OBR OncologyNew Legal Risk for Oncologists? Stark Law Fears Loom Ahead of Deadline

Community oncologists in the United States are at risk of violating the Stark Law if they continue to mail or use delivery services to ensure their patients have access to essential oral medications, after the COVID-19 public health emergency (PHE) ends on May 11th.

The Stark Law is a federal law that prohibits healthcare providers from referring patients to entities with which they have a financial relationship, unless certain exceptions apply. The FAQ document published by the Centers for Medicare & Medicaid Services (CMS) in September 2021 suggests that mailing oral drugs could violate the Stark Law, even if the practice does not receive any financial benefit from the delivery.

This interpretation is so broad that it could also bar relatives or caregivers from picking up patients’ medications. As a result, practices are facing a difficult choice: require patients to pick up medications in person or refer them to third-party mail-order pharmacies. The latter could lead to delays, denials, or sometimes errors because of a lack of direct communication between the pharmacy and physician.