CLN - Federal Insider
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has requested that Congress appropriate an additional $10 million for the Centers for Disease Control and Prevention’s (CDC) fiscal year 2026 budget to fund the development of quality pediatric reference intervals (PRIs), which are essential for delivering accurate pediatric diagnoses.
Despite the wide availability of reference intervals for adults, PRIs often exhibit poor quality or are nonexistent, ADLM wrote in a letter addressed to House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies chair Robert Aderholt (R-Ala.) and ranking member Rosa DeLauro (D-Conn.). Because laboratories don’t have the resources to obtain the necessary samples from healthy children to develop appropriate normal ranges, they rely on intervals derived from samples taken from sick children, which distort the “true” normal range. Although adult reference intervals may be used, these ranges don’t reflect the growth and developmental stages of children and can lead to misdiagnosis and inappropriate care, according to ADLM.
To remedy this situation, the CDC proposes collecting clinical samples through its National Health and Nutrition Examination Survey and using its Environmental Health Laboratory to generate reference intervals for children and disseminate the information to clinical laboratories, ADLM noted. However, the agency will need an additional $10 million to initiate and advance this work.
In the letter, ADLM is joined in requesting these funds by numerous organizations committed to ensuring that America’s children receive high quality and equitable healthcare.
The Department of Health and Human Services (HHS) hasn’t completed a thorough evaluation of the success and outcomes of available treatment options for various diseases and conditions, a recent report from the United States Government Accountability Office (GAO) shows.
Comparative clinical effectiveness research evaluates and compares the health outcomes of two or more medical treatments, services, or items, according to the GAO report. In 2010, Congress authorized the establishment of the Patient-Centered Outcomes Research Institute (PCORI) to conduct this research and improve its quality and relevance. Congress also directed HHS to publicly disseminate and help incorporate these research findings into clinical practice. PCORI and HHS were allotted a total of $3.1 billion for fiscal years 2019 through 2024 for this initiative.
HHS disseminated findings from 16 PCORI-funded studies from 2016 to March 2025, according to officials. In 2020, HHS had plans to evaluate its dissemination and implementation portfolio near-term goals and performance measures, GAO reported. However, it remains unclear whether the evaluation will be conducted as planned.
HHS has not requested proposals for evaluations, which officials attributed to delays in leadership changes in August 2024 and March 2025. Further complicating matters, in March 2025, HHS announced staff reductions and a departmental reorganization, which the agency only started to implement in July.
In the report, GAO recommends that the secretary of HHS complete an evaluation of the dissemination and implementation portfolio efforts supported by funding as planned, including the development and implementation of near-term goals and associated measures to regularly assess performance.
Three artificial intelligence (AI) laws affecting hospitals, state agencies, and other healthcare stakeholders were passed by Texas Governor Greg Abbott (R) in June. The laws mandate that providers disclose to patients some instances of when they use AI, meet state standards, and take steps to prevent harmful outcomes. They could serve as a model for other GOP states to follow when regulating AI in healthcare.
The most notable law that Abbott signed, The Texas Responsible Artificial Intelligence Government Act (HB149), or TRAIGA, says private and public sector stakeholders can’t use AI to encourage people to self-harm, infringe on constitutional rights, or discriminate against protected classes, among other things. Additionally, providers affiliated with government entities must disclose to patients or their representatives when they use AI for treatment, the bill says. According to Inside Health Policy, this represents a lighter touch than Colorado, which passed a broader bill including private sector AI disclosure requirements as well.
Another one of the bills Abbott signed, SB1188, allows practitioners to use AI for diagnoses so long as they follow Texas Medical Board standards, practice within the scope of their license, and disclose their use of AI to patients. Again, this takes a more hands-off approach than another blue state, Illinois, which recently banned AI from providing mental health and therapeutic decision-making, reported Inside Health Policy.
Additionally, Abbott signed SB1964 into law, which regulates how state agencies and local government use and manage AI systems.
Currently, states are poised to lead in the regulation of AI in healthcare instead of the federal government, because lawmakers in Congress are struggling to pass a comprehensive federal AI bill.