CR 11354 informs MACs of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA). Since these tests are marketed immediately after approval, the Centers for Medicare & Medicaid Services (CMS) must notify the MACs of the new tests so that they can accurately process claims. Make sure your billing staffs are aware of these CLIA-related changes.
CR 11354 presents the latest tests approved by the FDA as waived tests under CLIA.
The Current Procedural Terminology (CPT) codes for these new tests must have the modifier “QW” to be recognized as a waived test.
The tests mentioned on the first page of the list attached to CR 11354,do not require a “QW” modifier to be recognized as a waived test. The CPT codes are,
81002 URINALYSIS NONAUTO W/O SCOPE
81025 URINE PREGNANCY TEST
82270 OCCULT BLOOD FECES
82272 OCCULT BLD FECES 1-3 TESTS
82962 GLUCOSE BLOOD TEST
83026 HEMOGLOBIN COPPER SULFATE
84830 OVULATION TESTS
85013 SPUN MICROHEMATOCRIT
85651 RBC SED RATE NONAUTOMATED
The CPT code, effective date, and description for the latest tests approved by the FDA as waived tests under CLIA include,
80305QW, December 13, 2018, Shenzhen Bioeasy Biotechnology Co., Ltd, BIOEASY Multi-Drug Test Cup
80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Cup
80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Dip Card
87880QW, May 9, 2019, McKesson Consult Strep A Test Cassette
87502QW, May 28, 2019, Alere ID NOW Instrument {Nasal and Nasopharyngeal swabs}, for Influenza A/B
87634QW, May 29, 2019, Alere ID NOW Instrument {Nasopharyngeal swabs}, for respiratory syncytial virus
Source: New Waived Tests