Enhancing CLIA Act of 2026
- Sponsor
- Rep. Dunn, Neal P. [R-FL-2]
- Committees
- Ways and Means Committee (primary)
- Last action
- May 19, 2026
Bottom line
The bill aims to streamline the regulation of laboratory developed tests by placing them squarely under CLIA, establishing clear validity standards, and creating a transparent database, while explicitly limiting FDA's regulatory authority over these tests.
What it actually does
This bill significantly amends the Public Health Service Act, specifically the Clinical Laboratory Improvement Amendments (CLIA), to establish a new regulatory framework for Laboratory Developed Tests (LDTs). It clarifies that LDTs are regulated under CLIA, not the Federal Food, Drug, and Cosmetic Act (FDCA), and sets standards for analytical and clinical validity, a centralized database, and test error reporting. It also outlines a system for optional third-party affirmation of LDT validity and ensures Medicare coverage for tests validated under this new framework.
Proponents argue
Proponents argue that the current regulatory landscape for LDTs is fragmented and creates uncertainty, hindering innovation and patient access to critical diagnostic tools. This bill provides a clear, risk-based framework under CLIA, which is better suited for laboratory oversight, fostering innovation while ensuring patient safety and test quality. It prevents duplicative and burdensome FDA regulation that could stifle development and increase costs, ultimately benefiting patients through more accessible and reliable diagnostics.
Opponents contend
Opponents might argue that shifting LDT regulation solely to CLIA, and away from FDA oversight, could compromise patient safety by lowering standards for test validation. They may contend that FDA's expertise in device approval is necessary to ensure the rigorous clinical validity of these tests, especially as LDTs become more complex and widely used, and that the proposed third-party affirmation process may lack sufficient rigor or independence, potentially allowing less validated tests to reach patients.
The bill is moderately technical but clearly structured, allowing an informed reader to grasp its core changes within a reasonable timeframe.
Section 2(a)(1), amending Section 353(a) of the PHS Act
Clarification of Regulatory Authority and LDT Definitions
This provision explicitly states that laboratory operations, including Laboratory Developed Tests (LDTs), are regulated under the Clinical Laboratory Improvement Amendments (CLIA) and not under the Federal Food, Drug, and Cosmetic Act (FDCA). It also defines key terms such as 'analytical validity,' 'clinical validity,' 'clinical use,' 'investigational use,' and 'laboratory developed test,' specifying the conditions under which a test qualifies as an LDT and is exempt from FDA device regulation.
Supporters argue
Supporters argue this clarifies a long-standing ambiguity, preventing duplicative and potentially conflicting regulation by FDA and CMS. It ensures LDTs are regulated by the agency (CMS/CLIA) with direct expertise in laboratory oversight, fostering innovation and access to critical diagnostics.
Critics contend
Critics might argue this provision significantly weakens patient protections by removing LDTs from FDA's more rigorous pre-market review process for medical devices, potentially allowing less validated tests to reach patients.
Tradeoffs
This provision balances the desire for regulatory clarity and innovation in laboratory diagnostics against concerns about maintaining high standards for patient safety and test reliability.
Section 2(a)(2), adding new subsection (r)(1) to Section 353 of the PHS Act
Requirements for Analytical and Clinical Validity of LDTs
This section mandates that LDTs for clinical use must have a 'reasonable assurance of analytical and clinical validity' two years after enactment. It outlines how analytical validity (e.g., establishing performance specifications) and clinical validity (e.g., documented evidence like peer-reviewed literature, clinical studies, real-world data) can be established. It also introduces a system for optional 'supplemental affirmation' by approved third parties or the FDA, which does not expire unless the third party's approval is withdrawn.
Section 2(a)(2), adding new subsections (r)(2) and (r)(3) to Section 353 of the PHS Act
Public Database and Mandatory Error Reporting for LDTs
This provision requires laboratories performing LDTs for clinical use to submit specific information (e.g., test name, purpose, analytes, specimen type, performance summary) to a new centralized, transparent database established by the Secretary within two years. It also mandates reporting of test errors: within 5 days for errors causing death or imminent public health threats, and quarterly for errors causing serious harm other than death.
Section 2(a)(2), adding new subsection (r)(4) to Section 353 of the PHS Act
Secretary's Authority to Review LDT Validity
This section empowers the Secretary of Health and Human Services (HHS) to request information from a developing laboratory if there are 'specific scientific concerns, based on credible and verifiable information,' indicating that an LDT does not meet the applicable validity standard or is misrepresented. If concerns are not resolved after a review process, the laboratory must cease performing the test. Notably, the Secretary cannot delegate this specific authority to the FDA.
Section 2(b), amending sections 201(h)(1), 501(f)(1)(C), and 502(o) of the FDCA
Exclusion of LDTs from FDA Device Regulation
This section explicitly amends the Federal Food, Drug, and Cosmetic Act (FDCA) to state that 'laboratory developed tests as defined in the Enhancing CLIA Act of 2026' are not considered 'devices' subject to FDA regulation. It also clarifies that certain components or protocols used with LDTs are not subject to specific FDA requirements if they could otherwise be lawfully distributed, further solidifying the jurisdictional shift.
This provision states that an LDT is 'deemed' to have obtained a supplemental affirmation (meaning it meets the applicable standard) if it is approved by the New York State Department of Health, or determined reasonable and necessary under Medicare's MolDX Program, or falls into a category identified by the Secretary through regulation.
Section 2(a)(2), adding new subsection (r)(1)(G) to Section 353 of the PHS Act
Why it matters:This is standard legislative practice to recognize existing, well-regarded regulatory or review processes, providing a streamlined path for tests that have already undergone significant scrutiny and avoiding redundant review.
Case for: Proponents would argue this avoids redundant review for tests that have already met high standards through other established mechanisms, reducing burden on laboratories and accelerating patient access to validated diagnostics.
Case against: Critics might argue that these existing approvals or determinations might not perfectly align with the new 'applicable standard' defined in the bill, potentially creating inconsistencies or loopholes in the new framework for LDT validation.
Estimated impact: Provides an immediate pathway for certain LDTs to be considered compliant with the new validity standard without requiring additional, potentially costly, review.
This provision designates the Food and Drug Administration (FDA) as an 'approved third party' for providing supplemental affirmations that an LDT meets the applicable standard. Laboratories can request this affirmation from the FDA for a fee, but the FDA must review it only according to CLIA standards and procedures, explicitly not applying FDCA device standards or requirements.
Section 2(a)(2), adding new subsection (r)(1)(H) to Section 353 of the PHS Act
Why it matters:This is a politically sensitive compromise. It allows the FDA to retain *some* role in LDT validation, addressing concerns about complete removal of FDA oversight, but strictly limits that role to the CLIA framework, satisfying those who want to curb FDA's authority over LDTs.
Case for: Proponents would argue this offers laboratories an additional, potentially highly credible, option for supplemental affirmation, leveraging FDA's scientific expertise while ensuring the review adheres to the CLIA framework, which is preferred by the industry.
Case against: Critics might argue that even in this limited capacity, FDA's involvement could still lead to 'mission creep' or create an uneven playing field, or that the fee structure might disincentivize its use, making it an ineffective compromise.
Estimated impact: Provides an alternative pathway for LDT validation, potentially influencing how many labs seek FDA's 'third-party' review and shaping perceptions of regulatory rigor.
This provision mandates that for all existing and future Medicare National Coverage Determinations (NCDs) for clinical laboratory diagnostic tests, a supplemental affirmation from an approved third party under the amended CLIA Act shall be considered *equivalent* to an approval or clearance under the Federal Food, Drug, and Cosmetic Act.
Section 2(c), amending Section 1862(l)(1) of the Social Security Act
Why it matters:This is a critical operational detail that ensures LDTs validated under the new CLIA framework can be reimbursed by Medicare, which is essential for their widespread adoption and financial viability. It's a technical but highly consequential linkage.
Case for: Proponents argue this ensures that the new CLIA regulatory pathway for LDTs has practical effect, allowing validated tests to be covered by Medicare, which is crucial for patient access and laboratory sustainability. Without this, the new regulatory framework would be largely ineffective.
Case against: Opponents might argue that equating third-party CLIA affirmation with FDA approval/clearance for NCD purposes could lower the bar for Medicare coverage, potentially leading to reimbursement for tests that haven't undergone the most rigorous review, increasing costs or compromising quality.
Estimated impact: Directly impacts Medicare reimbursement for LDTs, potentially affecting billions in healthcare spending and access to diagnostics for Medicare beneficiaries.