American Clinical Laboratory Association

ACLA’s 2024 advocacy agenda promotes policy priorities in the areas of reimbursement, regulation, and preparedness & infrastructure, including laboratory workforce. As a whole, the advocacy agenda strives to promote policies that reflect the value of clinical laboratories, support innovation, and expand access to testing services that improve and save lives.

ACLA and its member company HealthTrackRx filed a lawsuit against the U.S. Food and Drug Administration challenging the Agency’s Final Rule regulating professional laboratory developed testing services as medical devices under the Federal Food, Drug, and Cosmetic Act.

ACLA is bringing this lawsuit because FDA’s Final Rule exceeds its lawful authority. Laboratory developed testing services are professional services, not manufactured medical devices.

In November 2023, Congress passed a short-term spending package that includes a one-year delay of implementation of Medicare payment cuts to clinical laboratory services. ACLA remains focused on securing a permanent solution to this problem through enactment of the bipartisan Saving Access to Laboratory Services Act (SALSA) in 2024.

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Accurate, reliable test results help provide a complete picture of health and align all players in the health system towards patient-centered care.