Advocacy - Lab Advocate
On June 12, members of ADLM’s Policy & External Affairs Core Committee (PEACC) visited Capitol Hill to meet with key congressional offices and highlight two critical issues for the laboratory community: the need for sustained federal investment in harmonizing clinical laboratory test results, and the likelihood that Congress will revisit LDT oversight following a March 31, 2025 court decision that vacated FDA’s final rule.
With FDA choosing not to appeal, the rule has effectively been blocked, raising the likelihood that Congress will revisit the issue. Staff acknowledged the ongoing policy vacuum and indicated that a legislative solution may be necessary, with some expressing interest in potential hearings or roundtables later this year. PEACC reinforced ADLM’s longstanding position that any update to LDT oversight should take place through the existing and effective CLIA framework that Congress has already established.
During the meetings, PEACC members also emphasized the central role that harmonized test results play in improving patient care, supporting the use of clinical data in artificial intelligence applications, and ensuring consistent diagnostics across healthcare settings. ADLMs urged support for increased funding in the FY 2026 federal budget for the CDC’s clinical standardization program, which helps laboratories align testing methods and ensure comparability of results nationwide.
ADLM will continue tracking policy developments and working to ensure that laboratory professionals guide policymaking decisions that define patient care, diagnostic access, and the future of the field.