CLN - Federal Insider
The House Committee on Appropriations has approved the Fiscal Year (FY) 2027 Labor, Health and Human Services (HHS), Education, and Related Agencies Bill, which includes $5 million for the Centers for Disease Control and Prevention (CDC) to improve pediatric reference intervals.
The development of better pediatric reference intervals is essential for children to get accurate diagnoses and effective care. The Association for Diagnostics & Laboratory Medicine (ADLM) commended the House Committee on Appropriations for supporting this initiative and urged legislators to pass this bill when it’s taken up by the entire Congress.
The current lack of accurate pediatric reference intervals is a serious issue that can lead to incorrect diagnoses and treatments for children. To correctly interpret pediatric lab test results, providers must evaluate results within the context of reference intervals, which are the range of normal test values expected in a healthy child. If a test result falls outside of the reference interval, this alerts the pediatrician that a child might have a condition requiring medical intervention. However, limited access to samples from healthy children has significantly hindered the establishment of accurate pediatric reference intervals.
For many years, ADLM has led an ad hoc coalition of major healthcare groups that has worked to remedy this issue and that includes several pediatric organizations and medical device manufacturers. Fifty-four groups, including ADLM, have urged Congress to fund the improvement of pediatric reference intervals. Now that this funding has been included in the FY2027 House Labor, HHS, Education, and Related Agencies Bill, ADLM will advocate that Congress include it in any final budget package.
On May 29, 2026, the Office of Management and Budget (OMB) published a proposed rule in the Federal Register that would make significant changes to the current federal grant making process.
If finalized, the proposal would pose problems for scientific initiatives in several ways. For one, it would require senior political appointees to review grant proposals in advance to “ensure they demonstrably advance the president’s policy priorities” — independent of peer review. The proposed rule states that peer review recommendations must “remain advisory” and not be “ministerially ratified or routinely deferred to” by senior appointees. If adopted, applicants may face greater uncertainty in award timing and outcomes and should be prepared for heightened scrutiny of the content in proposals.
Under the new OMB rule, federal agencies would have broad latitude to not only reject grant applicants according to the new proposal’s process, but also terminate active grants found to be inconsistent with the administration’s priorities or national interests.
The proposal seeks to establish a “domestic-first framework” for research and development awards, under which these awards must be given to entities that are U.S.-based. This would make agencies consider whether the international element of their scientific objectives is necessary, and limit expertise to domestic resources by blocking the use of research funds to collaborate with other countries. Additionally, the OMB proposal would bar awardees from using grant dollars to attend conferences, obtain professional memberships, or pay for publication costs.
Finally, the proposal would limit federal funding for certain diversity, equity, and inclusion-related activities; this and other changes above could affect some research on demographic health disparities, depending on how agencies implement the policy.
The Association for Diagnostics & Laboratory Medicine’s Policy & External Affairs Core Committee is currently reviewing the proposed rule and will develop a response for the association.
The OMB is accepting comments through July 13.
A bill introduced in the House of Representatives by U.S. congressman Neal Dunn (R-Fla.) in May would update CLIA to provide new provisions for oversight of laboratory developed tests (LDTs).
The bill, named the Enhancing CLIA Act of 2026, aims to provide new tools for tracking the performance and validation of LDTs and to clarify the status of these tests after the 2025 decision by the District Court for the Eastern District of Texas that they are medical services and not subject to Food and Drug Administration oversight.
“The Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory developed testing services,” Dunn said in a statement. “This legislation restores confidence in testing services while avoiding duplicative and burdensome requirements that limit patient access and slow scientific progress. We can ensure necessary oversight of the CLIA program without undermining the laboratories that deliver cutting-edge diagnostics to patients across the country.”
The bill would direct the Centers for Medicare and Medicaid Services (CMS) to establish a database containing information on LDTs, including performance characteristics and validation information; enable labs to submit LDTs for voluntary third-party review to confirm that they are analytically and clinically valid; and create a system for centralized error reporting.
The bill would also establish a statute that LDTs are not medical devices, but professional services regulated by CMS under CLIA. Additionally, it would designate LDTs as including not only traditional wet lab assays but also analyses of lab information and data.