New Waived Tests Have Retroactive Effective Dates

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:

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

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New Waived Tests Payable Under Medicare

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.

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

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FDA Approves New Waived Tests Under CLIA

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:

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

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CLIA Waived Tests Update

New Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA) were released Aug 27.

The CPT® codes for the following new tests must have the modifier QW CLIA waived test to be recognized as such (with the exception of code 82962).

Note that Medicare contractors will not search their files to either retract payment for claims already paid or to retroactively pay claims processed prior to implementation of these changes. They will, however, adjust such claims you bring to their attention.

Source: MLN Matters article MM7084

September 10th, 2010

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New Waived Tests Effective July 1

The Centers for Medicare & Medicaid Services (CMS) recently released the latest tests approved by the Food and Drug Administration (FDA) as waived tests under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Facilities must be appropriately certified for each test performed and CPT® codes for the following new tests must have the modifier QW CLIA waived test to be recognized as such (with the exception of codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651).

Recent CMS guidance includes special instructions for use of CPT® codes 80101QW Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class, G0430QW Drug screen, qualitative; multiple chromatographic method, each procedure and G0431QW Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class:

• If a laboratory with a CLIA certificate of waiver performs a qualitative drug screening test for multiple drug classes using a non-chromatographic method, then the test code G0430QW is the appropriate code to bill;
• The test code G0431 is a direct replacement for CPT® code 80101;
• Clinical laboratories with a CLIA certificate of waiver should utilize new test code G0431QW; and
• Effective July 1, CPT® 80101 will no longer be covered by Medicare. CPT® 80101QW was deleted as of April 1.

Source: CMS Transmittal 1968, Change Request (CR) 6906, issued May 28.

June 11th, 2010

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