A year of progress: ADLM advocacy highlights

The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has actively championed the interests of laboratory professionals and patients over the past year, engaging policymakers on critical issues ranging from test regulation to workforce shortages. This advocacy comes amid rapid changes in laboratory medicine and U.S. healthcare overall, including new regulatory proposals, economic pressures on labs, and a postpandemic reevaluation of public health infrastructure. Through all of this, ADLM has continued to pursue key advocacy initiatives that advance policies that support laboratory quality, innovation, and patient access.

Confronting FDA’s laboratory developed test oversight rule

In May 2024, the Food and Drug Administration (FDA) finalized a rule to unilaterally assert regulatory oversight over laboratory developed tests (LDTs), even though LDTs have long been effectively regulated under CLIA, which is overseen by the Centers for Medicare & Medicaid Services (CMS). This development followed several attempts to codify FDA oversight of LDTs in legislation via the VALID Act. This bill was not enacted due to the overwhelming outcry from the healthcare community, and also thanks to the advocacy of ADLM and fellow stakeholders.

After the FDA published its final rule, ADLM’s Policy & External Affairs Core Committee (PEACC) met with a number of key congressional offices to voice concerns that the FDA’s unilateral LDT regulation would be duplicative, saddle labs with significant operational and financial burdens, stifle innovation, and ultimately delay patient access to critical diagnostic tests. ADLM urged Congress to repeal the FDA rule and to address any LDT oversight gaps by modernizing CLIA’s existing framework instead. The association has long held that CLIA should remain the primary mechanism for updating clinical lab oversight and has called for updating CLIA regulations (e.g., inspection processes, quality control, proficiency testing, and the definition of LDTs) in order to address modern testing needs.

Backing its advocacy with data, ADLM conducted multiple member surveys to gather frontline evidence on the FDA rule’s potential impact. These results were shared with policymakers in early September 2024 as part of the association’s push to roll back the FDA final rule. Many hospital laboratories warned that duplicative FDA oversight would limit patient access to testing and would not improve testing quality. In particular, after the rule’s issuance, over half of clinical laboratories indicated they would likely discontinue some LDTs rather than attempt FDA approval, citing insufficient staff and resources to meet the FDA’s new requirements. In fact, 60% of surveyed hospital labs said they would be unable to comply with the FDA’s “unmet need” exception criteria and nearly 70% of those would stop offering the affected LDTs. ADLM conveyed these findings in a September 5, 2024, comment letter to congressional health committee leaders, emphasizing that the rule, set to phase in starting May 2025, could trigger widespread loss of locally developed tests and delay patient care.

ADLM has also long maintained that FDA lacks the statutory authority to regulate LDT services performed in clinical labs, a view shared by much of the laboratory community. This position was vindicated on March 31, 2025, when the U.S. District Court for the Eastern District of Texas ruled in American Clinical Laboratory Association (ACLA) v. FDA that the FDA’s LDT final rule was unlawful and vacated it. The court agreed that LDTs are fundamentally clinical services already regulated under CLIA, not medical devices, and noted that Congress — by declining to pass the VALID Act in 2022 — had chosen not to grant FDA explicit LDT oversight. With this decision, the FDA’s planned LDT regulations were nullified, pending any appeal.

ADLM, which joined a number of other healthcare stakeholders in submitting an amicus brief in support of the case, applauds the court’s decision as a major victory for clinical labs and patients. In a public statement, ADLM President Anthony Killeen, MD, BCh, PhD, DABCC, FADLM, emphasized that the FDA rule would have subjected labs to duplicative, burdensome requirements from both FDA and CMS, forcing many to cease offering essential tests.

Safeguarding patient access by preventing Medicare cuts

Even as the LDT debate intensified, ADLM continued its longstanding advocacy to protect laboratory test reimbursement under Medicare. In October 2024, ADLM submitted comprehensive comments to CMS objecting to planned cuts of up to 15% on roughly 800 lab test reimbursement rates. These cuts were scheduled for 2025 under the Clinical Laboratory Fee Schedule (CLFS), as mandated by the Protecting Access to Medicare Act (PAMA) of 2014.

In its comments, ADLM warned CMS that such steep reductions could “severely impact patient access to essential diagnostic tests, particularly in rural and underserved communities,” especially given laboratories’ rising operational costs and workforce shortages. The association underscored a fundamental flaw in CMS’s rate-setting process: The data collection method relied on a small subset of large commercial laboratories, skewing payment rates downward and failing to reflect the broader lab community. ADLM urged CMS to collaborate with Congress on a more equitable approach so that vital testing services would not be compromised by financially unsustainable rates.

Concurrently, ADLM and a coalition of laboratory stakeholders ramped up support for the Saving Access to Laboratory Services Act (SALSA) — bipartisan legislation designed to permanently reform PAMA. SALSA proposes a statistically representative sampling method for lab payment data in lieu of the onerous all-labs reporting system, and would limit yearly cuts, thereby providing greater stability and fairness in lab reimbursement. The laboratory community argued that passing SALSA would reduce administrative burdens on labs and help them to continue providing high-quality care without the constant threat of drastic cuts.

These efforts yielded a short-term victory in late 2024: As part of a government funding measure, Congress enacted a 1-year delay of the PAMA cuts, pushing the next round of cuts to 2025 and extending the data reporting deadline to January 2026. This marked the sixth consecutive year that ADLM and allied groups convinced lawmakers to postpone PAMA’s implementation. ADLM and its allies will continue pressing for a permanent PAMA fix to preserve patient access to essential tests and to ensure clinical labs remain financially sustainable in a changing healthcare environment.

Tackling the critical laboratory workforce shortage

ADLM’s advocacy has additionally worked to address another looming challenge — the national shortage of clinical laboratory professionals. On November 7, 2024, ADLM formally endorsed the Medical Laboratory Personnel Shortage Relief Act of 2024, signaling strong support for this bipartisan proposal to bolster the lab workforce.

In a letter to the bill’s sponsor, Rep. Deborah Ross (D-N.C.), ADLM detailed how severe staffing shortages in labs across the country were increasing workloads and stress on staff, raising the potential for risk of errors or delays in test results. Some laboratories — particularly in rural and underserved areas — have even faced temporary closures due to lack of personnel, directly limiting patient access to timely diagnostics. The workforce crisis stems from high retirement rates and too few new graduates entering the field, a gap only exacerbated by the COVID-19 pandemic’s strain on laboratory professionals.

ADLM supported the bill’s multi-pronged approach to address these issues. Firstly, the legislation would include medical laboratory professionals in the National Health Service Corps (NHSC), making labs in shortage areas eligible for placement of NHSC scholars and loan repayment recipients. By treating laboratory scientists as critical healthcare providers, this step would incentivize new graduates to serve in high-need areas, directly alleviating regional staffing gaps.

Secondly, the bill proposed a student loan repayment program for laboratory personnel, which ADLM noted would ease the financial burden on new professionals and encourage them to remain in the laboratory field long-term. Finally, the Act sought to increase funding for medical laboratory education, with an emphasis on programs that recruit underrepresented groups and foster culturally competent care. Investment in a diverse pipeline of well-trained laboratorians is critical for maintaining a robust workforce into the future, and ADLM has repeatedly communicated to lawmakers that strengthening the lab workforce is fundamental to ensuring quality patient care.

A changing political landscape

2025 poses the potential for significant shifts in the policy landscape affecting laboratory medicine. The new U.S. administration took office in January 2025 with a stated agenda of reducing federal regulations. In its first months, the Trump administration undertook an aggressive streamlining of the Department of Health and Human Services (HHS), including the elimination of certain advisory committees.

One such body was the Clinical Laboratory Improvement Advisory Committee (CLIAC), a federally chartered committee that for decades had been the premier forum for federal agencies, lab medicine experts, industry, and patient representatives to discuss and refine clinical laboratory regulations. Since 1992, CLIAC’s work had been pivotal in maintaining high quality standards in the nation’s 300,000-plus laboratories. The committee provided recommendations that helped update CLIA regulations as testing technology evolved. ADLM views the sudden dissolution of CLIAC as a misguided decision that should be easily rectified.

The association sent a letter to HHS Secretary Robert F. Kennedy Jr. in mid-March, and issued a public statement on May 15, 2025, calling on HHS to reinstate CLIAC immediately. ADLM warned that eliminating this invaluable federal advisory body not only removes a critical avenue for modernizing lab regulations in step with scientific innovation, but it also could undermine patient safety and test quality across the country.

ADLM also pointed out that cutting CLIAC would not even yield meaningful cost savings — the committee’s approximately $80 million cost was funded by user fees from the lab community, making any budget impact negligible. Given that robust CLIA oversight (through mechanisms like CLIAC) is central to ADLM’s vision for lab regulation, the association has pressed HHS to reverse course. In public statements, ADLM President Dr. Killeen has underscored that, because laboratory testing is so crucial to medical decision-making, maintaining a public forum like CLIAC is essential to ensuring that regulations keep pace with innovation without compromising patient care.

Strengthening public health data and laboratory infrastructure

ADLM’s advocacy in 2025 has extended beyond the laboratory bench to the broader public health and health data systems that rely on clinical labs. The COVID-19 pandemic exposed gaps in the nation’s public health data infrastructure and underscored the need for real-time data exchange between clinical labs and public health authorities. Recognizing this issue, ADLM has joined other healthcare organizations to push for sustained federal investment in data modernization and laboratory quality initiatives.

Lab test harmonization

In April 2025, ADLM led a coalition of 20 laboratory and medical groups in urging Congress to increase funding for the Centers for Disease Control and Prevention (CDC)’s Clinical Standardization Programs. In a letter to House and Senate appropriations leaders on April 10, the coalition emphasized that harmonization of lab test results — ensuring that a given test yields consistent, comparable results across different laboratories and instruments — is critical for improving patient care and enabling the future of data-driven healthcare.

Lack of uniform standards also hampers interoperability and the effective use of artificial intelligence (AI) in healthcare, as a Congressional AI Task Force highlighted in a recent report. To address this, ADLM and partners called on Congress to provide an additional $7.2 million in fiscal year (FY) 2026 for CDC’s laboratory harmonization efforts at the agency’s Environmental Health Laboratory (EHL). This relatively modest investment would expand programs to standardize results for key clinical tests, thereby strengthening laboratory quality nationwide and laying the groundwork for more reliable clinical decision support tools.

Pediatric reference intervals

Another key priority has been advancing pediatric reference intervals (PRI), which are critical for accurately interpreting laboratory test results in children. In a joint letter to House and Senate appropriators, an ADLM-led coalition of more than 40 signatories called for an additional $10 million in FY 2026 funding for the CDC to begin a national initiative to improve PRI. The CDC has proposed using its National Health and Nutrition Examination Survey (NHANES) to collect samples from healthy children, in addition to leveraging the EHL to generate and disseminate scientifically validated pediatric reference ranges. While the infrastructure exists, the agency needs additional resources to operationalize this work.

This investment would help clinical laboratories move away from relying on reference ranges based on adult values or samples from acutely ill pediatric populations — both of which distort the “true normal” and increase the risk of clinical error. Establishing standardized, developmentally appropriate reference intervals would improve diagnostic accuracy, advance health equity, and support better care for children nationwide, particularly those in underserved or rural communities where diagnostic precision is most critical. While ADLM recognizes the current fiscal constraints facing Congress, this effort lays essential groundwork for a future investment in pediatric health that is both targeted and cost-effective.

Data science and healthcare AI

In May 2025, ADLM signed on to another appropriations request focused on bolstering the country’s public health data infrastructure. Along with dozens of public health and healthcare groups, ADLM urged congressional appropriators to allocate $340 million in annual funding for the CDC’s Data Modernization Initiative (DMI) in FY 2026.

In a letter to the chairs and ranking members of the appropriations subcommittees, the coalition thanked Congress for prior support and stressed that modern, interoperable data systems are essential not just during crises, but for daily disease surveillance and community health. The requested funding would allow CDC and state health departments to continue replacing antiquated data collection methods with automated, real-time reporting pipelines. The groups also asked for dedicated funds for CDC’s new “One CDC Data” platform and the Center for Forecasting and Outbreak Analytics, tools aimed at integrating data streams and predicting health threats.

Advocating for children’s health programs

ADLM’s mission to advance healthcare through laboratory medicine naturally extends to protecting programs that benefit vulnerable patient populations, including newborns and children. In April 2025, ADLM turned its attention to the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) — another HHS advisory panel that had been disbanded under the new administration’s downsizing efforts. This committee of experts had been responsible for reviewing evidence on newborn screening tests and recommending which conditions should be included on the Recommended Uniform Screening Panel (RUSP) — the federal list of disorders that states consider for their newborn screening programs.

Over decades, ACHDNC played an indispensable role in expanding newborn screening nationwide. Thanks to its work, the number of core conditions on the RUSP grew to 38, and by 2025 every state was screening for the majority of those (at least 30 out of 38 conditions) — a large improvement from 15 years prior. Approximately 15,000 babies each year are born with one of these detectable conditions and benefit from early identification and treatment, often sparing them from death or lifelong disability. Recognizing these successes, ADLM was alarmed by the elimination of the ACHDNC and swiftly advocated for its restoration. On April 15, 2025, ADLM sent a letter to HHS Secretary Kennedy urging him to reinstate the ACHDNC and to allow its vital work to continue.

ADLM pressed HHS either to restore the advisory group or, at minimum, to clarify how the Department will handle the evaluation of new conditions and updates to the RUSP in the committee’s absence. The association highlighted examples like phenylketonuria (PKU) — once universally fatal or debilitating, now manageable due to newborn screening — to illustrate the life-altering stakes of these decisions.

Continuing advocacy in 2025 and beyond

ADLM’s advocacy over the past year has produced tangible results and has maintained the association’s position as a credible voice in ongoing policy discussions that affect the practice of laboratory medicine. From delaying steep Medicare payment cuts to helping to overturn an overreaching FDA rule, ADLM has worked to prevent disruptive changes while advancing policy proposals that reflect the realities faced by clinical laboratories. ADLM’s members can expect the association to remain actively involved in shaping the regulatory and legislative landscape with a focus on practical outcomes that support laboratory professionals and the patients they serve.

Interested in learning more about some of these topics at ADLM 2025 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo)? The meeting will feature sessions on data science, harmonization, and ADLM's pediatric health initiatives.