Will a CLIA Waiver Help Our Practice’s Bottom Line?

Question: During a practice meeting last week, the subject of Clinical Laboratory Improvement Amendments (CLIA) waivers came up. We are currently not CLIA-waived, and we will discuss it again at next month’s meeting. I was wondering if you could offer any input? Should we apply for a CLIA waiver?

Answer: Whether or not the waiver is worth it is up to your individual practice. However, a practice is not allowed to perform many basic laboratory services without CLIA-waived status. So if your practice does not get the waiver, you could be missing out on possible pay for some simple screens.

Example: Here are a few of the tests that have CLIA-waived status to help you decide:

• 81002 — Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy

• 82270 — Blood, occult, by peroxidase activity (e.g., guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (i.e., patient was provided three cards or single triple card for consecutive collection)

• 81025 — Urine pregnancy test, by visual color comparison methods

• 85651 — Sedimentation rate, erythrocyte; non-automated

• 83026 — Hemoglobin; by copper sulfate method, non-automated

• 82962 — Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use

• 85013 — Blood count; spun microhematocrit.

If your practice has CLIA-waived status, you can perform (and bill for) these tests and others. For your practice to perform CLIA-waived testing, Medicare requires that you:

• enroll in the CLIA program by obtaining a certificate pay the certificate fee every two years;

• follow the manufacturers’ instructions for the waived tests;

• notify your state agency of any changes in ownership, name, address or director within 30 days, or if you wish to add tests that are more complex; and

• permit inspections by a CMS agent, such as a surveyor from the state agency. (Your laboratory is not subject to a routine survey or inspection.)

For more info: Check out the application for the CLIA waiver here CMS.

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