Clinical Laboratory Improvement Amendments (CLIA) regulations require a facility to be appropriately certified for each test they do. CMS edits laboratory claims at the CLIA certificate level to make sure that Medicare and Medicaid only pay for laboratory tests in a facility with a valid, current CLIA certificate.

Since these tests are marketed immediately after approval, CMS tells the Medicare Administrative Contractors (MACs) of the new tests so they process claims accurately. There are 7 newly added waived complexity tests. These new tests must have the modifier QW to be recognized as a waived test. The HCPCS code, effective date, and description for these latest tests are:

  • 82010QW, 82962, May 27, 2022, AmVentureX Inc. BioCoach Blood Glucose and Ketone Monitoring System
  • 80305QW, June 07, 2022, Micro Distributing STATDIP One Step Drug Test;
  • 80305QW, June 07, 2022, Micro Distributing STATCup II One Step Drug Test Cup
  • 87880QW, June 09, 2022, Clarity Diagnostics LLC Clarity Strep A Rapid Test Strip
  • 87880QW, June 09, 2022, Independent Medical Co-op Inc. IMCO Strep A Rapid Test Strip
  • 80305QW, August 31, 2022, Instant Technologies Inc. iSCREEN Urine Test Dx Drug Screen Square Cup
  • 80305QW, August 31, 2022, Verséa Holdings Inc. Verséa THC One Step Marijuana Test Strip
  • 86386QW, September 06, 2022, Abbott Diagnostics Scarborough Inc. NMP22 BladderChek Test (Prescription Home Use) and (Professional Use)

HCPCS codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651 don’t require a QW modifier to be recognized as a waived test. MACs won’t search their files to either take back payment or retroactively pay claims affected by CR 12996. They’ll adjust claims you bring to their attention.

Source: U.S. Centers for Medicare & Medicaid Services (CMS)

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