What must agreements under Stark NOT take into account?

The Stark Law, officially known as the Physician Self-Referral Law, is designed to prevent conflicts of interest in physician referrals. One of the fundamental principles of this law is that agreements between physicians and entities for the provision of services must not be influenced by the financial incentives tied to the volume and value of referrals. This is to ensure that patient care decisions are based on medical necessity and quality, rather than financial gain.

In this context, the volume and/or value of referrals cannot be a consideration in the formation of an agreement under Stark, as doing so could incentivize physicians to refer patients based on profit motives instead of what is best for patient care. Therefore, the nature of any financial arrangements should be structured solely around the fair market value of services provided, rather than the quantity of referrals generated by the physician.

The other aspects mentioned—quality of patient care, the skills of the practitioner, and current market demands—are legitimate considerations in agreements because they directly relate to the delivery of appropriate and competent patient care, as well as ensuring that services are provided in line with community needs and standards. These elements help maintain the integrity and focus of healthcare services on patient welfare rather than solely on financial variables.