ADLM endorses the RESULTS Act

The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has endorsed the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act of 2025 in a letter addressed to United States Rep. Richard Hudson (R-N.C.).

By creating a new, more equitable Medicare clinical laboratory fee schedule (CLFS), the RESULTS Act would address the steep payment cuts that clinical laboratories are currently facing because of the Protecting Access to Medicare Act (PAMA), ADLM wrote in the letter.

In 2014, Congress passed PAMA, which directed the Centers for Medicare and Medicaid Services to rebase the CLFS to reflect private sector payment rates. Unfortunately, nearly all the data used to set the new fees comes from large commercial laboratories, which can perform testing more cheaply due to their economies of scale. The result is significant reductions in payment rates that will adversely affect all labs, particularly those in rural and underserved areas.

If enacted, the RESULTS Act would correct several deficiencies in the earlier statute. The biggest of these corrections would be ensuring that more representative payment data is utilized for setting fees. In addition, the measure would provide greater price stability through a more accurate, more predictable rate-setting process and by reducing the administrative burden on laboratories. ADLM believes these changes would result in a more streamlined, less burdensome payment process.

Without congressional action, more than 800 tests may be subjected to up to 15% cuts on January 1, 2026, ADLM wrote in the letter. These payment reductions will further exacerbate the financial burdens on laboratories and limit patient access to quality, timely testing services. RESULTS would forestall these and maintain the current payment structure through 2028 as the new CLFS is implemented.

FDA RESCINDS FINAL RULE ON LABORATORY DEVELOPED TESTS

The Food and Drug Administration (FDA) released a final rule rescinding its previous May 2024 rule, which had placed laboratory developed tests (LDTs) under duplicative FDA authority in addition to their longstanding regulation under CLIA. The new rule, which went into effect September 19, returns the FDA’s regulations on in vitro diagnostics to their previous form.

Specifically, the new amendment to the previous May 6, 2024, rule removes the words “including when the manufacturer of these products is a laboratory” from 21 CFR 809.3(a), reverting the regulation text to its state prior to the effective date of the rule.

The change was made to reflect an order from the U.S. District Court for the Eastern District of Texas. The court vacated the LDT rule in a decision issued on March 31, delegating the matter to Robert F. Kennedy Jr., the Secretary of Health and Human Services, for further consideration.

The decision came after a decades-long debate between the FDA and clinical laboratory industry over whether the agency could regulate LDTs. Although the agency maintained that it had legal authority to regulate LDTs and that it had only declined to enact it in large part because of a policy of “enforcement discretion,” most laboratory industry organizations argued that the agency did not have this authority.

Following the release of the May 2024 rule, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) filed lawsuits against the agency, requesting that the court strike down the rule. Several other health organizations, including the Association for Diagnostics & Laboratory Medicine (formerly AACC), supported ACLA and AMP by filing an amicus brief in support of their stance.

The court backed the plaintiffs in its ruling to vacate the FDA’s previous final rule, writing that the “text, structure, and history” of the Federal Food, Drug, and Cosmetic Act and CLIA show that the FDA lacks authority to regulate LDTs.

NIH PUBLISHES PLAN TO IMPLEMENT TRUMP SCIENCE STANDARDS POLICY

The National Institutes of Health (NIH) recently published its plan to implement President Donald J. Trump’s “Restoring Gold Standard Science” executive order issued in May, which aims to redefine the standards for conducting scientific research.

The NIH plan proposes nine tenets of high-quality scientific research: Reproducibility, transparency, communication of error and uncertainty, collaboration and interdisciplinary efforts, skepticism of scientific findings and assumptions, structured for falsifiability of hypothesis, subject to unbiased peer review, the acceptance of negative results as positive outcomes, and conducting research without conflicts of interest.

To foster reproducibility, the document states that the NIH intends to develop “new, targeted funding mechanisms and programs” as part of a larger effort to enact “culture change” across the field of research. In particular, the NIH emphasizes the sharing of negative or null results as an area of needed focus.

The NIH also plans to make several changes to the Intramural Research Program (IRP). As part of this effort, the agency is revising the IRP’s guidelines for research conduct and reviewing academic freedom practices within the IRP, with the stated goal of fostering amongst scientists a “willingness to challenge the conventional thinking.”

United States scientists have criticized Trump’s executive order as a bad faith appropriation of scientific language and principles. For example, Stand Up for Science, a nonprofit social welfare organization, noted that the administration has already defunded areas of research that do not align with its political ideologies, spread vaccine misinformation despite widespread evidence of the safety and effectiveness of vaccines, and incorrectly defined sex determination as binary although biology proves it is not.

The journal Science also raised concerns about the executive order, stating that it grants political appointees the power to “override conclusions and interpretations of government scientists, threaten their professional autonomy, and undermine the scientific capacity of research and regulatory agencies.” The Science editorial also notes that the plan includes open-ended terms and phrases such as “reproducibility,” and “accepting negative results as positive outcomes” without any requirement to consider widely accepted scientific or medical practices and conventions.

Read the full November-December issue of CLN here.