Clarification on the Effective Date on the Procedure Status Indicator for Current Procedural Terminology (CPT) Code 80101

CMS has been receiving inquiries on when the Medicare Procedure Status Indicator should be changed to “I” (Not valid for Medicare purposes, Medicare recognizes another code) for CPT 80101 (Drug Screen, Qualitative; Single Drug Class Method). There has been some confusion regarding the compliance between CR 6852 (Transmittal 653) issued on March 19, 2010 which changed the indicator effective April 1, 2010 and CR 6909 (Transmittal 1957) issued on April 28, 2010 which changed the indicator effective date to July 1, 2010 as well as a third source, the Clinical Laboratory Fee Schedule (CLFS) file that is utilized by the Medicare contractors, which changed the indicator effective date to January 1, 2010. CR 7140 clarifies that the effective date for the change of the Procedure Status indicator to “I” for CPT code 80101 has been set to January 1, 2010. This CR supersedes all previous CMS transmittals concerning the indicator change for CPT code 80101.

• For claims with Date of Service (DOS) on or after January 1, 2010, the new test code G0431 (Drug Screen, Qualitative; Single Drug Class Method) must be utilized by those clinical laboratories that do not require a Clinical Laboratory Improvement Act (CLIA) certificate of waiver as CPT codes 80101 and 80101QW are not valid on the Clinical Laboratory Fee Schedule as of January 1, 2010.
• Clinical laboratories should identify claims that were filed and denied during the period of January 1, 2010 through June 30, 2010, as a result of CPT 80101, and resubmit these claims with HCPCS code G0431. However, do not resubmit such claims if they were paid by Medicare.
• For claims with DOS on or after January 1, 2010, clinical laboratories that do require a CLIA certificate of waiver must utilize the new test code G0431QW.