User Guide — CLIA FAQ

CLIA is the acronym for the Clinical Laboratory Improvement Amendments.

CLIA oversees and certifies medical laboratories to bill for tests they perform.

Any practice that collects and performs tests on "specimens derived from a human being for purposes of providing diagnosis and treatment" must be certified by CLIA. If your lab collects specimens but does not test or bill for testing, you do not need a CLIA number.

Note: On the advanced view of the Charge Entry page, the Diagnostic Services service type add-on includes the Referring CLIA Facility Identifier field. This field is used to identify the CLIA number of the facility to which any labs have been outsourced. This field is required for Medicare claims for any laboratory that referred tests to another laboratory covered by the Clinical Laboratory Improvement Amendments.

Here is the link to find your state agencies:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/State_Agency_and_Regional_Office_CLIA_Contacts.html

There can be several reasons for this:

• Is your CLIA number correctly listed on the Department Numbers page — with the expiration date and certificate level? (See the Department Numbers page.) Is it listed for each department as necessary? It must be there to appear on the claim.

   

• When you enrolled each of your providers with Medicare, did you list your CLIA number on the application and send Medicare a copy of your certificate so that his/her enrollment included this CLIA certification? If you are unsure, contact your Medicare provider relations representative, who will help you update the provider's enrollment if necessary.

   

• Is the test you are billing for within the scope of your CLIA certification? Some tests require a higher level of certification than others — those that use a microscope for example. Medicare will deny these tests if your CLIA certification does not allow for them. Check your CLIA certificate for your level of certification and then check the CLIA website for tests allowed under that certification.

   

• Are you billing correctly? CLIA "waived" tests refer to tests that require only the most basic certification to be performed. If you do these tests, many require the modifier "QW" after the CPT code.

You should enter CLIA numbers using the Department Numbers page. Based on your level of CLIA certification (specified at the top of your CLIA certificate), select the appropriate provider number category: 

• CLIA — Compliance/Accred
• CLIA — PPMP
• CLIA — Waiver

Enter the CLIA number, including the effective dates found on the CLIA certificate. When updating a CLIA certificate, if the CLIA number and certification are unchanged, please update only the expiration date on the Department Numbers page.

Please also fax a copy of your CLIA certificate to the Enrollment Services Department at athenahealth at 1-888-864-4428.