FDA Announces Updated Guidance on 510K Processes On December 20, 2023, the U.S. Food and Drug Administration (FDA) announced new draft guidance on the 510(k) Third Party Review (3P510k) Program and the Third Party Emergency Use Authorization (EUA) Review (3PEUA). The draft guidance contains detailed steps regarding what is expected for submissions in both the...

Federal Rule on Electronic Record Interoperability Released The Federal Office of the National Coordinator for Health Information (ONC) released a final rule related to health information technology (IT) standards and criteria on December 14, 2023. According to the ONC website, here is a summary of the key relevant provisions: Algorithm Transparency: Establishes first of its kind...

Congress Introduces Legislation to Eliminate Reduction in Medicare Physician Reimbursement On December 7, 2023, Representatives Murphy (R-NC), Davis (D-IL), Wenstrup (R-OH), Panetta (D-CA), Bucshon (R-IN), and Burgess (R-TX) introduced the Preserving Seniors’ Access to Physicians Act of 2023, which would completely eliminate the 3.37% Medicare cut for physicians that goes into effect on January 1...

CMS Issues Final Rule on Outpatient and ASC Payment Policies On November 2, 2023, CMS released the calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems Final Rule, which includes proposals to update payment rates, policies, and regulations affecting Medicare services furnished in outpatient and ASC settings....