On May 21st, AACC sent a letter to the Department of Health and Human Services (HHS) Secretary Xavier Becerra raising concerns about ongoing efforts to create a dual regulatory structure that would place laboratory developed tests (LDTs) under both the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) oversight. The association asserted that LDTs are already subject to extensive regulation under the CMS Clinical Laboratory Improvement Amendments (CLIA) and that any changes should take place within the existing regulatory structure.
Last year, there were several legislative initiatives introduced to address this issue. In March 2020, Sen. Rand Paul introduced the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify the existing regulatory structure under CLIA. The bill was introduced as an alternative to the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, sponsored by Reps. Larry Bucshon and Dianne DeGette, which would extend FDA oversight to LDTs. AACC endorsed VITAL shortly after its original introduction. Sen. Paul recently reintroduced VITAL in May, and VALID is expected to be reintroduced in the coming weeks.
The association will continue working with its allies to ensure that all patients continue to have access to LDTs.