What is CLIA? The acronym stands for Clinical Lab Improvement Amendments, which Congress passed in 1988 to establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results, regardless of where the test was performed.1

This legislation defines a laboratory as “any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease or ... assessment of health.” So, if you register, your office can be a laboratory.

Also, the Centers for Medicare & Medicaid Services (CMS) assumed primary responsibility for financial management operations of the CLIA program. So, you can bill lab tests to Medicare.

Under CLIA, the FDA has authority over commercially marketed in vitro diagnostic tests. The FDA categorizes such tests by their potential for risk to public health. From lower risk to higher risk, these are:

  • Waived tests
  • Tests of moderate complexity
  • Tests of high complexity

While we can order many different kinds of tests that are performed in an outside lab, we need only concern ourselves with the first category for lab tests actually performed in our offices. CLIA-waived tests are simple laboratory examinations and procedures that are cleared by the FDA for home use. These “employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or pose no reasonable risk of harm to the patient if the test is performed incorrectly,” the FDA says.2

In 1997, these regulations were further revised to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver. And this is where lab testing is relevant to the practicing optometrist. While only a couple CLIA-waived tests are applicable to optometry at this time, they will become more numerous and cover a broader range of applications as technology progresses.

Coding for CLIA
Of course, it’s up to your state board of optometry to determine whether running a CLIA-waived test in your office is within your scope of practice. Assuming that it is, there are two things you must do before you can perform and get reimbursed for CLIA-waived tests in your practice. First, your office must be designated as a CLIA-approved laboratory. Second, one of the doctors in your practice must be designated and approved as a clinical lab director. (Go to www.cms.gov/clia to enroll.)

A few things to note regarding coding and billing for CLIA-waived testing. 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, only those tests that have the “waived” designation can be performed in your office and carry the QW modifier.

CPT codes for the tests that ODs typically perform are:

• 83861-QW—Tear osmolarity (i.e., TearLab test), defined as microfluidic analysis that uses an integrated collection and analysis device.

If you test both eyes, your claim form would look like this:

  • 83861-QW-LT
  • 83861-QW-RT

• 87809-QW—Adenoviral test (i.e., AdenoPlus, RPS Inc.), defined as infectious agent antigen detection by immunoassay with direct optical observation.

If you test both eyes, your claim form would look like this:

  • 87809-QW-RT
  • 87809-QW-LT

Additional notes: On your CMS 1500 form, indicate in box 29 that you are not using an outside lab, and place your office’s CLIA number (provided by CMS) in box 23.

While clinical lab tests are not a significant profit center for a practice, they are proving to be just as valuable to clinical care in an OD’s office as they have been for years in a general physician’s office.

1. How to Obtain a CLIA Certificate of Waiver (brochure). Centers for Medicare & Medicaid Services. 2006 March. Available at: www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf. Accessed May 2, 2013.
2. CLIA Waivers. US Food and Drug Administration website. Last updated 2009 June 19. Available at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124202.htm.  Accessed April 20, 2013.