Often there is a lot of attention paid to the Centers for Medicare & Medicaid Services (“CMS”) Inpatient Prospective Payment System (“IPPS”), Outpatient Prospective Payment System (“OPPS”), and Medicare Physician Fee Schedule...more
On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more