The Centers for Medicare & Medicaid Services (CMS) recently notified contractors of 11 new tests approved by the U.S. Food and Drug Administration (FDA) as waived tests under Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Effective Oct. 1, 2012, appropriately certified facilities may be reimbursed for the following 11 new waived tests:
| CPT® Code |
Effective Date |
Description |
| G0434QW |
March 14, 2012 |
Wondfo Oxycodone Urine Test {Dip card format} |
| G0434QW |
March 14, 2012 |
Wondfo Oxycodone Urine Test {Cup format} |
| 87880QW |
March 23, 2012 |
McKesson Strep A Test – Dipstick |
| 87880QW |
March 23, 2012 |
McKesson Strep A Test – Twist |
| 86318QW |
April 3, 2012 |
McKesson H. pylori Test (Whole Blood) |
| 87804QW |
April 20, 2012 |
Sofia Analyzer and Influenza A+B FIA (for user with nasal swabs and nasopharyngeal swabs) |
| 85610QW |
May 8, 2012 |
AlereINRatio®2 PT/INR Home Monitoring System {Prescription Home Use} |
| 83986QW |
May 8, 2012 |
Dale Medical Products, Inc. RightLevel pH |
| 83986QW |
May 8, 2012 |
Dale Medical Products, Inc. RightSpot pH |
| G0434QW |
May 22, 2012 |
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests |
| G0434QW |
May 22, 2012 |
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug |
Note the effective date for each test. Contractors will not search their files to retroactively pay claims, but facilities may bring such claims to the attention of their contractor.
See CMS transmittal 2496 for the complete list of waived tests.
July 26th, 2012
Certified facilities performing laboratory tests should be aware of a recent update to the list of codes subject to or excluded from Clinical Laboratory Improvement Amendments (CLIA) edits.
New codes subject to CLIA edits and payable under Medicare are shown in the table below.
| Code |
Effective date |
Description |
| G0434QW |
April 22, 2011 |
Diagnostic test group clarity multiple drug screen cups |
| 87804QW |
Dec. 9, 2011 |
BD Veritor System for rapid detection of flu A+B (For use with nasal and nasopharyngeal swabs) {includes a reader} |
| G0434QW |
Dec. 14, 2011 |
Alere Toxicology Services Alere iCassette DX Drug Screen |
| 82055QW |
Jan. 6, 2012 |
Jant Pharmacal Corporation Accustrip Saliva Alcohol Test Strip |
| 83861QW |
Jan. 23, 2012 |
TearLab Corporation TearLab Osmolarity System |
| G0434QW |
Jan. 26, 2012 |
Alere iCassette drug screen |
| 87804QW |
Jan. 27, 2012 |
Alere influenza A & B test (for use with nasal swabs only) |
| 87808QW |
Feb. 3, 2012 |
Sekisui Diagnostics, LLC OSOM Trichomonas Rapid Test |
| 87880QW |
March 1, 2012 |
Sekisui Diagnostics, LLC OSOM Strep A Test {direct from throat swab} |
| 86386QW |
Jan. 1, 2012 |
Nuclear matrix protein 22 (NMP22), qualitative |
| 87389QW |
Jan. 1, 2012 |
Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple-step method; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result |
| 0279T |
Jan. 1, 2012 |
Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); |
| 0280T |
Jan. 1, 2012 |
Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); interpretation and report |
CPT® 2012 added 101 new codes for molecular pathology (81200-81408) that are subject to CLIA edits; however, these codes are not payable under Medicare.
Effective Jan. 1, 2012, CPT® codes 88107 Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears and filter preparation with interpretation and 88318 Determinative histochemistry to identify chemical components (e.g., copper, zinc) have been discontinued. (To report smears and simple filter preparation, see 88104 Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears with interpretation or 88106 Cytopathology, fluids, washings or brushings, except cervical or vaginal; simple filter method with interpretation. For determinative histochemistry to identify chemical components, use 88313 Group II, all other (e.g., iron, trichrome), except stain for microorganisms, stains for enzyme constituents, or immunocytochemistry and immunoperoxidase.)
The Centers for Medicare & Medicaid Services (CMS) notified contractors of these changes on April 6, in Transmittal 2441. Contractors are to implement these changes by July 2, 2012. Contractors are not required to search their files to either retract or pay claims already submitted, but are instructed by CMS to adjust claims brought to their attention.
For more information, see CMS Transmittal 2439 and MLN Matters® articles MM7795, MM7766.
April 12th, 2012
Medicare administrative contractors (MACs) have been alerted by the Centers for Medicare & Medicaid Services (CMS) that the following new waived tests under the Clinical Laboratory Improvements Amendments of 1988 will continue to be waived in 2012.
To be considered as waived, the newly recognized tests must be reported with the codes below and the modifier QW appended.
81003QW Germaine Laboratories Inc. AimStrip Urine Analyzer
G0434QW UCP Biosciences, Inc. UCP Drug Screening Test Cups
G0434QW Diagnostic Test Group Clarity Multiple Drug Screen Cups
81003QW Mediwatch urinewatch Urine Analyzer
G0434QW Insight Medical Drug of Abuse Urine Cassette Test
G0434QW Insight Medical Drug of Abuse Urine Cup Test
G0434QW Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cassette) Test
G0434QW Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cup) Test
G0434QW Jant Pharmacal Accutest Drug of Abuse Urine (Cassette) Test
G0434QW Jant Pharmacal Accutest Drug of Abuse Urine (Cup) Test
G0434QW Total Diagnostic Solutions Drug of Abuse Urine (Cassette) Test
G0434QW Total Diagnostic Solutions Drug of Abuse Urine (Cup) Test
G0434QW Diagnostic Test Group Clarity Simple Drug Screening Cups
G0434QW Diagnostic Test Group Clarity Multi-Drug Test Cards
81003QW Uri-Trak 120 Urine Analyzer
G0434QW UCP Biosciences, Inc. U-Checker Drug Screening Test Cup
For more information, check CMS Transmittal 2321.
October 28th, 2011
A proposed rule, drafted jointly by the Centers for Medicare & Medicaid Services (CMS), the Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention (CDC), would amend a patient privacy provision of two federal laws to grant patients access to test results directly from laboratories through the use of health information technology (health IT). (more…)
September 16th, 2011
The Centers for Medicare & Medicaid Services (CMS) released, June 17, the latest laboratory tests approved by the Food and Drug Administration (FDA) as waived tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). According to CMS Transmittal 2244, there will be five new tests that are covered under Medicare Parts A and B effective Oct. 1, 2011.
Listed below are the latest FDA-approved waived tests:
| Code |
Effective Date |
Description |
| 87880QW |
Feb. 2, 2011 |
BTNX Rapid Response Strep A Rapid Test Strips |
82274QW
G0328QW |
March 24, 2011 |
OC-Light iFOB Test |
| G0434QW |
April 1, 2011 |
CLIA-waived, Inc. Rapid Drug Test Cup{OTC} |
| G0434QW |
April 1, 2011 |
Instant Technologies, iCup DX Drug Screen Cup |
| 86318QW |
April 7, 2011 |
Stanbio Rely H. plyori Rapid Test (Whole Blood) (Finger-stick only) |
Note that drug tests reported with HCPCS Level II code G0434QW or CPT® code 82055QW, and the screening test to measure sperm concentration (reported with CPT® code 89300QW), may not be covered in all instances. Contact your Medicare carrier for claims instructions.
With the exception of CPT® codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651, tests must have the modifier QW to be recognized as a waived test.
July 1st, 2011