Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the importance of developing and implementing needs assessments related to engaging healthcare professionals to provide services to pharmaceutical or medical device companies. It describes a four-step process for identifying and documenting the business purpose of such arrangements, including 1) developing and implementing a written needs assessment policy, 2) identifying the business purpose, 3) completing a provider analysis, and 4) addressing additional considerations and documenting the need.
Just as a physician assesses the needs of his or her patients, companies manufacturing and providing pharmaceuticals or developing medical devices must assess the need to involve physicians in their business operations. As the federal government strives to bring more transparency to relationships between physicians and life sciences companies, an organization’s decision to collaborate with healthcare professionals (“HCPs”) should be evaluated utilizing more structured and formal processes. It is not enough to merely analyze and document that the remuneration for identified HCP services is consistent with fair market value.
Read the full article in the January 2017 issue of Life Science Compliance Update.