LDT Final Rule Could be Released Soon

Six weeks after the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) released a joint statement urging the FDA handle the oversight of laboratory developed tests (LDTs), the FDA appears poised to release its final rule giving it that authority. On March 1, the FDA submitted its final rule to the Office of Management and Budget for approval, the final step needed before the FDA can release its final rule.

Before the comment period had even ended on the Agency’s proposed rule, the FDA outlined plans to quickly release final regulations taking oversight of laboratory developed tests from CMS. In the Department of Health and Human Services’ (HHS) Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions, the FDA proposed to release its final rule by April 2024. Clearly, the FDA has prioritized claiming oversight over LDTs.

The aggressive push by the Agency is noteworthy. Given the speed with which the FDA went from proposed rule to final rule, it is hard to imagine the Agency made significant changes to its proposed oversight approach. Moreover, many, if not most, of the 6,700+ comments the Agency received on the rule were negative. Included among the comments opposing the FDA’s proposal were those from ASCP and many from laboratory and hospital organizations. Our comments urged the FDA not to finalize its proposed rule due to the critical importance LDTs have on patient care. For ASCP’s comments on the proposed rule, click here. 

In addition, ASCP secured unanimous support from the American Medical Association’s (AMA) House of Delegates for our resolution urging the FDA to extend the proposed rule’s comment period (click here for more) to provide stakeholders more time to weigh in on the proposal. ASCP also released several action alerts resulting in more than 1,700 comments sent to the FDA—about 25 percent of all the comments the FDA received—along with more than 6,000 letters sent to Congress. ASCP also worked with other pathology and laboratory medicine associations, which were almost universally opposed to the proposed rule.

ASCP anticipates that the final rule could be released before the end of April. When it is released, ASCP will thoroughly review the rule and discuss next steps with its leadership and other laboratory stakeholders concerned about the impact the final rule could have on patient care.

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