Enhancing CLIA Act of 2026

Bill Number

H.R. 8890

Origin Chamber

House

Congress

119th Congress, Session 2

Policy Area

Health

Status

Introduced

Latest Action

2026-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Last Updated

2026-06-24T18:59:58Z

AI-Generated Summary

Purpose The legislation, titled the Enhancing Clinical Laboratory Innovation and Access Act of 2026 (or Enhancing CLIA Act of 2026), amends Section 353 of the Public Health Service Act (commonly known as CLIA) to establish a regulatory framework specifically for laboratory developed tests (LDTs). Its primary aim is to regulate LDTs under CLIA rather than the Federal Food, Drug, and Cosmetic Act, while introducing standards for analytical and clinical validity, transparency mechanisms, and oversight processes.

Key Provisions

• Definitions and Scope: Introduces detailed definitions for terms such as analytical validity (accuracy and reliability in identifying or measuring analytes), clinical validity (ability to achieve stated clinical purposes), laboratory developed test (tests developed and performed in certified high-complexity labs, including modifications to existing devices, but excluding commercially distributed protocols), clinical use, investigational use, and digital laboratory data. Laboratory operations are explicitly regulated under CLIA, not the FD&C Act.
• Validity Standards: Beginning two years after enactment, LDTs for clinical use must demonstrate reasonable assurance of both analytical and clinical validity (supported by evidence like peer-reviewed literature, clinical guidelines, or studies). Investigational-use LDTs require only analytical validity.
• Supplemental Affirmations: Laboratories may obtain optional affirmations from approved third parties (including the FDA) that an LDT meets the applicable standard. Deemed affirmations apply to tests approved by New York State, certain Medicare reviews, or categories specified by regulation. FDA affirmations use CLIA standards and a fee equivalent to device user fees.
• Centralized Database: Requires labs to submit test details (e.g., name, purpose, performance specifications, specimen types) to a CMS-managed public database starting two years after enactment, with schedules for new and existing tests. Updates must occur within 30 days of changes.
• Error Reporting: Mandates reports of undetected inaccurate results suggesting serious harm (within 5 days for death or imminent threats; quarterly for other serious harm). Reports do not constitute admissions of liability.
• Review and Enforcement: The Secretary may request information on tests lacking affirmations or with validity concerns; labs must cease offering non-compliant tests until resolved.
• Investigational Use: LDTs for this purpose must meet analytical standards and carry disclaimers.
• CLIA Updates: Directs new examination types for molecular diagnostics and next-generation sequencing; requires public notice for subregulatory changes and annual forums with labs; mandates periodic regulatory reviews.
• Amendments to Other Laws: Excludes LDTs from the FD&C Act device definition; treats third-party affirmations as equivalent to FDA approvals for Medicare national coverage determinations; allows LDTs with affirmations for companion diagnostics in drug approvals.
• Transition Rules: Existing device-approved LDTs may convert to CLIA regulation; regulations generally take effect two years after enactment.

Significant Changes to Existing Law

• Explicitly removes LDTs from FD&C Act device regulation (including sections on adulteration, misbranding, and classification), shifting primary authority to CLIA.
• Establishes new validity standards, third-party review options, a public database, and mandatory error reporting not previously required under CLIA.
• Prohibits delegation of certain validity determinations to the FDA while allowing it limited affirmation authority under CLIA criteria.
• Updates Medicare coverage policy to equate third-party affirmations with device clearances.
• Revises the regulatory definition of in vitro diagnostic products to exclude LDTs.

Potential Impacts

• Government Agencies: Clarifies roles, with CMS (via CLIA) gaining primary oversight of LDTs; FDA involvement limited to optional affirmations and transition handling. Requires new database infrastructure and regulatory updates.
• Citizens: May increase access to innovative LDTs through streamlined oversight while adding requirements for validity evidence and error reporting to enhance patient safety.
• International Relations: No direct provisions; potential indirect effects on global lab standards or trade in diagnostic technologies are not addressed.

Main Stakeholders Affected

• Clinical laboratories and their parent organizations (primary developers and performers of LDTs).
• The Secretary of Health and Human Services, CMS, and FDA (regulatory and database responsibilities).
• Patients and healthcare providers (users of LDT results).
• Third-party reviewers (new role in supplemental affirmations).
• Medicare program and payers (coverage determinations).
• Entities involved in device distribution or companion diagnostics.

Notable Legal, Constitutional, or Political Implications

• Legal: Reinforces separation of CLIA and FD&C Act jurisdictions, potentially resolving prior regulatory overlap; includes safeguards against conflicts of interest in oversight and protections for trade secrets in the database.
• Constitutional/Political: No explicit discussion in the bill; focuses on administrative authority and transition processes without addressing broader constitutional questions.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Dunn, Neal P. [R-FL-2]

Recent Actions

• 2026-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• 2026-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• 2026-05-19: Introduced in House
• 2026-05-19: Introduced in House

Bill Versions

• Enhancing Clinical Laboratory Innovation and Access Act of 2026 — issued 2026-05-19 — PDF (45 pages)