Healthcare providers who perform & bill laboratory tests on Medicare patients are subject to new CLIA-related regulations in 2022. Please keep reading to discover if this update affects your practice.
The CMS now includes several new procedure codes into its list of CLIA-waived laboratory tests.
First up, though – what is CLIA?
The Clinical Laboratory Improvement Amendment (CLIA) is a certificate issued to healthcare providers that test clinical specimens for the purpose of diagnosis, treatment, or prevention of a certain clinical condition. This certificate is issued by the CMS only to individual practitioners and facilities that do not “outsource” their laboratory tests, i.e., to those who analyze and prepare the reports on their own. The certificate is always referenced under unique alphanumeric ID. Healthcare providers are required to demonstrate this CLIA ID on their claims, when applicable. When a certain laboratory test is described as “CLIA-waived”, it means that it is FDA-approved and payable by the CMS. Hence, healthcare providers are required to indicate their CLIA ID on claims that contain at least one procedure code that is used to bill a CLIA-waived test. In addition, modifier QW must be appended on such procedure codes.
If you perform laboratory tests in your office, you may have rendered, or currently intend to render, the following procedures:
• 87801 - Binx Health io Instrument (for use with female vaginal swabs and male urine), infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s) technique
• 87801 - Visby Medical Sexual Health Click Test (for use with self-collected vaginal swabs), infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s) technique
• 86308 - Cardinal Health Mono Rapid Test (whole blood), heterophile antibodies; screening
There are numerous exceptions to this new policy. Specifically, some procedure codes do not need to be reported with a QW modifier, even though they are still considered to be CLIA-waived tests. While this list is constantly updated, you can check the list of codes related to this particular policy here.
Non-compliance with this new regulation leads to claim denials, underpayments, and recoupments. Namely, if you bill a CLIA-waived test without an applicable modifier, and do not indicate your CLIA ID – payment for such test will be denied.
However, the CMS will not recoup payments for the above-mentioned procedure codes if such were billed prior to January 1, 2022, without a modifier.