81002 R2321CP
User Manual: 81002
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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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