81002 R2321CP

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CMS Manual System

Department of Health
& Human Services (DHHS)

Pub 100-04 Medicare Claims
Processing

Centers for Medicare
& Medicaid Services (CMS)

Transmittal 2321

Date: October 21 2011

Change Request 7566
SUBJECT: New Waived Tests
I. SUMMARY OF CHANGES: This instruction informs contractors of new waived tests approved by the
Food and Drug Administration under Clinical Laboratory Improvement Amendments of 1988. Since these
tests are marketed immediately after approval, the Centers for Medicare and Medicaid Services must notify
its contractors of the new tests so that the contractors can accurately process claims. This Recurring Update
Notification (RUN) can be found in Chapter 16, Section 70.8.
EFFECTIVE DATE: January 1, 2012
IMPLEMENTATION DATE: January 3, 2012
Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized
material. Any other material was previously published and remains unchanged. However, if this revision
contains a table of contents, you will receive the new/revised information only, and not the entire table of
contents.
II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated)
R=REVISED, N=NEW, D=DELETED-Only One Per Row.
R/N/D

CHAPTER / SECTION / SUBSECTION / TITLE

N/A
III. FUNDING:
For Fiscal Intermediaries (FIs), Regional Home Health Intermediaries (RHHIs):
No additional funding will be provided by CMS; Contractor activities are to be carried out within their
operating budgets.
For Medicare Administrative Contractors (MACs):
The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined
in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is
not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically
authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to
be outside the current scope of work, the contractor shall withhold performance on the part(s) in question
and immediately notify the Contracting Officer, in writing or by e-mail, and request formal directions
regarding continued performance requirements.
IV. ATTACHMENTS:
Recurring Update Notification
*Unless otherwise specified, the effective date is the date of service.

Pub. 100-04

Attachment – Recurring Update Notification
Transmittal: 2321 Date: October 21, 2011
Change Request: 7566

SUBJECT: New Waived Tests
Effective Date:
Implementation Date:

January 1, 2012
January 3, 2012

I.

GENERAL INFORMATION

A.

Background:

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be
appropriately certified for each test performed. To ensure that Medicare & Medicaid only pay for laboratory
tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory
claims are currently edited at the CLIA certificate level.
Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under
CLIA. The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier
QW to be recognized as a waived test. However, the tests mentioned on the first page of the attached list (i.e.,
CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) do not require a QW
modifier to be recognized as a waived test.
CPT Code
81003QW

Effective Date
February 14, 2011

G0434QW

April 22, 2011

G0434QW

April 22, 2011

81003QW

March 24, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 17, 2011

G0434QW

June 30, 2011

G0434QW

June 30, 2011

Description
Germaine Laboratories Inc. AimStrip
Urine Analyzer
UCP Biosciences, Inc. UCP Drug
Screening Test Cups
Diagnostic Test Group Clarity Multiple
Drug Screen Cups
Mediwatch urinewatch Urine Analyzer
Insight Medical Drug of Abuse Urine
Cassette Test
Insight Medical Drug of Abuse Urine
Cup Test
Instant Technologies, Inc. iScreen Drug
of Abuse Urine (Cassette) Test
Instant Technologies, Inc. iScreen Drug
of Abuse Urine (Cup) Test
Jant Pharmacal Accutest Drug of Abuse
Urine (Cassette) Test
Jant Pharmacal Accutest Drug of Abuse
Urine (Cup) Test
Total Diagnostic Solutions Drug of
Abuse Urine (Cassette) Test
Total Diagnostic Solutions Drug of
Abuse Urine (Cup) Test
Diagnostic Test Group Clarity Simple
Drug Screening Cups
Diagnostic Test Group Clarity Multi-

81003QW
G0434QW

July 14, 2011
July 21, 2011

Drug Test Cards
Stanbio Uri-Trak 120 Urine Analyzer
UCP Biosciences, Inc. U-Checker Drug
Screening Test Cups

On August 22, 2011, Quidel Technical support notified us that the Quidel QuickVue Advance pH and Amines
Test was discontinued as of May 2007. Therefore, this test system has been deleted from the attachment.
B. Policy: The CLIA regulations require a facility to be appropriately certified for each test performed. To
ensure that Medicare and Medicaid only pay for laboratory tests categorized as waived complexity under CLIA
in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate
level.
II.

BUSINESS REQUIREMENTS TABLE

Number Requirement

7566.1
7566.2

7566.3

III.

The Medicare contractor shall include the new tests listed
above in CLIA-covered code files with the QW modifier.
Contractors shall not search their files to either retract
X
payment or retroactively pay claims; however, contractors
should adjust claims if they are brought to their attention.
Contractors shall not use the explanatory information X
under the “Use” column in the attachment as the reason for
rejecting a claim.

X

X

PROVIDER EDUCATION TABLE

Number Requirement

7566.4

Responsibility (place an “X” in each
applicable column)
A D F C R
SharedOTHE
/ M I A H
System
R
B E
R H Maintainers
R I F M V C
M M
I
I C M W
A A
E
S S S F
C C
R
S
X
X

A provider education article related to this instruction will
be available at
http://www.cms.hhs.gov/MLNMattersArticles/ shortly
after the CR is released. You will receive notification of
the article release via the established "MLN Matters"
listserv.

Responsibility (place an “X” in each
applicable column)
A D F C R
SharedOTH
/ M I A H
System
ER
B E
R H Maintainers
R I F M V C
M M
I
I C M W
A A
E
S S S F
C C
R
S
X
X

Number Requirement

Responsibility (place an “X” in each
applicable column)
A D F C R
SharedOTH
/ M I A H
System
ER
B E
R H Maintainers
R I F M V C
M M
I
I C M W
A A
E
S S S F
C C
R
S

Contractors shall post this article, or a direct link to this
article, on their Web site and include information about it
in a listserv message within one week of the availability of
the provider education article. In addition, the provider
education article shall be included in your next regularly
scheduled bulletin. Contractors are free to supplement
MLN Matters articles with localized information that
would benefit their provider community in billing and
administering the Medicare program correctly.

IV.

SUPPORTING INFORMATION

Section A: For any recommendations and supporting information associated with listed requirements,
use the box below: N/A
Use "Should" to denote a recommendation.
X-Ref
Recommendations or other supporting information:
Requireme
nt
Number
N/A
Section B: For all other recommendations and supporting information, use this space: N/A
V. CONTACTS
Pre-Implementation Contact(s): Kathy Todd (410) 786-3385
Post-Implementation Contact(s): Contact your Contracting Officer’s Technical Representative (COTR) or
Contractor Manager, as applicable.
VI. FUNDING
Section A: For Fiscal Intermediaries (FIs) and Carriers:
No additional funding will be provided by CMS; contractor activities are to be carried out within their operating
budgets.
Section B: For Medicare Administrative Contractors (MACs):

The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in
your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not
obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically
authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to be
outside the current scope of work, the contractor shall withhold performance on the part(s) in question and
immediately notify the Contracting Officer, in writing or by e-mail, and request formal directions regarding
continued performance requirements.
ATTACHMENT – TESTS GRANTED WAIVED STATUS UNDER CLIA

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

81002

Dipstick or tablet reagent urinalysis –
non-automated for bilirubin, glucose,
hemoglobin, ketone, leukocytes, nitrite,
pH, protein, specific gravity, and
urobilinogen

Various

Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections

81025

Urine pregnancy tests by visual color
comparison

Various

Diagnosis of pregnancy

82270
82272
(Contact your
Medicare carrier for
claims instructions.)

Fecal occult blood

Various

Detection of blood in feces from whatever cause, benign or malignant
(colorectal cancer screening)

82962

Blood glucose by glucose monitoring
devices cleared by the FDA for home
use

Various

Monitoring of blood glucose levels

83026

Hemoglobin by copper sulfate – nonautomated

Various

Monitors hemoglobin level in blood

84830

Ovulation tests by visual color
comparison for human luteinizing
hormone

Various

Detection of ovulation (optimal for conception)

85013

Blood count; spun microhematocrit

Various

Screen for anemia

85651

Erythrocyte sedimentation rate – nonautomated

Various

Nonspecific screening test for inflammatory activity, increased for majority
of infections, and most cases of carcinoma and leukemia

This list includes updates from Change Request 7566

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

80047QW,
82330QW,
82374QW,
82435QW,
82565QW,
82947QW,
82950QW,
82951QW,
82952QW,
84132QW,
84295QW,
84520QW,
85014QW

Abbott i-STAT Chem8+ Cartridge
{Whole Blood}

i-STAT Corporation

Measures ionized calcium, carbon dioxide, chloride, creatinine, glucose,
potassium, sodium, urea nitrogen, and hematocrit in whole blood

80048QW

1.

Abaxis Piccolo Blood Chemistry
Analyzer (Basic Metabolic Reagent
Disc){Whole Blood}

Abaxis, Inc

Measures total calcium, carbon dioxide, chloride, creatinine, glucose,
potassium, sodium, and urea nitrogen in whole blood

2.

Abaxis Piccolo xpress Chemistry
Analyzer (Basic Metabolic Reagent
Disc){Whole Blood}

Abaxis, Inc

1.

Abaxis Piccolo Blood Chemistry
Analyzer (Electrolyte Metabolic
Reagent Disc){Whole Blood}

Abaxis, Inc.

2.

Abaxis Piccolo xpress Chemistry
Analyzer (Electrolyte Metabolic
Reagent Disc){Whole Blood}

Abaxis, Inc.

1.

Abaxis Piccolo Blood Chemistry
Analyzer (Comprehensive
Metabolic Reagent Disc){Whole
Blood}

Abaxis, Inc.

2.

Abaxis Piccolo xpress Chemistry
Analyzer (Comprehensive
Metabolic Reagent Disc){Whole
Blood}

Abaxis, Inc.

80051QW

80053QW

This list includes updates from Change Request 7566
* Newly added waived test system

Measures carbon dioxide, chloride, potassium, and sodium in whole blood

Measures alanine amino transferase, aspartate amino transferase, albumin,
total bilirubin, total calcium, carbon dioxide, chloride, creatinine, glucose,
alkaline phosphatase, potassium, total protein, sodium, and urea nitrogen in
whole blood

2

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

80061QW,
82465QW (Contact
your Medicare
carrier for claims
instructions.),
83718QW,
84478QW

1.

Abaxis, Piccolo xpress Chemistry
Analyzer {Lipid Panel Reagent
Disc} (Whole Blood)

Abaxis, Incorporated

Measures total cholesterol, HDL cholesterol, and triglycerides in whole
blood

2.

Infopia USA LipidPro lipid profile
and glucose measuring system
(LipidPro Lipid Profile test strips)

Infopia Co., Ltd.

3.

Piccolo Point of Care Chemistry
Analyzer (Lipid Panel Reagent
Disc) (Whole Blood)

Abaxis, Incorporated

4.

Polymer Technology Systems
CardioChek PA Analyzer {PTS
Panels Lipid Panel Test Strips}

Polymer Technology
Systems, Inc.

80061QW,
82465QW (Contact
your Medicare
carrier for claims
instructions.),
83718QW,
84460QW,
84478QW

Cholestech LDX (Lipid Profile – ALT
(GPT)){Whole Blood}

Cholestech Corp.

Measures alanine aminotransferase, total cholesterol, HDL cholesterol, and
triglycerides in whole blood

80069QW

1.

Abaxis Piccolo Blood Chemistry
Analyzer (Piccolo Renal Function
Panel){Whole Blood}

Abaxis, Incorporated

Measures albumin, total calcium, total carbon dioxide, chloride, creatinine,
glucose, phosphorus, potassium, sodium and urea nitrogen in whole blood

2.

Abaxis Piccolo xpress Chemistry
Analyzer (Piccolo Renal Function
Panel){Whole Blood}

Abaxis, Incorporated

This list includes updates from Change Request 7566
* Newly added waived test system

3

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

Phamatech QuickScreen One Step
Amphetamine Test

Phamatech

Screening test for the presence/detection of amphetamine in urine

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

Accu-Stat Drugs of Abuse Home
Test for Marijuana (THC)

Accu-Stat Diagnostics, Inc.

Screening test for the presence/detection of cannabinoids (THC) in urine

2.

ADC CLIA Waived Marijuana
(THC) Test

Advantage Diagnostics
Corporation (ADC)

3.

First Check Diagnostics LLC, First
Check Home Drug Test Marijuana

ACON Laboratories, Inc.

4.

Phamatech QuickScreen One Step
THC Screening Test

Phamatech

5.

Phamatech At Home Drug Test
(Model 9078)

Phamatech

6.

Phamatech At Home Drug Test
(Model 9078T)

Phamatech

7.

Worldwide Medical Corporation,
First Check Home Drug Test
(THC)

Worldwide Medical
Corporation

1.

Phamatech At Home Drug Test
(Model 9073)

Phamatech

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

This list includes updates from Change Request 7566
* Newly added waived test system

Screening test for the presence/detection of cocaine metabolites in urine

4

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW(cont.)
(This test may not
be covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

2.

Phamatech At Home Drug Test
(Model 9073T)

Phamatech

Screening test for the presence/detection of cocaine metabolites in urine

3.

Phamatech QuickScreen One Step
Cocaine Screening Test

Phamatech

1.

Phamatech At Home Drug Test
(Model 9068)

Phamatech

2.

Phamatech QuickScreen One Step
Methamphetamine Test

Phamatech

1.

DyanGen NicCheck II Test Strips

DynaGen, Inc.

2.

Mossman Associates, Inc.
NicCheck I Test Strips

Mossman Associates, Inc.

1.

Phamatech At Home Drug Test
(Model 9083)

Phamatech

2.

Phamatech QuickScreen One Step
Opiate Screening Test

Phamatech

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

This list includes updates from Change Request 7566
* Newly added waived test system

Screening test for the presence/detection of methamphetamines in urine

Detects nicotine and/or its metabolites in urine, which is used as an aid in
indicating the smoking status of an individual and as an aid in the
identification of a smoker as a low or high nicotine consumer

Screening test for the presence/detection of opiates in urine

5

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

Phamatech At Home Drug Test
(Model 9133)

Phamatech

Screening test for the presence/detection of phencyclidine (PCP) in urine

2.

Phamatech QuickScreen One Step
PCP Screening Test

Phamatech

1.

Accu-Stat Drugs of Abuse Home
Test for Marijuana (THC) and
Cocaine (COC)

Accu-Stat Diagnostics, Inc.

2.

Advantage Diagnostics Advantage
Marijuana (THC) and Cocaine
Home Drug Test

ADC

3.

ADC CLIA Waived Marijuana
(THC) and Cocaine Test

ADC

4.

Forefront Diagnostics
Drugfree@Home THC/COC Test
Kit

Forefront Diagnostics, Inc.

5.

Worldwide Medical Corporation,
First Check Home Drug Test
(THC-COC)

Worldwide Medical
Corporation

1.

Alfa Scientific Designs, Inc.
Instant-View Drug of Abuse Urine
Cassette Test

Alfa Scientific Designs, Inc.

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

This list includes updates from Change Request 7566
* Newly added waived test system

Screening test for the presence/detection of cannabinoids (THC) and cocaine
metabolites in urine

Screening test for the presence/detection of morphine and oxycodone in
urine

6

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW
(cont.)(This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions.)

2.

Alfa Scientific Designs, Inc.
Instant-View Drug of Abuse Urine
Cup Test

Alfa Scientific Designs, Inc.

Screening test for the presence/detection of morphine and oxycodone in
urine

3.

Insight Medical Drug of Abuse
Urine Cassette Test*

Alfa Scientific Designs, Inc.

4.

Insight Medical Drug of Abuse
Urine Cup Test*

Alfa Scientific Designs, Inc.

5.

Instant Technologies, Inc. iScreen
Drug of Abuse Urine (Cassette)
Test*

Alfa Scientific Designs, Inc.

6.

Instant Technologies, Inc. iScreen
Drug of Abuse Urine (Cup) Test*

Alfa Scientific Designs, Inc.

7.

Jant Pharmacal Accutest Drug of
Abuse Urine (Cassette) Test*

Alfa Scientific Designs, Inc.

8.

Jant Pharmacal Accutest Drug of
Abuse Urine (Cup) Test*

Alfa Scientific Designs, Inc.

9.

Total Diagnostic Solutions Drug of
Abuse Urine (Cassette) Test*

Alfa Scientific Designs, Inc.

10. Total Diagnostic Solutions Drug of
Abuse Urine (Cup) Test*

Alfa Scientific Designs, Inc.

1.

ADC

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

ADC CLIA Waived Multiple Drug
Test Card

This list includes updates from Change Request 7566
* Newly added waived test system

Screening test for the presence/detection of cannabinoids (THC), cocaine
metabolites, methamphetamines, opiates, and PCP in urine

7

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW
(cont.)(This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions.)

2.

Advantage Diagnostics Corporation
ADC Multiple Drug Test Card

Advantage Diagnostics
Corporation

Screening test for the presence/detection of cannabinoids (THC), cocaine
metabolites, methamphetamines, opiates, and PCP in urine

3.

Alatex Scientific Peace of Mind
Multiple Drugs of Abuse Test

Advantage Diagnostics
Corporation

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

Phamatech At Home Drug Test (Model
9150T)

Phamatech

Screening test for the presence/detection of amphetamines, THC, cocaine
metabolites, methamphetamines, and opiates in urine

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

Worldwide Medical Corporation, First
Check Home Drug Test Panel 4
(THC-COC-OPI-MET)

Worldwide Medical
Corporation

Screening test for the presence/detection of THC, cocaine metabolites,
opiates and methamphetamines in urine

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

Accu-Stat Drugs of Abuse Home
Test for Marijuana, Cocaine,
Amphetamine, Methamphetamines,
Opiates and Phencyclidine

Accu-Stat Diagnostics, Inc.

Screening test for the presence/detection of amphetamines, THC, cocaine
metabolites, methamphetamines, opiates, and PCP in urine

2.

accutest Multi-Drug, Multi-Line
Screen Test Device

ACON Laboratories, Inc.

3.

Acon One Step Multi-Drug, MultiLine Screen Test Device
(Professional Use)

ACON Laboratories, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

8

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW(cont.)
(This test may not
be covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

4.

Biotechnostix Rapid Response One
Step Multi-Drug, Multi-Line Screen
Test Device

ACON Laboratories, Inc.

Screening test for the presence/detection of amphetamines, THC, cocaine
metabolites, methamphetamines, opiates, and PCP in urine

5.

iCassette Multi-Drug, Multi-Line
Screen Test Device

ACON Laboratories, Inc.

6.

RediScreen Multi-Drug, Multi-Line
Screen Test Device

ACON Laboratories, Inc.

7.

Redwood Toxicology Laboratory
Reditest 6 Cassette substance abuse
screening device {Professional
Use}

Innovacon, Inc.

1.

Biotechnostix Rapid Response
Multi-Drug, Multi-Line Screen Test
Card with Integrated Cup

ACON Laboratories, Inc.

2.

Drug Detection Devices Ltd. MultiDrug Multi-Line Screeners Dip
Drug Test With the Integrated
Screeners AutoSplit KO Test Cup

Innovacon, Inc.

3.

First Check Diagnostics First Check
Multi Drug Cup

First Check Diagnostics LLC

4.

Innovacon Integrated E-Z Split Key
Cup II {Professional Use}

Innovacon, Inc.

5.

Noble Medical Inc. Split-Specimen
Cup

ACON Laboratories, Inc.

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

This list includes updates from Change Request 7566
* Newly added waived test system

Screening test for the presence/detection of amphetamines, THC, cocaine
metabolites, methamphetamines, methylenedioxymethamphetamine
(MDMA), opiates, and PCP in urine

9

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW
(cont.)(This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions.)

6.

1 Step Detect Associates DTX Drug
Test Cup Integrated E-Z Split Key
Cup II

Biosite Inc.

Screening test for the presence/detection of amphetamines, THC, cocaine
metabolites, methamphetamines, MDMA , opiates, and PCP in urine

7.

Quest Diagnostics Incorporated,
Express Results Integrated MultiDrug Screen Cup {professional
use}

Innovacon, Inc.

8.

Wolfe Drug Testing RealityCheck
Integrated Specimen Cup

Innovacon, Inc.

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

Branan Medical Corporation ToxCup
Drug Screen Cup

Branan Medical Corporation

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, methadone,
methamphetamines, MDMA, opiates, oxycodone, and PCP in urine

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

Innovacon Multi-Clin Drug Screen
Test Device

Innovacon, Inc.

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, MDMA, opiates, oxycodone,
PCP, propoxyphene and tricyclic antidepressants in urine

2.

Inverness Medical Innovations
Signify ER Drug Screen

Biosite Inc.

3.

Jant Pharmacal Accutest MultiDrug
ER11 Drug Screen Test Device

Innovacon, Inc.

4.

Abbott Diagnostics Signify ER
Drug Screen Test

Innovacon, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

10

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

Alfa Scientific Designs, Inc. Instant
View Multi-Drug of Abuse Urine
Test

Alfa Scientific Designs, Inc.

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, methamphetamines,
methadone, MDMA, morphine, PCP and tricyclic antidepressants in urine

2.

Alfa Scientific Designs, Inc. Instant
View Multi-Drug of Abuse Urine
Cup Test

Alfa Scientific Designs, Inc.

3.

BTNX Inc. Know Multi-Drug One
Step Screen Test Panel (Urine)

Alfa Scientific Designs, Inc.

4.

BTNX Inc. Rapid Response MultiDrug One Step Screen Test Panel
(Urine)

Alfa Scientific Designs, Inc.

5.

Confirm Biosciences Drugconfirm
instant multi-drug test kit, MultiDrug of Abuse Urine Test

Alfa Scientific Designs, Inc.

6.

Insight Medical Multi-Drug of
Abuse Urine Test

Alfa Scientific Designs, Inc.

7.

Micro Distributing II, Ltd MultiDrug of Abuse Urine Test

Alfa Scientific Designs, Inc.

8.

Millenium Laboratories Multi-Drug
of Abuse Urine Test

Alfa Scientific Designs, Inc

9.

Physicians’ Test Multi-Drug of
Abuse Urine Test

Alfa Scientific Designs, Inc.

10. On the Spot Drug Testing MultiDrug of Abuse Urine Test

Alfa Scientific Designs, Inc.

11. Quik Test USA, Inc. Multi-Drug of
Abuse Urine Test

Alfa Scientific Designs, Inc.

12. Screen Tox Multi-Drug of Abuse
Urine Test

Alfa Scientific Designs, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

11

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW
(cont.)(This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions.)

13. Total Diagnostic Solutions MultiDrug of Abuse Urine Test

Alfa Scientific Designs, Inc

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, methamphetamines,
methadone, MDMA, morphine, PCP and tricyclic antidepressants in urine

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

Aventir Biotech LLC Home Check
Multiple Drug Test Cup

Tianjin New Bay
Bioresearch Co. Ltd.

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, methamphetamines,
methadone, morphine, oxycodone, PCP and tricyclic antidepressants in
urine

2.

Aventir Biotech LLC Home Check
Multiple Drug Cup Test
{Professional version}

Tianjin New Bay
Bioresearch Co. Ltd

3.

Syntron Bioresearch Quikscreen
Multiple Drug Cup Test
{Professional version}

Tianjin New Bay
Bioresearch Co. Ltd

1.

Amedica Biotech Amedica Drug
Screen Test Cup

Amedica Biotech, Inc.

2.

Amedica Biotech AmediCheck
Instant Test Cup

Amedica Biotech, Inc.`

3.

Ameditech, Inc ImmuTest Drug
Screen Cup

Biosite Inc.

4.

Branan Medical Corporation
Fastect II Drug Screen Dipstick
Test

Branan Medical Corporation

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

This list includes updates from Change Request 7566
* Newly added waived test system

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, methadone,
methamphetamines, MDMA, opiates, oxycodone, PCP and tricyclic
antidepressants in urine

12

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW
(cont.)(This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions.)

5.

Branan Medical Corporation,
FasTox Multiple Drug Dipcard

Branan Medical Corporation

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, methadone,
methamphetamines, MDMA, opiates, oxycodone, PCP and tricyclic
antidepressants in urine

6.

Branan Medical Corporation,
QuickTox Drug Screen Dipcard

Branan Medical Corporation

7.

CLIAwaived, Inc. Rapid Drug Test

Biosite Inc.

8.

CLIAwaived, Inc. Rapid Drug Test
Cup {OTC}

Biosite Inc.

9.

Express Diagnostics, DrugCheck
Waive Cup

Biosite Inc.

10. First Check Diagnostics First Check
12 Drug Test

First Check Diagnostics LLC

11. Instant Technologies, iCup DX
Drug Screen Cup

Biosite Inc.

12. Jant Pharmacal Corporation
ACCUTEST Drug Test Cup

Amedica Biotech, Inc

13. Millennium Laboratories Clinical
Supply, Inc Multi-Drug Pain Med
Screen Cup

Biosite Inc.

14. NexScreen LLC, NexScreen Cup

Amedica Biotech, Inc.

15. Noble Medical Inc. NOBLE 1 Step
Cup {OTC}

Biosite Inc.

16. Redwood Toxicology Laboratory,
Inc Reditest Freedom Cup

Biosite Inc.

17. Twin Spirit, Inc. DrugSmart Cup

Amedica Biotech, Inc.

18. US Diagnostics ProScreen Drugs of
Abuse Cup {OTC}

Biosite Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

13

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)

1.

American Screening Corporation
OneScreen Drug Test Cards

UCP Biosciences, Inc.

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, THC, cocaine metabolites, MDMA, methamphetamines,
methadone, morphine, opiates, oxycodone, PCP, and tricyclic
antidepressants in urine

2.

American Screening Corporation
OneScreen Drug Test Cups

UCP Biosciences, Inc.

3.

American Screening Corporation
Reveal Multi-Drug Testing Cups

UCP Biosciences, Inc

4.

Diagnostic Test Group Clarity
Multi-Drug Test Cards*

UCP Biosciences, Inc

5.

Diagnostic Test Group Clarity
Multiple Drug Screen Cards*

UCP Biosciences, Inc.

6.

Diagnostic Test Group Clarity
Simple Drug Screening Cups*

UCP Biosciences, Inc.

7.

Express Diagnostics International
Inc. DrugCheck Waive Drug Test
Cards

UCP Biosciences, Inc.

8.

Express Diagnostics International
Inc. DrugCheck Waive Multiple
Drug Screen Cups

UCP Biosciences, Inc.

9.

UCP Biosciences, Inc. Drug
Screening Test Cards

UCP Biosciences

10. UCP Biosciences, Inc. Drug
Screening Test Cups*

UCP Biosciences, Inc.

11. UCP Biosciences, Inc. Multiple
Drug Screen Cups

UCP Biosciences

12. UCP Biosciences, Inc. U-Checker
Drug Screening Test Cups*

UCP Biosciences, Inc.

13. UCP Biosciences, Inc., UCP Home
Drug Screening Test Cards

UCP Biosciences, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

14

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

G0434QW (This
test may not be
covered in all
instances. Contact
your Medicare
carrier for claims
instructions.)
80178QW

American Bio Medica Rapid TOX

American Bio Medica Corp.

Screening test for the presence/detection of amphetamines, barbiturates,
benzodiazepines, buprenorphine, THC, cocaine metabolites, MDMA,
methamphetamines, methadone, opiates, oxycodone, PCP, propoxyphene,
and tricyclic antidepressants in urine

ReliaLAB Inc. InstaRead Lithium
System {fingerstick or venipuncture
whole blood}

Akers Laboratories, Inc.

Measures lithium blood levels in whole blood

81003QW

1.

Biosys Laboratories Optima Urine
Anlayzer

BioSys Laboratories, Inc.

Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections

2.

Chemstrip Mini UA – qualitative
dipstick for glucose, bilirubin,
ketone, specific gravity, blood, pH,
protein, urobilinogen, nitrite,
leukocytes – automated

Boehringer Mannheim
Corporation

3.

Cole-Talyor Marketing Inc. CTI120 Urine Strip Analyzer

Acon Laboratories, Inc.

4.

Consult diagnostics Urine Analyzer

BioSys Laboratories, Inc.

5.

Germaine Laboratories Inc.
AimStrip Urine Analyzer*

Acon Labortories, Inc.

6.

Henry Schein OneStepPlus Urine
Analyzer

Macherey-Nagel GmbH &
Co., Kg.

7.

Hypoguard Diascreen Urine
Chemistry Analyzer

Hypoguard USA, Inc.

8.

Jant Pharmacal Corporation
Accustrip URS Reader

9.

Mediwatch urinewatch Urine
Analyzer*

10. Physician Sales & Service, Inc. PSS
Select Urine Analyzer
This list includes updates from Change Request 7566
* Newly added waived test system

Acon Labortories, Inc.
BioSys Laboratories, Inc.

15

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

81003QW(cont.)

11. Roche Diagnostics Urisys 1100
Urine Analyzer

Roche Diagnostics Corp.

Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections

12. Roche Diagnostics/Boehringer
Mannheim Chemstrip 101 Urine
Analyzer

Roche
Diagnostics/Boehringer
MannheimCorporation

13. Stanbio Uri-Trak 120 Urine
Analyzer*

Acon Labortories, Inc.

14. ThermoBiostar PocketChem
UA

ThermoBiostar

81003QW,
82044QW,
82570QW

Siemens Clinitek 50 Urine Chemistry
Analyzer

Siemens Healthcare
Diagnostics Inc.

Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections;
and the semi-quantitative measurement of albumin and creatinine in urine

81003QW,
82044QW,
82570QW,
84703QW

1.

Siemens Clinitek Status Urine
Chemistry Analyzer

Siemens Healthcare
Diagnostics

Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections;
the semi-quantitative measurement of albumin and creatinine in urine; and
the diagnosis of pregnancy

2.

Siemens, Clinitek Status+ Analyzer

Siemens Healthcare
Diagnostics

3.

Siemens, Clinitek Status Connect
System

Siemens Healthcare
Diagnostics

81007QW

Diatech Diagnostics Uriscreen (for OTC
use)

Savyon/USA

Detects catalase in urine which is associated with urinary tract infections
(UTIs). White blood cells and some bacteria associated with UTIs are
positive for catalase.

82010QW

PTS Bioscanner (for OTC use) - for
blood ketones

Polymer Technology
Systems, Inc.

Measures ketones in whole blood

Abbott Laboratories

Monitoring of blood glucose levels and measures ketones in whole blood

82010QW,
82962

1.

Abbott Laboratories, Medisense
Products Precision Xtra
Advanced Diabetes Management
System (K983504)

2.

Abbott Medisense Precision Xtra
Advanced Diabetes Management
System (K040814)

This list includes updates from Change Request 7566
* Newly added waived test system

Abbott Laboratories

16

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)
82010QW,
82962(cont.)
82040QW,
82150QW,
82247QW,
82977QW,
84075QW,
84155QW,
84450QW,
84460QW

TEST NAME

MANUFACTURER

USE

3.

Nova Biomedical Nova Max Plus
Glucose and B-Ketone Monitoring
System

Nova Biomedical Corp.

Monitoring of blood glucose levels and measures ketones in whole blood

1.

Abaxis Piccolo Point of Care
Chemistry Analyzer (Liver Panel
Plus Reagent Disc){whole blood}

Abaxis, Inc.

Measures alanine aminotransferase, albumin, alkaline phosphatase, amylase,
aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and
total protein levels in whole blood

2.

Abaxis Piccolo xpress Chemistry
Analyzer {Liver Panel
Plus} (Whole Blood)

Abaxis, Inc

82040QW,
82310QW,
82565QW,
82947QW,
82950QW,
82951QW,
82952QW,
84520QW

Arkay SPOTCHEM EZ Chemistry
Analyzer (Spotchem II Basicpanel 1)
{Whole Blood}

Polymedco, Inc.

Measures albumin, total calcium, creatinine, glucose and total protein
levels in whole blood

82043QW

HemoCue Albumin 201 System

HemoCue, Inc.

Quantitative measurement of albumin in urine by immunoassay

82044QW

1.

Beckman Coulter ICON Microalb

Beckman Coulter, Inc.

Determination of low concentrations of albumin in urine by immunoassay,
which is helpful for early detection in patients at risk for developing renal
disease

2.

Boehringer Mannheim Chemstrip
Micral

Boehringer Mannheim

3.

Diagnostic Chemicals
ImmunoDip Urinary Albumin
Test

Diagnostic Chemicals
Limited

This list includes updates from Change Request 7566
* Newly added waived test system

17

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82044QW (cont.)

4.

Diagnostic Chemicals
ImmunoDip Urinary Albumin
Screen (Urine Dipstick)

Diagnostic Chemicals
Limited (USA)

Determination of low concentrations of albumin in urine by immunoassay,
which is helpful for early detection in patients at risk for developing renal
disease

5.

Genzyme Daignostics OSOM
ImmunoDip Urinary Albumin Test

Genzyme Diagnositcs

6.

Roche Diagnostics Chemstrip
Micral (urine dipstick)

Roche Diagnostics
Corporation

82247QW,
84075QW,
84155QW,
84450QW,
84460QW

Arkay SPOTCHEM EZ Chemistry
Analyer (Spotchem II Basicpanel 2)
{Whole Blood}

Polymedco, Inc.

Measures alanine aminotransferase, alkaline phosphatase, aspartate
aminotransferase, total bilirubin and urea levels in whole blood

82055QW (This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions.)

1.

OraSure Technologies Q.E.D. A150 Saliva Alcohol Test

OraSure Technologies, Inc.

Quantitative determination of alcohol (ethanol) in saliva

2.

OraSure Technologies Q.E.D. A350 Saliva Alcohol Test

OraSure Technologies, Inc.

3.

STC Diagnostics Q.E.D. A150
Saliva Alcohol Test

STC Technologies Inc.

4.

STC Diagnostics Q.E.D. A350
Saliva Alcohol Test

STC Technologies Inc.

82120QW,
83986QW

1.

Litmus Concepts FemExam
TestCard (from vaginal swab)

Litmus Concepts, Inc.

Qualitative test of a vaginal fluid sample for elevated pH (pH greater than or
equal to 4.7) and the presence of volatile amines

82271QW

1.

Aerscher Hemaprompt FG

Aerscher Diagnostics

Rapid screening test to detect the presence of gastric occult blood

2.

SmithKline Gastroccult

SmithKline

Rapid screening test to detect the presence of gastric occult blood

This list includes updates from Change Request 7566
* Newly added waived test system

18

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82271QW,
83986QW

Beckman Coulter Primary Care
Diagnostics Gastrocult

Beckman Coulter, Inc.

Rapid screening test to detect the presence of gastric occult blood and
determine the pH (acid-base balance) of gastric aspirates

82274QW
G0328QW

1.

American IVD Biotechnology
Services Inc. FOB/CRC
Advanced+

Ind Diagnostic Inc.

Detection of blood in feces from whatever cause, benign or malignant
(colorectal cancer screening) by immunoassay

2.

Beckman Coulter Hemoccult ICT
(K961062) & (K080812)

Beckman Coulter, Inc.

3.

BTNX Inc. Know Fecal Occult
Blood (FOB) Self Test

Alfa Scientific Designs, Inc.

4.

BTNX Inc. Rapid Response Fecal
Immunochemical Test (FIT)

Ind Diagnostic Inc.

5.

BTNX Inc. Rapid Response
Immunological Fecal Occult Blood
Test (IFOBT)

Teco Diagnostics

6.

BTNX Inc. Rapid Response Fecal
Occult Blood (FOB) Self Test

Alfa Scientific Designs, Inc

7.

Care Diagnostics Clarity IFOB Test

Care Diagnostics, Inc.

8.

Clarity Hemosure One-Step
Immunological Fecal Occult Blood
Test

Wampole Laboratories

9.

Clearview Ultra FOB Test

RAC Medical Group, Inc.

10. Consult Diagnostics
Immunochemical Fecal Occult
Blood Test (iFOBT)

Immunostics, Inc.

11. Enterix InSure™ Fecal Occult
Blood Test

Enterix, Inc.

12. Enterix InSure Fecal
Immunochemical Test

Enterix, Inc.

13. Enterix Insure II Fecal
Immunochemical Test

Enterix, Inc.

14. Germaine Laboratories AimStep
Immunological Fecal Occult Blood
Test (iFOBT)

New Bay Bioresearch Co.
Ltd.

This list includes updates from Change Request 7566
* Newly added waived test system

19

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82274QW
G0328QW(cont.)

15. Germaine Laboratories Compliance
Gold iFOB (immunological fecal
occult blood) Test

New Bay Bioresearch Co.
Ltd.

Detection of blood in feces from whatever cause, benign or malignant
(colorectal cancer screening) by immunoassay

16. Henry Schein One Step+ iFOBT

Immunostics, Inc.

17. immoCare Fecal Occult Blood Test

Care Diagnostic, Inc.

18. Immunostics, Inc., hema-screen
Specific Immunochemical Fecal
Occult Blood Test

Immunostics, In

19. InSure Quik Fecal
Immunochemical Test (F.I.T.)

Enterix, Inc.

20. Inverness Medical Clearview
iFOBT Complete Fecal Occult
Blood Test

New Bay Research Co. Ltd.

21. Jant Pharmacal Accutest
Immunological Fecal Occult Blood
Test (iFOBT)

New Bay Bioresearch Co.
Ltd.

22. OC-Light iFOB Test

Polymedco, Inc

23. OcculTech Fecal Occult Blood
Rapid Test

YD Diagnositcs Corp.

24. Polymedco Poly Stat OC-light FOB
Test

Polymedco, Inc.

25. Teco Rapid Fecal Occult Blood
(FOB) Card Test

Teco Diagnostics

1.

Abaxis Piccolo Blood Chemistry
Analyzer (Piccolo Metlyte 8 Panel
Reagent Disc) {Whole Blood}

Abaxis, Inc.

2.

Abaxis Piccolo xpress Chemistry
Analyzer (Piccolo Metlyte 8 Panel
Reagent Disc) {Whole Blood}

Abaxis, Inc

82374QW,
82435QW,
82550QW,
82565QW,
82947QW,
84132QW,
84295QW,
84520QW

This list includes updates from Change Request 7566
* Newly added waived test system

Measures chloride, creatine kinase, creatinine, glucose, potassium, sodium,
total carbon dioxide and urea nitrogen (BUN) in whole blood

20

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82435QW,
82947QW,
82950QW,
82951QW,
82952QW,
84132QW,
84295QW,
84520QW,
85014QW

Abbott i-STAT 6+ Cartridge {Whole
Blood}

i-Stat Corporation

Measures chloride, glucose, potassium, sodium, urea nitrogen, and
hematocrit in whole blood

82465QW (Contact
your Medicare
carrier for claims
instructions.)

1.

Advanced Care

Johnson & Johnson

Cholesterol monitoring

2.

Boehringer Mannheim Accu-Chek
InstantPlus Cholesterol

Boehringer Mannheim

3.

ChemTrak AccuMeter

ChemTrak

4.

ENA.C.T Total Cholesterol Test

ActiMed Laboratories, Inc.

5.

ActiMed Laboratories ENA.C.T.
Total Cholesterol Test (PDU)

ActiMed Laboratories, Inc.

6.

Lifestream Technologies
Cholesterol Monitor

Lifestream Technologies,
Inc.

7.

Lifestream Technologies Personal
Cholesterol Monitor

Lifestream Technologies,
Inc.

8.

Polymer Technology Systems
(PTS) MTM Bioscanner 1000 (for
OTC use) for cholesterol

Polymer Technology
Systems, Inc.

9.

PTS Bioscanner Test Strips
Chloesterol

Polymer Technology
Systems, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

21

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82465QW (Contact
your Medicare
carrier for claims
instructions.),
83718QW

1.

Polymer Technology Systems
CardioChek Brand Analyzer (PTS
Panels CHOL+HDL Panel Test
Strips)

Polymer Technology
Systems, Inc.

Measures total cholesterol and HDL cholesterol in whole blood

2.

Polymer Technology Systems
CardioChek PA Analyzer (PTS
Panels CHOL+HDL Panel Test
Strips)

Polymer Technology
Systems, Inc.

3.

Polymer Technology Systems
Cardiochek PA Analyzer (PTS
Panels CHOL+HDL Test Panel
Test Strips)

Polymer Technology
Systems, Inc.

1.

Polymer Technology Systems
Cardiochek PA Analyzer (PTS
Panels Chol + Glu Test Panel)

Polymer Technology
Systems, Inc.

Measures total cholesterol and monitors blood glucose levels

2.

Roche Diagnostics AccuChek
Instant Plus Dual Testing System

1.

Polymer Technology Systems
CardioChek Brand Analyzer (PTS
Panels CHOL+HDL+GLUC Panel
Test Strips)

Polymer Technology
Systems, Inc.

Measures total cholesterol, HDL cholesterol, and glucose in whole blood

2.

Polymer Technology Systems
CardioChek PA Analyzer (PTS
Panels CHOL+HDL+GLUC Panel
Test Strips)

Polymer Technology
Systems, Inc.

82465QW (Contact
your Medicare
carrier for claims
instructions.),
82962

82465QW (Contact
your Medicare
carrier for claims
instructions.),
83718QW,
82947QW,
82950QW,
82951QW,
82952QW

This list includes updates from Change Request 7566
* Newly added waived test system

22

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82465QW (Contact
your Medicare
carrier for claims
instructions.),
83718QW,
84478QW,
82947QW,
82950QW,
82951QW,
82952QW,
80061QW

1.

Cholestech LDX

Cholestech Corp.

Measures total cholesterol, HDL cholesterol, triglycerides, and glucose in
whole blood

2.

Infopia USA LipidPro lipid profile
and glucose measuring system

Infopia CO., Ltd.

82465QW (Contact
your Medicare
carrier for claims
instructions.),
82947QW,
82950QW,
82951QW,
82952QW,
83036QW,
84478QW

Wako APOLOWAKO Analyzer (Whole
Blood)

Wako Chemicals USA, Inc.

Measures total cholesterol, hemoglobin A1c, glucose, and triglycerides in
whole blood

82465QW(Contact
your Medicare
carrier for claims
instructions.),
82947QW,
82950QW,
82951QW,
82952QW,
83718QW,
84478QW,
84450QW,
84460QW

Abaxis Piccolo xpress Chemistry
Analyzer {Lipid Panel Plus Reagent
Disc} (Whole Blood)}

Abaxis, Inc.

Measures cholesterol, HDL cholesterol, glucose, alanine aminotransferase,
aspartate aminotransferase, and triglycerides in whole blood

This list includes updates from Change Request 7566
* Newly added waived test system

23

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82523QW

Ostex International Osteomark NTX
Point of Care Prescription Home Use

Ostex International Inc.

Measures normalized cross-linked N-telopeptides of type 1 collagen in urine

82565QW

Abbott i-STAT Crea Cartridge {Whole
Blood}

i-Stat Corporation

Quantitative measurement of creatinine in whole blood

82565QW,
84520QW

Abaxis Piccolo xpress Chemistry
Analyzer (Kidney Check Panel){Whole
Blood}

Abaxis, Inc.

Quantitative measurement of creatinine and urea nitrogen in whole blood

82040QW,
82150QW,
82247QW,
82310QW,
82565QW,
82947QW,
82950QW,
82951QW,
82952QW,
82977QW,
84075QW,
84155 QW,
84450QW,
84460QW,
84520QW,
84550QW

1.

Abaxis Piccolo Blood Chemistry
Analyzer (General Chemistry 13
Panel){Whole Blood}

Abaxis, Inc.

Quantitative measurement of alanine aminotransferase, albumin, alkaline
phosphatase, amylase, aspartate aminotransferase, calcium, creatinine,
gamma glutamyltransferase, glucose, total bilirubin, total protein, urea
nitrogen and uric acid in whole blood

2.

Abaxis Piccolo xpress Chemistry
Analyzer (General Chemistry 13
Panel){Whole Blood}

Abaxis, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

24

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82565QW,
82947QW,
82950QW,
82951QW,
82952QW,
82977QW,
84450QW,
84460QW,
84520QW

1.

Abaxis Piccolo Blood Chemistry
Analyzer (General Chemistry 6
Panel){Whole Blood}

Abaxis, Inc.

Quantitative measurement of alanine aminotransferase, aspartate
aminotransferase, creatinine, gamma glutamyltransferase, glucose and urea
nitrogen in whole blood

2.

Abaxis Piccolo xpress Chemistry
Analyzer (General Chemistry 6
Panel){Whole Blood}

Abaxis, Inc.

82679QW (This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims
instructions.),
83002QW

Clearplan Easy Fertility Monitor (for
luteinizing hormone and estrone 3
glucuronide)

Unipath Limited

Detection of luteinizing hormone and estrone 3 glucuronide in urine to
identify the optimal time for conception

82947QW,
82950QW,
82951QW,
82952QW

1.

HemoCue B-Glucose Photometer

HemoCue, Inc.

Measures glucose levels in whole blood

2.

HemoCue Glucose 201
Microcuvettes and Glucose 201
Analyzer

HemoCue, Inc.

3.

Abbott i-STAT G Cartridge {Whole
Blood}

i-Stat Corporation

This list includes updates from Change Request 7566
* Newly added waived test system

25

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82947QW,
82950QW,
82951QW,
82952QW,
84132QW,
84295QW,
85014QW

Abbott i-STAT EC4+ Cartridge {Whole
Blood}

i-Stat Corporation

Measures glucose, potassium, sodium, and hematocrit in whole blood

82985QW

LXN Fructosamine Test System

LXN Corporation

Used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period (Not a useful test for screening diabetes mellitus)

82962,
82465QW(Contact
your Medicare
carrier for claims
instructions.)

Roche Diagnostics Accutrend Plus
System {fingerstick whole blood}

Roche Diagnostics

Monitoring of blood glucose levels and cholesterol

82962,
82985QW

1.

LXN Duet Glucose Control
Monitoring System

LXN Corporation

Monitoring of blood glucose levels and measures fructosamine, which is
used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period

2.

LXN IN CHARGE Diabetes
Control System

LXN Corporation

1.

Acon Laboratories, Inc. FSH
Menopause Predictor Test

ACON Laboratories, Inc.

2.

Acon Laboratories, Inc. FSH One
Step Menopause Test Device
{Professional Use}

ACON Laboratories, Inc.

3.

Acon Laboratories, Inc. FSH One
Step Menopause Test Strip
{Professional Use}

ACON Laboratories, Inc.

4.

Applied Biotech, Inc. RU25 Plus
FSH Menopause Test

Applied Biotech, Inc.

5.

Biotechnostix, Inc. Rapid Response
FSH One Step Menopause Test
Device

ACON Laboratories, Inc.

83001QW

This list includes updates from Change Request 7566
* Newly added waived test system

Detects follicle stimulating hormone in urine

26

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

83001QW(cont.)

6.

Genosis Fertell Female Fertility
Test

Genosis, Inc.

Detects follicle stimulating hormone in urine

7.

Genua Menopause Monitor Test

Genua 1944 Inc

8.

Synova Healthcare MenocheckPro
(Professional Use)

Applied Biotech, Inc.

1.

Axis-Shield Afinion AS100
Analyzer

Axis-Sheild Poc As

2.

Siemens Medical Diagnostics DCA
Vantage Analyzer

Siemens Healthcare
Diagnostics, Inc.

3.

Siemens DCA 2000 Analyzer

Siemens Healthcare
Diagnostics, Inc.

4.

Siemens DCA 2000+ Analyzer

Siemens Healthcare
Diagnostics, Inc

1.

Bayer A1CNow+ {For professional
use}

Bayer Corp.

2.

Bio-Rad Micromat II Hemoglobin
A1c Prescription Home Use Test

Bio-Rad Laboratories

3.

Cholestech GDX A1C Test
(Prescription Home Use)

Cholestech Corporation

4.

Provalis Diagnostics Glycosal
HbA1c Test

Provalis Diagnostics Ltd.

5.

Provalis Diagnostics In2it In-Office
Analyzer (II) A1C Prescription
Home Use Test System

Provalis Diagnostics Ltd

83036QW

83037QW

Measures the percent concentration of hemoglobin A1c in blood, which is
used in monitoring the long-term care of people with diabetes

Measures the percent concentration of hemoglobin A1c in blood, which is
used in monitoring the long-term care of people with diabetes using devices
cleared by the FDA for home use

83605QW

KDK Corporation Lactate Pro System

KDK Corporation

Quantitative measurement of lactate in whole blood

83655QW

ESA Biosciences LeadCare II Blood
Lead Testing System (whole blood)

ESA Biosciences, Inc.

Quantitative measurement of blood lead in whole blood

83718QW

PTS Bioscanner (for OTC use) - for
HDL cholesterol

Polymer Technology
Systems, Inc.

Measures HDL cholesterol in whole blood

This list includes updates from Change Request 7566
* Newly added waived test system

27

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

83718QW,
84478QW,
82947QW,
82950QW,
82951QW,
82952QW

Polymer Technology Systems
CardioChek PA Analyzer (PTS Panels
Metabolic Chemistry Panel Test Strips)

Polymer Technology
Systems, Inc.

Measures HDL cholesterol, triglycerides, and glucose in whole blood

83721QW

Polymer Technology Systems
Cardiochek PA Analyzer

Polymer Technology
Systems, Inc.

Measures LDL cholesterol in whole blood

83880QW

1.

Biosite Incorporated

Quantitative measurement of B-type natriuretic peptide (BNP)

2.

Biosite Triage Meter {Whole
Blood}
Biosite Triage Meter Plus {Whole
Blood}

83986QW

All qualitative color comparison pH
testing - body fluids (other than blood)

Various

pH detection (acid-base balance) in body fluids such as semen, amniotic
fluid, and gastric aspirates

83986QW

1.

FemTek pHEM-ALERT

FemTek, LLC

Vaginal pH detection (acid-base balance)

2.

Common Sense Ltd. Norma-Sense
Vaginal Discharge pH Test

Common Sense Ltd.

3.

Common Sense Ltd. VA-Sense Kit

Common Sense, Ltd.

4.

Common Sense Ltd. VS-Sense Test
{qualitative}

Common Sense, Ltd

5.

Lil’ Drug Store Products Inc. VagiScreen Vaginal Health Test

Lil’ Drug Store Products Inc.

84295QW,
84132QW,
85014QW

Abbott i-STAT E3+ Cartridge {Whole
Blood}

i-Stat Corporation

Measures potassium, sodium, and hematocrit in whole blood

84443QW

1.

Aventir Biotech LLC, Forsure TSH
Test {Whole Blood}

Screening Devices Canada
Inc.

Qualitative determination of human thyroid stimulating hormone (TSH) in
whole blood, which is a rapid TSH assay for hypothyroidism screening in
adults

2.

BTNX, Inc Rapid Response
Thyroid Stimulating Hormone
(TSH) Test Cassette

Screening Devices Canada
Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

28

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

84443QW (cont.)

3.

CLIAwaived Inc. Thyroid Test
Rapid TSH Cassette {Whole
Blood}

Screening Devices Canada
Inc.

Qualitative determination of human thyroid stimulating hormone (TSH) in
whole blood, which is a rapid TSH assay for hypothyroidism screening in
adults

4.

ThyroTec, Inc. ThyroTest Whole
Blood TSH Test

ThyroTes, Inc.

5.

Jant Pharmacal Accutest TSH
{Whole Blood}

Screening Devices Canada
Inc.

6.

Qualigen, Inc. FastChek TSH
{Whole blood}

Screening Devices Canada
Inc.

84520QW,
84450QW

Arkray SPOTCHEM EZ Chemistry
Analyzer{whole blood}

Arkray, Inc.

Quantitative determination of blood urea nitrogen (BUN) and aspartate
aminotransferase in whole blood

84450QW

Cholestech LDX Aspartate
Aminotransferase (AST)(SGOT)

Cholestech Corporation

Quantitative determination of aspartate aminotransferase in whole blood

84460QW

Cholestech LDX Alanine
Aminotransferase (ALT) Test

Cholestech Corporation

Quantitative determination of alanine aminotransferase in whole blood

84703QW

Bayer Clinitek 50 Urine Chemistry
Analyzer - for HCG, urine

Bayer Corp.

Diagnosis of pregnancy

85014QW

Wampole STAT-CRIT Hct

Wampole Laboratories

Screen for anemia

85018QW

1.

Biosafe Laboratories, Inc.,
Anemiapro Self Screener

Biosafe Laboratories, Inc.

Measures hemoglobin level in whole blood

2.

HemoCue Donor Hemoglobin
Checker System HemoCue

HemoCue, Inc.

3.

HemoCue Hemoglobin System

HemoCue, Inc.

4.

HemoCue Hemoglobin 201+
(Capillary, Venous, Arterial Whole
Blood)

HemoCue, Inc.

5.

HemoCue Hemoglobin
201+/HemoCue Hemoglobin
Microcuvette System

HemoCue, Inc.

6.

HemoCue Hb 301 System

HemoCue, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

29

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

85018QW(cont.)

7.

GDS Diagnostics HemoSite Meter for hemoglobin

GDS Technology, Inc.

Measures hemoglobin level in whole blood

8.

GDS Technology STAT-Site MHgb
Test System

GDS Technology

85576QW

Accumetrics VerifyNow Aspirin Assay

Accumetrics Inc.

Qualitative assay to measure platelet aggregation

85610QW (Contact
your Medicare
carrier for claims
instructions.)

1.

AvoSure PT System (prescription
home use)

Avocet Medical, Inc.

Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen
for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin
effect; screen for Vitamin K deficiency

2.

AvoSure Pro (professional use)

Avocet Medical, Inc.

3.

CoaguChek PST for Prothrombin
Time

Boehringer Mannheim
Corporation

4.

CoaguSense Self-Test Prothrombin
Time/INR Monitoring System
(Prescription Home Use)

Coagusense, Inc.

5.

HemoSense INRatio System

HemoSense, Inc.

6.

ITC Protime Microcoagulation
System for Prothrombin Time

International Technidyne
Corporation (ITC)

7.

International Technidyne ProTime
Microcoagulation System (ProTime
3 Cuvette) Prescription Home Use

International Technidyne
Corporation

8.

International Technidyne ProTime
Microcoagulation System (ProTime
3 Cuvette) Professional Use

International Technidyne
Corporation

9.

Lifescan Harmony INR
Monitoring System -- Prescription
Home Use and Professional Use

Lifescan, Inc.

10. Roche/Boehringer Mannheim
CoaguChek System for Professional
Use

This list includes updates from Change Request 7566
* Newly added waived test system

Roche Diagnostics/
Boehringer Mannheim
Corporation

30

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

85610QW(cont.)
(Contact your
Medicare carrier for
claims instructions.)

11. Roche Diagnostics Coaguchek PST

Roche Diagnostics

Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen
for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin
effect; screen for Vitamin K deficiency

12. Roche Diagnostics Coagu Chek S
Systems Test (for prothrombin
time)

Roche Diagnostics

13. Roche Diagnostics CoaguChek XS

Roche Diagnostics

1.

Bion Diagnostic Sciences BTA stat
Test (for home use)

Bion Diagnostic Sciences,
Inc.

2.

Matritech, Inc. NMP22
BladderCheck Test for
Professional and Prescription Home
Use

Maritech, Inc.

1.

Acceava Mono II {Whole Blood}

Biosite Inc.

2.

Acceava Mono Cassette {For whole
Blood}

Princeton BioMeditech Corp.

3.

Acon Mononucleosis Rapid Test
Device {Whole Blood}

ACON Laboratories, Inc.

4.

Acon Mononucleosis Rapid Test
Strip {Whole Blood}

ACON Laboratories, Inc.

5.

Applied Biotech SureStep Mono
Test (whole blood)

Applied Biotech, Inc.

6.

BioStar Acceava Mono Test (whole
blood)

Wyntek Diagnostics, Inc.

7.

Cardinal Health SP Brand Rapid
Test Mono {Whole Blood}

Cardinal Health

8.

Clearview MONO Whole Blood,
K042272/A013

Inverness Medical
Professional Diagnostics

86294QW

86308QW

This list includes updates from Change Request 7566
* Newly added waived test system

Immunoassay for the qualitative detection of bladder tumor associated
antigen in urine of persons diagnosed with bladder cancer, and used as an
aid in the management of bladder cancer patients

Qualitative screening test for the presence of heterophile antibodies in
human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis

31

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86308QW (cont.)

9.

Innovacon, Inc.

Qualitative screening test for the presence of heterophile antibodies in
human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis

Clearview MONO Whole Blood,
K042272/A016

10. Clearview Mono-plus II

Applied Biotech, Inc.

11. Consult Diagnostics Mononucleosis
Cassette {Whole Blood}

Princeton BioMeditech Corp.

12. Genzyme Contrast Mono (whole
blood)

Genzyme Diagnostics

13. Genzyme OSOM Mono Test

Wyntek Diagnostics, Inc.

14. Icon Mono

Beckman Coulter, Inc.

15. Immuno Detector Mono {Whole
Blood}

Princeton BioMeditech Corp.

16. Instant Technologies iScreen
Mononucleosis Rapid Test Device
{Whole Blood}

ACON Laboratories, Inc.

17. Instant Technologies iScreen
Mononucleosis Rapid Test Strip
{Whole Blood}

ACON Laboratories, Inc.

18. Jant Accutest Infectious
Mononucleosis Test (whole blood)

Applied Biotech, Inc.

19. Jant Pharmacal Accutest Value +
Mononucleosis Rapid Test {Whole
Blood}

Innovacon, Inc.

20. LifeSign Status Mono {for whole
blood}

Princeton BioMeditech Corp.

21. LifeSign UniStep Mono Test
(whole blood)

Princeton BioMeditech Corp.

22. McKesson Medi-lab Performance
Infectious Mononucleosis Test

Applied Biotech, Inc.

23. Meridian ImmunoCard STAT
Mono (for whole blood)

Applied Biotech, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

32

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86308QW (cont.)

24. PerMaxim RediScreen
Mononucleosis {Whole Blood}

ACON Laboratories, Inc.

Qualitative screening test for the presence of heterophile antibodies in
human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis

25. Polymedco, Inc. Poly stat Mono

Applied Biotech, Inc.

26. Poly Stat Mono Test {Whole
Blood}

Innovacon, Inc.

27. ProAdvantage by NDC Infectious
Mononucleosis Test Device (Whole
Blood Only)

Biosite Inc.

28. Quidel Cards O.S. Mono (for whole
blood)

Quidel Corporation

29. Quidel QuickVue+ Infectious
Mononucleosis (Whole Blood)

Quidel Corporation

30. RAC Medical Clarity MONO
Mononucleosis Rapid Test Device
{Whole Blood}

ACON Laboratories, Inc.

31. Remel RIM A.R.C. Mono Test

Applied Biotech, Inc.

32. Seradyn Color Q Mono (whole
blood)

Genzyme Diagnostics

33. Signify Mono Cassette {Whole
Blood}

Innovacon, Inc.

34. Signify Mono Whole Blood

Inverness Medical
Professional Diagnostics

35. Stanbio Rely Mono Rapid
Test{Whole Blood}

Innovacon, Inc.

36. Wampole Mono-Plus WB

Wampole Laboratories

37. Wyntek Diagnostics OSOM Mono
Test (whole blood)

Wyntek Diagnostics, Inc.

38. Wyntek Signify Mono Test

Wyntek Diagnostics, Inc.

1.

SmithKline Diagnostics, Inc.

86318QW

2.

Abbott FlexPak HP Test for whole
blood

Abbott Laboratories Signify H.
Pylori Cassette {Whole Blood}
This list includes updates from Change Request 7566
* Newly added waived test system

Immunoassay for rapid, qualitative detection of IgG antibodies specific to
Helicobacter pylori in whole blood

Innovacon, Inc.

33

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86318QW (cont.)

3.

Abbott TestPack Plus H. pylori (for
whole blood)

Abbott Laboratories

Immunoassay for rapid, qualitative detection of IgG antibodies specific to
Helicobacter pylori in whole blood

4.

Acon H. pylori Test Device

ACON Laboratories, Inc.

5.

Alfa Scientific Designs Instant
View H. Pylori Whole Blood Rapid
Test

Alfa Scientific Designs, Inc.

6.

Applied Biotech SureStep H. pylori
WB Test (whole blood)

Applied Biotech, Inc.

7.

Beckman Coulter Primary Care
Diagnostics Flexsure HP Test for
IgG Antibodies to H. Pylori in
Whole Blood

Beckman Coulter, Inc.

8.

Becton Dickinson Link 2 H. pylori
Rapid Test (for whole blood)

Cortecs Diagnostics Limited

9.

Cardinal Health SP Brand Rapid
Test H. pylori (K990892)

Applied Biotech Inc.

10. Cardinal Health SP Brand Rapid
Test H. pylori {Whole
Blood}(K024350/A15)

Innovacon, Inc.

11. Diagnostic Test Group Clarity H.
pylori Rapid Test Device {Whole
Blood}

Princeton BioMeditech Corp.

12. EarlyDetect H. Pylori Whole Blood
Rapid Test

Alpha Scientific Designs,
Inc.

13. Fisher Healthcare Sure-Vue H.
pylori Test {Whole Blood}

Innovacon, Inc.

14. Germaine Laboratories, Aimstep H.
pylori {whole blood}

ACON Laboratories, Inc.

15. Henry Schein One Step+ H. Pylori
Rapid Test Device (Whole Blood)

Innovacon, Inc.

16. Immunostics Detector H. Pylori
WB (H. pyloi Antibody Test)
{Whole Blood}

Princeton BioMeditech Corp.

This list includes updates from Change Request 7566
* Newly added waived test system

34

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86318QW (cont.)

17. Instant Technologies iScreen
H.pylori Rapid Test Device

ACON Laboratories, Inc.

Immunoassay for rapid, qualitative detection of IgG antibodies specific to
Helicobacter pylori in whole blood

18. Inverness Medical Clearview H.
pylori Test {whole blood}

Innovacon, Inc.

19. JANT Pharmacal Corp. H. pylori
WBTest

Applied Biotech, Inc.

20. Inverness Medical Signify H. Pylori
Whole Blood

Innovacon, Inc.

21. LifeSign Status H.pylori (for whole
blood)

Princeton BioMeditech

22. Meridian BioScience ImmunoCard
STAT! H.pylori Whole Blood Test

Applied Biotech, Inc.

23. Polymedco, Inc. Poly stat H.pylori

Applied Biotech, Inc.

24. Polymedco Poly Stat H. Pylori Test
(Whole Blood)

Innovacon, Inc.

25. Pro-Advantage by NDC H. pylori
Device (Whole Blood)

Innovacon, Inc.

26. QuickVue One-Step H. Pylori Test
for Whole Blood

Quidel Corporation

27. Quidel QuickVue One-Step
H.pylori II Test.

Quidel Corporation

28. Remel RIM A.R.C. H.pylori Test

Remel

29. SmithKline Diagnostics FlexSure
HP Test for IgG Antibodies to H.
pylori in Whole Blood

SmithKline Diagnostics, Inc.

30. Stanbio Rely H. plyori Rapid Test
(Whole Blood) (Finger-stick only)

Alere

31. Trinity Uni-Gold™ H.pylori

Trinity Biotech

32. Wampole Laboratories Clearview
H. pylori II {finger stick or whole
blood}

Applied Biotech , Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

35

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86618QW

Wampole PreVue B. burgdorferi
Antibody Detection Assay

Wampole Laboratories

Qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi
(causative agent of Lyme disease) in whole blood

86701QW

1.

OraSure Technologies OraQuick
Rapid HIV-1 Antibody Test

OraSure Technologies, Inc.

Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1)

2.

OraSure OraQuick Rapid HIV-1
Antibody Test – fingerstick and
venipuncture whole blood

OraSure Technologies, Inc.

3.

Trinity Biotech Uni-Gold
Recombigen HIV Test (Fingerstick,
Venipuncture Whole Blood)

Trinity Biotech

1.

OraSure OraQuick Advance Rapid
HIV-1/2 Antibody Test {oral fluid,
fingerstick whole blood and
venipuncture whole blood}

OraSure Technologies, Inc.

2.

Clearview Complete HIV 1/2
{Fingerstick Venipuncture, whole
blood}

Chembio Diagnostic
Systems, Inc.

1.

Ballard Medical Products CLOtest

Ballard Medical Products

2.

Delta West CLOtest

Delta West
Tri-Med Specialties

3.

GI Supply HP-FAST

Mycoscience Labs, Inc.

4.

GI Supply, Div. Chek-Med Systems
HP One

GI Supply

5.

Medical Instruments Corporation
Pronto Dry H. pylori

Medical Instruments
Corporation

6.

Serim Pyloritek Test Kit

Serim

1.

Stesans Maybe?Mom Mini
Ovulation Microscope

LEC Associates

2.

O2 Unlimited Donna Ovulation
Tester

O2 Unlimited Corp.

G0433QW

87077QW

87210QW

This list includes updates from Change Request 7566
* Newly added waived test system

Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood ,
venipuncture whole blood and/or oral fluid specimens

Presumptive identification of Helicobacter pylori in gastric biopsy tissue,
which has been shown to cause chronic active gastritis (ulcers)

Detects ferning pattern in saliva which is used in the determination of
ovulation (optimal for conception)

36

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87449QW

ZymeTx Zstatflu Test

Zymetx, Inc.

Qualitative determination of influenza types A and B from throat swab
specimens that does not differentiate between types A and B

87804QW

Quidel QuickVue® Influenza Test

Quidel Corporation

Qualitative detection of influenza type A and type B antigens from nasal
swab, nasal wash or nasal aspirate specimens that does not differentiate
between influenza types A and B

87804QW

1.

Quidel Quickvue Influenza A+B
Test

Quidel Corporation

Qualitative detection of influenza type A and type B antigens from nasal
swab, nasopharyngeal (NP) swab, nasal wash, nasal aspirate or nasal
specimens that does differentiate between influenza types A and B

2.

BinaxNow Influenza A & B Test,
K092223

Binax, Inc

3.

BinaxNOW® Influenza A & B Test
in nasopharyngeal (NP) swab and
nasal wash/aspirate specimens,
K041049

Binax, Inc.

4.

BinaxNOW Influenza A & B Test
{Nasopharyngeal (Np) Swab and
Nasal Wash/Aspirate Specimens},
K053126

Binax, Inc.

5.

BinaxNOW Influenza A & B Test
{Nasopharyngeal (Np) Swab and
Nasal Wash/Aspirate Specimens
and Nasal Specimens (NS)}

Binax, Inc.

1.

Binax Now Flu A Test

Binax, Inc.

2.

BTNX, Inc. Rapid Response
Influenza A Test Cassette

SA Scientific, Inc.

3.

EarlyDetect Pro Influenza A Test

SA Scientific, Inc.

4.

SA Scientific SAS Influenza A Test

SA Scientific, Inc.

1.

Binax Now Flu B Test

Binax, Inc.

2.

BTNX, Inc. Rapid Response
Influenza BTest Cassette

SA Scientific, Inc.

3.

EarlyDetect Pro Influenza B Test

SA Scientific, Inc.

87804QW

87804QW

This list includes updates from Change Request 7566
* Newly added waived test system

Qualitative detection of influenza type A antigen in nasopharyngeal
specimens

Qualitative detection of influenza type B antigen in nasopharyngeal
specimens

37

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87804QW (cont.)

4.

SA Scientific SAS Influenza B Test

SA Scientific, Inc.

Qualitative detection of influenza type B antigen in nasopharyngeal
specimens

87807QW

1.

Binax NOW RSV Test (K021687)

Binax, Inc.

Rapid immunoassay for the qualitative detection of respiratory syncytial
virus antigen

2.

Binax NOW RSV Test
(K032166/A005)

Binax, Inc.

3.

Fisher Scientific Sure-Vue RSV
Test

SA Scientific, Inc.

4.

Integrated Biotechnology Quick
Lab RSV Test

Integrated Biotechnology
Corp.

5.

Quidel Quick Vue RSV Test

Quidel Corporation

6.

SA Scientific SAS RSV Alert

SA Scientific, Inc.

87808QW

Genzyme OSOM Trichomonas Rapid
Test

Genzyme Corp.

Immunoassay for the qualitative detection of Trichomonas vaginalis
antigens from vaginal swabs

87809QW

Rapid Pathogen Screening RPS Adeno
Detector

Rapid Pathogen Screening

Immunochromatographic test for the qualitative detection of adenoviral
antigens from eye fluid

87880QW

1.

Abbott Signify Strep A Test (from
throat swab only)

Wyntek Diagnostics, Inc.

Rapidly detects GAS antigen from throat swabs and used as an aid in the
diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever

2.

Abbott Laboratories Signify Strep
A Dipstick

Innovacon, Inc.

3.

Acon Strep A Rapid Strip Test

ACON Laboratories, Inc.

4.

Acon Strep A Twist Rapid Test

ACON Laboratories, Inc.

5.

Applied Biotech SureStep Strep A
(II) (direct from throat swab)

Applied Biotech, Inc.

6.

Beckman Coulter ICON DS Strep
A Test

Princeton BioMeditech Corp.

7.

Beckman Coulter ICON SC Strep A
Test

ACON Laboratories, Inc.

8.

Beckman Coulter Primary Care
Diagnostics ICON DS Strep A

ACON Laboratories, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

38

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.)

9.

Beckman Coulter, Inc.

Rapidly detects GAS antigen from throat swabs and used as an aid in the
diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever

Beckman Coulter Primary Care
Diagnostics ICON FX Strep A
Immunochemical Strep A Test

10. Becton Dickinson BD Chek Group
A Strep A Test

Innovacon, Inc.

11. Becton Dickinson LINK 2 Strep A
Rapid Test (direct from throat
swab)

Applied Biotech, Inc.

12. Binax NOW Strep A Test

Binax, Inc.

13. BioStar Acceava Strep A Test
(direct specimen only)

Wyntek Diagnostics, Inc.

14. Biotechnostix Rapid Response
Strep A Rapid Test Device

Acon Laboratories Co.

15. Biotechnostix Rapid Response
Strep A Rapid Test Strip

Acon Laboratories Co.

16. BTNX Rapid Response Strep A
Rapid Test Strips

Sa Scientific, Inc.

17. BTNX, Inc. Strep A Rapid Test

Sa Scientific, Inc.

18. Cardinal Health SP Brand Rapid
Test Strep A Dipstick(K033855)

Applied Biotech Inc.

19. Cardinal Health SP Brand Rapid
Test Strep A Dipstick
(K010582/A028)

Innovacon, Inc.

20. CLIA waived inc Rapid Strep A
Test

Sa Scientific, Inc.

21. DE Healthcare Products, TruView
Strep A Test

DE Healthcare Products

22. DE Healthcare Products TruView
Strep A Cassette Test

ACON Laboratories, Inc.

23. Diagnostic Test Group Clarity Strep
A Rapid Test Strips

Princeton BioMeditech Corp.

24. Fisher HealthCare Sure-Vue Strep
A (direct from throat swab)

Applied Biotech, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

39

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.)

25. Genzyme Contrast Strep A (direct
from throat swab)

Genzyme Diagnostics

Rapidly detects GAS antigen from throat swabs and used as an aid in the
diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever

26. Genzyme OSOM Strep A Ultra
Test – 25 Test Kit Size

Genzyme Corporation

27. Genzyme OSOM Ultra Strep A
Test

Genzyme General

28. Germaine Laboratories StrepAim
Rapid Dipstick Test

Germaine Laboratories, Inc.

29. Germaine Laboratories Strep AIM
Tower

Germaine Laboratories, Inc.

30. Henry Schein Inc, One Step+ Strep
A Test

Henry Schein

31. Henry Schein Inc, One Step+ Strep
A Dipstick Test

Henry Schein

32. Immunostics Detector Strep A
Direct

ACON Laboratories, Inc.

33. Immunostics Immuno/Strep A
Detector

ACON Laboratories, Inc.

34. Instant Technologies iStrep Strep A

ACON Laboratories, Inc.

35. Inverness Medical BioStar Acceava
Strep A Test

Innovacon, Inc.

36. Inverness Medical BioStar Acceava
Strep A Twist

Innovacon, Inc.

37. Inverness Medical Signify Strep A
Cassette (Inverness Medical
Innovations)

Innovacon, Inc.

38. Jant Pharmacal AccuStrip Strep A
(II) (direct from throat swab)

Applied Biotech, Inc.

39. Jant Pharmacal Accustrip Strep A
Value+ Test Strip

Innovacon, Inc.

40. Jant Pharmacal Accutest Integrated
Strep A Rapid Test Device

Innovacon, Inc.

This list includes updates from Change Request 7566
* Newly added waived test system

40

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.)

41. Laboratory Supply Company (LSC)
PEP Strep A Cassette Test

Acon Laboratories Co.

Rapidly detects GAS antigen from throat swabs and used as an aid in the
diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever

42. LSC PEP Strep A Dipstick Test

Acon Laboratories Co.

43. LifeSign LLC Status Strep A

Princeton BioMeditech

44. Mainline Confirms Strep A Dots
Test (direct from throat swab)

Applied Biotech, Inc.

45. McKesson Medi-Lab Performance
Strep A Test Dipstick

Applied Biotech, Inc.

46. Meridian Diagnostics ImmunoCard
STAT Strep A (direct from throat
swab)

Applied Biotech, Inc.

47. Moore Medical The Supply Experts
Strep A Rapid Test – Dipstick

Innovacon, Inc.

48. PSS Consult Diagnostics Strep A
Dipstick

Innovacon, Inc.

49. PSS World Medical Select
Diagnostics Strep A Dipstick

Innovacon, Inc.

50. PSS World Medical Select
Diagnostics Strep A Twist

Innovacon, Inc.

51. Polymedco, Inc. Poly stat A (II)

Applied Biotech, Inc.

52. Polymedco Poly Stat Strep A
Liquid Test

Applied Biotech, Inc

53. QuickVue In-Line One-Step Strep
A Test (K934484)

Quidel Corporation

54. QuickVue Dipstick Strep A

Quidel Corporation

55. Quidel QuickVue In-Line Strep A

Quidel Corporation

56. Quidel QuickVue In-Line Strep A
{direct from throat
swab}(K934484/A013)

Quidel Corporation

57. RAC Medical Clarity Strep A
Rapid Test Strips

Acon Laboratories Co.

This list includes updates from Change Request 7566
* Newly added waived test system

41

TESTS GRANTED WAIVED STATUS UNDER CLIA
CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.)

58. Remel RIM A.R.C. Strep A Test

Applied Biotech, Inc.

Rapidly detects GAS antigen from throat swabs and used as an aid in the
diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever

59. SmithKline ICON Fx Strep A Test
(from throat swab only)

Binax, Inc.

60. Stanbio Laboratory E-Z Well Strep
A Rapid Device Test

Acon Laboratories Co.

61. Stanbio QuStick Strep A

Stanbio Laboratory

62. Wyntek Diagnostics OSOM Strep
A Test

Wyntek Diagnostics, Inc

63. Wyntek OSOM Ultra Strep A
Test

Wyntek Diagnostics, Inc.

1.

Gryphus Diagnostics BVBlue

Gryphus Diagnositcs, LLC

2.

Genzyme Diagnostics OSOM
BVBlue Test

Gryphus Diagnositcs, LLC

87905QW

Enzyme activity test for the detection of sialidase activity in vaginal fluid
specimens, an enzyme produced by bacterial pathogens such as Gardnerella
vaginais, Bacteroides spp., Prevotella spp., and Mobiluncus spp.

87899QW

Meridian Bioscience Immunocard
STAT! HpSA {Stool}

Meridian Bioscience, Inc.

Immunoassay for the qualitative detection of Helicobacter pylori antigens
in stool specimens

89300QW(This test
may not be covered
in all instances.
Contact your
Medicare carrier for
claims instructions)

1.

Embryotech Laboratories
FertilMARQ Home Diagnostic
Screening Test for Male Infertility

Embryotech Laboratories,
Inc.

Screening test to measure sperm concentration

2.

SpermCheck Vasectomy

Princeton BioMeditech Corp.

Detects sperm in semen following a vasectomy

Genosis Ltd.

Determines whether the concentration of motile sperm is above a cut-off
level of 10 million motile sperm cells per ml

89321QW

Fertell Male Fertility Test

This list includes updates from Change Request 7566
* Newly added waived test system

42



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