Legal, Regulatory and Contractual Issues When Structuring Value-Based Agreements

Mintz Member Lauren Moldawer will be speaking on a panel titled, "Legal, Regulatory and Contractual Issues When Structuring Value-Based Agreements" at the 14th Association for Value-Based Cancer Care Summit in New York, NY.

The past several years has seen much interest by the pharmaceutical industry in Value-Based Agreements (VBAs), but also many challenges throughout an evolving legal and regulatory framework. Some might argue that pharma participation in VBAs has been stalled due to legal and regulatory constraints, including antikickback requirements and best price reporting requirements.  The panel will review and discuss review the key regulatory considerations when designing and proposing VBAs, including antikickback safe harbors, best price reporting updates, FDA requirements and state laws.  The panel will address potential challenges commonly observed with structuring VBAs.  Finally, the panel will address new CMS guidance and other legislative policies coming out of Washington, as well as the impact of the upcoming election and potential Administration change on VBAs.