AACC Urges CLIA Modernization to Address LDT Issue

The American Association for Clinical Chemistry (AACC) is urging policymakers to ‘modernize’ the Clinical Laboratory Improvement Amendments (CLIA) as a means for addressing recently expressed concerns about the oversight of laboratory developed tests (LDTs).  In a newly released position statement, the Association recommends that the Centers for Medicare and Medicaid Services (CMS) retain its lead role overseeing LDTs and that key operational provisions within CLIA be updated. 

The Association suggests a number of changes to CLIA, including:

• Requiring laboratories to demonstrate clinical validity for LDTs;
• Providing additional guidance to laboratories on how to ensure quality testing;
• Ensuring that CLIA inspection teams include individuals with appropriate expertise to evaluate LDTs; and
• Establishing a process for adding and deleting tests to the list of analytes subject to PT.

AACC also recommends that policymakers carefully examine the definition of an LDT, asserting that minor changes to a test not affecting its clinical claim or interpretation should be excluded from the definition.  In addition, AACC suggests that a physician’s off-label use of a test be excluded in many instances. 

AACC’s new position statement will help inform the congressional debate over LDTs, where key House and Senate committees are considering which agency should have primary oversight over LDTs.  The House is discussing a measure that would allow for greater involvement by FDA; the Senate has not drafted its own LDT legislation.  AACC is an active participant in these policy discussions. 

We will provide additional information on the LDT deliberations in future editions of the Laboratory Advocate.