CMS FAQ reviews when CLIA requirements apply to home tests

The Centers for Medicare & Medicaid Services last week released a FAQ clarifying when the Clinical Laboratory Improvement Amendments apply to over-the-counter home tests, including COVID-19 tests. For example, tests that are cleared, approved or authorized for home use by the Food and Drug Administration generally are not regulated under CLIA when self-administered, but require a CLIA certificate when someone else performs, interprets or reports the results, the FAQ notes.