On October 10, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) hosted a congressional briefing where experts in laboratory medicine described the need for more accurate pediatric reference intervals (PRIs) and the Centers for Disease Control and Prevention’s (CDC’s) plan for addressing this problem. PRIs are vital for effectively interpreting children’s test results, yet there is considerable inconsistency in existing PRIs, putting children at risk for misdiagnosis and inappropriate treatment. The reference intervals available for many diagnostic tests fail to reflect normal health conditions in children, who may not always be able to communicate their symptoms like adults.
CDC projects it will need an additional $10 million from Congress to establish appropriate PRIs. Over the next 10 years, the agency plans to improve PRIs by leveraging its existing infrastructure, particularly the National Health and Nutrition Examination Survey (NHANES). This program will be used to collect more data on children and develop new laboratory methods for various biomarkers.
ADLM PROVIDES INPUT ON INITIATIVE TO MODERNIZE CDC
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) wrote to congressional leaders to provide input on modernizing the Centers for Disease Control and Prevention (CDC), highlighting four patient-focused areas CDC should take the lead on or be involved in.
The association urged Congress to designate funding for CDC to improve the ability to interpret pediatric test results, including through the development of more accurate pediatric reference intervals. On a broader scale, harmonization of clinical laboratory tests leads to consistent diagnosis and early interventions, as evidenced by the success of cholesterol test harmonization. ADLM noted that if Congress invests in CDC’s ongoing commitment to support clinical laboratory testing, the quality of lab tests can be greatly enhanced without the need for additional Food and Drug Administration oversight, such as the agency’s push to increase their oversight of laboratory developed tests, which ADLM opposes.
Additionally, the letter stressed the need for CDC to have the capacity to oversee pandemic surveillance efforts in coordination with state and local health departments. Congress should provide funds necessary for CDC to rebuild public health infrastructure and prepare for future health crises, ADLM wrote.
CMS STATEMENT ON CURRENT STATUS OF BLOOD TESTS FOR ORGAN TRANSPLANT REJECTION
The Centers for Medicare & Medicaid Services (CMS) released a statement confirming that neither CMS nor the Medicare Administrative Contractors (MACs) have made changes that affect patients’ ability to have blood tests used to monitor for organ transplantation rejection. Traditionally, the standard for assessing transplant rejection or injury has been a biopsy in conjunction with serologic criteria. Because biopsies are invasive and carry risks, tests that negate the need for a biopsy can be used for patients with transplanted hearts, lungs, or kidneys, as laid out in a Local Coverage Determination (LCD).
The Molecular Testing for Solid Organ Allograft Rejection LCD became effective on June 6, 2021, but over time, MACs became aware of improper billing and overutilization of these tests. This year, MACs issued revised billing instructions to providers and released a new LCD in which coverage criteria remain intact. Patients with Medicare can continue to access blood tests for organ transplantation rejection when medically appropriate and ordered by their physicians.