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The first step in qualifying to meet the requirements of a value-based Stark exception or a valuebased Anti-Kickback Statute safe harbor is that the parties establish a “value-based enterprise.” The concept of a value-based enterprise is very definitionally driven, so before attempting to create a value-based enterprise it is imperative to fully understand the regulatory requirements.
A value-based enterprise is essentially a network of participants (such as clinicians, providers, and suppliers) that have agreed to collaborate regarding a target patient population, focusing on increasing efficiencies in the delivery of care and improving outcomes for that patient population.
A value-based enterprise can be as simple as two parties in a value-based arrangement, with a written agreement that specifies the rights, responsibilities and obligations of the parties. A value-based enterprise can also be more complex, such as a separate legal entity with many parties and a formal governing body and organizational documents. A value-based enterprise must be working to achieve at least one value-based purpose while implementing a value-based activity for a defined target patient population.
This overview of a value-based enterprise will first review the Stark Law definitions necessary to create a value-based enterprise and will then highlight where the definitions are different for Anti-Kickback Statute safe harbor purposes.