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) 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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