CRS: HHS’ LDT Policy Shifts Raise Regulatory, Coverage Issues

Wade Ackerman spoke with Inside Health Policy about the HHS' decision to remove laboratory-developed tests from FDA oversight. Mr. Ackerman says laboratory-developed test regulation has long been a hot topic among stakeholders. “The pandemic put the nation's attention on testing, and the HHS' statement set in motion LDT regulation being an even more high-profile issue on the Hill. My suspicion is that FDA will prioritize the need for legislation in the next Congress, and the question will be whether the Hill can bring everyone to the table and find a landing spot,” he adds.

He goes on to say that it has been a challenge to create legislation that has the right balance of ensuring accurate and reliable testing, continued innovation and robust patient access. However, the pandemic highlighted the need for an LDT regulatory framework. The next Congress may present a unique time for legislation.