New Waived Tests

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA. The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. However, the tests mentioned on the first page of the attached list (i.e., CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are the following:

• 80305QW, May 25, 2018, American Screening Corporation, Inc., Precision DX Panel Dip M300;

• 80305QW, May 25, 2018, American Screening Corporation, Inc., Precision DX Panel Dip M2000;

• 80305QW, May 25, 2018, American Screening Corporation, Inc., Precision DX Quick Cup M300;

• 80305QW, May 25, 2018, American Screening Corporation, Inc., Precision DX Quick Cup M2000;

• 86618QW, August 30, 2018, Quidel Sofia 2 {Fingerstick whole blood};

• 80305QW, October 2, 2018, McKesson Medical-Surgical, Mckesson Drugs of abuse PPX Test Cup;

• 80305QW, October 4, 2018, Jant Pharmacal Corp. Accutest VALUPAK Drug Screen Cup;

• 80305QW, October 9, 2018, McKesson Medical-Surgical Inc. McKesson Multi Panel Drugs of abuse Test Cup;

• 83036QW, October 23, 2018, Alere Technologies AS, AS100 Analyzer;

• 83036QW, October 23, 2018, Alere Technologies AS, Afinion 2 Analyzer;

• 80305QW, November 2, 2018, American Screening LLC, Precision Plus Quick Cup Tests; 80305QW, November 2, 2018, American Screening LLC, Precision DX Quick Cup Tests;

• 87804QW, November 21, 2018, Polymedco Inc., Poly stat Flu A&B {for use with nasal and nasophayngeal swabs}; and

• 87634QW, November 23, 2018, Mesa Biotech Accula (Accula RSV Test).

CR: 11080

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4195CP.pdf