Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to
statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of
either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and
accurate statement of their contents. CPT only copyright 2014 American Medical Association. All rights reserved.
Page 1 of 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Subscribe to the MLN Connects® Provider eNews: a weekly electronic publication
with the latest Medicare program information, including MLN Connects® National
Provider Call announcements, claim and Pricer information, and Medicare Learning
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®
educational product updates.
MLN Matters®
Number: MM9416 Related Change Request (CR) #: CR 9416
Related CR Release Date: November 13, 2015 Effective Date: January 1, 2016
Related CR Transmittal #: R3406CP Implementation Date: January 4, 2016
New Waived Tests
Provider Types Affected
This MLN Matters® Article is intended for clinical diagnostic laboratories submitting
claims to Medicare Administrative Contractors (MACs) for services provided to
Medicare beneficiaries.
Provider Action Needed
This article is based on Change Request (CR) 9416 which informs your MACs of new
Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by
the Food and Drug Administration (FDA). Since these tests are marketed immediately after
approval, the Centers for Medicare & Medicaid Services (CMS) must notify its contractors
of the new tests so that MACs can accurately process claims. CR 9416 informs MACs of the
newly added waived complexity tests. See the Background and Additional Information
Sections of this article for further details, and make sure that your billing staff is aware of
these changes.
MLN Matters® Number: MM9416 Related Change Request Number: 9416
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to
statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of
either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and
accurate statement of their contents. CPT only copyright 2014 American Medical Association. All rights reserved.
Page 2 of 4
Background
CLIA regulations require a facility to be appropriately certified for each test performed. To ensure
that CMS only pays 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.
Note: CR 8871 mentioned that effective for services performed on or after June 2, 2014, the
HCPCS G0472, HCV screening, will be recognized as a covered service. The HCPCS code
G0472QW describes the hepatitis C antibody test performed using the OraQuick HCV Rapid
Antibody Test and OraQuick Visual Reference. The OraQuick HCV Rapid Antibody Test and
OraQuick Visual Reference test was mentioned as a new waived test in CR 8054. The related MLN
Matters® articles for CR8871 and CR 8054 may be viewed at MM8871 and MM8054.
CR9416 Updates
The latest tests approved by the FDA as waived tests under CLIA are listed in the tables that
follows. The Current Procedural Terminology (CPT) codes for these new tests in Table 1 must have
the modifier ‘QW’ to be recognized as a waived test.
Table 1: TESTS GRANTED WAIVED STATUS UNDER CLIA
(Requires QW Modifier)
CPT Code(s) Effective Date Description
86308QW
January 21, 2015
Medline Mono Test Cassette {Whole Blood)
G0434QW
June 5, 2015
AssureTech Co. LTD, AssureTech Oxycodone
Strip {OTC}
G0434QW
June 5, 2015,
AssureTech Co. Ltd, AssureTech Secobarbital
Strip {OTC};
G0434QW
June 5, 2015
AssureTech Co. Ltd, AssureTech
Secobarbital/Oxycodone Panel Dip {OTC}
G0434QW
June 5, 2015
AssureTech Co. Ltd, AssureTech
Secobarbital/Oxycodone Quick Cup {OTC}
G0434QW
June 5, 2015
AssureTech Co. Ltd, AssureTech
Secobarbital/Oxycodone Turn Key-Split Cup
{OTC}
82274QW, G0328QW
June 26, 2015 Medline iFOB Test
MLN Matters® Number: MM9416 Related Change Request Number: 9416
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to
statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of
either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and
accurate statement of their contents. CPT only copyright 2014 American Medical Association. All rights reserved.
Page 3 of 4
CPT Code(s) Effective Date Description
G0434QW
July 16, 2015 Noble Medical Inc. Noble 1 Step + Cup
82274QW, G0328QW
July 28, 2015 Sekisui Diagnostics, LLC OSOM iFOB Test
86318QW
August 19, 2015
Alere Clearview H. pylori Whole Blood Only
{Whole Blood};
86318QW
August 19, 2015
Alere Signify H. pylori Whole Blood Only
{Whole Blood}
87880QW
August 21, 2015
LABSCO Advantage Strep A
G0434QW
August 31, 2015
UCP Biosciences, Inc. UCP Drug Test Mini
Cups
G0434QW
Sept. 22, 2015
American Screening Corporation, Reveal Mini
Drug Test Cups
G0434QW
October 13, 2015
,Assure Tech Co., Ltd AssureTech
Buprenorphine Strip;
G0434QW
October 13, 2015
Assure Tech Co., Ltd AssureTech Methadone
Strip;
G0434QW
October 13, 2015
Assure Tech Co., Ltd AssureTech
Buprenorphine/Methadone Panel Dip;
G0434QW
October 13, 2015
Assure Tech Co., Ltd AssureTech
Buprenorphine/Methadone Quick Cup; and
G0434QW
October 13, 2015
Assure Tech Co., Ltd AssureTech
Buprenorphine/Methadone Turn Key-Split Cup.
However, the tests referenced in the attachment of CR9416 titled, “TESTS GRANTED WAIVED
STATUS UNDER CLIA”, do not require a ‘QW’ modifier to be recognized as a waived test. These
tests have been extracted from that document and are listed in Table 2.
MLN Matters® Number: MM9416 Related Change Request Number: 9416
Page 4 of 4
Table 2: TESTS GRANTED WAIVED STATUS UNDER CLIA
(Do not require QW Modifier)
CPT Code(s) Test Name Use
81002
Dipstick or tablet reagent
urinalysis – non-automated for
bilirubin, glucose, hemoglobin,
ketone, leukocytes, nitrite, pH,
protein, specific gravity, and
urobilinogen
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
Diagnosis of pregnancy
82270, 82272
Contact your
Medicare carrier for
claims instructions
Fecal occult blood
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
Monitoring of blood glucose levels
83026
Hemoglobin by copper sulfate –
non-automated
Monitors hemoglobin level in blood
84830
Ovulation tests by visual color
comparison for human
luteinizing hormone
Detection of ovulation (optimal for
conception)
85013
Blood count; spun
microhematocrit
Screen for anemia
85651
Erythrocyte sedimentation rate –
non-automated
Nonspecific screening test for
inflammatory activity, increased for
majority of infections, and most
cases of carcinoma and leukemia
Note: MACs will not search their files to either retract payment or retroactively pay claims
processed prior to the implementation of CR 9416. However, your MAC should adjust claims if
you bring such claims to their attention.
Additional Information
The official instruction, CR 9416, issued to your MAC regarding this change is available at
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Transmittals/Downloads/R3406CP.pdf on the CMS website.
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to
statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of
either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and
accurate statement of their contents. CPT only copyright 2014 American Medical Association. All rights reserved.
