MLN
Matters. . .Information for Medicare Providers
(Issued by the Centers for Medicare &
Medicaid Services) |
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Part B Information
MLN Matters Matters Number:
MM6021
Related Change Request (CR) #: 6021
Related CR Release Date: May 30, 2008
Effective Date: July 1, 2008
Related CR Transmittal #: R1527CP
Implementation Date: July 7, 2008
Clinical Laboratory
Fee Schedule - New Waived Tests
Provider Types Affected
Clinical diagnostic laboratories that bill Medicare
carriers or Part A/B Medicare Administrative Contractors (A/B
MAC) for laboratory tests
What You Need to Know
CR 6021 announces the latest tests that the Food and Drug
Administration (FDA) has approved (effective July 1, 2008)
as waived tests under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA).
Please be aware that In order for a laboratory with a valid,
current certificate of waiver to bill for these tests, the
assigned Current Procedural Terminology (CPT) codes must contain
the QW modifier. The new waived tests, CPT codes, and effective
dates for each are provided in Table 1, below.
Make sure that your billing staffs are aware of these newly
approved FDA waived tests under CLIA.
Background
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
regulations require that a laboratory facility be appropriately
certified for each test that it performs. Further, these regulations
require facilities with a Certificate of Waiver (COW) to perform
only CLIA waived tests
| Note: To ensure that
Medicare only pays laboratories with a CLIA certificate
of waiver for tests that are approved as waived complexity
under the Clinical Laboratory Fee Schedule (CLFS), laboratory
claims are currently edited at the CLIA certificate level. |
In addition, the Centers for Medicare & Medicaid Service
(CMS) is mandated by Section 1833(h) of the Social Security
Act to add updated test codes to the CLFS, and CR 6021 announces
the latest tests that the FDA has approved as waived tests
under CLIA.
In order for a CLIA-enrolled, waived laboratory to bill for
these tests, the Current Procedural Terminology (CPT) codes
associated with them must contain a QW modifier. Table 1,
below, lists the CPT codes, descriptions, and effective dates
for these latest tests that the FDA has approved as waived
tests under CLIA. Please note that the CPT codes for the tests
in the table must have the modifier QW to be recognized as
waived tests.
Table 1
FDA-Approved Waived Tests under CLIA
|
CPT Code |
Description
|
| 80047QW dates of service on or after January 1, 2008 |
Basic Metabolic Panel (Calcium, Ionized) |
| 80048QW dates of service on or after January 16, 2008 |
Basic Metabolic Panel, (Calcium, total) |
| 80051QW dates of service on or after October 30, 2007 |
Electrolyte Panel |
| 80053QW dates of service on or after January 16, 2008 |
Comprehensive Metabolic Panel |
| 82042QW dates of service on or after October 4, 2006 |
Albumin; Urine or Other source, Quantitative, Each Specimen |
| 82150QW dates of service on or October 4, 2006 |
Amylase |
| 82247QW dates of service on or after October 4, 2006 |
Bilirubin; Total |
| 82977QW dates of service on or after October 4, 2006 |
Glutamyltransferase, Gamma (GGT) |
| 84075QW dates of service on or after October 4, 2006 |
Phosphatase, Alkaline |
| 84157QW dates of service on or after October 4, 2006 |
Protein, Total, Except by Refractometry; Other Source
(e.g., Synovial Fluid, Cerebrospinal Fluid) |
| 84520QW dates of service on or after October 4, 2006 |
Urea Nitrogen; Quantitative |
| 87808QW dates of service on or after January 1, 2007 |
Infectious Agent Antigen Detection by Immunoassay with
Direct Optical Observation; Trichomonas Vaginalis |
| 87999QW dates of service on or after July 1, 2007 |
Unlisted Microbiology Procedure |
Be aware that carriers and A/B MACS will not search their
files to either retract payment or retroactively pay claim
processed prior to implementation of CR6021, but they will
adjust such claims if you bring them to their attention.
Additional Information
You can find the official instruction to your carrier or A/B
MAC by going to CR 6021, located at http://www.cms.hhs.gov/Transmittals/downloads/R1527CP.pdf
on CMS Web site.
If you have any questions, please contact your carrier or
A/B MAC at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip
on the CMS Web site.
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.
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