When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal Physician Self-Referral Law (the “Stark Law”), which has draconian penalties, such as clawback of Medicare payments plus additional stiff monetary penalties and possible exclusion from participation in federal health care programs.
During the COVID-19 PHE, CMS issued temporary waivers, including a waiver of the “location requirement” of the In-Office Ancillary Services (“IOAS”) exception. That waiver allowed physician groups that furnish certain durable medical equipment, orthotics, prosthetic devices – including intermittent urinary catheters (“IUCs”) – and other medical supplies (collectively referred to here as “DME”) to provide home delivery of such DME to their Medicare patients without facing sanctions for violating the Stark Law.[1] With the end of the PHE having occurred over three months ago, that temporary waiver of sanctions ended and can no longer be relied upon for legal compliance with the Stark Law.[2]