Over the summer, AACC’s Policy & External Affairs Core Committee (PEACC) met virtually with legislators and staff from 16 congressional offices to advocate for two of the association’s main legislative priorities; protecting access to laboratory developed test (LDTs) and securing funding for the Centers for Disease Control and Prevention (CDC) to improve pediatric reference intervals (PRIs).
The regulation of LDTs continues to be a foremost priority for AACC as the debate among the healthcare community and Congress over whether the Food & Drug Administration (FDA) should oversee them continues to play out. LDTs are already stringently regulated by the Centers for Medicare and Medicaid Services through the Clinical Laboratory Improvement Amendments (CLIA). AACC believes that extending FDA oversight to these tests would prove duplicative and onerous, and inevitably limit patient access to these tests. During their meetings, PEACC members raised awareness about the impact this issue would have on the ability of their organizations to conduct cutting edge testing for the patient populations they serve.
The committee also talked to lawmakers and staff about the need to improve PRIs. This year, AACC succeeded in securing report language the House of Representative’s fiscal year (FY) 2022 funding bill encouraging CDC to initiate efforts to improve the accuracy of pediatric reference intervals. The association previously secured report language in the FY 2020 budget agreement requesting that CDC submit a plan a plan to Congress for improving PRIs. During their discussions, PEACC members encourage congressional offices to build on that support and secure funding for the effort in FY 2023 budget. The association and its allies will continue to remain engaged with legislative offices on issues that impact the clinical laboratory community.