New Waived Tests effective 1/1/2016
November 30, 2015Listed 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.
|
CPT Code(s) |
Effective Date |
Description |
|
86308QW |
January 21, 2015 |
Medline Mono Test Cassette {Whole Blood) |
|
G0434QW |
June 5, 2015 |
AssureTech Co. LTD, AssureTech Oxycodone Strip {OTC} |
|
G0434QW |
June 5, 2015, |
AssureTech Co. Ltd, AssureTech Secobarbital Strip {OTC}; |
|
G0434QW |
June 5, 2015 |
AssureTech Co. Ltd, AssureTech Secobarbital/Oxycodone Panel Dip {OTC} |
|
G0434QW |
June 5, 2015 |
AssureTech Co. Ltd, AssureTech Secobarbital/Oxycodone Quick Cup {OTC} |
|
G0434QW |
June 5, 2015 |
AssureTech Co. Ltd, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup {OTC} |
|
82274QW, G0328QW |
June 26, 2015 |
Medline iFOB Test |
|
G0434QW |
July 16, 2015 |
Noble Medical Inc. Noble 1 Step + Cup |
|
82274QW, G0328QW |
July 28, 2015 |
Sekisui Diagnostics, LLC OSOM iFOB Test |
|
86318QW |
August 19, 2015 |
Alere Clearview H. pylori Whole Blood Only {Whole Blood}; |
|
86318QW |
August 19, 2015 |
Alere Signify H. pylori Whole Blood Only {Whole Blood} |
|
87880QW |
August 21, 2015 |
LABSCO Advantage Strep A |
|
G0434QW |
August 31, 2015 |
UCP Biosciences, Inc. UCP Drug Test Mini Cups |
|
G0434QW |
Sept. 22, 2015 |
American Screening Corporation, Reveal Mini Drug Test Cups |
|
G0434QW |
October 13, 2015 |
,Assure Tech Co., Ltd AssureTech Buprenorphine Strip; |
|
G0434QW |
October 13, 2015 |
Assure Tech Co., Ltd AssureTech Methadone Strip; |
|
G0434QW |
October 13, 2015 |
Assure Tech Co., Ltd AssureTech Buprenorphine/Methadone Panel Dip; |
|
G0434QW |
October 13, 2015 |
Assure Tech Co., Ltd AssureTech Buprenorphine/Methadone Quick Cup; and |
|
G0434QW |
October 13, 2015 |
Assure Tech Co., Ltd AssureTech Buprenorphine/Methadone Turn Key-Split Cup. |
Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3406CP.pdf