Enhancing CLIA Act of 2026

Summary#

This bill changes how laboratory developed tests (LDTs) are regulated. It amends the Clinical Laboratory Improvement Amendments (CLIA) to define LDTs, require standards for analytical and clinical validity, and place primary regulatory authority with the Secretary of Health and Human Services under CLIA rather than treating LDTs as devices under the Federal Food, Drug, and Cosmetic Act. Key features include a required standard that LDTs meet reasonable assurance of analytical validity (and clinical validity for clinical use) beginning 2 years after enactment; an optional "supplemental affirmation" process by third parties approved by the Secretary (the FDA is designated as an approved third party and may provide affirmations for a fee); a centralized electronic database of LDTs for clinical use maintained by CMS; mandatory short-term and quarterly reporting for certain test errors and serious harms; Secretary review authority to request information and require cessation of an LDT that does not meet standards; rules for investigational use labeling; changes to several FDA statutory definitions so some devices used with LDTs are not treated as devices under the FD&C Act; recognition that certain third‑party supplemental affirmations will count for Medicare coverage decisions; transition rules and timelines for regulations, a centralized database, and conversion provisions for tests with existing or pending FDA submissions; and CLIA updates such as creating new specialties, required notice before subregulatory changes, annual open forums with laboratories, and a five‑year review cycle for CLIA regulations.

What it means for you#

  • Clinical laboratories that develop or perform LDTs must meet defined performance standards for analytical validity and, for clinical use, clinical validity, starting 2 years after the law takes effect.
  • Laboratories must submit detailed information about each clinical LDT to a centralized CMS database on a prescribed schedule and update it when needed.
  • Laboratories must report certain undetected inaccurate results quickly (within 5 days for events suggesting death or imminent public health threat) and file quarterly reports for other serious harms.
  • Laboratories may seek a supplemental affirmation from Secretary‑approved third parties (including FDA) that an LDT meets standards; FDA may charge a fee no greater than the existing premarket notification user fee.
  • The Secretary can request information about an LDT, and may require a laboratory to stop performing the test until the Secretary confirms the issue is resolved.
  • The bill affects laboratories, CMS, the Secretary, approved third parties, and the FDA; it does not require patients to take any action directly.

Expenses#

No publicly available information about total costs or budgetary estimates is provided in the bill text. The bill directs the Secretary to establish a centralized database and to promulgate regulations within set timelines and says the Secretary "may expend such funds as the Secretary determines necessary" for an orderly transition. The bill authorizes a fee to the FDA for supplemental affirmation reviews not greater than the applicable premarket notification user fee, but it does not specify dollar amounts or appropriations.

Proponents' View#

No publicly available information.

Opponents' View#

No publicly available information.