American Clinical Laboratory Association

ACLA’s 2024 Advocacy Agenda

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.

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ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices

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.

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Saving Access to Laboratory Services Act

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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Supporting Patient Health:

Value of Laboratory Tests and Diagnostics

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

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Who we are

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

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