Enhancing Clinical Laboratory Innovation and Access (CLIA) Act 

On May 19, 2026, Representative Neal Dunn, M.D. introduced the Enhancing Clinical Laboratory Innovation and Access Act, also referred to as the “Enhancing CLIA Act." In a press release announcing the proposed legislation, Representative Dunn stated that “[t]he Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory-developed testing services”.

In a press release, Congressman Dunn stated that the Enhancing CLIA Act will address the following:

• “Direct CMS to establish a transparent and publicly accessible database with key information regarding laboratory-developed testing services (LDTs), including summaries of performance specifications and validation information
• Reaffirm that LDTs are professional services regulated by CMS under CLIA
• Clarify that LDTs include innovative analyses of digital laboratory information, such as genomic data derived from previously sequenced patient samples
• Leverage existing review and oversight mechanisms to allow laboratories to voluntarily obtain confirmation from a recognized third party that an LDT is analytically and clinically valid
• Establish centralized error reporting and bolster CMS oversight authority if credible information indicates an LDT lacks analytical or clinical validity”

While the text of the proposed legislation has not been released, there is hope that the Enhancing CLIA Act will answer long-disputed questions regarding the regulation of LDTs. In particular, the legislation appears poised to settle the question of whether the FDA or CMS has the authority to regulate LDTs. In 2024, after the FDA issued a Final Rule asserting the FDA’s authority to regulate LDTs, a court case vacated that Final Rule just a year later in 2025 [American Clinical Laboratory Association v. U.S. Food and Drug Administration, No. 4:24-CV-479-SDJ (E.D. Tex. Mar. 31, 2025)]. If passed as proposed by Representative Dunn, the Enhancing CLIA Act would provide clear affirmation that the regulation of LDTs falls under the purview of CMS.

The Enhancing CLIA Act introduces a voluntary program whereby laboratories may obtain confirmation of their LDT validity studies by a CMS-recognized third party. While voluntary, participation in this third-party review process would provide a valuable safeguard to laboratories that will now also be required to report testing errors to CMS. Additionally, CMS will establish a publicly available centralized database of LDTs performed by laboratories, along with certain required information about each LDT. By utilizing the voluntary third-party confirmation process, laboratories can signal the quality of their LDTs in their public database postings. Depending on laboratories’ adoption of the voluntary confirmation process nationwide, it may become an industry standard to have LDTs reviewed by a CMS-approved third party.

The Enhancing CLIA Act is also poised to expand the types of laboratory technology that are regulated as LDTs. This would aid in eliminating current confusion regarding developments in laboratory technology which have occupied a gray area under current CLIA regulations.

All laboratories, especially laboratories utilizing LDTs, should be prepared to review the language of the proposed Enhancing CLIA Act when it is released. The laboratory industry is likely to view the Enhancing CLIA Act as a welcome update to the existing CLIA regulations, so support for passing this legislation could build quickly.

If laboratories have questions about the interpretation or feasibility of the proposed legislation, they should contact a healthcare attorney. The healthcare attorneys at McDonald Hopkins are monitoring for developments regarding the Enhancing CLIA Act, and are happy to answer any questions you may have about the proposed legislation. Please contact McDonald Hopkins' Healthcare Practice Group with any questions or concerns.