Samantha is a director with Baker Tilly’s digital solutions practice. She is an experienced team member within the life sciences consulting space. She specializes in commercial compliance and risk management after 15 years of experience with leading consulting firms. Samantha has executed audits, risk assessments and fair market value (FMV) strategies for several healthcare clients ranging from pharmaceutical manufacturers to national payers. She is a subject matter specialist in commercial compliance and often publishes thought leadership and presents at international conferences on the topic.
- Conducted risk assessments of various activities across function areas for pharmaceutical and medical device manufacturers to identify gaps in current processes and provided recommendations for improvements and effective compliance monitoring
- Acted in leadership position for fair market value (FMV) service offering with activities including, but not limited to, creating internal work documents and processes, developing and qualifying potential client leads, conducting internal team trainings, leading large global FMV engagements (more than $150,000), etc.
- Determined global fair market value (FMV) rate structures for healthcare professionals (HCPs) and certain non-HCPs performing consulting services (advisory boards, speaker programs, training, ad hoc) for pharmaceutical manufacturers
- Conducted manufacturer survey and identified information relevant to benchmarking best practices within the life sciences industry for assessing, documenting and approving bona fide service fees
- Estimated the FMV of services received within fee-for-service arrangements that satisfied the qualitative prongs of the bona fide service fee test as defined by the Centers for Medicare and Medicaid Services (CMS)
- Evaluated “current state” processes, procedures and documentation to support manufacturer in its efforts to comply with government price reporting obligations and proposed a “future state” process to increase efficiencies
- Acted as interim global chief compliance officer and fractional global compliance officer for rare disease companies launching their first product in the United Staes and key European markets
- Performed several gap assessments to identify necessary governance elements (e.g., policies procedures, processes, organization structure, management reporting, etc.) to implement for companies transitioning from clinical stage to a commercial organization
- Conducted risk assessments of various activities across function areas to identify gaps in current processes and provided recommendations for improvements, effective compliance and monitoring
- Determined global fair market value (FMV) rate structures for healthcare professionals (HCPs) and certain non-HCPs performing consulting services (advisory boards, speaker programs, training, ad hoc) for pharmaceutical manufacturers
- Conducted manufacturer survey and identified information relevant to benchmarking best practices within the life sciences industry for assessing, documenting and approving bona fide service fees
- Estimated the FMV of services received within fee-for-service arrangements that satisfied the qualitative prongs of the bona fide service fee test as defined by the Centers for Medicare and Medicaid Services (CMS)
- Evaluated “current state” processes, procedures and documentation to support manufacturer in its efforts to comply with government price reporting obligations and proposed a “future state” process to increase efficiencies
