Advocacy - Lab Advocate
Over the past year, ADLM amplified its advocacy efforts to protect patient access to diagnostic testing, promote diagnostic quality and harmonization, and ensure responsible oversight of emerging technologies. Through targeted congressional engagement, formal regulatory comments, and an expanding grassroots network, ADLM worked to ensure laboratory medicine remained central to federal health policy discussions.
This year’s advocacy agenda centered on three connected priorities: advancing children’s health through improved pediatric reference intervals, promoting harmonized and responsible implementation of artificial intelligence in laboratory medicine, and securing fair, sustainable reimbursement to protect patient access. Together, these efforts reflect ADLM’s commitment to quality, equity, and innovation across the diagnostic continuum.
Children’s health remained a central focus of ADLM’s advocacy efforts. Reliable diagnostic testing is foundational to pediatric care, yet persistent gaps in pediatric reference intervals (PRIs) continue to affect clinical decision-making, test interpretation, and health outcomes for children.
Throughout the year, ADLM worked to elevate the importance of establishing and maintaining accurate, age-appropriate pediatric reference intervals that reflect physiological changes across infancy, childhood, and adolescence. Inadequate or outdated PRIs can lead to misinterpretation of test results, delayed diagnoses, or unnecessary follow-up testing—underscoring the need for sustained, coordinated action.
ADLM educated policymakers on the critical role the Centers for Disease Control and Prevention (CDC) can play in developing and maintaining pediatric reference intervals and advancing laboratory harmonization efforts. The association has also actively worked to secure federal funding to support CDC programs that enable high-quality pediatric reference interval development and data standardization - reinforcing that improving children’s health outcomes requires sustained, system-level investment.
To further elevate this issue, ADLM will host a congressional briefing on February 4 to educate congressional staff and policymakers on the clinical importance of pediatric reference intervals, harmonization, and diagnostic quality, and the essential role of federal partnerships in closing existing gaps.
As artificial intelligence and machine learning (AI/ML) tools become increasingly integrated into diagnostic testing and clinical decision-making, ADLM prioritized engagement with federal regulators to ensure these technologies are implemented in ways that support harmonization, equity, and diagnostic reliability.
ADLM submitted formal comments in response to FDA requests for input on AI/ML-enabled medical devices, grounded in the association’s AI and laboratory quality position statements. The comments emphasized that AI systems are only as reliable as the underlying laboratory data and standards on which they are built.
ADLM underscored the need for:
Throughout these engagements, ADLM emphasized that AI oversight must align with existing CLIA requirements, recognize laboratory expertise, and avoid duplicative regulation that could undermine both innovation and diagnostic quality. By tying AI policy directly to harmonization and standardization, ADLM reinforced that responsible innovation depends on strong laboratory foundations.
A major focus of ADLM’s advocacy this year was addressing ongoing challenges stemming from implementation of the Protecting Access to Medicare Act (PAMA). Despite repeated congressional delays, structural flaws in the Medicare Clinical Laboratory Fee Schedule (CLFS) persist, placing continued financial strain on laboratories and threatening access to essential diagnostic services—including pediatric testing and specialized care.
ADLM actively supported bipartisan legislation—the RESULTS Act (S. 2761 / H.R. 5269)—designed to stabilize CLFS payments and correct how private-payer data are collected and weighted. Throughout the year, ADLM engaged congressional offices, submitted hearing materials, and worked alongside laboratory allies to highlight how under-representative data reporting has led to artificially suppressed payment rates.
Advocacy around the RESULTS Act emphasized the real-world consequences of reimbursement instability, particularly for hospital-based, rural, and specialty laboratories that serve vulnerable populations. ADLM consistently reinforced that sustainable reimbursement is foundational to maintaining diagnostic quality, workforce stability, and patient access.
Member engagement remained a cornerstone of ADLM’s advocacy strategy. Through coordinated grassroots campaigns, action alerts, and targeted outreach, ADLM empowered members to share real-world expertise with policymakers.
Grassroots advocacy reinforces ADLM’s priorities on pediatric diagnostics, AI oversight, and reimbursement reform by grounding policy discussions in clinical reality. Member engagement—particularly during RESULTS Act advocacy and CLC Hill Day efforts—helps policymakers understand how reimbursement instability and regulatory uncertainty directly affect test availability, innovation, and patient care.
As the policy landscape continues to evolve, ADLM remains committed to advocacy that advances children’s health, promotes harmonized and responsible innovation, and secures sustainable reimbursement. ADLM thanks its members for their continued engagement. Together, we will continue advocating for policies that recognize the essential role of laboratory medicine in high-quality, equitable healthcare.