The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant in the LDT debate, proposed a legislative solution to modernize the Clinical Laboratory Improvement Amendments (CLIA), including premarket review by the Centers for Medicare & Medicaid (CMS) or its designated third parties, as a substitute. Under the AMP proposal, FDA would only review laboratory-developed testing protocols (LDPs) – a new term coined by AMP to stress that these are healthcare professional services – under limited circumstances. At the same time, it will increase CMS regulation of LDPs compared to today.
At the heart of the proposal is a risk-based scheme that will determine whether a LDP must undergo premarket review. AMP explains that it is duplicative to have two separate agencies regulate LDPs, and CMS, as the agency that implements CLIA, is the appropriate agency for the task.
The FDA is working on revising the two draft guidances that outlined the LDT framework (the “Framework” guidance and the “Notification” guidance). The House Energy & Commerce Committee has released a discussion draft which proposes a separate alternative to the Framework. In addition, a group of labs and in vitro diagnostic kit companies called the Diagnostic Test Working Group have tried to craft their own legislative solution. It is expected that additional proposals will emerge as the matter continues to be debated.