Internal Medicine Coding Alert

Published on Thu Sep 11, 2008 PDF

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?

Nevada Subscriber

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

Example: Here are a few of the tests that have CLIA-waived status:

• 81002 -- Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrate, 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 internal medicine practice has CLIA-waived status, you can perform (and code for) these tests and others. In order for your IM 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 you are performing

• 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

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

For more info: Check out the application for the CLIA waiver at http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf.