The Centers for Medicare & Medicaid Services (CMS) recently released the latest tests approved by the Food and Drug Administration (FDA) as waived tests under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Facilities must be appropriately certified for each test performed and CPT® codes for the following new tests must have the modifier QW CLIA waived test to be recognized as such (with the exception of codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651).

Recent CMS guidance includes special instructions for use of CPT® codes 80101QW Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class, G0430QW Drug screen, qualitative; multiple chromatographic method, each procedure and G0431QW Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class:

• If a laboratory with a CLIA certificate of waiver performs a qualitative drug screening test for multiple drug classes using a non-chromatographic method, then the test code G0430QW is the appropriate code to bill;
• The test code G0431 is a direct replacement for CPT® code 80101;
• Clinical laboratories with a CLIA certificate of waiver should utilize new test code G0431QW; and
• Effective July 1, CPT® 80101 will no longer be covered by Medicare. CPT® 80101QW was deleted as of April 1.

Source: CMS Transmittal 1968, Change Request (CR) 6906, issued May 28.

2 Responses to “New Waived Tests Effective July 1”

1. Raeburn Says:
   June 16th, 2010 at 11:23 am

   The question 1, The best HCPCS Level II code G0431 is a direct replacement for which CPT code. In the article it states 80101, but as you will see the answer will not 80101, but 81003. They really need to fix that answer.

2. Rita Lawson Says:
   June 16th, 2010 at 12:52 pm

   I agree. Thanks for the response.

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