Life Sciences Summit on Operational Best Practices in Compliance

While the strategic goal of any compliance program is to promote ethical and compliant behavior in the way the organization conducts business, an operational objective is to ensure controls and frameworks are in place to mitigate risks. To do this, compliance teams must be sure they are focusing their resources and efforts in the right places. There are a number of factors that weigh into risk assessment including the type of products being sold, the company’s risk tolerance, and so forth. Knowing where the government focuses its enforcement efforts is another variable to consider. In this unique panel discussion, using hypothetical fact patterns, hear what really strikes prosecutors as meaningful – from both those currently involved in government enforcement and those who were previously prosecutors but are now in house.

• Explore hypothetical fact patterns to learn what types of behaviors, activities, policies, etc. are most poignant during government inquiries and investigations
• Examine how current in-house legal and compliance executives view different areas of risk given their prosecutorial background
• Debate whether the same areas most focused on when a prosecutor are the same areas focused on now, and vice-versa

As the health care market evolves, the role of the payer has become increasingly important to an organization’s commercial strategy. This is being amplified by the changing payer marketplace – including the consolidation of the largest private payer organizations, the shift toward value-based payment structures, new delivery models such as ACOs, and opportunities for collaboration between manufacturers and other stakeholders in the value chain. These changing dynamics are forcing the industry to change its business processes, and as such creating new compliance risks that must be addressed from a compliance operational perspective.

• Discuss how these changing risks impact your 2016 annual work plan
• Explore the operational capabilities necessary to put controls in place to mitigate these risks
• Identify the policies and SOPs that must be re-assessed to ensure they address the business operations that are adapting to the new model
• Determine whether new policies must be created for payer marketing groups, or how to expand existing health care policies
• Highlight the areas of potential concern related to new ways companies are engaging payers, providers, and patients, and addressing managed markets and reimbursement scenarios
• Identify the impact on compliance regarding scenarios such as:
• Are companies going to be more aggressive in their discounting?
• Will the consolidation of the private payer market mean that they have more leverage/purchasing power?
• What do GPO interactions look like now?
• How is the growing specialty pharmacy arena changing operations?
• Will the government and payer organizations put more pressure on the co-pay mitigation programs that companies offer, impacting the future of these programs?

The industry is in an era of rapid change and with it, the business models of life sciences organizations are evolving. Business models are changing in a number of ways: whether due to new leadership or organizational structure (therapeutic/disease state focus or geographical, from growth, acquisition, or consolidation, etc.); or simply how internal resources are developed, devoted to, and interacting with varying customers (patients, HCPs, and payers). This session examines the operational implications of these changing business models to ensure compliance programs, processes, and resources keep pace.

• Examine whether the traditional compliance program structure and areas of focus are appropriate within the current business model
• Distinguish areas to re-assess with an eye towards integration, coordination, and capabilities
• Identify where programs and resources must shift to put controls in place to detect and mitigate risks in new models

Whether your organization already has a global compliance infrastructure, or is just developing a footprint outside of the U.S., compliance teams must be sure that their people, structure, capabilities, and operational effectiveness can address global expansion.

• Explore the operational pain points, opportunities, and realities of a global compliance infrastructure
• Discuss ways to create harmony with internal processes to manage relationships with HCPs across affiliates
• Identify strategies to deputize international team members to support compliance programs abroad
• Implement procedures to optimize limited international resources by transferring system ownership to other departments
• Communicate the importance of this system ownership to business leadership
• Achieve program success with proactive communication and supporting resource development
• Evaluate operational processes to ensure program effectiveness around U.S. and global Anti-Bribery, Anti-Corruption, and Anti-Kickback rules, regulations, and laws

To achieve operational effectiveness, compliance departments should re-assess areas where they could streamline operations, transfer processes or system ownership to the business, or outsource all together. Identify areas that compliance doesn’t need to own, and learn through case examples how organizations were able to transfer responsibilities yet still stay involved for support and oversight. Each case study demonstrates:

• Motivations for transferring the process or system ownership
• Explore what needs to be done in different phases of the transfer
• Anticipated barriers to making it a reality
• Actual barriers that weren’t initially considered
• Examples of how barriers were overcome and lessons learned
• Benefits realized after the shift occurred

Organizations can improve the effectiveness of their live speaker program monitoring by training and deploying internal resources from other parts of the business, including medical affairs, commercial, and audit. This approach allows an organization to reduce costs while building a culture of shared accountability to ensure promotional activities are conducted consistent with policy. Furthermore, building the expertise of internal monitoring personnel helps avoid false positives/false negatives and ensure trust. Explore how using collaboration with the business to conduct its live speaker program monitoring and other field sales monitoring activities improves compliance operations in regards to its detective controls.

Informal discussion among peers, kept on point by knowledgeable facilitators, is a proven method of effective best practice sharing. Participate in one of the below roundtable discussion groups to share real-life experiences, lessons learned, and practical applications to improve your professional and program effectiveness.

Discussion Topics Include:

• Integration of compliance processes during M&A;
• The advantages and disadvantages of separating legal and compliance function
• Best ways to handle investigative and disciplinary policies and actions
• Challenges of global HCP management and data privacy implications