CLN Daily 2026
Over the past year, ADLM’s advocacy has been guided by a central message: Laboratory medicine is essential to patient care, public health, scientific innovation, and the future of healthcare. Since the last ADLM Annual Meeting, members, volunteer leaders, committees, working groups, coalition partners, and staff have worked together to ensure that policymakers understand how federal decisions affect clinical laboratories and the patients who depend on accurate, reliable, and accessible testing.
This work comes at a consequential time for the field. Federal policymakers continue to consider major questions involving pediatric testing, Medicare reimbursement, artificial intelligence (AI), laboratory data quality, public health infrastructure, federal research policy, and the future of laboratory oversight. Across these issues, ADLM has brought forward the expertise of laboratory professionals to explain how policy decisions affect clinical practice and why laboratory medicine is an essential part of healthcare policymaking.
One of ADLM’s most important advocacy priorities over the past year has been improving pediatric reference intervals. Reference intervals help clinicians determine whether a laboratory result is normal or abnormal. Pediatric reference intervals must account for age, stage of development, sex, ethnicity, geography, and other factors that affect test interpretation. Because it is difficult to obtain samples from healthy children, many pediatric tests still lack precise reference intervals. These gaps can increase the risk of misdiagnosis, delayed care, unnecessary follow-up testing, or inappropriate treatment.
ADLM members have been central to this work. Pediatric reference intervals are a highly technical laboratory issue, but ADLM member experts have helped translate that issue into a clear patient care priority for policymakers. Through coalition advocacy, congressional outreach, scientific input, and education of lawmakers and congressional staff, ADLM has continued to make the case that children need laboratory results interpreted against reference intervals that reflect typical pediatric development and the diversity of the populations laboratories serve.
Over the past year, ADLM continued urging Congress to provide dedicated funding to the Centers for Disease Control and Prevention (CDC), so that the agency can leverage its existing infrastructure to support the development of better pediatric reference intervals. This advocacy was built on years of member-driven work to explain why individual laboratories cannot solve this challenge alone, and why federal investment is needed to support a more consistent national approach.
The issue gained significant momentum in the fiscal year 2027 appropriations process. The House Labor, Health and Human Services (HHS), Education, and Related Agencies appropriations bill included $5 million for the CDC to develop and implement nationwide pediatric reference intervals for use by laboratories and healthcare providers. ADLM has urged Congress to include this funding in any final budget package and will continue working with member experts, congressional champions, coalition partners, and federal agencies to keep pediatric reference interval development a national priority.
Senator Shelley Moore Capito (R-W.Va.) has also played an important role in advancing the issue with Senate appropriators, helping secure report language supporting improved pediatric reference intervals in both the fiscal year 2025 and fiscal year 2026 Senate Labor, HHS, Education, and Related Agencies appropriations bills. In recognition of this leadership, ADLM named Sen. Capito the recipient of the association’s Outstanding Legislator Award for the 119th Congress.
For an exploration of the foundational context of pediatric reference intervals and modern, data-driven methodologies, attend the ADLM 2026 scientific session, “Pediatric reference intervals: Progress, challenges, and future perspectives,” in Anaheim, California.
ADLM also continued to make Medicare reimbursement reform a top advocacy priority. The association has repeatedly urged Congress to reform the Protecting Access to Medicare Act because the current Clinical Laboratory Fee Schedule data collection system does not adequately capture the full laboratory market. Without reform, laboratories face recurring cuts that could affect access to testing, particularly for community laboratories, hospital outreach laboratories, and laboratories that serve vulnerable populations.
ADLM members have been central to this work. Through ADLM’s reimbursement focused engagement, laboratory leaders have helped identify the real-world impact of continued payment reductions and provided the technical expertise needed to explain why the current system is flawed. Their input has strengthened ADLM’s message to Congress that sustainable reimbursement is not only a laboratory issue, but also a patient access issue.
During the past year, ADLM endorsed the RESULTS Act and worked with coalition partners to press Congress for long-term PAMA reform. Congress also provided short-term relief by delaying the next round of CLFS payment reductions through 2026. Although this delay was an important step, ADLM and its coalition partners have made it clear that temporary relief does not resolve the underlying structural problems with the current system. The association will continue working with members and partners to advocate for permanent PAMA reform that protects access to testing, supports innovation, and creates a more accurate and representative reimbursement framework.
For a comprehensive overview of reimbursement practices in laboratory medicine, attend the scientific session “Navigating reimbursement and coding: The basics, AI, and emerging healthcare technologies,” at ADLM 2026.
AI has become one of the most active federal policy areas. ADLM has worked to ensure that laboratory medicine has a strong voice in discussions regarding its application to healthcare as AI tools increasingly rely on clinical data to support diagnosis, risk prediction, workflow automation, and clinical decision support. ADLM has emphasized that laboratory data quality must be central to any responsible AI framework.
ADLM’s advocacy in this area has been shaped by members who understand how laboratory data are generated, validated, interpreted, and used in patient care. This expertise has helped ADLM communicate that AI policy cannot focus only on algorithms, but must also address the quality, comparability, and clinical meaning of the data that AI systems use.
ADLM submitted comments to the Food and Drug Administration (FDA) on AI enabled medical device performance and urged the agency to draw on the quality systems already used in clinical laboratories. The association highlighted the importance of validation, verification, external evaluation, continuous performance monitoring, and laboratory professional expertise in evaluating AI tools that affect laboratory workflows or patient results.
ADLM also submitted comments to HHS on the adoption of AI in clinical care, urging the department to strengthen laboratory data standards, oversight, and equity in health AI. Additionally, ADLM released a position statement calling on Congress and federal agencies to modernize laboratory regulations and establish clear guardrails for AI in laboratory medicine. The position statement emphasized specific priorities, including laboratory data harmonization, bias mitigation, validation and verification standards, continuous performance monitoring, and appropriate oversight of AI tools that rely on laboratory data.
In addition to responding to federal AI policy proposals, ADLM has continued to convene laboratory medicine experts to examine the implications of AI for clinical laboratories and patient care. Through an expert working group, ADLM is developing a policy report on AI in laboratory medicine that will address issues such as validation, laboratory data quality, interoperability, bias, post deployment monitoring, reimbursement, and the role of laboratory professionals in AI governance. Although this work is still underway, it reflects ADLM’s commitment to ensuring that policymakers understand the central role that laboratories must play in the responsible development and use of AI in healthcare.
Attend the ADLM 2026 scientific session “Academy guidance document on data analytics: Advancing data analytics maturity in the clinical laboratory for a data-driven future” for a high-level overview of the essential components required to establish robust data analytics programs within institutions based on expert recommendations from the Academy of Diagnostics & Laboratory Medicine.
ADLM’s AI advocacy is closely connected to its longstanding work on laboratory data harmonization. AI systems are only as reliable as the data used to develop, validate, and deploy them. When laboratory results vary across instruments, methods, reference intervals, or reporting formats, that variation can affect clinical interpretation, interoperability, and the performance of data driven tools.
ADLM members have long been leaders in explaining why harmonization matters for patient care. The association’s scientific and clinical expertise have helped policymakers understand that laboratory data infrastructure is not a technical side issue. It affects diagnosis, treatment decisions, public health surveillance, clinical research, interoperability, and the future use of AI in healthcare.
ADLM continued advocating for increased federal investment in the CDC’s Clinical Standardization Programs and related laboratory harmonization work. In coalition letters to congressional appropriators, the association and partner organizations have urged Congress to support CDC efforts that improve the consistency and comparability of laboratory results across settings. Congress has provided funding for this work in recent years, and ADLM and its coalition partners have continued advocating for additional resources to scale up these programs.
This work reflects one of ADLM’s central advocacy messages: High-quality laboratory data are foundational to high-quality healthcare. By bringing member expertise to policymakers, ADLM has continued to make the case that investments in harmonization and standardization are investments in patient safety, public health, and trustworthy innovation.
Dive into harmonization and standardization and their importance for patient care at the ADLM 2026 scientific sessions “Insights on PTH testing from the CDC clinical standardization programs: Current status and what’s next” and “Cardiac troponin I utilization: Impactful consequences from lacking standardization and harmonization.”
ADLM also continued to engage in policies that affect the future oversight of laboratory developed tests. For years, ADLM has opposed duplicative FDA regulation of laboratory developed tests and has urged policymakers to preserve CLIA as the primary framework for laboratory oversight. ADLM members have played an important role in helping policymakers understand that laboratory developed tests are essential clinical tools that laboratories develop, validate, and perform to meet patient needs.
Following years of advocacy by ADLM, its members, and partner organizations, a federal court vacated the FDA’s 2024 laboratory developed test rule, and the FDA later issued a final rule reverting its in vitro diagnostic regulations to the framework that existed before the 2024 rule took effect.
With that rule no longer in effect, attention has shifted to whether and how Congress may consider updates to CLIA. ADLM is reviewing the Enhancing Clinical Laboratory Innovation and Access Act of 2026, introduced by United States (U.S.) Representative Neal Dunn (R-Fla.), which would update the regulation of diagnostic testing services under CLIA. ADLM will continue evaluating this and other proposals and working with member experts to ensure that any legislative approach reflects the realities of clinical laboratory practice, maintains high standards for quality and patient safety, and protects access to essential testing.
ADLM also engaged in federal policies that affect the broader scientific and public health environment. In each of these areas, ADLM’s advocacy has been grounded in the same principle: Laboratory policy should be informed by scientific evidence, clinical expertise, and the perspectives of laboratory professionals.
Along with other laboratory and medical organizations, ADLM urged HHS to reinstate the Clinical Laboratory Improvement Advisory Committee (CLIAC) and schedule future meetings. CLIAC provides an important forum for laboratory experts to advise the CDC, the Centers for Medicare & Medicaid Services, and the FDA on CLIA regulations and laboratory quality. Restoring this advisory body would help ensure that federal laboratory policy benefits from scientific and clinical expertise.
ADLM also joined partners in supporting the independence and integrity of evidence-based preventive care recommendations, including the work of the U.S. Preventive Services Task Force. This advocacy reflects the association’s broader commitment to ensuring that federal health policy is guided by evidence, clinical expertise, and patient needs.
ADLM is also reviewing a proposed rule from the Office of Management and Budget that would revise governmentwide federal grantmaking requirements, including rules that apply to research funding. The proposal includes provisions related to senior appointee review of discretionary awards, consideration of presidential policy priorities, the advisory role of peer review, and limits on publication costs under federal awards. ADLM plans to submit comments on the proposal’s potential implications for clinical laboratory research, scientific publication, peer review, and the broader research enterprise.
The past year demonstrated the impact of sustained, member-driven advocacy. ADLM members helped translate complex scientific and policy issues into clear messages about patient access, laboratory quality, public health, and innovation. Their expertise strengthened ADLM’s comments to federal agencies, informed congressional outreach, supported coalition advocacy, and helped policymakers understand why laboratory medicine must be central to healthcare decision-making.
Together, ADLM members, volunteer leaders, committees, working groups, coalition partners, and staff helped elevate pediatric reference intervals as a federal children’s health priority, advance Medicare reimbursement reform, strengthen the role of laboratory medicine in national AI policy discussions, advocate for stronger laboratory data infrastructure, engage on the next phase of laboratory oversight, and defend evidence-based policy-making.
Looking ahead, ADLM will continue advocating for final appropriations support for pediatric reference intervals, permanent PAMA reform, increased investment in laboratory harmonization, responsible AI policy, appropriate CLIA-based laboratory oversight, and federal research policies that support innovation and scientific exchange. The association will also continue working with members to ensure that advocacy priorities reflect the needs of laboratories and the patients they serve.
As healthcare becomes increasingly data driven, the role of laboratory medicine will only become more important. ADLM’s advocacy over the past year made it clear that laboratory professionals are essential not only to today’s patient care system, but also to the future of healthcare.