Putting the CLIA Number on Claims

The CLIA number is how a payer connects a lab test on a claim to a certified laboratory. Without it, or with the wrong one, a lab claim can be rejected even when the test was performed correctly by a certified lab. CMS puts it bluntly: "A laboratory cannot perform testing or claim Medicare and/or Medicaid payment for services performed without a CLIA certificate and/or valid CLIA identification number" (State Operations Manual, Chapter 6, section 6006).

Where does the CLIA number go on a claim?

Paper CMS-1500, item 23. Medicare's instructions: "Enter the 10-digit Clinical Laboratory Improvement Act (CLIA) certification number for laboratory services billed by an entity performing CLIA covered procedures" (Claims Processing Manual, Pub. 100-04, Chapter 26, item 23).

Electronic 837 professional claim. "The CLIA number is reported in: ASC X12 837 professional claim format REF segment as REF02, with qualifier of 'X4' in REF01, or Field 23 of the paper CMS-1500" (Chapter 16, section 70.10).

Institutional claims. The same section notes: "The CLIA number is not required on the ASC X12 institutional claim data set or its related paper Form CMS-1450."

One limit trips people up on paper. Item 23 is shared with other information, including prior authorization numbers and investigational device numbers, and "Item 23 can contain only one condition. Any additional conditions should be reported on a separate CMS-1500 claim form." If a claim needs both a CLIA number and another item 23 entry, split it.

What does a CLIA number look like?

Ten characters, letters and numbers. CMS describes the structure: "Positions 1 and 2 identify the State in which the laboratory was located when it initially applied for a CLIA certificate... Position 3 is the alpha letter 'D' to identify the provider/supplier as a laboratory certified under CLIA; and Positions 4 through 10 are the unique facility number identifiers" (SOM section 6008). The Quick Start Guide calls it "Your laboratory's unique 10-character alphanumeric CLIA Identification Number," and it appears on your emailed fee coupon before the certificate arrives.

Two consequences for billing staff. A lab that relocated to another state keeps its original number, so a state code that does not match the lab's current address is not an error. And a typo in any of the ten characters points the claim at a different lab or at nothing.

Which CLIA number do you use?

The number of the lab that performed the test. Item 23 asks for the number of "an entity performing CLIA covered procedures." For groups with several locations, that means the certificate of the site where the specimen was tested, since each fixed location has its own certificate. See one certificate per site. Billing every clinic's tests under one "main" number fails exactly when the main site's certificate type or menu differs from the clinic that tested.

What certificate dates decide whether a test can be paid?

• The effective date. "The effective date of the initial Certificate for PPM procedures, Certificate of Registration, or a Certificate of Waiver for new laboratories is the date the CLIA application, Form CMS-116... is entered into the CLIA Data System" (SOM section 6006.6). Tests performed before it fall outside any certificate. See when you may start testing.
• The expiration date. A Certificate of Waiver "is valid for no more than 2 years" (42 CFR 493.37(e)(1)). CMS emails the renewal invoice six months ahead; an unpaid renewal is a billing problem waiting to happen. See renewing a CLIA certificate.
• A sanction date. If CMS finds a waiver lab out of compliance, "such payments will be suspended on the effective date specified in the notice to the laboratory of a non-compliance determination even if there has been no appeals decision issued" (493.37(e)(3)).

Why do claims with a valid CLIA number still deny?

Because Medicare edits lab claims against the certificate behind the number, not just the number's format. "Laboratory claims are currently edited at the CLIA certificate level" to make sure Medicare and Medicaid "only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver" (CMS Transmittal 13465). A waiver lab billing a nonwaived code, or a waived code without its QW modifier, fails that edit. See the QW modifier and the codes that do not need it.

Payer enrollment is the other half. A practice's Medicare, Medicaid and commercial files need the lab's CLIA information on record, and that is enrollment work rather than CLIA work. White Glove Credentialing covers it, starting with enrolling in Medicare through PECOS. For the difference between a rejected and a denied claim, see White Glove Medical Billing's denial versus rejection.

How do we keep the certificate side clean?

We make sure every testing location has its own current certificate, the right type for what it bills, and an emailed coupon that reaches someone who pays it. Renewal and Compliance Tracking is $299 per year for the first lab and $99 per year for each additional site. See pricing.