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AAP News Vol. 13 No. 9 September 1997, p. 25 © 1997 American Academy of Pediatrics
If you've seen an increase in the number of claim denials for laboratory services or noticed that your CLIA inspector is asking a lot of questions about your laboratory bills, you may be feeling the effects of a new Health Care Financing Administration (HCFA) program that uses CLIA resources to detect improper billing and uses lab claims to discover CLIA violations. HCFA has advised Medicare carriers that beginning July I claims should be denied for lab tests performed in physician office laboratories (POLs) that do not have valid CLIA certificates or for physicians who bill for lab tests beyond the scope of their CLIA registration. Under CLIA '88, all facilities performing laboratory tests on human specimens to screen, diagnose or test for health purposes must register to obtain a CLIA certificate. There are several kinds of CLIA certificates, each with a specific set of tests, user fees and level of government regulation. The certificates are valid for up to two years, but must be renewed.
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