Quarterly Update for CLFS and Laboratory Services Subject to Reasonable Charge Payment

New Codes Effective April 1, 2021 Proprietary Laboratory Analysis (PLAs) Table 1 lists new codes we added to the national HCPCS file with an effective date of April 1, 2021. These new codes are contractor-priced (where applicable) until they are nationally priced and undergo the CLFS annual payment determination process in accordance with Sections 1833(h)(8) and 1834(A)(c) of the Act. MACs will only price PLA codes for laboratories within their jurisdiction.

Table 1 – Codes Added to the National HCPCS File, Effective April 1, 2021 Laboratory CPT Code Short Descriptor

• Guardant360® CDx, Guardant Health Inc, Guardant Health Inc 0242U TRGT GEN SEQ ALYS PNL 55-74
• PlGF Preeclampsia Screen, PerkinElmer Genetics, PerkinElmer Genetics, Inc 0243U OB PE BIOCHEM ASSAY PGF ALG
• Oncotype MAP™ PanCancer Tissue Test, Paradigm Diagnostics, Inc, Paradigm Diagnostics, Inc 0244U ONC SOLID ORGN DNA 257 GENES
• ThyGeNEXT® Thyroid Oncogene Panel, Interpace Diagnostics, Interpace Diagnostics ONC THYR MUT ALYS 10 GEN&37
• PrecisionBlood™, San Diego Blood Bank, San Diego Blood Bank 0246U RBC DNA GNOTYP 16 BLD GROUPS
• PreTRM®, Sera Prognostics, Sera Prognostics, Inc® 0247U OB PRTRM BRTH IBP4 SHBG MEAS

Table 2 – Deleted Codes Effective April 1, 2021

• 0098U
• 0099U
• 0100U

CR Transmittal Number: R10656CP

Source: https://www.cms.gov/files/document/mm12178.pdf