January 2007
The Clinical Laboratory Improvement Amendment Act (CLIA) of 1998, Public Law 100-578, amended §353 of the Public Health Services Act to extend to the Department of Health and Human Services authority to regulate all laboratories that examine human specimens to provide information to assess, diagnose, prevent or treat any disease or impairment. CLIA mandates that virtually all laboratories including Physician Office Laboratories (POLs) meet applicable Federal requirements and have a CLIA certificate in order to receive reimbursement from Federal programs. CLIA also lists requirements for laboratories performing only certain tests to be eligible for a Certificate of Waiver or a Certificate for Physician-Performed Microscopy (PPMP) procedures.
The latest tests approved and/or changed by the Food and Drug Administration, as waived tests, have been shaded for your convenience.
When you submit claims for diagnostic laboratory services to Medicare, you must enter your CLIA certification number in Item 23 of the CMS-1500 claim form or in the equivalent field position for electronic submitters. A claim that is received without this number will be a Returned Unprocessable Claim (RUC). RUC rejections have no appeal rights, and must be resubmitted with correct information for payment.
If the same physician has performed tests in more than one laboratory on the same CMS-1500 claim form, the appropriate CLIA number should be associated with the tests. This will require the provider to submit a separate claim for each location (CLIA number) where a test was performed.
For more information about CLIA, visit CMS's website at www.cms.hhs.gov/clia/. If you are uncertain of your CLIA certification, contact:
Betty Logan
Georgia Department of Human Resources
Office of Regulatory Services
Diagnostic Services Unit
2 Peachtree Street 33-391
Atlanta, GA 30303-3142
404 657-5447
Types of CLIA Certificates
Certificate of Waiver - This certificate is issued to a laboratory to perform only waived tests.
Certificate for Provider-Performed Microscopy Procedures (PPMP) - This certificate is issued to a laboratory in which a physician, midlevel practitioner, or dentist performs tests listed in the PPMP chart. This certificate also permits providers to perform laboratory services listed in the CLIA Waived Tests chart.
Due to the size of the list of tests granted waived status under CLIA, it is being made available in Adobe's Portable Document Format (PDF). Adobe's Acrobat Reader is required and is available, free of charge, from Adobe's website. Download the list here.
MLN Matters MM5404