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New Lab Codes Effective July 1, 2021

The New HCPCS Lab Codes are released which is Effective from July 1, 2021. These new codes are contractor-priced (where applicable) until they are nationally priced and undergo the CLFS annual payment determination process.  The MACs will only price PLA codes for laboratories within their jurisdiction. and Type of Service (TOS) for all the codes should be "5". 0248U - Oncology (brain), spheroid cell culture in a 3D microenvironment, 12 drug panel, tumor-response prediction for each drug. 0249U - Oncology (breast), semiquantitative analysis of 32 phosphoproteins and protein analytes, includes laser capture microdissection, with algorithmic analysis and interpretative report. 0250U - Oncology (solid organ neoplasm), targeted genomic sequence DNA analysis of 505 genes, interrogation for somatic alterations (SNVs [single nucleotide variant], small insertions and deletions, one amplification, and four translocations), microsatellite instability and tumor-mutation burden. 0251U

New Waived Tests for Labs - Modifier QW Updates

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed.  To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver. The listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA.  The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test.  However, the below-mentioned tests did not require a QW modifier to be recognized as a waived test. Example (i.e., CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651)  81002 - Dipstick or tablet reagent urinalysis – non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen. 81025 - Urine pregnancy tests by visual color comparison. 82270