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Eight New CLIA-Waived Tests Recognized by CMS

by | Dec 14, 2022 | News, Open Content

Labs will be able to bill their MACs for the newly recognized tests starting April 1, 2023.

On Nov. 23, the Centers for Medicare & Medicaid Services (CMS) issued Transmittal 11717 notifying Medicare Administrative Contractors (MACs) of eight new CLIA-waived complexity tests approved by the FDA that labs will be allowed to bill to Medicare, starting on April 1, 2023. In addition to the appropriate Healthcare Common Procedure Coding System (HCPCS) code, labs will need to list the QW modifier for the test to be recognized as a waived test.

Newly Recognized CLIA-Waived Tests

(listed in chronological order of FDA approval date)

CPTManufacturerTest Name
82010QWAmVentureX Inc.BioCoach Blood Glucose and Ketone Monitoring System
80305QWMicro DistributingSTATDIP One Step Drug Test
80305QWMicro DistributingSTATCup II One Step Drug Test Cup
87880QWClarity Diagnostics LLCClarity Strep A Rapid Test Strip
87880QWIndependent Medical Co-op Inc.IMCO Strep A Rapid Test Strip
80305QWInstant Technologies Inc.iSCREEN Urine Test Dx Drug Screen Square Cup
80305QWVerséa Holdings Inc.Verséa THC One Step Marijuana Test Strip
86386QWAbbott Diagnostics Scarborough Inc.NMP22 BladderChek Test (Prescription Home Use) and (Professional Use)
Source: Centers for Medicare & Medicaid Services Transmittal 11717

Remember to list the CLIA number of your lab in Item 23 of the CMS-1500 form or electronic equivalent to avoid having the claim rejected even when billing for a CLIA-waived test. If your lab currently has just one Medicare Part B provider number covering more than one testing site, each of the sites must have a CLIA number and the bill should list the CLIA number of the particular site where the billed test was actually performed.

For more details, see the longer article in our upcoming January 2023 National Lab Reporter, posted in advance of PDF publication.