# 119-hr-8890: Enhancing CLIA Act of 2026

119-hr-8890, Enhancing CLIA Act of 2026, is a 119th Congress bill sponsored by Rep. Dunn, Neal P. [R-FL-2] (R-FL); status introduced; PRIA reads it as touching household money (as of 2026-09-21).

- Canonical: https://policyrisk.com/legislation/119-hr-8890
- As of: 2026-09-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-8890
- Congress: 119
- Title: Enhancing CLIA Act of 2026
- Status: introduced
- Introduced: 2026-05-19
- Sponsor: Rep. Dunn, Neal P. [R-FL-2] (R-FL)
- Cosponsors: 0
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-21

## 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.

## Provisions PRIA read

- Public lab-test database and reporting: benefit, medium. 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 d…
- New lab test rules and enforcement: mixed, medium. 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…
- Rules for converting tests into devices: mixed, medium. 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…
- Third-party test review and Medicare coverage: mixed, medium. 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 appro…
- CMS rule timelines and lab modernization: mixed, low. 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…

## Related bills

- 119-hr-4669: FEMA Act of 2025
- 119-hr-4393: DIGNIDAD (Dignity) Act of 2025
- 119-hr-2570: Maximum Pressure Act
- 119-hr-4317: PBM Reform Act of 2025
- 119-hr-3132: CHOICE for Veterans Act of 2025
- 119-hr-8413: SECURE Data Act

## Sources
- [119-hr-8890 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/8890)

## Related
- [119-hr-4669: FEMA Act of 2025](https://policyrisk.com/legislation/119-hr-4669)
- [119-hr-4393: DIGNIDAD (Dignity) Act of 2025](https://policyrisk.com/legislation/119-hr-4393)
- [119-hr-2570: Maximum Pressure Act](https://policyrisk.com/legislation/119-hr-2570)
- [119-hr-4317: PBM Reform Act of 2025](https://policyrisk.com/legislation/119-hr-4317)
- [119-hr-3132: CHOICE for Veterans Act of 2025](https://policyrisk.com/legislation/119-hr-3132)
- [119-hr-8413: SECURE Data Act](https://policyrisk.com/legislation/119-hr-8413)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-8890 (as of 2026-09-21).