FDA Approves New Waived Tests Under CLIA

The Centers for Medicare & Medicaid Services (CMS) released, June 17, the latest laboratory tests approved by the Food and Drug Administration (FDA) as waived tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). According to CMS Transmittal 2244, there will be five new tests that are covered under Medicare Parts A and B effective Oct. 1, 2011.

Listed below are the latest FDA-approved waived tests:

Code Effective Date Description
87880QW Feb. 2, 2011 BTNX Rapid Response Strep A Rapid Test Strips
March 24, 2011 OC-Light iFOB Test
G0434QW April 1, 2011 CLIA-waived, Inc. Rapid Drug Test Cup{OTC}
G0434QW April 1, 2011 Instant Technologies, iCup DX Drug Screen Cup
86318QW April 7, 2011 Stanbio Rely H. plyori Rapid Test (Whole Blood) (Finger-stick only)

Note that drug tests reported with HCPCS Level II code G0434QW or CPT® code 82055QW, and the screening test to measure sperm concentration (reported with CPT® code 89300QW), may not be covered in all instances. Contact your Medicare carrier for claims instructions.

With the exception of CPT® codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651, tests must have the modifier QW to be recognized as a waived test.


Latest posts by admin aapc (see all)

Leave a Reply

Your email address will not be published. Required fields are marked *