Waived tests only
Moderate or high complexity testing needs a different certificate type, and microscopic tests are not covered.
Montana DPHHSMedical Eye Care · Compliance
CLIA Waived Testing Guide The certificate behind every point-of-care eye test.
Tear osmolarity, MMP-9 and adenovirus tests are laboratory tests under federal CLIA rules. A certificate of waiver lets a practice run FDA-waived tests in the office, provided the manufacturer's instructions are followed to the letter.
CMS-116the CLIA application form
$248certificate of waiver fee
2 yearsvalidity of a certificate of waiver
QWmodifier for CLIA-waived tests
The rules
What a certificate of waiver covers
Only tests the FDA has categorized as waived, using the sample types they are waived for, can be run under this certificate.
Follow the insert
Personnel must follow the manufacturer's instructions; otherwise the test is treated as high complexity.
42 CFR 493.15Laboratory director
A waived lab needs a director, with no federal education or experience requirements for this certificate type.
CMSReport changes
Changes in laboratory director must be reported within 30 days.
Montana DPHHSGetting certified
The process runs through your state agency.
- Complete form CMS-116
- Send it to your state agency
- Pay the certificate fee
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Application
Complete the CMS-116 and submit it to the state agency, except in New York and Washington, which run their own programs.
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Fees and renewal
The certificate of waiver fee is $248, and the certificate is valid for two years.
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Kits and controls
Use only unexpired kits and reagents, store them as labeled, and run controls as the package insert directs.
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Billing
Report waived tests with the QW modifier and the CLIA number on the claim.
Eye care tests
Common waived tests in eye care
Each test has its own page with workflow details.
Tear osmolarity
Reported with 83861-QW. ScoutPro is stocked at wholesale.
MMP-9
InflammaDry is reported with 83516-QW.
Adenovirus
QuickVue Adenoviral is reported with 87809-QW.
Reference details
Eye care tests and codes
| Tear osmolarity | 83861-QW, with RT and LT when both eyes are tested |
|---|---|
| MMP-9 immunoassay (InflammaDry) | 83516-QW |
| Adenovirus antigen (QuickVue Adenoviral) | 87809-QW |
| Blood draw for send-out panels | 36415, where state scope allows |
Common compliance gaps
- Running a test with an expired kit or reagent
- Using a sample type the test is not waived for
- Skipping control runs required by the insert
- Missing CLIA number on claims
State rules
Some states, including New York and Washington, administer their own laboratory programs. Check with your state agency before you start testing.
Questions about CLIA waivers
Which form do I file?
Form CMS-116, sent to your state agency, unless you are in New York or Washington.
How much does a certificate of waiver cost?
$248, according to state CLIA guidance, and the certificate lasts two years.
Who can perform waived tests?
Any person may perform them, but they must follow the manufacturer's instructions exactly.
What happens if instructions are not followed?
The test is no longer considered waived and is treated as high complexity, which a certificate of waiver does not cover.
How do I bill a waived test?
Append the QW modifier to the test code and include the CLIA number. Confirm payer rules.
Where can I get test kits?
ScoutPro test cards, InflammaDry and QuickVue Adenoviral kits are available from the Vision Rescue wholesale catalog.
References
- CMS. How to apply for a CLIA certificate. CMS
- Montana DPHHS. Certificate of Waiver FAQ, 2025. Montana DPHHS
- Review of Optometry. Coding point-of-care testing. Review of Optometry
Run point-of-care tests the right way
Get certified, follow every insert, and keep tests and controls stocked.
Written for licensed eye care professionals. This page is general information, not legal or billing advice. Fees and rules change; confirm current requirements with CMS and your state agency.