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)
| CPT | Manufacturer | Test Name |
| 82010QW | AmVentureX Inc. | BioCoach Blood Glucose and Ketone Monitoring System |
| 80305QW | Micro Distributing | STATDIP One Step Drug Test |
| 80305QW | Micro Distributing | STATCup II One Step Drug Test Cup |
| 87880QW | Clarity Diagnostics LLC | Clarity Strep A Rapid Test Strip |
| 87880QW | Independent Medical Co-op Inc. | IMCO Strep A Rapid Test Strip |
| 80305QW | Instant Technologies Inc. | iSCREEN Urine Test Dx Drug Screen Square Cup |
| 80305QW | Verséa Holdings Inc. | Verséa THC One Step Marijuana Test Strip |
| 86386QW | Abbott Diagnostics Scarborough Inc. | NMP22 BladderChek Test (Prescription Home Use) and (Professional Use) |
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.