Enhancing CLIA Act of 2026
Sponsored By: Representative Dunn, Neal P. [R-FL-2]
Introduced
Summary
This bill would create a federal framework to ensure greater oversight and transparency for laboratory‑developed tests (LDTs) by requiring validation, reporting, and a centralized database. It uses a mix of lab verification, third‑party supplemental affirmation, and alignment with device rules to raise standards for clinical testing and data sharing.
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Bill Overview
Analyzed Economic Effects
5 provisions identified: 1 benefits, 0 costs, 4 mixed.
Public lab-test database and reporting
If enacted, HHS would create a centralized public database for lab-developed tests within 2 years. Laboratories would have to submit detailed test-level information and keep it updated. Labs would report undetected inaccurate results that suggest death or an imminent public-health threat within 5 days and send quarterly aggregated reports for other serious harms.
New lab test rules and enforcement
If enacted, labs would have to meet new analytical and clinical validity standards to offer lab-developed tests for clinical use starting 2 years after enactment. Investigational-use tests would need the exact label 'For investigational use only' on reports and promo materials. The Secretary could require labs to stop offering a test when credible scientific concerns arise and would set time-bound steps for labs to respond and resolve problems.
Rules for converting tests into devices
If enacted, the bill would treat certain lab-developed tests that already have or are seeking FDA filings as FDA devices until specific events occur. Laboratories will have 60 days after enactment to tell FDA whether they plan to modify a test to meet the device definition. When a test stops being a device under the bill's triggers, the test would be deemed to have supplemental FDA affirmation.
Third-party test review and Medicare coverage
If enacted, HHS could approve private third parties to review lab tests and issue supplemental affirmations starting 2 years after enactment. Laboratories could also ask the FDA for such affirmation for a fee capped at the premarket notification user fee. The bill would let Medicare treat any approved third-party affirmation like FDA approval for coverage decisions, which could expand tests Medicare will cover.
CMS rule timelines and lab modernization
If enacted, CMS would publish proposed regulations required by the bill within 180 days and finish a centralized database and conflict rules within 2 years. CMS must hold annual open-door forums and give 90 days' notice before major policy changes. Most new rules could not take effect until 2 years after enactment, but one regulatory definition change must occur within 30 days and take effect immediately.
Sponsors & CoSponsors
Sponsor
Dunn, Neal P. [R-FL-2]
FL • R
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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