American Clinical Laboratory Association

ACLA’s 2025 Advocacy Agenda

ACLA’s 2025 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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Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA

ACLA and its member company, HealthTrackRx, won a legal challenge against the U.S. Food and Drug Administration’s (FDA) Final Rule that would have regulated virtually all laboratory developed testing services as medical devices. The U.S. District Court for the Eastern District of Texas has vacated the Final Rule in its entirety, holding that FDA’s attempt to regulate professional laboratory testing services as medical devices exceeds the authority granted to FDA in the Food, Drug, and Cosmetic Act (FDCA).

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Championing Long-term PAMA Reform

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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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.

Clinical laboratories are the driving force for the next generation of precision medicine and care delivery.

Americans depend on clinical laboratories as the first line of defense against acute, chronic and infectious disease.

Our work helps improve patient health and quality of life while reducing costs for public and private health programs.

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Recent News & Updates

March 31, 2025

Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA

Washington, D.C.— The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, today announced a victory in its legal challenge to the U.S. Food and … Read More

September 25, 2024

ACLA Applauds Congressional Action to Delay Medicare Cuts, Urges Long-Term Reform

Washington, D.C.— The American Clinical Laboratory Association (ACLA) today commended Congress for including much-needed relief from looming Medicare payment cuts to clinical laboratory services in … Read More

May 29, 2024

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

Washington, D.C. – Today the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, filed a lawsuit against the U.S. Food and Drug Administration … Read More

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Policy Issues

PAMA Reform

In 2014, Congress passed the Protecting Access to Medicare Act (PAMA) to ensure millions of seniors could maintain access to critical health services, including laboratory … Read More

Public Health Preparedness and Infrastructure

Throughout the COVID-19 pandemic and subsequent Mpox Public Health Emergency (PHE), ACLA members provided extraordinary leadership and support for the U.S. Government’s response efforts by … Read More

Regulatory Issues

Developing a comprehensive approach to diagnostic reform – one that fosters innovative care delivery – is vital to our ability to tackle the most challenging … Read More

Reimbursement And Coverage

Clinical laboratories are reimbursed for providing services to Medicare beneficiaries using either the Physician Fee Schedule (PFS) or the Clinical Laboratory Fee Schedule (CLFS), depending … Read More

Value Of Clinical Labs

America’s clinical laboratories serve as the foundation for public health preparedness and response and for everyday prevention, diagnosis, and treatment of disease for patients across … Read More

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Recent tweets

American Clinical Laboratory Association @aclalabs ·

16 May

With the ability to quickly diagnose rare genetic disorders, rapid whole genome sequencing (rWGS) allows critically ill infants to access timely and life-saving care. #ThePowerofKnowing

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American Clinical Laboratory Association @aclalabs ·

15 May

Whether it’s through routine screenings or precision diagnostics, clinical laboratories help detect disease earlier, treat it more effectively, and improve health outcomes at every stage. Learn more about #ThePowerOfKnowing:

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American Clinical Laboratory Association @aclalabs ·

13 May

Personalized care starts with precise diagnostics. And for women, clinical laboratory tests lay the foundation for tailored treatment. This #WomensHealthMonth, we celebrate care as unique as each patient. #ThePowerofKnowing

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American Clinical Laboratory Association

American Clinical Laboratory Association

ACLA’s 2025 Advocacy Agenda

Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA

Championing Long-term PAMA Reform

Supporting Patient Health:

Value of Laboratory Tests and Diagnostics

Who we are

Recent News & Updates

Policy Issues

Recent tweets

Contact Us