What are the key reasons for the current AKS safe harbors and Stark law exemptions?

The new Final Rules are guided by three key factors: (1) coordinating patient care; (2) eliminating barriers to implementing value-based services, which concentrate on improving care quality and reducing costs rather than the quantity of care provided; and (3) establishing or amending safe harbors and exceptions so that organizations can adopt value-based policies without fear of breaching Stark and AKS.

What elements are needed for a comprehensive Value-Based Enterprise (VBE) arrangement?

There are some elements to consider. Defining the VBE and its individual participants; appointing a person to oversee its execution, financing, and outcomes; defining a target population; specifying a value-based objective and relevant value-based actions; and complying with the nuances of the new Stark law exceptions and AKS safe harbors are just a few of the key things that need to be included in a governing document.

Is there a distinction between the AKS and the Stark rule in terms of who counts as a VBE participant?

Yeah, indeed. The AKS and the Stark Law Final Rules vary dramatically on this issue. The AKS maintains a “ineligible entity registry” that excludes such entities from the safe harbors, including the following:

Pharmaceutical manufacturers, distributors, and wholesalers (collectively referred to as “pharmaceutical companies” in this preamble); PBMs; laboratory companies; pharmacies that primarily compound or dispense compounded drugs (collectively referred to as “compounding pharmacies” in this rule); manufacturers of devices or medical supplies; entities or individuals that s (for example, some physician-owned distributors).

May people on the AKS’s “ineligible entity list” still contribute to a VBE?

Yeah, indeed. Many medical device and software companies can generate reports that can be de-identified so that the VBE can see how patient outcomes have changed over time with a certain set of parameters. As a result, the VBE or VBE participants will be able to accomplish targets such as lowering hospital readmission rates.


Brian Brijbag Stark Law