Waived Tests New in 2026

FDA categorizes new test systems as waived throughout the year, and Medicare catches up on a schedule. "The Food and Drug Administration approves CLIA waived tests on a flow basis. The CMS identifies CLIA waived tests by providing an updated list of waived tests to the A/B MACs (A) and (B) on a quarterly basis via a Recurring Update Notification" (Medicare Claims Processing Manual, Chapter 16, section 70.8).

For 2026, that update came in Change Request 14273, released November 14, 2025 and effective January 1, 2026 (CMS Transmittal 13465; MLN Matters MM14273). It added two codes.

Which waived test codes are new for 2026?

CMS told its contractors to "permit the use of code 87494QW and 87812QW for claims submitted by facilities with a valid, current CLIA certificate of waiver with dates of service on or after January 1, 2026." Both codes must carry the QW modifier: "Include the QW modifier to make sure we recognize these CPT codes as waived tests" (MM14273). See the QW modifier.

As of October 10, 2026, CMS's list of 2026 transmittals shows no further "New Waived Tests" change request issued this year. That will change; check the transmittals page and the FDA database before relying on this list.

What does 87494QW mean for a waiver lab?

A chlamydia and gonorrhea nucleic acid test that a Certificate of Waiver lab can bill when the specific test system it uses is categorized as waived. The code describes a method, not a product. Before adding it:

• Confirm the exact system in FDA's CLIA database. The CMS notice points there: "FDA approval information about the test(s), and their use, can be found by using the search feature" of the database and "referring to the FDA Review Decision Summary documentation." Only the categorized system, used with its instructions, is waived.
• Use only the specimen types the instructions allow. Anything else is off-label, and when a kit is used off-label, CMS says "the test complexity defaults to high complexity." See off-label use of waived tests.
• Check state law for who may collect and test. California, for example, lets pharmacists perform waived tests for sexually transmitted infections but not when the test requires "specimens collected by vaginal swab" (Bus. & Prof. Code 4052.4(b)). See pharmacy test-and-treat.

What does 87812QW mean for a waiver lab?

One visual antigen test that answers both COVID-19 and influenza A and B, billed as a single waived code. Urgent care clinics, pharmacies and practices that already run separate rapid tests can consolidate, as long as the combined kit they buy is the categorized system and its instructions are followed. See CLIA for urgent care groups.

Does a waiver lab need to report a newly waived test?

Not in advance under the federal rule. A waiver lab's duty to notify before testing applies to tests that are not waived (42 CFR 493.39(a)). Adding a newly waived test still changes your test list and volume, which CMS lists among the changes reported in writing, and some states require more. New York's Limited Service Laboratory registrants may run only the tests on their registration certificate, and additions take effect only when an amended certificate issues. See adding tests to your menu.

How do you track new waived tests yourself?

1. FDA's CLIA database is the source of truth for categorization, and its search form lets you filter by effective date. See how to tell whether a test is CLIA-waived.
2. CMS's transmittals titled "New Waived Tests" add codes to Medicare's claims files, each with an effective date of service.
3. MLN Matters articles summarize each change request for billing staff.

A claim denied in the gap between FDA's categorization and Medicare's update can be fixed: MACs "won't search their files to either retract payment or retroactively pay claims. However, MACs will adjust claims if you bring them to their attention" (MM14273).

Can we check a new test against your certificate?

Yes. A $149 Readiness Review checks a planned test against FDA categorization, your certificate type and your state's registration, and the fee is credited toward any filing it leads to. A routine update to your file afterward is a $149 CLIA Change Request.