CLN - Federal Insider
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has requested federal funding for two important healthcare initiatives in the federal government’s fiscal year 2026 budget. ADLM is seeking $10 million for the Centers for Disease Control and Prevention (CDC) to enhance pediatric reference intervals (PRIs), well-known by clinical laboratories as essential for accurate pediatric diagnoses.
Many current PRIs are inadequate, potentially leading to misdiagnoses in children, according to ADLM. Enhanced CDC resources to develop and update PRIs would enable clinicians to deliver age-specific, individualized treatments for all patients. “Many of the existing PRIs fall short,” ADLM wrote in a letter to lawmakers. “They frequently miss capturing the full spectrum of biological changes in children as they grow, leading to potential misdiagnoses or misguided treatment protocols. Investing in this area means prioritizing an accurate, evidence-based approach to pediatric healthcare.”
ADLM also is requesting $7.2 million for CDC’s clinical laboratory test standardization work. Assay standardization and harmonization can prevent discrepancies between test results that should be equivalent, ensuring that clinicians can interpret patient results consistently, regardless of location or instrumentation. In the letter, ADLM emphasized that bipartisan support reflects the importance of this work.
ADLM urges CMS to fix lab fee cuts
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) wrote to the Centers for Medicare and Medicaid Services (CMS) to express strong concerns over proposed cuts to Medicare payments for clinical laboratory tests. The letter to CMS Administrator Chiquita Brooks-LaSure underscored the potential negative impacts on patient access and laboratory operations of further cuts to reimbursement.
Congress has acted to delay implementation of the CMS cuts — for now. Lawmakers passed a short-term Continuing Resolution to keep the government funded through December 20 that included a 1-year delay in the cuts. This marks the sixth consecutive year that Congress has postponed Protecting Access to Medicare Act (PAMA) cuts.
CMS’s proposed rule would have reduced payments by 15% starting January 1, 2025, as part of ongoing adjustments mandated by PAMA. ADLM argues that the current data collection process, which heavily weights the pricing from large commercial laboratories, does not accurately represent the broader laboratory field, including hospital laboratories, academic medical centers, and others.
ADLM has supported the Saving Access to Laboratory Services Act (SALSA) to ensure a fair data collection process and stabilize payment rates. ADLM is calling for collaboration with CMS and legislators to implement these reforms, emphasizing the critical role of laboratories in healthcare delivery.
Lab data exchange in focus in proposed rule from Office of the National Coordinator
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) recently submitted comments on the proposed rule on healthcare information interoperability from the Office of the National Coordinator (ONC), emphasizing that interoperability is vital for improving patient care, reducing costs, and enhancing public health through laboratory medicine.
ADLM supports the integration of the United States Core Data for Interoperability (USCDI) Version 4 but is advocating for ONC to add more data elements to improve laboratory data exchange. These include device and test kit identifiers to help healthcare providers and public health officials to trace specific test kits and devices; specimen collection date/time for interpreting time-sensitive tests and tracking clinical progression; and test performed date/time to enhance quality management and monitoring for potential device defects. ADLM also underscored the need for robust but clear guidelines around information blocking.
Read the full November/December 2024 CLN issue here.