Urge your U.S. Representative to cosponsor H.R. 5526 - The Seniors' Access to Critical Medications Act of 2023

In a September 2021 FAQ document, CMS responded to a question regarding the location requirements of Stark law specifically as it pertains to the furnishing of prescription drugs and medical devices. CMS clarified its narrow interpretation of exceptions to the "furnished" location requirement so that only items dispensed directly at a physician's office are permitted. CMS specifically noted that:


The "location requirement" at 42 C.F.R. ยง411.355(b)(2) would not be satisfied if a patient receives an item by mail outside the physician's office, as it would not be dispensed to the patient in the office. This is true regardless of whether Medicare coverage and payment rules would permit the supplier to mail the item to the patient and bill the Medicare program for the item.


Under this interpretation, if a physician was to mail a drug to a patient or have a caregiver pick it up from the practice, it would constitute a violation of Stark law. This requirement had been temporarily waived during the COVID-19 PHE, which ended on May 11, 2023, but is now in effect.


Representatives Harshbarger (R-TN), Wasserman Schultz (D-FL), Fleischmann (R-TN), Davis (D-NC), Miller-Meeks (R-IA), and Balderson (R-OH) introduced H.R. 5526, the Seniors' Access to Critical Medications Act of 2023, to rectify this issue. The bill clarifies that drugs and the supplies to administer them would not run afoul of the location requirement in Stark law, and directs the Secretary to withdraw the FAQ document described above.


We need your help to fix this problem and ensure that CMS doesn't stand in the way of patients receiving life-saving medications. Please take a few minutes to submit an email to your U.S. Representative urging them to sign on as cosponsors of H.R. 5526.