CMS's CLIA Modernization RFI: What Labs Should Know Before the September 14 Deadline
Short answer: CMS published a Request for Information on July 16, 2026, asking the lab industry how to modernize CLIA regulations that have barely changed since 1992 — covering everything from AI-assisted result interpretation to performance standards for tests without FDA clearance. Comments close September 14, 2026. It's not a proposed rule yet, but it's the clearest signal in years of where CLIA enforcement is headed, and it lands alongside a separate bill, H.R. 8890, that would hand CMS formal authority over laboratory-developed tests.
Why CMS is asking now
On July 16, 2026, CMS published a Request for Information in the Federal Register (docket CMS-3485, document 2026-14358) titled "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations." The RFI's own framing is blunt: laboratory testing technology has changed enormously since CLIA's implementing regulations took effect in 1992, and the regulations largely haven't. CMS is asking, in its words, "what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking."
An RFI is not a proposed rule. Nothing in it is binding, and nothing changes for labs on September 15. What it signals is where CMS is likely to spend its rulemaking attention next — and industry comments submitted now will shape the shape of whatever proposed rule eventually follows. The comment window closes September 14, 2026, giving labs and their trade associations a two-month window from publication to weigh in.
What CMS specifically wants to hear about
The RFI's scope is broad, spanning several areas that touch molecular and genetic testing labs directly:
Two items on that list matter most for molecular and genetic testing labs specifically. First, CMS is asking how it should set performance specifications for tests that don't have FDA clearance — language that lands squarely on laboratory-developed tests, the same category caught in the FDA litigation described below. Second, CMS wants input on AI and software use in postanalytic interpretation, which touches any lab using algorithmic variant classification, automated reporting, or AI-assisted pathology review. The RFI also asks about clinical cytogenetics, immunohematology and electronic crossmatching, microbiology blood-culture contamination monitoring, and how CLIA should treat "data-only" facilities that interpret results without performing the underlying testing.
The bigger picture: LDT oversight is still unsettled
The RFI doesn't arrive in a vacuum. It follows more than a year of regulatory whiplash over who actually has authority to oversee laboratory-developed tests. The FDA finalized a rule in 2024 asserting device authority over LDTs; a federal district court vacated that rule in 2025 on Loper Bright grounds following ACLA v. FDA, and the FDA subsequently rescinded it. Comprehensive FDA device regulation of LDTs is, for now, off the table.
That doesn't mean LDTs are unregulated — it means oversight is fragmented across more parties than before. FDA retains authority over the tangible inputs to LDT development: test components, distributed kits, and software that meets the definition of Software as a Medical Device, plus its research-use-only and investigational-use-only policies. CMS retains its CLIA authority over the laboratories themselves. State laboratory regulators, accreditation bodies, payers, the Federal Trade Commission, and private litigants each retain potential roles depending on the specific test, claims made about it, and commercial model.
H.R. 8890 — Congress's parallel answer
Congress isn't waiting for CMS's rulemaking process to play out. On May 19, 2026, Rep. Neal Dunn (R-FL) introduced H.R. 8890, the Enhancing Clinical Laboratory Innovation and Access Act of 2026, which takes a different structural approach than the vacated FDA rule: it puts LDT oversight under CMS and CLIA rather than under FDA device authority.
The bill would codify that LDTs are not FDA-regulated devices, establish enhanced CLIA requirements including analytical and clinical validity standards specifically for LDTs, and create a centralized public database where labs register LDT performance and validation information. It adds mandatory error reporting to CMS when a test causes serious harm, and creates an optional supplemental affirmation process — voluntary third-party validation that would give labs some protection from CMS enforcement challenges if they use it. The bill also modernizes CLIA certification specialties to explicitly cover molecular diagnostics, digital pathology, and next-generation sequencing, and proposes a two-year transition period for implementation. As of this writing, professional societies including ASCP have said they are still formally reviewing the bill's text rather than taking a public position.
What this means for labs, medical directors, and RCM teams right now
Nothing here changes a billing rule or a CLIA certificate requirement today. The practical work is upstream of that. Lab and medical directors should read the full RFI text and decide whether to submit comments before September 14 — CMS explicitly frames this as fact-finding, and the comment record is the input CMS will point to when it eventually drafts a proposed rule, whether or not H.R. 8890 also moves. Labs already navigating CMS's existing coverage framework for genetic testing should note the RFI's question about performance specifications for non-FDA-cleared tests in particular; it previews the kind of validity documentation CMS may expect labs to produce going forward, regardless of which legislative or regulatory vehicle ultimately carries it.
Compliance and RCM teams should treat this as a two-front story worth tracking in parallel, the same way they've had to track CMS's other recent program-integrity moves such as the CRUSH rule now at OMB: a bill that would give CMS clear statutory authority over LDTs, and an RFI that suggests CMS intends to update its own CLIA regulations regardless of whether that bill passes. Neither track has a finalized rule yet, and neither should be built into 2027 compliance plans as settled law — but both are worth flagging to leadership now, while the comment window and legislative session are still open.
Frequently asked questions
What is the CMS CLIA regulations RFI, and is it binding?
It's a Request for Information published July 16, 2026 (docket CMS-3485), asking the public how CLIA regulations — largely unchanged since 1992 — should be modernized. It is not binding and does not itself change any requirement; it's fact-finding ahead of a possible future proposed rule.
When do comments on the CLIA RFI close?
September 14, 2026, sixty days after the RFI's July 16, 2026 publication in the Federal Register.
What is H.R. 8890, and how does it relate to the RFI?
H.R. 8890, the Enhancing Clinical Laboratory Innovation and Access Act of 2026, is a separate bill introduced May 19, 2026, that would give CMS formal statutory authority over laboratory-developed tests through an enhanced CLIA framework. It is not the RFI, but both point toward CMS and CLIA, rather than FDA device law, as the likely future home for LDT oversight.
Does the FDA still regulate laboratory-developed tests?
Not comprehensively. FDA's 2024 device-authority rule over LDTs was vacated by a federal court in 2025 and subsequently rescinded. FDA still regulates test components, distributed kits, and software meeting the Software as a Medical Device definition, alongside its research-use-only and investigational-use-only policies.
Should labs submit comments on the RFI?
That's a business and compliance decision for each lab, often best made with counsel or a trade association such as ACLA, ASCP, AMP, or CAP. Given the September 14 deadline, labs that want their operational concerns reflected in future rulemaking have a limited window to act.
This article summarizes federal rulemaking activity and pending legislation as of September 2026 for general information for laboratory, compliance, and revenue-cycle audiences. It is not billing, legal, or medical advice; verify current status against CMS.gov, the Federal Register, and Congress.gov directly, and consult qualified legal or compliance professionals before submitting comments or making operational decisions.
Sources: Federal Register, "Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations" (CMS-3485, document 2026-14358), published July 16, 2026; Covington & Burling LLP, "Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026," June 2026; Arnold & Porter, "Oversight of Laboratory Developed Tests One Year After ACLA v. FDA: Assessing Legislative Proposals in Context," July 2026; ASCP, "New Legislation Clarifies CMS Authority Over Laboratory Developed Tests," June 10, 2026. Visit the ScreenMyGene homepage for more coverage and coding resources.