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 2014, Congress passed the Protecting Access to Medicare Act (PAMA) to reform payment to clinical laboratories under the Clinical Laboratory Fee Schedule (CLFS). CMS’s flawed implementation led to rates that fail to reflect private payer rates as intended, years of payment cuts, and a lack of recognition of rising inflation. ACLA urges Congress to enact long-term PAMA reform to protect access to quality laboratory diagnostics and services.

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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.

Join us for the 2025 ACLA Annual Meeting on February 27 in Washington, D.C. to hear from a slate of expert speakers and panelists who will cover a range of emerging topics relevant to the clinical laboratory industry, including the latest regulatory and legislative developments, reimbursement issues, trends in diagnostic innovation, post-election politics, insights from Capitol Hill, and more.