CLIA Waived Tests

The objective of the Clinical Lab Improvement Amendments (CLIA) program is to ensure quality laboratory testing.

Optometrists are allowed to perform "waived" tests, categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result."

To perform waived tests, you must:

    1. Enroll in the CLIA program by obtaining a certificate and designate an OD clinical lab director;

    2. Pay all registration fees annually and the certificate fee every two years;

    3. Follow the manufacturers’ instructions for the waived tests you are performing;

    4. Notify the Department of Public Health of any changes in ownership, name, address or director within 30 days; and

    5. Permit inspections by the California Department of Public Health.

Apply for CLIA Testing

Federal Registration:

Application for a CLIA certificate, Form CMS-116: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf

Directions when filling out Form CMS-116:

    1. Section III. Type of Laboratory, please select box 22: Practitioner Other – Optometrist.

    2. Do not fill out (i.e. leave blank) Section VII. Non-Waived Testing, as ODs only perform waived tests.

State Registration:

    • LAB 155 — Application for Clinical Laboratory Registration

    • LAB 116 — Laboratory Personnel Report

    • LAB 183 — Director Attestation

Waived CLIA Tests

CLIA testing allowed under law for optometry:

    1. A clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and designated (see below) necessary for the diagnosis of conditions and diseases of the eye or adnexa, or if otherwise specifically authorized by this chapter.

    2. The following are the types of tests referenced in above:

      • Ordering of smears, cultures, sensitivities, complete blood count, mycobacterial culture, acid fast stain, urinalysis, tear fluid analysis, and X-rays necessary for the diagnosis of conditions or diseases of the eye or adnexa. An optometrist may order other types of images subject to prior consultation with an ophthalmologist or appropriate physician and surgeon.

Waived Tests:

CMS CPT code list of waived tests: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf

For a list of waived tests sorted by analyte name, visit the FDA website at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

For a list of waived tests sorted by the test categorization date and by the test system name, visit the FDA website at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm

Billing

Lab tests are paid from a national laboratory fee schedule and do not follow the RBRVS reimbursement model. The codes are designated in the 8XXXX range in the CPT. Additionally, you can only perform tests that have the “waived” designation and carry the –QW modifier designation.

For testing both eyes and coding for them, include two lines. The claim form looks like the following:

  • 8XXXX-QW-LT

  • 8XXXX-QW-RT

Tests that optometrists typically perform are:

TearLab—83861-QW (Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity)

AdenoPlus87809-QW (Infectious agent antigen detection by immunoassay with direct optical observation; adenovirus)

InflammaDry83516-QW (Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method)