Enhancing CLIA Act of 2026

(a) CLIA specialties. No later than 180 days after enactment, the Secretary shall issue a proposed regulation to establish new types of examinations that may be performed by laboratories under section 353 of the Public Health Service Act (42 U.S.C. 263a) consistent with the current state of clinical laboratory science and technology, including the advancements with respect to molecular diagnostics, digital pathology, and next generation sequencing. Within 1 year of finalizing such regulations, the Secretary must evaluate whether additional proficiency testing programs should be approved for these new specialties under section 353(f)(3)(C) of such Act (42 U.S.C. 263a(f)(3)(C)).

(b) Notice of subregulatory changes. If the Centers for Medicare and Medicaid Services intend to issue new or revised sub-regulatory guidance and policies related to the regulation of laboratories under section 353 of the Public Health Service Act (42 U.S.C. 263a), including new or revised State operations manuals applicable to the regulation of laboratories, it must describe such proposed action in a public report at least 90 days prior to taking such action and allow an opportunity for public comment.

(c) Engagement with laboratories. The Centers for Medicare and Medicaid Services must hold regular open door forums with clinical laboratories, no less frequently than annually, to discuss issues related to the regulation of laboratories under section 353 of the Public Health Service Act (42 U.S.C. 263a).

(d) Regulation updates. At least once every 5 years, the Centers for Medicare and Medicaid Services must review the regulations promulgated under section 353 of the Public Health Service Act (42 U.S.C. 263a), and—

(1) issue a request for information in the Federal Register regarding whether updates to such regulations are necessary to reflect advancements in laboratory science and technology; and

(2) establish a public docket, to remain open for no less than 180 days, to solicit public comments on the request for information issued under paragraph (1).