CMS answers questions about the CLIA program

CLIA covers all lab testing

If you are interested in or already operate an in-house laboratory, it will be subject to the Clinical Laboratory Improvement Amendments (CLIA). Here are answers to the most common questions the Centers for Medicare and Medicaid Services receives from practices about CLIA:

Q: If I don’t bill Medicare or Medicaid, do I still need CLIA certification?

A: The CLIA law requires any laboratory performing testing on specimens derived from a human being for purposes of providing diagnosis, treatment, etc., to enroll with the CLIA program, regardless of whether or not the laboratory receives payment from Medicare, Medicaid, or any other third-party payer.

Q: If I’m only doing blood draws, do I need a CLIA number?

A: No. You do not require a CLIA number if the facility only collects specimens and performs no testing.

Q: I’m only doing waived tests. Why do I need a CLIA number?

A: The law requires that all laboratories performing testing, no matter what type of testing they are performing, must have a certificate and obtain a CLIA number.

Q: What about inspections?

A: Many labs are exempt from routine CLIA inspections, including those that perform only waived tests or certain microscopic tests as part of a patient exam. Accredited labs are inspected by their accrediting organization, and labs in CLIA-exempt states (with standards at least as stringent as CLIA) are inspected by the state. These labs pay their inspection fees to the accrediting organization or exempt state, respectively.

Q: My certificate is still current. Why am I getting a bill?

A: The bill you have received is most likely for your next certificate. The CLIA program bills laboratories 6-12 months in advance for the appropriate fees for that particular certificate. This is because CLIA is a user-fee funded program and fees must be collected prior to the laboratory’s survey being performed and/or the certificate being issued.

Q: Is CLIA a self-funded program?

A: Yes. Congress mandated that the program be entirely supported by fees. All laboratories must register with the Department of Health and Human Services, obtain a certificate, and pay a certificate fee. Labs performing moderate- or high-complexity tests are inspected every two years . . . with fees assessed to cover inspection costs.