Stakeholders respond to Senate LDT reform inquiry

Prominent stakeholders have written to a top Republican lawmaker in response to an inquiry into the regulation of diagnostic tests, including laboratory-developed tests (LDTs). While the stakeholders disagree on key issues, several have expressed a preference for legislative action on diagnostics, rather than a regulatory overhaul spearheaded by the US Food and Drug Administration (FDA).

The inquiry, led by Sen. Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, follows FDA’s proposed rule to phase out its policy of regulatory discretion for LDTs and require labs that run certain tests to submit premarket applications. Cassidy has claimed that FDA does not have statutory authority to implement the rule and that it would threaten patient care.

In March, Cassidy asked stakeholders to comment on whether the current oversight of LDTs by the Center for Medicare and Medicaid Servies (CMS) under the 1988 Clinical Laboratory Improvement Amendments (CLIA) is sufficient or needs to be updated. He also asked broader questions about how FDA’s proposed rule would affect the healthcare industry.

The American Hospital Association (AHA) wrote to the senator arguing that the proposed rule would be too costly for hospitals, prevent patients from receiving timely care, and create a backlog for regulators. It also echoed previous comments from the LDT rule public docket, arguing that LDTs are safe and effective, and that FDA’s regulations would be a major hindrance to patients.

“The AHA is concerned that the FDA has overreached in its proposal to regulate LDTs as medical devices,” said the group. “We urge Congress to exempt hospitals and health systems from being included in this FDA device framework or help ensure that regulatory oversight of LDTs is modernized in a manner that both supports medical innovation and ensures that these clinical laboratory tests remain accessible, safe and effective.”

AdvaMedDx, the diagnostic arm of the medtech lobby group AdvaMed, responded to questions about whether CLIA needs to be updated, stating that the law does not require premarket evaluation of tests’ accuracy or clinical validity, and do not include a postmarket oversight mechanism to ensure the tests continue to work as intended. It also noted that CMS itself has stated that updating the legislation would be insufficient to ensure analytical and clinical validity of LDTs.

Congress came close to passing a diagnostics reform law, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, in 2022. In the absence of legislative action, FDA has moved forward with a plan to bring LDTs under its oversight through new regulation. AdvaMedDx said they still support a comprehensive legislative fix to the currently regulatory oversight of in vitro diagnostics (IVDs). (RELATED: US lawmakers again propose diagnostics reform bill, Regulatory Focus, 30 March 2023)

“The current regulatory framework was established decades ago and while there have been important targeted improvements, it has remained fundamentally unchanged, despite dramatic advancements in the field,” said AdvaMedDx Executive Director Zach Rothstein. “An updated and modernized framework, reflecting the unique nature of diagnostics, is essential to foster continued innovation and ensure patients and providers have confidence in the accuracy and validity of the tests they use and rely upon.”

“AdvaMedDx strongly supports legislative reform to modernize the device framework so that it is tailored to provide an appropriate, risk-based oversight program for innovative IVDs—including test ‘kits’ that can be run in multiple laboratories or in POC settings; LDTs; and the instruments upon which these assays (tests) run,” he added.

AdvaMedDx said that while FDA has modernized its review process for diagnostics in general, VALID would have created certain benefits such as a streamlined review pathway called the Technology Certification (Tech Cert) program. The group also noted that Congress recently passed legislation that gives FDA explicit authority to allow products with predetermined change control plans (PCCPs) on the market but noted it has limited benefits for diagnostics.

“In many cases, a diagnostics platform can have multiple applications, such as the potential to identify multiple diseases, or provide decision support for multiple conditions,” said Rothstein. “These use cases would potentially implicate multiple intended uses. A concept like Tech Cert in VALID would provide appropriate tools for FDA to be assured of the safety and effectiveness of the new use case without requiring new review cycles and submissions for each such use case.”

The American Clinical Laboratory Association (ACLA), which has been the main critic of FDA's plan to implement LDT oversight through rulemaking, also wrote to Cassidy arguing the rule oversteps FDA's legal authority and would have devastating consequences for the healthcare system. The group argued that the agency's medical device regulatory framework, which would be used to regulate LDTs, is not fit to regulate the tests since they are not "tangible medical device products." Instead, the group argues the tests are services provided by laboratory professionals and treating them like devices makes no sense.

ACLA CEO Susan Van Meter, agreed that FDA needs congressional authority through legislation such as VALID to oversee LDTs, and bemoaned that it failed to pass. She also argued that FDA’s device risk classification framework was not right for diagnostics but under a new statutory framework for diagnostics, the agency could develop a new risk classification scheme that is more appropriate for diagnostics in general.

"Under a modern risk classification, low-risk tests should be exempt from premarket review. This is appropriate because premarket review is not necessary to protect the public health when other regulatory controls are applied to low-risk tests, such as labeling, quality, and adverse event reporting," said Van Meter. "Other categories of tests should be exempt from premarket review to further availability of tests needed to satisfy clinical and public health needs, even if those tests are not low-risk."

ACLA said CLIA should be updated to take into consideration more recent changes to the diagnostics industry such as remote testing and the use of software. It said the changes would likely not require Congressional action and can be achieved by updating the regulations.

"ACLA steadfastly maintains that legislation is the right—and only—approach for FDA to regulate laboratory develop testing services,” said Van Meter. “We would be pleased to again work with Congress to advance appropriate legislation that preserves the critical role of laboratory diagnostics and ensures that patients continue to have access to lifesaving tests."

AHA response

ACLA response

Stakeholders respond to Senate LDT reform inquiry

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