The U.S. healthcare industry sets stringent compliance rules for laboratory services. Clinical Laboratory Improvement Amendments (CLIA) compliance is one of the most frequently misinterpreted aspects of physician billing. This is unfortunate because the CLIA program is the most important federal regulation that laboratory services must comply with.
Congress created this government program in 1988 to establish quality requirements for laboratory tests performed on human specimens. Laboratory owners or employees must complete the application process to obtain CLIA certification.
Note that the Centers for Medicare & Medicaid Services (CMS), Food & Drug Administration (FDA), and Centers for Disease Control (CDC) are responsible for issuing CLIA certificates.
A current certification may be necessary for effective claim submission, adherence to compliance, and reimbursement in medical billing, particularly for laboratory and diagnostic testing. That’s why anyone managing laboratory claims, diagnostic billing, or revenue cycle operations must comprehend CLIA in medical billing.
What is a CLIA Number in Medical Billing?
According to CMS regulations, every claim for lab services must have a valid CLIA number associated with a certificate that matches the complexity of the test performed. A certified laboratory or testing center is assigned a unique 10-character identification (or CLIA number) by the CMS. It certifies that the site is authorized to perform and charge for the specific degree of test difficulty.
You can bill for laboratory services using this 10-digit number, which is exclusive to your facility and your federal credential. The number itself is more than simply a formality on the claim. It is used by payers to instantly confirm that the billing entity has an active certificate relevant to the service being billed. A claim for a moderate-complexity code may be denied if a practice’s CLIA certificate only covers waived testing.
CLIA Certificate Types
Here is a detailed explanation of each of the five CLIA certificate types:
Certificate of Waiver (CoW)
A Certificate of Waiver is issued to laboratories that perform tests the FDA has categorized as waived simple. This means those tests are simple, low-risk tests (like blood glucose monitoring, urine dipstick analysis, and rapid strep or flu tests) that have a minimal chance of producing inaccurate results when performed correctly.
Certificate for Provider-Performed Microscopy Procedures (PPMP)
This certificate allows a physician, mid-level practitioner, or dentist to execute a limited number of moderate-complexity microscopy operations, such as wet mounts or KOH preps, during a patient visit. PPMP certificates also provide waived testing, but not for general moderate- or high-complexity work.
Certificate of Compliance (CoC)
A Certificate of Compliance is issued after a laboratory completes a CLIA inspection conducted by a state survey agency or CMS. It certifies that the laboratory complies with all applicable federal quality standards for moderate- to high-complexity testing.
Certificate of Registration
A Certificate of Registration is a temporary certificate granted to laboratories that intend to conduct moderate- or high-complexity testing. It enables the laboratory to start operations while preparing for its first inspection and compliance assessment.
Certificate of Accreditation (COA)
A Certificate of Accreditation is presented to laboratories recognized by a CMS-approved accrediting agency. Laboratories demonstrate compliance with the standards set by the accrediting organization instead of being directly inspected by CMS, which must be equivalent to or stricter than CLIA requirements.
CLIA Categories
Laboratory tests are classified into various categories based on their complexity and the degree of control needed. Clinical Laboratory Improvement Amendments sort every test the FDA has cleared or approved into one of three complexity categories: waived, moderate complexity, and high complexity.
Waived tests carry a low risk of erroneous results and require minimal training to perform, which is why CMS allows them under the least restrictive certificate. Whereas tests of moderate and high complexity are intricate, specialized procedures requiring rigorous technical supervision, competent interpretation, and quality control methods.
CLIA Proficiency Testing Requirements
A crucial requirement for this certification is proficiency testing (PT), which is intended to ensure that labs regularly provide accurate and trustworthy test findings. Laboratories that conduct tests of moderate or high complexity are required to sign up for a CMS-approved proficiency testing program for each specialization and subspecialty they offer.
Participating laboratories receive unknown samples as part of the initiative. The laboratory’s standard operating procedures are used to test these samples, and the results are sent to the proficiency testing provider for assessment. The performance of that laboratory is then compared with established reference standards or other participating laboratories.
How Do I Get a CLIA Number?
If you are considering certification for your lab, follow these steps:
- A practice must submit form CMS-116 and the appropriate fee, depending on the type of certificate, to its State Agency to apply for a CLIA number.
- The form requests information regarding the testing location, the kinds of tests conducted, and the certificate that is being sought.
- A Certificate of Waiver application usually proceeds more quickly.
- Applications for a Certificate of Compliance must pass an inspection before the certificate is granted.
- The 10-character number is assigned by CMS after approval, and before it is ever used on a claim, it must be confirmed to be active and accurately recorded.
Final Thoughts
CLIA in medical billing is more than just compliance. Keeping your certificate up to date, matching your test menu to your certificate type, and ensuring that the right CLIA information is on every claim that requires it are the easiest ways to lower denials.
Understanding these regulations is essential for clinicians who conduct any in-office or ancillary lab testing, as it allows them to ensure accurate payment, avoid audits, and maintain good standing with Medicare and Medicaid.
Want to improve the financial health of your diagnostic laboratory? Get in touch with experienced teams that provide medical billing and coding services specifically designed to keep claims accurate and income flowing without the additional administrative work.
