ADLM submitted comments to the Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) in response to their Request for Information (RFI) on potential updates to the Clinical Laboratory Improvement Amendments (CLIA). The association emphasized that laboratory medicine has changed dramatically since the current CLIA framework was established, with advances in technology and artificial intelligence (AI) creating new considerations for laboratory oversight. ADLM urged regulators to update CLIA in a way that reflects modern laboratory practice while preserving flexibility that allows innovation and high-quality patient care.
The association emphasized that CLIA should have a modern framework to address technologies that were not widely used when the regulations were originally developed. Today’s laboratories increasingly rely on next-generation sequencing, multiplex molecular testing, mass spectrometry, digital pathology, AI, and other advanced tools. ADLM recommended to CMS and CDC that validation requirements should reflect the specific technology being used, its intended clinical application, and patient risk rather than applying a single approach to fundamentally different testing methods.
The comments emphasized that CLIA’s performance-based approach remains one of the program’s greatest strengths. According to ADLM, laboratories should retain flexibility to establish qualification, competency, validation, and quality-management practices that are proportional to the complexity and risk of the testing performed.
ADLM highlighted the importance of recognizing the full range of laboratory activities that occur before testing begins. ADLM noted that specimen quality issues can affect patient care, increase costs, delay testing, and create additional burdens for both providers and patients. The association encouraged CMS and CDC to provide clearer guidelines while allowing laboratories flexibility to implement procedures that fit their operational needs.
ADLM’s comments also addressed emerging areas such as clinical breath testing. The association encouraged the agencies to clarify how CLIA recognizes the complexity and clinical application of these technologies. The association recommends a risk-based approach that differentiates between simple point-of-care systems and more complex testing platforms rather than treating all breath testing as a single category.
As laboratories continue to adopt new technologies and testing approaches, federal oversight must evolve alongside scientific advances. ADLM will continue to advocate for a science-based, objective grantmaking process that supports rigorous research and ensures federal investments advance laboratory medicine, public health, and patient care.