Congress passed the Clinical Laboratory Improvements Amendment (CLIA) in 1988 to have testing accuracy and reliability across the entire landscape of healthcare labs in the USA. It applies to every healthcare facility and site providing testing and diagnosis services regardless of where a test was performed and who administered it. 

“All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).”,(source: www.cdc.gov)

There are 3 federal institutes involved in the CLIA process i.e. 

• The Food and Drug Administration (FDA)
• The Center for Medicaid Services (CMS)
• The Centers for Disease Control and Prevention (CDC)

The complexity of a manufacturer’s test is based on 7 categories; 

• Knowledge
• Training & experience
• Reagents & material preparation
• Characteristics of operational steps
• Calibration, quality control, & proficiency testing
• Test system troubleshooting & equipment maintenance
• Interpretation & judgment

Each category gets a score of 1, 2, or 3.

1 = lowest level of complexity

3 = highest level of complexity

The scores are then added up and assigned to 7 categories. Manufacturers that get a score up to 12 are categorized as moderate complexity. While the manufacturers who get a score greater than 12 are categorized as having high complexity. A test manufacturer that gets a score of 12 or less may apply for a CLIA Waiver with the FDA. 

Why Do You Need CLIA Certification For Lab Billing Services?

Generally, CLIA requires all healthcare facilities that perform even one applicable test, including waived tests, on samples driven from the human body in order to diagnose, prevent, or treat any disease or impairment. 

Even if a healthcare facility performs tests for these purposes, it is considered a laboratory under CLIA. Therefore, such facilities should apply and obtain a certificate from the CLIA program that highlights the complexity of tests performed. 

However, a provider may not need a CLIA certificate if your laboratory is located in the states of New York or Washington, as those States have their own laboratory regulatory programs. 

You can contact an appropriate State Agency to determine if you want to obtain a CLIA certificate. 

There are different types of CLIA certificates and all of them have their relative timeline for effectiveness. 

Let’s dive into the details of different types of CLIA certificates and learn how long they are effective; 

What are the different types of CLIA certificates? 

Here are the different types of CLIA certificates; 

1. Certificate of Waiver (COW):

This certificate is issued to a laboratory that performs only waived tests. 

2. Certificate for Provider-performed Microscopy (PPM) procedures:

This certificate is issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the patient’s visit. Also, it includes a limited list of provider-performed microscopy procedures which are categorized as moderate complexity testing. 

3. Certificate Of Registration:

This certificate is issued to a laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine if it complies with the CLIA regulations. 

Only laboratories applying for a certificate of accreditation will receive a certificate of registration.

4. Certificate of Compliance (COC): 

It is issued to a laboratory once the State Agency or CMS surveyors conduct a survey (inspection) and identify the laboratory is compliant with the applicable CLIA requirements. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing. 

5. Certificate of Accreditation (COA):

It is issued to a laboratory according to the laboratory’s accreditation by an accreditation organization approved by CMS. this type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing. 

There are 7 CMS-approved accreditations as of today; 

• AABB
• American Association for Laboratory Accreditation (A2LA)
• Accreditation Association for Hospitals and Health Systems/ Healthcare Facilities
• Accreditation Program (AAHHS/HFAP)
• American Society for Histocompatibility and Immunogenetics (ASHI)
• COLA
• College of American Pathologists (CAP)
• The Joint Commission

You must apply to CMS for COA concurrently to apply for accreditation by one of the CMS-approved accreditation organizations. 

How Long Are The CLIA Certificates Effective?

All types of CLIA certificates are generally effective for two years. 

What Is The Importance Of A CLIA Certificate?

CLIA certification is quite important for healthcare labs because it guarantees that laboratories are compliant with the standards for accuracy, precision, and reliability in their testing. 

It is also important to sustain a better quality of patient care as accurate lab tests are fundamental for accurate diagnosis and the right decisions for medical treatment. If labs don’t ensure accuracy in their testing then it can lead to dire consequences for patients including misdiagnosis or delay in treatment. 

How To Be a CLIA-certified Lab?

A laboratory must go through a certification process that includes an on-site survey in which a laboratory is assessed for compliance with CLIA regulations. 

The laboratory must also submit a CLIA application; pay a fee, and fulfill other requirements. Once the laboratory gets accredited, it should maintain the certification by continuously meeting the CLIA standards. 

The Centers for Medicare and Medicaid Services (CMS) grants the CLIA certification 

CLIA certification is granted by the Centers for Medicare and Medicaid Services (CMS) and is based on rigorous standards for quality control, personnel qualifications, and laboratory facilities. Without CLIA certification, a laboratory may not be able to bill Medicare or Medicaid for its services in the US. 

How To Apply For A CLIA Certification?

Healthcare labs should follow this process to get CLIA certification; 

1. Complete the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification from (CMS-116) and mail it to their CLIA state Agency. You can also learn more about this application from the following link; https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf
2. Then you have to pay applicable certification-type fees. Annual testing volume and scope determine moderate and high complexity labs’ additional fees. 
3. Then you have to get surveyed, if applicable. 
4. After getting accreditation, you have to comply with CLIA standards as long as you’re running your practice. 

What Kind of Fees Do You Have to Pay for a CLIA Certificate?

There is a different fee structure for each type of CLIA certification; 

• If you apply for a COW or a PMM certificate, you’ll pay a waiver fee or PPM fee every two years. There are no registration or compliance fees. 

• If you apply for a COC, you’ll pay a one-time registration fee that will cover the cost of the initial inspection by the State Agency. CMS will send you a Certificate of Registration. Once the inspection team determines your compliance, you’ll pay a compliance certificate fee to CMS. Then CMS will send you a COC. 

Then a two-year certificate cycle is established and you’ll pay a compliance survey fee and have a survey every two years. If the survey finds your lab to be in compliance, you’ll pay a compliance certificate fee and CMS will send you a renewed COC. 

•  If you apply for a COA certificate type, you’ll pay a registration fee to cover the cost of the CLIA enrollment. Once CMS receives verification from the accreditation organization that you’ve selected, you’ll pay an accreditation certificate fee and validation survey fee to CMS and you’ll receive a renewed COA every two years as long as you stay compliant with CLIA standards. 

You’ll also pay fees to the accreditation organization. You can learn more about the amount of certificate fees from the CMS CLIA website under “CLIA Certificate Fee Schedule” or from your State Agency. 

If you want to learn about compliance (survey) fees then you can contact your State Agency or accreditation organization. This fee depends upon the type of certification and number of tests you deliver to the patients. It also covers the cost of the CLIA program because CLIA is entirely user-free funded. 

What Is A CLIA Number In Medical Billing?

CLIA number is a ten-character alpha-numeric code on the CLIA certificate. This number is used to identify and track your lab’s history. The CLIA number is used to make inquiries to the State Agency and CMS about your laboratory. 

What Is The Significance Of CLIA Number In Laboratory Billing Services?

CLIA number is important for lab billing services for the following reasons; 

It Is Used To Ensure Smooth Execution of Lab Billing Service

Different practitioners, physicians, and clinicians perform various lab tests and procedures to deliver patient care services. If providers want to send medical bills for these services then they must have a valid CLIA certificate that ensures their compliance with CLIA regulations. 

In this way, you can ensure insurance payers, Medicare and Medicaid that your services are on-par, accurate, and compliant. 

It Determines The Complexity of Lab Testing With CLIA Certification:

The CLIA program, administered by the Centers for Medicare & Medicaid Services (CMS), provides standards for the laboratories to help them maintain the quality, accuracy, and reliability of the services provided by healthcare labs. 

Healthcare providers must acquire a CLIA certificate according to the complexity of the laboratory tests provided by their facility (as the types of CLIA certificates have been mentioned above). 

It Ensures Eligibility For Reimbursement:

Several insurance payers i.e. Medicare and Medicaid, require healthcare providers to acquire a valid CLIA certificate to become eligible for reimbursement for their services. 

It is difficult for healthcare providers to execute their laboratory billing solutions seamlessly without the appropriate CLIA certification. The absence of this certification can also cause lab billing and coding specialists to face claim denials, penalties, or even exclusion from participating in government healthcare programs. 

It Is Important To Ensure Compliance & Audit: 

Any healthcare facility that wants to get CLIA certification must fulfill the specific requirements for laboratory personnel, equipment, quality control, and documentation. 

Lab billing specialists should make sure that the healthcare provider’s services are billed according to the standards defined by CLIA. as they may be subject to audits and inspections by regulatory institutions. 

It Helps You Determine Accurate Codes & Modifiers For Lab Billing Services:

It is the primary responsibility of lab billing and coding specialists to use appropriate Current Procedural Terminology (CPT) codes and CLIA-related modifiers to indicate the provider’s CLIA certification status. 

Accurate medical coding and the use of CLIA-specific modifiers are essential to make sure that the medical bills are filed accurately. It will help you streamline laboratory billing services and ensure compliance for lab healthcare revenue cycle management. 

It is important to have a CLIA certification for lab billing services to ensure proper reimbursement and avoid claim denials. 

Moreover, healthcare providers should adhere to CLIA regulations to sustain the integrity of laboratory testing, maintain compliance with payer requirements, and maximize reimbursement for laboratory testing. 

Lab billing and coding specialists should understand and apply CLIA-related protocols in the lab healthcare revenue cycle management to avoid potential issues or penalties that come across laboratory billing and coding services. 

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