Compliance Auditing & Monitoring
Compliance Auditing & Monitoring
While it is important to take a detailed look at traditional areas of risk, it is equally important to know what is coming around the corner. Our clients rely on us to protect their value through the design of effective auditing and monitoring programs, methodologies and procedures in order to provide insights into what is next in the ever-evolving compliance landscape.
Government regulators have made it clear they want life sciences companies to be proactive in addressing areas of non-compliance in their organization. The first step in addressing non-compliance is to identify it.
As such, government bodies have dictated that life sciences, medical device and pharmaceutical organizations need to have a robust auditing and monitoring program in place.
The life sciences industry is constantly being bombarded with new and evolving regulatory guidelines, laws and subsequent enforcement actions. It is imperative that companies remain current on their legal and regulatory obligations and proactively address these areas of risk ahead of any government investigation or action.
Compliance Auditing
It is imperative that companies assess the health of their compliance program on an ongoing basis. The primary output of your company’s annual compliance needs assessment is the prioritized list of activities and functions which are exposed to varying level of risk.
Areas falling into the high to moderate level of risk need to be audited to expose the breakdown in controls which lead to non-compliant actions.
Audits should include at least the following four components:
- Workplan Development
What is the scope and objectives of the audit? How should the audit be rolled out to ensure effectiveness without impeding upon daily business operations? What are the detailed tasks needed to complete the audit? What are the roles, responsibilities and deadlines of the team? What sampling methodology will be used for transaction testing? How will we ensure a risk based approach? - Documentation Review
Do you have the right governance documentation in place? Is it complete? - Systems/Process Review
What is the actual process that occurring and is it in line with internal policies and procedures as well as external guidelines? - Transaction Testing
Do the requisite control documents exist for a sample set of reviewed activities? If so, are they being completed, processed, reviewed and approved appropriately?
Once executed, it can then be determined whether instances of non-compliant behavior are “one-off” violations or if there is a more systemic problem going on. This clarity allows companies to then put in place effective corrective action to curb the tide and get back on the right track.
How we can help
Baker Tilly Life Sciences provides a comprehensive suite of services to address your compliance auditing needs:
- Compliance auditing program design
- Risk-based audit plan development
- Audit policy and procedure documentation
- Audit execution and corrective action plan development
Areas to audit
Typical areas to audit include, but are not limited to, the following:
- External funding requests – e.g. educational grants, IIT grants, sponsorships, charitable contributions
- HCP Compensation – e.g. FMV and compensation processes
- Strategic customer interactions – e.g. wholesalers, GPOs, MCOs, rebates
- Access support programs – e.g. HUB operations, reimbursement support, co-pay assistance, patient assistance programs
- Educational outreach – e.g. speaker programs, nurse educators
- Distributor and other third party operations
Compliance Monitoring
No matter how much preparation, training and documentation we do, there is still a high level of uncertainly related to the question: “Do we really know what is going on out there”? Compliance Monitoring is the most effective way to address that fear, uncertainty and doubt. Since it is performed in real time, monitoring allows you to continually assess the health of the compliance program on an ongoing basis.
Continuous monitoring can take the form of transaction/paper based monitoring as well as in-person “live” monitoring of specific activities.
Baker Tilly has independent, scalable compliance experts that help in execute on your compliance monitoring needs.
Ensuring a robust program
The following tasks can be completed by our team to ensure a robust monitoring program:
- Program Design
- Program Management and Oversight
- Monitoring Checklist Development
- Sample Selection (methodology development and execution)
- Training and Deploying of Monitors (both client based resources and our own team of monitors)
- Tracking and Reporting results of monitoring activities
- Program insights and recommendations on how to improve upon the program in the future
- Partnering with the business to move to a “self- monitoring” environment
Supporting monitoring needs
At Baker Tilly, our Life Sciences Consulting team supports our clients’ transactional and live monitoring needs for risk areas across the organization, including, but not limited to, the following:
- Speaker programs
- Advisory boards
- Medical education programs
- Expense reports
- Social media
- Patient influencers
- Conferences
- Email and call notes
- Global payments for bribery and corruption
- HCP screening
- Field ridealongs
– Sales representatives
– Medical science liaisons
– Patient advocacy specialists
– Account managers
– Managed care specialists
Our focus on value protection means we remain engaged with our clients to support their ongoing auditing and monitoring strategies.