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 FDA as waived tests under CLIA. CPT codes for the following new tests must have the modifier QW to be recognized as a waived test. Tests with CPT codes shown on the first page of the attachment to CR8951 (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 listed in the following table.
| CPT Code | Effective Date | Description |
| 87807QW | March 18, 2014 | BD Veritor System for Rapid Detection of RSV (For use with nasopharyngeal specimens){Includes a reader} |
| G0434QW | May 12, 2014 | Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Dip Card Tests |
| 87807QW | May 30, 2014 | Sofia RSV |
| G0434QW | June 9, 2014 | Healgen THC One Step Marijuana Test Strip |
| G0434QW | June 9, 2014 | Healgen THC One Step Marijuana Test Cassette |
| G0434QW | June 9, 2014 | Healgen THC One Step Marijuana Test Cup |
| G0434QW | June 9, 2014 | Healgen THC One Step Marijuana Test Dip Card |
| G0434QW | June 9, 2014 | Healgen mAMP One Step Methamphetamine Test Strip |
| G0434QW | June 9, 2014 | Healgen mAMP One Step Methamphetamine Test Cassette |
| G0434QW | June 9, 2014 | Healgen mAMP One Step Methamphetamine Test Cup |
| G0434QW | June 9, 2014 | Healgen mAMP One Step Methamphetamine Test Dip Card |
| 87880QW | June 11, 2014 | Poly stat Strep A Strip Test {Specimen type (Throat Swab)} |
| 87880QW | June 25, 2014 | StrepAim {Specimen type (Throat Swab)} |
| G0434QW | June 27, 2014 | Wal-Mart Stores, Inc. ReliOn Home Drug Urine Cup Test |
| 86308QW | July 7, 2014 | Jant Pharmacal Corp. Accutest Rapid Mono Test {Whole Blood} |
| 87880QW | July 9, 2014 | Cardinal Health Strep A Dipstick – Rapid Test (Throat Swab Specimen) |
| G0434QW | July 18, 2014 | Healgen COC One Step Cocaine Test Strip |
| G0434QW | July 18, 2014 | Healgen COC One Step Cocaine Test Cassette |
| G0434QW | July 18, 2014 | Healgen COC One Step Cocaine Test Cup |
| G0434QW | July 18, 2014 | Healgen COC One Step Cocaine Test Dip Card |
| G0434QW | July 18, 2014 | Healgen MOP One Step Morphine Test Strip |
| G0434QW | July 18, 2014 | Healgen MOP One Step Morphine Test Cassette |
| G0434QW | July 18, 2014 | Healgen MOP One Step Morphine Test Cup |
| G0434QW | July 18, 2014 | Healgen MOP One Step Morphine Test Dip Card |
| 81003QW | August 8, 2014 | Medline 120 Urine Analyzer |
MACs will not search their files to either retract payment or retroactively pay claims processed prior to implementation of CR8951; however, they should adjust claims if you bring such claims to your MAC’s attention.
The official instruction, CR8951 issued to your MAC regarding this change is available at http://www.cms.gov/Regulations-and–Guidance/Guidance/Transmittals/Downloads/R3149CP.pdf on the CMS website.
If you have any questions, please contact your MAC at their toll-free number. That number is available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Net work-MLN/MLNMattersArticles/index.html under – How Does It Work.
