Advocacy - Comment Letter
The Association for Diagnostics & Laboratory Medicine (ADLM) welcomes the opportunity to provide testimony to the House Appropriations Subcommittee on Labor, Health & Human Services, Education, and Related Agencies regarding our nation’s fiscal year (FY) 2027 budget priorities. ADLM is urging the subcommittee to support two initiatives vital to improving the quality and efficacy of healthcare in the United States:
ADLM, the American Academy of Pediatrics, the Children’s Hospital Association, the National Rural Health Association, and more than 40 other organizations have written to the subcommittee urging additional funding for the Centers for Disease Control and Prevention (CDC) to improve the quality of pediatric reference intervals (PRIs) - the range of numeric values expected in a healthy child – available to health practitioners to care for their young patients.
When making a diagnosis, the healthcare professional considers the laboratory test value within the context of a reference interval. If the test result falls outside of the defined reference interval for a healthy child – either higher or lower – the practitioner may order a medical intervention to address a health condition or change an ongoing treatment protocol. If the diagnosis or treatment change is incorrect, it could result in patient harm. Therefore, it is critical that the range of values used by practitioners to interpret test results are accurate and reflect normal biological changes.
Whereas the reference intervals for adults are generally reliable, there are considerable inconsistencies and large gaps in the ranges available for children. Healthcare practitioners need reference intervals reflective of healthy children at each unique stage of physical development, from birth through adolescence to adulthood. In addition, the intervals must also take into consideration any variations due to biological factors, such as ethnicity and gender.
Accurate and actionable PRIs are particularly important for our youngest patients, who are often unable to verbally communicate their symptoms. Unfortunately, many current PRIs are outdated and do not reflect normal biologic changes in children. Most laboratories do not have access to appropriate pediatric samples to create their own PRIs and therefore must rely on those outdated PRIs. This situation was highlighted in a study in JAMA Peds 2022.1 In addition, having each laboratory develop their own PRIs will add substantial costs to the healthcare system. The vast majority of pediatric clinical laboratories do not have the personnel or resources to accomplish this on their own.
The Subcommittee recognized the importance of this issue by including report language in its FY25 and FY26 appropriations bills encouraging CDC to move forward in this area. The agency has stated that it has the existing infrastructure to initiate and advance this vital work but would need $10 million to start developing and disseminating these intervals. ADLM and its partners support providing the CDC Environmental Health Laboratory with the needed funding to improve the quality of PRIs for our nation’s children.
ADLM and its allies also request your assistance with the harmonization of clinical laboratory test results. Laboratories often use different methods to diagnose a condition, resulting in practitioners receiving different numeric values and reference ranges for diagnosing that same condition. This lack of harmonization makes it difficult to develop widely applicable clinical guidelines or performance measures that can better inform health care decision-making. There is also the potential for patient harm when results from one institution are used at another for medical decisions, and the methods have not been standardized.
Tests that are harmonized (or standardized) provide the same numeric value for a patient, regardless of the method or instrument used or the setting where the tests are performed. An early example of harmonization is cholesterol, which is widely utilized by the medical community to diagnose heart disease. A 2011 study published in Preventing Chronic Disease reports that early drug intervention based on cholesterol levels saved the health system $338 million to $7.6 billion annually between 1980 – 2000.2 Thus, harmonization can improve patient care while also saving money.
In recent years, the subcommittee and Congress have supported expanding CDC’s harmonization efforts, resulting in new activities to improve the detection and management of hormone disorders, kidney disease, cancer, and heart disease. CDC is the only laboratory in the U.S. that assists laboratories with achieving accurate and harmonized test results.
With additional funding, CDC will be able to continue its current harmonization activities and expand its efforts to harmonize new biomarkers used to prevent and treat kidney disease, cancer, diabetes, cardiovascular diseases, and diseases of the endocrine system, as well as start improving PRIs. This will include new and emerging technologies, such as point of care testing devices, used in patient care and public health. ADLM and its partners respectfully request that the subcommittee provide an additional $7.2 million ($9.2 million in total) for CDC to advance its harmonization activities. Congress has provided $2 million annually for this program since FY18. The subcommittee included, and the House passed, a $4 million increase for this initiative in the FY20 budget, but it was not included in the final House-Senate agreement.
ADLM is a global scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. We look forward to working with the subcommittee on these most important issues as it goes through the FY27 budget process. If you have any questions, please email Vince Stine, PhD, ADLM’s Senior Director of Government and Global Affairs, at [email protected], or Evan Fortman, MPA, ADLM’s Manager of Government Affairs, at [email protected].
1 Lyle Alicia N. et al, Current State of Pediatric Reference Intervals and the Importance of Correctly Describing the Biochemistry of Child Development: A Review. JAMA Pediatrics 2022; 176(7):699-714
2 Hoerger TJ, Wittenborn JS, Young W. A cost-benefit analysis of lipid standardization in the United States. Preventing Chronic Disease 2011; 8: A136