POLICY PRIORITIES

Diagnostic pricing variation is a consistent issue with studies showing that COVID tests vary as much as $1,000 for similar tests and that genetic test prices can vary as much as 300 percent year over year. Pricing and reimbursement uncertainty pose challenges for payers, providers, and laboratory communities – a more stable and sustainable pathway forward is necessary and in everyone’s best interests.

The pandemic and subsequent moves by the Biden administration have thrown much traditional understanding of medical necessity on its head - with some testing being mandated as free and with zero out-of-pocket costs. Additionally, CMS has moved to standardize electronic prior authorizations by 2027, including requirements for automation.

FDA is poised to overhaul the regulation of laboratory-developed tests (LDTs) through rulemaking and oversight of the entire testing industry may never be the same. LAB has been at the forefront of this issue since 2014, and we will continue to work to ensure consistent oversight and regulation of tests across the laboratory market.

Advanced lab testing and genomic sequencing hold the key to enhanced clinical diagnoses, medical research, and the promise of precision medicine. However, uncertain regulations and high costs place questions around the future availability of these testing regimes. Ensuring consistent quality and availability of lab testing across payers and communities – especially the underserved – can help drive improvement to health outcomes, disease management, and prevention where healthcare delivery has left many behind.