Applying for a CLIA Certificate of Waiver: A Step-by-Step Guide

Applying for a CLIA certificate of waiver might initially seem daunting, but the process is quite simple. With some organization and the right resources, you can get your application completed and approved without too much hassle. Let’s walk through each step so you know exactly what to expect.

Key Takeaways:

• Preparation is Key: Before applying for a CLIA certificate of waiver, gather information on tests, CPT codes, and manufacturer details.
• CMS Form 116: This form is essential for your application and can be found on the CMS website.
• Application Process: Double-check entries to avoid delays and ensure a smooth approval process.
• Certificate Validity: Once approved, your CLIA waiver is valid for two years, allowing you to perform in-house waived tests.
• Follow Up: Keep up with state-specific requirements and fee payments to maintain your certification.

Step 1: Gather Your Information

Before you even start applying for a CLIA certificate of waiver, ensure you have a clear idea of the types of tests you plan to perform. Remember, the CLIA waiver is specifically for waived tests, so you’ll want to have a list ready with the following details:

• Test Names: Write down the specific tests (e.g., rapid strep, urine HCG, glucose monitoring).
• CPT Codes: Each test will have a corresponding CPT code. You’ll need these for both the application and for billing later.
• Manufacturer Details: Make sure you know the manufacturers of the tests you’ll be using. You’ll need to follow their guidelines for quality control and documentation.

Pro Tip: Include only the tests you’re certain you’ll be performing in-house. If you add more waived tests to your lab, you can update your application later.

Step 2: Visit the CMS or State Health Department Website

To find the CLIA waiver application, head over to either:

• Search for “CLIA waiver application” on the CMS website, and you’ll find a downloadable form, usually CMS Form 116.
• Your state’s health department website: Many states have specific pages dedicated to CLIA certification and will provide a link to the application.

These websites can also provide helpful information on state-specific requirements for your CLIA certificate of waiver.

Step 3: Fill Out the Application

The CLIA waiver application (Form CMS-116) is relatively straightforward, but here are some key sections to pay attention to:

• Type of Laboratory: Select “Certificate of Waiver” as your intended certification type.
• Tests Performed: List all the waived tests you plan to perform and their CPT codes.
• Lab Director Information: Typically, this is the provider or practice owner. It’s their responsibility to ensure all testing is conducted correctly and in compliance with CLIA waiver regulations.

Pro Tip: Double-check your entries to ensure accuracy. Any errors could delay the approval process, meaning you’ll have to wait longer to receive your CLIA waiver.

Step 4: Submit Your Application and Pay the Fee

Once your application is complete, submit it according to the instructions provided by the CMS or your state health department. After a brief review period, you’ll receive a notice to pay the CLIA waiver fee.

The CLIA waiver fee is relatively low, and once paid, you’ll receive your CLIA certificate of waiver, typically valid for two years. This certificate allows you to perform the listed waived tests in your practice.