CLFS Update Requires Clarification

The Centers for Medicare & Medicaid Services (CMS) recently issued a Medicare Learning Network (MLN) article to clarify how clinical diagnostic laboratories should bill for certain types of tests covered by Medicare and paid under the Clinical Laboratory Fee Schedule (CLFS).

Specifically, MLN SE1001 addresses how labs should presently bill new 2010 HCPCS Level II codes G0430 and G0431 and existing CPT® codes 80100 and 80101.

The current descriptions for said codes are:

  • 80100 Drug screen, qualitative; multiple drug classes chromatographic method, each procedure
  • G0430 Drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure
  • 80101 Drug screen, qualitative; single drug class method (eg, immunoassay, enzyme assay), each drug class
  • 80101QW Drug screen, qualitative; single drug class method (eg, immunoassay, enzyme assay), each drug class – CLIA waived test
  • G0431 Drug screen, qualitative; single drug class method (eg, immunoassay, enzyme assay), each drug class

From Jan. 1 to March 31, labs should report 80100 for qualitative drug screening tests for multiple drug classes when using chromatographic methods and G0430 when not using chromatographic methods.

HCPCS Level II G0431 is a direct replacement for CPT® code 80101. Although CMS is delaying implementation of G0431 until April 1, the agency instructs labs who do not require a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver to report qualitative drug screening tests for a single class of drugs, regardless of testing methodology, using G0431. Presently, labs requiring a CLIA certificate of waiver should continue to bill 80101QW.

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