CLIA-waived tests

Point of care Claims vary may be moderate or high complexity or CLIA waived tests FDA 510(k) or PMA CLIA Oversight depending on categorization of test... 

CPT codes also indicate which laboratory procedures were offered. On the billing claim form, each laboratory test or laboratory panel performed is coded separately. An example of a CPT laboratory code is 83036, which corresponds to a hemoglobin A c determination (AMA, 2006). The CPT code 83036QW indicates a hemoglobin A c determination was performed using a CLIA-waived device. A complete list of CLIA-waived tests and their CPT codes is located on the CMS Web site (CMS, 2007b, 2007c). 

Centers for Medicare and Medicaid Services. 2003. What is waived testing Available at www.fda.gov/cdrh/ clia accessed on June 14, 2003. 

There are several additional instances when Medicare does recognize pharmacists or pharmacies as providers. One example is when a pharmacist or pharmacy becomes a mass immunizer. Another example is when a pharmacy becomes a provider of durable medical equipment (Snella et al., 2004). Pharmacists also may submit claims to Medicare for CLIA-waived laboratory tests, but this recognition is specifically as a CLIA-waived laboratory and not for any other direct patient care or MTM services. 

Centers for Medicare and Medicaid Services (CMS). 2007c. List of Waived Tests—Updated April 1, 2007. Available at www.cms.hhs.gov/CLIA/downloads/CR5484. waivedtbl.pdf. 

Table 1 Cholesterol monitoring tests granted CLIA waived status...

IVD kits or systems for sale at multiple sites Regulated IVDs FDA 510(k) or PMA premarket submissions CLIA Oversight dependent on categorization of test (high or moderate complexity or waived)... 

Table 1 Tests granted waived status under CLIA used in drug monitoring...

Currently, most pharmacy-based testing falls within the waived category and is exempt from extensive quality standards. However, given the importance of timely and accurate laboratory data in the provision of pharmaceutical care, it is likely that pharmacy-based laboratory testing will expand in breadth and scope.Therefore, pharmacists need to be aware of the quality issues raised and addressed by CLIA 1988. 

---