Evaluating the Effectiveness of a Corporate Compliance Program: A Holistic Approach

Why Should You Attend:

Life sciences compliance professionals in organizations, who are charged with the responsibility of implementing a corporate compliance program, are likely to believe that they have put in place an effective program. But how do compliance professionals know if their program is really managing risk if they have not actually tested the program’s effectiveness?

This webinar will examine the importance of evaluating the effectiveness of a corporate compliance program and provide insights on the methodologies for conducting such an evaluation. It will explore the enforcement environment faced by life sciences companies and the specific requirements imposed on the boards of directors by Office of Inspector General (OIG) Corporate Integrity Agreements to evaluate the effectiveness of corporate compliance programs.

Areas Covered in the Webinar:

• Corporate Integrity Agreement requirements
• Taking a holistic approach in evaluating effectiveness of corporate compliance programs
• Assessment of each element of your corporate compliance program
• Assessment of overall success of your corporate compliance program
• PhRMA Code external verification

Who Will Benefit:

This webinar will prove beneficial to personnel in life sciences companies/organizations receiving public payor reimbursement, and those working with pharmaceutical companies, medical devices companies and healthcare providers. Employees with key responsibilities who will benefit include:

• Chief compliance officers and their staff
• Chief risk officers and their staff
• Enterprise risk management personnel
• General counsel/healthcare compliance legal counsel
• Members of compliance committees
• Senior management with responsibility to manage risk
• Board of directors

Instructor Profile:

Brian Dahl has built corporate compliance programs from the ground up at two pharmaceutical companies – Teva Pharmaceuticals and Takeda Pharmaceuticals – and brings that experience to the service of ProPharma Group clients who are in the process of developing, implementing, maintaining, or continuously improving their corporate compliance programs. His in-house experience uniquely qualifies him to understand the realities of both implementing a corporate compliance program in today’s challenging enforcement environment and positioning the compliance function as a valued business partner within a pharmaceutical company. He is a recognized subject matter expert on pharmaceutical corporate compliance and a frequent speaker on the topic.

Mr. Dahl’s career in pharmaceutical corporate compliance began in 2001, at the very beginning of the enforcement era against the pharmaceutical industry. Six months before the government’s seminal settlement with TAP Pharmaceuticals, Brian joined Takeda’s law department and took on the responsibility of building Takeda’s corporate compliance program. He later created and led Takeda’s Office of Ethics & Compliance to formalize the company’s compliance infrastructure. Brian received his J.D. from the University of Iowa College of Law and his Master of Health Administration degree from the College of Public Health at the University of Iowa.

Topic Background:

Time and time again, government enforcement officials have made it clear that life sciences companies and organizations must do more than merely put in place a corporate compliance program that looks great on paper. Companies and organizations that fail to put in place effective corporate compliance programs run the risk of not having the appropriate controls in place to manage the risk of their activities running afoul of federal healthcare program requirements.

Violations of federal healthcare program requirements can have severe implications, including criminal and civil enforcement actions against both entities and individuals. Allegations of violations of statutes such as the Food, Drug and Cosmetic Act, the Anti-Kickback Statute, and the False Claims Act frequently result in monetary penalties that can reach into the tens and hundreds of millions of dollars. Even smaller companies and organizations can find themselves paying out a significant percentage of their annual revenues to settle such allegations. And these amounts do not include the resources that an organization must commit to satisfying the terms of a Corporate Integrity Agreement or other similar settlement agreement, which generally require both putting in place a government-dictated corporate compliance program and engaging a third-party reviewer to oversee and assess that program. Moreover, the threat of exclusion from participation in federal healthcare programs looms as an enormous stick in the OIG’s arsenal that allows it to coerce companies, organizations, and individuals to settle enforcement actions on onerous terms.

The OIG encourages and, through its Corporate Integrity Agreements, requires companies to do auditing and monitoring of specific types of activities to test that their programs are managing risk. Evaluating the effectiveness of a corporate compliance program is a holistic approach to doing this sort of testing that takes into account multiple subjective and objective measures to validate that a program is, in fact, managing risk.

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