CMS Seeking Comment on CLIA Rule Allowing Remote Access to Digital Laboratory Data
The Centers for Medicare & Medicaid Services is seeking comment on a proposed rule to amend regulations from the Clinical Laboratory Improvement...
The Centers for Medicare & Medicaid Services (CMS) posted the October 2026 Quarterly Update to the Clinical Laboratory Fee Schedule (CLFS) and Clinical Laboratory Improvement Amendments (CLIA) Healthcare Common Procedure Coding System (HCPCS) codes.
The new codes table lists codes being added to the HCPCS file. While these codes will not need to be manually added to the HCPCS files, Medicare administrative contractors (MACs) will set the prices where applicable until the codes are nationally priced and undergo the CLFS annual payment determination process.
All HCPCS codes listed in the new codes table with an indicator of “N” in the “CLIA waived?” column are subject to CLIA edits, requiring laboratories to have one of the following:
The following CPT codes are being deleted: 0556U, 0557U, and 0585U. MACs will not search their files to retract payment or retroactively pay claims but will adjust any claims that are brought to their attention.
Without a valid, current CLIA certificate, CMS will not pay for these tests unless laboratories bill the appropriate HCPCS code with a QW modifier.
All changes are effective Oct. 1, 2026.
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