How could the 2024 election affect clinical laboratories?

How will the election affect laboratory developed test (LDT) oversight?

The election alters the political environment in which decisions affecting laboratory developed test (LDT) oversight will be made. The incoming president is opposed to expansive government regulation. During his first administration, the policy debate largely centered around Congress. An internal Department of Health and Human Services (HHS) memo questioned whether the Food and Drug Administration (FDA) had the authority to regulate LDTs. On this issue, President Trump is likely to be more sympathetic to laboratory concerns than the Biden White House, which has permitted the Food and Drug Administration to advance this policy objective.

What are the chances that CLIA modernization will get attention in the new Congress?

CLIA modernization, in the near term, is tied to congressional discussions of LDTs. If the new administration revokes the FDA rule or the courts decide against the FDA, then the issue of LDT oversight will go back to Congress. The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) and many others in the healthcare community have suggested that any changes to LDT oversight should take place within the current CLIA regulatory framework. The issue may gain traction if legislators, such as Sen. Bill Cassidy, R-La., the incoming chair of the Senate Health, Education, Labor and Pensions Committee, decide to take up the broader issues of device and laboratory testing reform.

Will AI policy change?

In 2023, the Biden Administration issued an executive order outlining how the federal government would oversee the development of artificial intelligence (AI). HHS stated it would create an AI council to develop strategic priorities involving machine learning and healthcare. President-elect Trump has vowed to repeal this directive but has given little guidance on how he plans to move forward. Congress will continue to be active in this issue as both the House and Senate have created bipartisan task forces to develop blueprints for regulating AI.

What other topics will ADLM advocate for under the new administration?

ADLM remains committed to improving the quality of pediatric testing. We have succeeded in getting congressional recognition for better pediatric reference intervals (PRIs) but need to obtain the funding to develop and disseminate them. Over the past year, Rep. John Joyce, MD, R-Pa., the co-chair of the House Children’s Healthcare Caucus, who recently won re-election, took a leadership role in championing this cause. ADLM is hopeful that a new Congress and new administration will provide the necessary funding to begin this long process of advancing pediatric care.

What are some other issues Congress may tackle?

Medicare and Medicaid reimbursement are always possible issues given their amount of spending and the size of the deficit. Also, new administrations always seek to root out fraud and abuse when looking to curtail spending, so that issue may garner additional interest as well. The Affordable Care Act seems safe, as President-elect Trump has stated he will seek to improve the law rather than replace it. One issue that may get some attention is financial relief for laboratory professionals and others in the healthcare community who agree to work in underserved areas. ADLM supports these efforts.

Dennis J. Dietzen, PhD, DABCC, FACB, is the division chief of pathology and laboratory medicine and first Megan Dishop Endowed Chair of Pathology at Phoenix Childrenʼs in Arizona. +Email: [email protected]