What is the consequence of not complying with all conditions of a Stark exception?

Compliance with Stark Law exceptions is crucial because these exceptions are designed to provide safe harbors for certain financial arrangements between healthcare providers and entities. If all conditions of a Stark exception are not met, the exception is rendered invalid, meaning that the financial arrangement could be subject to penalties and enforcement actions.

In such cases, both the provider and the healthcare entity could face legal repercussions, which may include repayment of amounts received, fines, or restrictions on their ability to participate in federal healthcare programs. This underscores the importance of adhering to every aspect of the Stark exceptions, as any failure to do so can lead to serious consequences. Thus, the correct understanding is that without compliance with all conditions, the exception remains invalid, exposing the involved parties to significant risks.