Implications of the Genesis Federal Court Decision on 340B Patient Definition

Constance (Connie) A. Wilkinson, Member of the Firm, co-presents "Implications of the Genesis Federal Court Decision on 340B Patient Definition," a webinar hosted by the 340B Report.

In a highly anticipated court decision on November 3, the U.S. District Court for the District of South Carolina ruled that the plain wording of the 340B statute does not require a covered entity to have initiated a healthcare service resulting in a prescription filled with a 340B drug. The judge determined that: “It is not the role of HRSA to legislate and limit the 340B program by restricting the definition of the term ‘patient,’ thereby frustrating the ability of the 340B statute to accomplish its purpose.”

While the decision was limited to Genesis Healthcare, it could have broad implications for the future applicability and enforcement of the patient definition as well as other highly debated matters such as the contract pharmacy program.

Connie and the panel will discuss the implications as well as potential limitations of the decision. 

Among the topics to be addressed in this lively discussion:

• Explanation of the decision and its scope
• The court’s definition of patient and 340B’s purpose
• What steps should providers and manufacturers take next, if anything?
• Chances of a federal appeal 
• Implications for other highly contested areas such as the contract pharmacy program
• Potential increased role of Administrative Dispute Resolution process

For more information, visit 340Breport.com.