New Legislation Clarifies CMS Authority Over Laboratory Developed Tests

June 10, 2026

Congressman Neal Dunn, MD, has introduced the Enhancing Clinical Laboratory Innovation and Access (CLIA) Act of 2026, which updates the Clinical Laboratory Improvement Amendments (CLIA) to affirm that oversight of laboratory developed tests is under the Center for Medicare & Medicaid Services authority, not the Food and Drug Administration’s. The measure would help foster advances in diagnostic testing and modern laboratory science by allowing clinical laboratories to continue to innovate on diagnostic testing.

Key provisions of the bill:

Requiring CMS to create a public database containing information on LDT performance and validation.

Reaffirming CMS authority over LDTs under CLIA.

Clarifying that LDTs include analyses of digital laboratory data, such as genomic information.

Allowing laboratories to obtain voluntary third-party validation of LDT analytical and clinical performance.

Strengthening CMS oversight through centralized error reporting and enhanced authority to address concerns about test validity.

The legislation aims to provide regulatory certainty, improve accountability, and support continued innovation in laboratory diagnostics. At present, only draft text has been made available. Once the bill’s text is published, ASCP will initiate a formal review of the legislation and will be working with the laboratory community on this measure.

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