affiliates or subsidiaries.

Organization Needs• The pharmaceutical industry is highly scrutinized by

the public and government, placing a emphasis on transparency initiatives:• Continuous adherence to federal and state legislation

governing interactions with Healthcare Professionals and Organizations

• Effective mitigation of risks associated with these relationships

• It is our responsibility to ensure our compliance programs are effective and that our HCP interactions are compliant:• OIG's 7 Elements of an Effective Compliance Program

Types of Analytics & Rules for the Road• The Open Payments program created an opportunity

for E&C programs to capture and analyze organization level spend data

• You can use analytics and data to tell any story• Identifying the key questions for analysis is the most

important step• Disclose up front the limitations on the data

Source: http://www.rosebt.com/blog/descriptive-diagnostic-predictive-prescriptive-analytics

Educational Meal Spend• Key Question: Are Meals provided to HCPs as part of an

educational presentation compliant with regulations and policies?

• Areas of Governance: PhRMA Code of Interactions with HCPs, Company HCP Interactions Policy, Time & Expense Policy, state specific legislation, etc.

Total HCP Spend vs. Instituted Cap(s)• Key Question: How much has the organization “spent” on an

HCP as compared to set caps? Does the spend breakdown make sense in relation to one another?

• Areas of Governance: Company HCP Interactions Policy, Code of Conduct, state specific legislation (MN, CA), Corporate Integrity Agreement (if applicable), etc.

Medical Reprint Distribution• Key Question: Are reprints being distributed to the appropriate

audience? Are they distributed in a consistent and compliant fashion (by HCP, by territory)?

• Areas of Governance: PhRMA Code, Excluded Specialties Policy, etc.

Approved specialties?

“Advanced Analytics” using Open Payments data• Outlier Analyses: Are products in similar TA and treatment

classes reporting similar funding for education, research, and commercial purposes?

• Are KOLs being accurately tiered (for FMV purposes)?

Future Analytics• Industry colleagues have shared areas of analysis

that have provided positive results within their respective organizations:• Samples provisions – geographic and quantity analyses by

representative layered on top of Open Payments spend. This can in turn help drive additional policy and procedure controls for samples dissemination

• Anti-Bribery, Anti-Corruption (Foreign Corrupt Practices Act, UK and US Anti-Bribery Laws) – spend by purpose, affiliate/subsidiary and geographic area, which can in turn help identify risk areas for targeted review

o Find non-compliant payments o Identify outliers based on benchmarks and

business ruleso Competitor bench-marking and analysis

Kelly TopeDirector of Compliance Zimmer Biomet

Disclaimer

This presentation was prepared by Kelly Tope in her personal capacity. The information, views, and opinions expressed in this presentation are her own and do not necessarily reflect the views and opinions of Zimmer Biomet.

All materials have been prepared for informational purposes only and not for the purpose of providing legal advice. The information presented is not legal advice, is not to be acted on as such, and is subject to change without notice.

Data/Analytics Continuum

Organizational Value & Systems ComplexityLow Value High Value

Manage riskMonitor behaviorBenchmarkingPost-reporting

analytics

Real-time analysisPredict behaviors

Business intelligenceBig picture+

Basic Functional Optimal

Disparate data sources

Lack of integrationInability to see big

pictureFacilitates

transparency reporting only

Organizational Uses for Data AnalyticsKey compliance uses

• Identify legal or compliance violations.

• Identify high risk areas to better target, monitor and audit activities.

• Identify and manage perceived off-label use of products or devices.

• Provide reports and dashboards to business stakeholders for certification and approval of data prior to report submission to states and federal government.

Key business uses• Enhance decision making

in commercial operations.• Identify ways to streamline

costs.• Identify competitor activity.• Benchmark HCP and HCO

spend.• Identify potential

researchers.• Budgeting.

Find Non-Compliant Payments

Exceeds cap: $150 dinner limit

Find Non-Compliant PaymentsImproper recipients or arrangements

Identify outliers based on benchmarks and business rules

Kelly TopeDirector of Compliance Zimmer Biomet

Visualize outlier physician spend and drill down for detailed list of transactions.

Title

Contrast and compare CMS data for competitive insights

Benchmark competitor spend by physician

Identify the top paid physicians by competitor

Determine whether competitors are paying your top paid physicians

Review natures of categories vs competitors

Spending trends compared to competitors

Specialty groups utilized by competitors

o qordata’s Open Payments Analytics to analyze spending patterns and cover compliance risks

Mohammad OvaisFounder & CEO qordata

Common Compliance use cases for analytics

1. Executive Summary & metrics

2. Outlier Analysis

3. Off Label Spending

4. Kick back Analysis with Prescription dataBeyond Open Payments

you had the data, why you did not know?

Find what’s in your data.

Reduce risk of reporting errors and outliers.

Detect questionable spend early.

Do more with less resources

How compliance teams are using analytics in your peer organizations

Learned TodayCan it help?

Adding analytics function in the compliance team …

Next StepsWould analytics be valuable to our compliance team?

Next Steps …You Can Get Ready Access (Subscription) to try Open Payments Analytics Complete Solution:

• 30 day risk-free trial if you sign up by Sept 30th 2016 and mention this webinar.

• We will even load your 2016 data as well

• Multiple logins for your team and other departments

• Create 1 custom dashboard based on your requirements

Next Steps …You Can Get Ready Access (Subscription) to try Open Payments Analytics Complete Solution:

• 30 day risk-free trial if you sign up by Sept 30th 2016 and mention this webinar.• We will even load your 2016 data as well• Multiple logins for your team and other departments• Create 1 custom dashboard based on your

requirements

Q&A

Next Webinar:

Retrospect and Looking Forward A Review of Two Full Years of Open Payments Data and Media CoverageT H E I N D I C A T I O N S F O R T H E F U T U R EOctober 13, Thursday at 11 AM CST. 

Thomas Sullivan

Former political consultant who founded Rockpointe, Inc., a bio-medical education company in 1995

Founder CME Coalition and Co-Founder ACRE

Editor of Policy and Medicine Publisher Life Science Compliance

Update

Thank You