What must be included in a Stark exception agreement?

A Stark exception agreement must include written documentation to ensure that the terms and conditions of the agreement are clear, enforceable, and compliant with the Stark Law regulations. This law governs physician self-referral and is designed to prevent conflicts of interest in healthcare by prohibiting physicians from referring patients to facilities or services in which they have a financial interest unless certain exceptions apply.

Written documentation serves as a formal record of the arrangement, which is crucial for both compliance purposes and for guiding the behavior of the parties involved. It helps to establish the intention and scope of the agreement, providing clarity regarding each party's obligations and the nature of the business relationship. The absence of such documentation could lead to ambiguity, making it more difficult to demonstrate adherence to the regulations if the arrangement is ever scrutinized during an audit or investigation.

The other options do not meet the requirements set forth by Stark Law. A handshake or oral assurances alone do not provide the necessary legal foundation or assurance of compliance, making them insufficient for the purpose of a Stark exception agreement. Thus, having written documentation is indispensable for maintaining proper compliance within the healthcare system.