CMS Releases New CLIA-Waived Tests, Billing Codes
CMS notified contractors of new CLIA-waived tests effective Oct 1, 2015. There are 36 newly waived complexity tests, the latest approved by the FDA. Once again, the list is dominated by drug-related tests. The tests listed in the table below all require the QW modifier be attached to the CPT code for recognition as a waived test. The following table provides a listing of the new CLIA-waived tests with their CPT Code, effective date and description. CPT CODE EFFECTIVE DATE DESCRIPTION G0434QW Jan. 28, 2015 Healgen Amphetamine Test Cassette G0434QW Jan. 28, 2015 Healgen Amphetamine Test Cup G0434QW Jan. 28, 2015 Healgen Amphetamine Test Dip Card G0434QW Jan. 28, 2015 Healgen Amphetamine Test Strip G0434QW Jan. 28, 2015 Healgen Oxycodone Test Cassette G0434QW Jan. 28, 2015 Healgen Oxycodone Test Cup G0434QW Jan. 28, 2015 Healgen Oxycodone Test Dip Card G0434QW Jan. 28, 2015 Healgen Oxycodone Test Strip G0434QW Mar. 4, 2015 Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Cassette G0434QW Mar. 4, 2015 Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Cup G0434QW Mar. 4, 2015 Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Dip Card CPT CODE EFFECTIVE DATE DESCRIPTION G0434QW Mar. 4, 2015 Healgen Scientific LLC Healgen MDMA (Ecstasy) […]
CMS notified contractors of new CLIA-waived tests effective Oct 1, 2015. There are 36 newly waived complexity tests, the latest approved by the FDA. Once again, the list is dominated by drug-related tests. The tests listed in the table below all require the QW modifier be attached to the CPT code for recognition as a waived test.
The following table provides a listing of the new CLIA-waived tests with their CPT Code, effective date and description.
CPT CODE |
EFFECTIVE DATE |
DESCRIPTION |
G0434QW |
Jan. 28, 2015 |
Healgen Amphetamine Test Cassette |
G0434QW |
Jan. 28, 2015 |
Healgen Amphetamine Test Cup |
G0434QW |
Jan. 28, 2015 |
Healgen Amphetamine Test Dip Card |
G0434QW |
Jan. 28, 2015 |
Healgen Amphetamine Test Strip |
G0434QW |
Jan. 28, 2015 |
Healgen Oxycodone Test Cassette |
G0434QW |
Jan. 28, 2015 |
Healgen Oxycodone Test Cup |
G0434QW |
Jan. 28, 2015 |
Healgen Oxycodone Test Dip Card |
G0434QW |
Jan. 28, 2015 |
Healgen Oxycodone Test Strip |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Cassette |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Cup |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Dip Card |
CPT CODE |
EFFECTIVE DATE |
DESCRIPTION |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen MDMA (Ecstasy) Test Strip |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen Phencyclidine Test Cassette |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen Phencyclidine Test Cup |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen Phencyclidine Test Dip Card |
G0434QW |
Mar. 4, 2015 |
Healgen Scientific LLC Healgen Phencyclidine Test Strip |
G0434QW |
Mar. 31, 2015 |
Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cards |
G0434QW |
Mar. 31, 2015 |
Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cups |
G0434QW |
April 20, 2015 |
Chemtron Biotech, Inc. Chemtrue Drug Screen Cup Tests |
G0434QW |
April 20, 2015 |
Chemtron Biotech, Inc. Chemtrue Drug Screen Cup Tests with OPI 2000 |
G0434QW |
April 29, 2015 |
Quest Products, Inc. DrugHAWK MDMA and OPI Drug Test Cup (Urine) |
G0434QW |
April 30, 2015 |
Quest Products, Inc. DrugHAWK Drug Test Cup |
G0434QW |
May 6, 2015 |
Quest Products, Inc. DrugHAWK Buprenorphine Drug Test Cup |
87651QW |
May 15, 2015 |
Roche Molecular, cobas Liat System |
87880QW |
May 26, 2015 |
Medline Strep ATest Strip (Throat Swab) |
80061QW, 82465QW, 83718QW, 84478QW |
May 28, 2015 |
Polymer Technology Systems, Inc., CardioCheck Plus Test Systems (PTS Panels Lipid Panel test strips) |
80061QW, 82465QW, 83718QW, 84478QW |
May 28, 2015 |
Polymer Technology Systems, Inc., CardioChek Home Test Systems (CardioChek Home Lipid Panel test strips) |
82947QW |
May 28, 2015 |
Polymer Technology Systems, Inc., CardioChek Plus Test Systems (PTS Panels eGLU test strips) |
82947QW |
May 28, 2015 |
Polymer Technology Systems, Inc., CardioChek Plus Test Systems (PTS Panels Glucose test strips) |
82947QW |
May 28, 2015 |
Polymer Technology Systems, Inc., CardioChek Home Test Systems (CardioChek Home eGLU test strips) |
82947QW |
May 28, 2015 |
Polymer Technology Systems, Inc., CardioChek Home Test Systems (CardioChek Home Glucose test strips) |
G0434QW |
June 3, 2015 |
Native Diagnostics International DrugSmart Drug Screen Cup Tests with OPI 2000 |
G0434QW |
June 3, 2015 |
Onsite Testing Specialists, Inc. On-Site Testing Specialists Drug Screen Cup Tests |
G0434QW |
June 3, 2015 |
Onsite Testing Specialists, Inc. On-Site Testing Specialists Drug Screen Cup Tests with OPI 2000 |
G0434QW |
June 4, 2015 |
Transmetron, Inc. Invitro Pro Drug Test Cards |
87651QW |
July 15, 2015 |
Alere i Instrument |
The CMS Transmittal announcing the latest FDA approved waived tests also notes that the new CPT code 87651QW has been assigned to the “Streptococcus group A test performed on the Roche Molecular cobas Liat System and the Alere i Instrument” which use nucleic acid amplification technology. That Transmittal 3327, Change Request 9261, Pub. 100-04, dated Aug. 14, 2015, and a complete list of CLIA waived devices is available on the CMS website in the Regulations & Guidance Tab, under Transmittals. Note that Contractors won’t look for claims affected but are required adjust claims that are brought to their attention.
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