CLIA approved CPT lab code list

CLIA requires that for each test it performs, a laboratory facility must be appropriately certified. 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. The Current Procedural Terminology (CPT) codes that the Centers for Medicare & Medicaid (CMS) considers to be laboratory tests under CLIA (and thus requiring certification) change each year. Make sure your billing staffs are aware of these changes.

Listed below are the latest tests approved by the FDA as waived tests under CLIA. The CPT codes for the following new tests must have the modifier QW to be recognized as a waived test. However, the 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.

CPT Code Effective Date Description

G0434QW from August 21, 2015 to December 31, 2015 Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card
G0477QW on and after January 1, 2016 Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card
G0477QW March 8, 2016 Tanner Scientific Multi-Panel Drug Test Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Easy Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Split Key Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Cassette
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Dip Card
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Easy Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Split Key Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Cassette
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Dip Card
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Easy Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Split Key Cup
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Cassette
G0477QW March 18, 2016 Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Dip Card
87338QW March 22, 2016 Meridian Bioscience Immunocard STAT! HpSA (Stool)
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Dip Card
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Quick Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Strip
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Amphetamine Turn-Key Split Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine Dip Card
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine Quick Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine Strip
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Cocaine TurnKey Split Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine Dip Card
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine Quick Cup
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine  Strip
G0477QW March 31, 2016 Assure Tech Co., Ltd. AssureTech Morphine Turn-Key Split Cup
G0477QW April 21, 2016 Chemtron Biotech, Inc. Chemtrue Multi-Pane Drug Screen Cup Tests
G0477QW April 21, 2016 Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Cup with OPI 2000 Tests

The new waived complexity code 87338QW [Qualitative or semiquantitative detection test for helicobacter pylori in stool, multiple-step method] was assigned for the detection of Helicobacter pylori antigens in stool performed using the Meridian Bioscience Immunocard STAT! HpSA (Stool) test