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September 06, 2024

District Court Finds Stark IOAS Exception Does Not Apply to Mailed Drugs

On August 30, 2024, the U.S. District Court for the District of Columbia dismissed an oncology trade association’s challenge to HHS guidance  prohibiting doctors from dispensing drugs in locations outside of their office.The association challenged a series of “Frequently Asked Questions” released by CMS that explained that location requirements under the Stark Law “would not be satisfied if a patient receives an item by mail outside the physician’s office.” The district court ultimately found that HHS’s position rested on a correct interpretation of the Stark Law exception  permitting self-referrals for “in-office ancillary services.” 

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