This is the second in a five-part series discussing the new Value-Based Regulations adopted last year by the Centers for Medicare & Medicaid Services and the Office of Inspector General. Click here for a full list of related posts. 

Creating a “value-based enterprise” is the key first step necessary to satisfy the requirements of a Stark value-based exception or an Anti-Kickback Statute value-based safe harbor.

A value-based enterprise is a network of participants (including clinicians, providers, and suppliers) that have agreed to collaborate with respect to a target patient population, with a goal towards increasing efficiencies in the delivery of care and improving outcomes for that patient population.

The concept of a value-based enterprise is very definitionally driven.  Before attempting to create a value-based enterprise it is imperative to fully understand the regulatory requirements.

A “value-based enterprise” is defined as two or more value-based participants: (i) collaborating to achieve at least one value-based purpose; (ii) each of which is a party to a value-based arrangement; (iii) that have an accountable body or person responsible for financial and operational oversight of the value-based enterprise; and (iv) that have a governing document that describes the value-based enterprise and how the value-based enterprise participants intend to achieve its value-based purpose(s).

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.  It 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.
 
To read more about the Value-Based Enterprise Regulatory Requirements click here.  Be on the lookout in the coming days for Part 3 of the series, How to Create a Care Coordination Value-Based Enterprise.