The Enhancing CLIA Act of 2026: What H.R. 8890 Would Change for Genetic Testing Labs
Short answer: The Enhancing Clinical Laboratory Innovation and Access Act of 2026, H.R. 8890, was introduced May 19, 2026 by Rep. Neal Dunn. It would declare laboratory developed tests not to be medical devices and move oversight to CMS under an expanded CLIA program, with new requirements applying two years after enactment. It is a proposal, not law.
Why this bill exists
In May 2025 the U.S. District Court for the Eastern District of Texas vacated FDA's 2024 final rule on laboratory developed tests (LDTs), holding that LDTs are not devices under the Federal Food, Drug, and Cosmetic Act. According to Arnold & Porter's July 2026 analysis, FDA did not appeal and the rule was rescinded, leaving FDA to assert jurisdiction over test components, distributed kits, and software while limiting enforcement. For the current status of that fight, see our FDA LDT rule status explainer.
That left a policy gap. Labs are regulated under CLIA for analytical performance, but CLIA was not built around clinical validity, molecular specialties, or sequencing. CLP Magazine describes H.R. 8890 as the first legislative response to the ruling. ACLA, the lab industry association, said in its May 19, 2026 statement that the bill incorporates policy recommendations it had made on CLIA modernization and affirms CMS authority over clinical laboratories.
What the bill would do
Covington's June 2026 summary of the bill text describes several moving parts. The definition of an LDT covers an examination or procedure performed in a CLIA-certified, high-complexity laboratory that is developed and performed in the same laboratory or within common corporate ownership. It would expressly exclude commercially distributed protocols for unaffiliated labs, and would extend to analysis of patient-specific digital laboratory data. The amendments state that LDTs are not medical devices under the FDCA.
The central requirement is a standard: LDTs would need to demonstrate reasonable assurance of analytical and clinical validity. CMS could prohibit tests found not to meet that standard. The requirements would take effect two years after enactment, and labs with existing FDA clearances or approvals could keep that status during the transition.
The MolDX fast lane
The most consequential provision for genetic testing labs is the optional supplemental affirmation. Per Covington, it is granted automatically if a test is New York State approved, covered by the MolDX program, or previously FDA cleared or approved. CMS could not challenge a test holding a supplemental affirmation. FDA would automatically qualify as a third-party reviewer for these affirmations, but no premarket review would be required for LDTs.
In plain terms, MolDX coverage would become a regulatory credential as well as a payment one. Labs already working through MolDX technical assessments, and tracking registered identifiers as covered in our DEX Z-code guide, would be positioned better than labs that have not. That is an inference from the bill text as summarized by counsel, not a statement from CMS.
Transparency and error reporting
Labs would submit test information to a centralized database, including test name, purpose, analytes, and performance specifications. The bill would also require reporting of serious harm: within 5 days for death or imminent threats, and quarterly for other serious harm. These obligations are new compared with current CLIA practice for most LDT labs and would carry real compliance workload for quality and regulatory teams.
CLIA modernization and process changes
The bill goes beyond LDTs. Per Covington, CMS would be directed to propose new CLIA specialties reflecting molecular diagnostics, digital pathology, and next-generation sequencing; provide 90 days of advance notice of subregulatory changes; hold an annual open forum with laboratories; and conduct a regulatory review every five years with public comment. Separately, CMS has been collecting input on CLIA regulations through a request for information, and Arnold & Porter reports OMB completed its review on July 7, 2026. Our CLIA RFI analysis covers that track.
Where it stands, and how to plan
Arnold & Porter describes the bill as being monitored for additional cosponsors and committee consideration, with a Senate companion still pending and the legislative window narrowing ahead of the November elections. ARUP's chief medical officer called it an important proposal that should spark crucial conversations across the lab community. Treat passage this Congress as uncertain.
That does not make it irrelevant. Medical directors and compliance leads can use the bill as a planning scenario. Inventory LDTs by whether they already have FDA clearance, New York approval, or MolDX coverage. Document analytical and clinical validity evidence in a form that could be shown to a regulator. Identify who would own harm-event reporting. Keep payer documentation tight, because claims still turn on policy criteria, as our denial-prevention guide explains. Teams that want order-time policy mapping can review the ScreenMyGene platform.
FAQ
Is the Enhancing CLIA Act law?
No. H.R. 8890 was introduced May 19, 2026 by Rep. Neal Dunn. Arnold & Porter's July 2026 analysis describes it as awaiting additional cosponsors and committee consideration, with a Senate companion pending. If enacted, its new requirements would apply two years later. Labs should not change compliance obligations based on it yet.
Would the bill put LDTs under FDA review again?
No. It states that LDTs are not medical devices under the FDCA and requires no premarket FDA review of LDTs. Oversight would shift to CMS under an expanded CLIA framework. FDA would automatically qualify as a third-party reviewer for supplemental affirmations, and existing clearances or approvals would be recognized during transition.
How does MolDX coverage figure in the bill?
Per Covington, a test covered by the MolDX program would automatically receive a supplemental affirmation, as would tests approved by New York State or previously FDA cleared or approved. CMS could not challenge tests holding that affirmation. Labs without one would need to show reasonable assurance of analytical and clinical validity.
What new reporting would labs face?
Labs would submit test details, including name, purpose, analytes, and performance specifications, to a centralized database. They would report serious harm within 5 days when it involves death or imminent threats, and quarterly for other serious harm. These requirements would apply two years after enactment under the bill.
What did ACLA say about the bill?
In a May 19, 2026 statement, ACLA President Susan Van Meter thanked Rep. Dunn, said ACLA welcomes enhanced oversight of LDT services that maintains innovation, affirmed CMS regulatory authority consistent with the ACLA v. FDA decision, and noted the bill incorporates policy recommendations ACLA previously made.
This article is provided for general educational and business-decision-support purposes for laboratory, revenue-cycle, and clinical-ordering professionals. It summarizes pending legislation as described by third-party sources on October 3, 2026, and is not legal, regulatory, or compliance advice. Bills change or fail; verify the current text and status before acting.
Sources: Covington, Enhancing CLIA Act of 2026 (June 2026); Arnold & Porter, Oversight of LDTs One Year After ACLA v. FDA (July 2026); ACLA statement (May 19, 2026); CLP Magazine, Federal Bill Seeks to Update CLIA Oversight of LDTs.