November 2023

Laboratory Developed Test Rule Comment Deadline is December 4

The deadline to comment on a U.S. Food & Drug Administration (FDA) proposed rule to begin regulating Laboratory Developed Tests (LDTs) is December 4. ASCLS encourages all members of our community to read the proposal and provide input. The proposed rule would amend the FDA’s regulations to make explicit that LDTs (defined by FDA as…

Additional One Year Delay on PAMA Cuts Passes Congress

The House of Representatives and Senate have passed approving a continuing resolution (CR) that includes a one-year delay of implementation of the PAMA Medicare payment cuts to clinical laboratory services and data reporting, until January, 2025. The President is expected to sign it into law this week. Thank you to all who participated in some…