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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 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).
In an opinion that accepts many of ACLA’s primary arguments, the court found that “the text, structure, and history of the FDCA and [the Clinical Laboratory Improvement Amendments (CLIA)] make clear that FDA lacks the authority to regulate laboratory-developed test services.” The court emphasized that “devices” under the FDCA “are articles of commerce, not the kinds of services performed by doctors and laboratories,” and that Congress specifically addressed the regulation of clinical laboratories and their services through CLIA, an independent statutory framework.
“The court’s ruling ensures that clinical laboratories can continue to focus on their primary mission – offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day,” said ACLA President Susan Van Meter. “This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.”
Rejecting FDA’s request for further briefing, the court vacated the rule in its entirety, reinforcing that courts must “nullify and revoke” agency actions found to be illegal.
As a result of the decision, the Rule and its associated compliance deadlines are no longer in effect.
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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.
ACLA Lawsuit Memorandum Opinion and Order
ACLA Lawsuit Judgment
ACLA Elects Officers for 2025-2027 Board of Directors
Washington, D.C.— The American Clinical Laboratory Association (ACLA) elected its Board of Directors for the 2025-2027 term, reaffirming its commitment to advancing diagnostic innovation and patient care. The election took place today at the 2025 ACLA Annual Meeting.
William G. Morice II, M.D., Ph.D., president and CEO of Mayo Collaborative Services/Mayo Clinic Laboratories, has been elected as ACLA Board Chair. Adam H. Schechter, chairman, CEO, and president of Laboratory Corporation of America, has been elected as Vice Chair, and Kevin T. Conroy, chairman and CEO of Exact Sciences Corporation, has been elected as Treasurer.
ACLA also welcomes its full 2025-2027 Board of Directors, which includes returning and newly elected members:
- Steve Chapman, CEO of Natera (first-time member)
- Jim Davis, chairman, CEO, and president of Quest Diagnostics
- Paul J. Diaz, president and CEO of Myriad Genetics, Inc.
- Martin Price, executive chairman and CEO of HealthTrackRx (first-time member)
- Cory A. Roberts, M.D., M.B.A., CEO of Sonic Healthcare USA
- Chris Smith, CEO of NeoGenomics Laboratories
- Katherine Stueland, president and CEO of GeneDx (first-time member)
- Andy Theurer, CEO of ARUP Laboratories
- Susan Van Meter, president of ACLA
- Elias Zerhouni, M.D., president of OPKO Health/BioReference Health
“These esteemed industry leaders bring unparalleled expertise and a steadfast commitment to ensuring patients and providers have access to high-quality, innovative diagnostic services,” said ACLA President Susan Van Meter. “Their leadership will be instrumental in advancing policies that strengthen clinical laboratories’ ability to deliver timely, reliable testing — helping to prevent disease, improve health outcomes, and reduce health care costs.”
Learn more about ACLA here.
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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.
ACLA Secures Critical Changes to Medicare Local Coverage Determination for Cancer Genetic Tests
Washington, D.C.— The American Clinical Laboratory Association (ACLA) is pleased to announce significant changes to a coverage policy that was poised to disrupt broad access to genetic testing for Medicare beneficiaries with cancer. Medicare Administrative Contractors (MACs) Novitas and First Coast Service Options (FCSO) have finalized their “Genetic Testing for Oncology: Specific Tests” Local Coverage Determinations (LCDs), incorporating ACLA’s core recommendation to eliminate a provision that would have automatically denied coverage for any genetic test not included in at least one of three identified third-party “knowledgebases.”
In 2023, ACLA, along with 44 other key stakeholders, submitted a letter urging the MACs to reevaluate their coverage policies and ensure access to genetic testing services for oncology patients. The letter underscored the importance of coverage that reflects the rapid advancements in genetic testing, which are vital for accurately diagnosing and tailoring treatment for various cancers. It also highlighted that restrictive LCDs could hinder access to essential testing, thereby impacting personalized treatment plans and patient outcomes.
“We are grateful for the positive outcome and that Medicare beneficiaries will continue to have access to these vital tests,” said ACLA President Susan Van Meter. “Genetic testing plays a critical role in diagnosing and treating cancer, and it is essential that patients have access to the most advanced testing options available.”
The narrowed down finalized LCDs now include only a limited number of positive or negative coverage decisions for specific molecular tests without broadly impacting access to other genetic tests. This outcome reflects years of dedicated advocacy by ACLA in collaboration with dozens of leading patient and provider organizations, ensuring continued access to clinically appropriate genetic testing for Medicare beneficiaries.
ACLA recently released its 2025 advocacy agenda, which promotes policy priorities in the areas of reimbursement, regulation, and preparedness and infrastructure. Learn more here.
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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.
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 the short-term spending package passed on Wednesday, September 25.
The Continuing Appropriations and Extensions Act, 2025 provides a critical one-year reprieve from Medicare cuts of up to 15 percent for approximately 800 laboratory services that were slated to take effect in January 2025. Without this delay, these drastic cuts would have jeopardized patient access to vital diagnostic testing across the country and slowed the pace of diagnostic innovation. This action marks the fifth time Congress has delayed Medicare cuts to clinical laboratories, following multiple years of deep reductions.
“We are pleased that Congress has delayed pending reductions, recognizing the harm repeated Medicare reductions would have on the nation’s health care system that relies on clinical laboratory testing every day to inform patient care,” said ACLA President Susan Van Meter. “This is a welcome step to ensuring patients can continue to rely on timely and accurate diagnostic services.”
ACLA deeply appreciates the steadfast support from bipartisan and bicameral members of Congress who continue to champion long-term payment reform, working together to secure a lasting solution to stabilize the Medicare Clinical Laboratory Fee Schedule.
“There is widespread and bipartisan recognition that long-term reform is urgently needed,” added Van Meter. “A sustainable reform of the Medicare payment system for clinical laboratory services is vital to protect and enhance patient care, foster innovation, and ensure the stability of clinical laboratories nationwide.”
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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.
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 (FDA) in the United States District Court for the Eastern District of Texas, challenging the Agency’s May 6, 2024, Final Rule, which inappropriately seeks to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetics Act (FDCA).
Congress has never granted FDA authority to regulate the professional testing services that laboratories provide, which are federally regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).
For years, ACLA has worked collaboratively with Congress, FDA and other stakeholders to develop legislation that would establish an appropriate regulatory framework for diagnostics. Rather than continue that dialogue, FDA chose instead to act unilaterally and impose an ill-fitting device regime on laboratory testing services. Given the far-reaching negative impacts on our nation’s laboratory community, ACLA believes it must bring this lawsuit to clarify that FDA’s Final Rule exceeds its authority. The lawsuit challenges the Final Rule because FDA has exceeded its statutory authority and acted arbitrarily and capriciously in violation of the Administrative Procedure Act.
“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” said ACLA President Susan Van Meter. “The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products. These professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve. The Rule will disrupt this paradigm, creating negative consequences for the entire health care system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide.”
Laboratory testing services are often created to address unmet patient needs. They provide patients and physicians with diagnostic information to inform clinical care, power precision medicine, contribute to the discovery of novel therapeutics, and lead the fight against emerging pathogens. Forcing them into the rigid regulatory framework designed for manufactured medical devices will undermine the dynamic and patient-centered nature of clinical laboratory services.
ACLA maintains that legislation is the right – and only – approach for FDA to regulate professional testing services offered by laboratories. The industry remains committed to working with Congress, FDA, and other stakeholders to advance appropriate legislation that preserves the critical role of laboratory diagnostics and ensures that patients continue to have access to lifesaving tests.
Below are links to ACLA’s previous statements, comments on the Proposed Rule, and testimony to Congress:
ACLA’s Statement on the Final Rule
ACLA’s Comments on FDA’s Proposed Regulation of Laboratory Developed Tests as Medical Devices
ACLA Statement on LDT Proposed Rule Comments by FDA and CMS
ACLA President to Testify on Regulation of Diagnostic Tests
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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.
ACLA Challenge to FDA’s Final Rule Regulating Laboratory Developed Testing Services as Medical Devices
ACLA Statement on FDA Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices
Washington, D.C. – In response to the U.S. Food & Drug Administration (FDA) releasing its Final Rule to regulate laboratory developed testing services as medical devices under the Federal Food, Drug, and Cosmetic Act, the following statement can be attributed to American Clinical Laboratory Association (ACLA) President Susan Van Meter:
“The FDA today released a final rule to regulate laboratory developed testing services as medical devices. While ACLA is currently reviewing the rule, our position has been clear and consistent: Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine.
ACLA has grave concerns about this rule as a matter of both policy and law. The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics. The rule also exceeds FDA’s statutory authority, as Congress has never granted the agency authority to regulate laboratory developed testing services offered by laboratory professionals.
We are disappointed that FDA has continued down this path. That is not just ACLA’s view. At a recent congressional hearing, it was clear that there is little support for the agency’s approach among members of Congress and key stakeholders. Clinical laboratories are already subject to robust regulation and oversight, and ACLA maintains that new legislation would be required for the FDA to regulate laboratory developed testing services.
ACLA has committed to working with Congress, FDA, and other stakeholders on legislation that would create a regulatory framework tailored to the dynamic nature of laboratory diagnostics. We urge FDA to resume work on legislation rather than unilaterally imposing medical device authorities that Congress never intended for this purpose. The future of patient care depends on it.”
ACLA previously submitted comments addressing the many problems with FDA’s proposal. Learn more here.
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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.
