Where do I send my CLIA waiver application?
Send your completed Form CMS-116 to the CLIA State Agency for the state or territory where your laboratory or testing site is physically located, not to a federal CMS office. The form tells applicants to send it "to your local State Agency," with no payment. The agency processes it, assigns your CLIA number and triggers your emailed fee coupon.
Arizona: Arizona Department of Health Services, Division of Public Health Services, Office of Laboratory Licensing and Certification, 250 N. 17th Avenue, Phoenix, AZ 85007 · CLIAAZ@AZDHS.GOV
Other states and territories: use the CMS CLIA State Agency contact list (PDF).
CLIA-exempt states: New York and Washington run state licensure programs that CMS lists as exempt from CLIA program requirements. Labs there work with the state program (New York's Clinical Laboratory Evaluation Program or Washington's Medical Test Site Program). See the CMS list of exempt states (PDF).
What is a CLIA Certificate of Waiver, and who qualifies?
CMS describes the Certificate of Waiver (CoW) as a certificate "issued to a laboratory that only performs waived tests" (CLIA Quick Start Guide, March 2026). You qualify if every test you perform is categorized as waived. Common examples are some rapid strep tests, dipstick urinalysis and certain fingerstick glucose systems, but each specific test system must be confirmed in the FDA's CLIA test categorization database or CMS's list of currently waived analytes. If you can't find a test's complexity, ask your State Agency.
CLIA applies even if you run just one or a few basic tests, and even if you don't charge for them. Facilities that only collect specimens or only ship them are not considered laboratories (Form CMS-116 instructions).
How to apply for a CLIA Certificate of Waiver, step by step
For a field-by-field walkthrough, see our CMS-116 form instructions.
Step 1: Download the current Form CMS-116
Get the fillable Form CMS-116 from cms.gov. Confirm it's marked Form CMS-116 (03/24), OMB No. 0938-0581, expiration 03/31/2027. CMS says to type your answers and save the file as a PDF.
Step 2: Complete Section I, General Information
Check Initial Application and enter your Anticipated Start Date.
Leave the CLIA Identification Number blank. "If an initial application leave blank, a number will be assigned."
Enter the facility name (it will appear on your certificate), Federal Tax Identification Number, and a monitored business email address. Check the box to receive notifications and electronic certificates by email.
The facility address must be where testing is performed. No P.O. Boxes.
CMS says the mailing and corporate address fields "are no longer required and may be left blank," because coupons and certificates now arrive by email.
Enter the director's name, phone number and credentials.
Step 3: Section II, Type of Certificate Requested
Check "Certificate of Waiver (Complete Sections I – VI and IX – X)." Waiver applicants don't need to attach the subpart M director qualification documents. That requirement applies to non-waived testing, including PPM.
Step 4: Sections III–V
Section III, Type of Laboratory: check one code (for example 20 Pharmacy, 21 Physician Office or 19 Mobile Laboratory).
Section IV, Hours of Laboratory Testing: enter testing hours in HH:MM format (not military time), or check 24/7.
Section V, Multiple Sites: answer "No" unless you meet one of the three exceptions on the form (mobile or temporary sites, limited public health testing, or a hospital campus).
Step 5: Section VI, Waived Testing
List each analyte/test, test name and manufacturer, then the estimated total annual test volume for all waived tests. If you're applying only for a Certificate of Waiver, the form tells you to skip Sections VII (PPM Testing) and VIII (Non-Waived Testing).
Step 6: Sections IX–X and signature
Section IX: check your Type of Control (ownership) and answer the foreign-ownership question.
Section X: list any other separately certified labs your director directs.
The owner or director signs and dates the form, in ink or with a secure electronic signature.
Step 7: Submit to your State Agency, with no payment
Send the form to the State Agency where the lab is located. The form says: "Do not send any payment with your completed 116 application." Some states require extra forms, so check with your agency (Quick Start Guide).
Step 8: Pay the fee on pay.gov
Once the form is processed, CMS emails a fee coupon with your 10-character CLIA ID and the amount due. The CLIA Certificate Fee Schedule (updated 2024) lists the Certificate of Waiver at $248 per two-year certificate. CMS notes that your State Agency can confirm the exact amount you owe.
Since March 1, 2026, CLIA is paperless. CMS no longer mails paper coupons or certificates and no longer accepts checks. You pay through pay.gov by ACH, debit or credit card (CMS Paperless FAQ). Emails come from noreply-cms-ccsq@ccsq.cms.hhs.gov, so add that address to your safe senders list.
Can you apply for a CLIA waiver online?
Partly. The CMS sources reviewed for this page describe a fillable PDF form, a State Agency submission, and online fee payment. They don't describe a federal online portal for submitting the application itself. Here is how it works: - The application is the fillable Form CMS-116 PDF. You type it, save it and sign it (a secure electronic signature is allowed). Then you submit it to your State Agency by whatever method that agency accepts, such as email, mail or fax. Each agency's contact details are on the CMS State Agency list. - The fee is paid online at pay.gov, which is required as of March 1, 2026. - The certificate arrives by email. You can also view and reprint it with the CLIA Certificate Lookup on QCOR.
What happens next, and how long it takes
CMS doesn't publish one national processing time. Timing depends on your State Agency and on how complete your application is. The Quick Start Guide lays out the sequence:
The State Agency processes the form and assigns your CLIA number.
You get the fee coupon by email.
You pay on pay.gov. Payments process overnight.
You get your Certificate of Waiver by email and can begin waived testing.
All CLIA certificates are valid for 2 years. Certificate of Waiver labs get a renewal invoice 6 months before the certificate expires.
What a Certificate of Waiver lab must do
Follow the manufacturer's instructions. Under CLIA, a waiver lab must "follow manufacturers' instructions for performing the test" and must permit inspections (42 CFR 493.15(e)).
Allow inspections. The Quick Start Guide lists Certificate of Waiver labs as "not routinely surveyed." However, the consent statement you sign on the CMS-116 lets HHS inspect the lab and its records "at any reasonable time."
Report changes. Tell your State Agency within 30 days about changes in ownership, name, location or director. Notify it immediately, before you begin, if you plan to do testing outside your certificate.
Stay within waived tests. "If this is a Certificate of Waiver, it certifies the laboratory to perform only examinations or procedures that have been approved as waived tests" (CMS certificate text).
When to upgrade to PPM, Compliance or Accreditation
If you add even one non-waived test, you need a different certificate before you start running it: - Certificate for PPM: for providers performing the microscopy procedures listed in Section VII of the form, such as wet mounts, KOH preps and urine sediment exams. - Certificate of Compliance or Accreditation: for any moderate or high complexity testing. You first get a Certificate of Registration. You also must submit the director's subpart M qualifications, and you'll be surveyed (typically within the first year).
File a CMS-116 marked "Change in Certificate Type." See upgrading from a CLIA waiver to moderate/high complexity and how to start a clinical laboratory.
Once you move to nonwaived testing, you can meet CLIA QC requirements with default QC or with an Individualized Quality Control Plan (IQCP). IQCP does not apply to waived tests. See CDC's Individualized Quality Control Plan resources.
See IQCP eligibility for which tests qualify.
Arizona: where to send your CLIA waiver application
The CMS CLIA State Agency contact list names Arizona's agency as:
Arizona Department of Health Services, Division of Public Health Services, Office of Laboratory Licensing and Certification 250 N. 17th Avenue, Phoenix, AZ 85007 · Email: CLIAAZ@AZDHS.GOV
Ask ADHS whether Arizona requires any additional state forms with your application.
Other states
Every state and territory's CLIA agency, with its address, fax and email, is on the same CMS State Agency list (PDF). If your lab is in a CLIA-exempt state, the state licenses it directly, and CMS's electronic fee coupons and certificates don't apply. CMS publishes a list of exempt states.
Useful websites for waived testing sites
These resources come from the CDC's Useful websites list for waived testing sites, with links updated where an agency has moved a page.
CDC Waived Tests: CDC's overview of waived testing, its training and its recommended good laboratory practices for Certificate of Waiver sites.
Ready? Set? Test! Patient Testing Is Important. Get the Right Results.: CDC's free online course on recommended practices for people who perform waived tests.
Guidance for SARS-CoV-2 Rapid Testing in Point-of-Care Settings: CDC clinical guidance for SARS-CoV-2 rapid testing in point-of-care settings.
Clinical Laboratory Improvement Amendments (CLIA), CMS: CMS's main CLIA program page, covering certificates, fees, regulations and guidance.
Apply for a CLIA Certificate: CMS instructions for applying for a CLIA certificate, including for international laboratories.
Laboratory Quick Start Guide to CMS CLIA Certification (PDF): a CMS guide to CLIA certificate types and the steps to get certified.
How to Obtain a CLIA Certificate of Waiver (PDF): a CMS brochure explaining how to apply for and keep a Certificate of Waiver.
CLIA State Agency Contacts (PDF): the CMS directory of state survey agency CLIA contacts.
CLIA Waived Test List, FDA: the FDA's searchable database of CLIA-waived tests, organized by analyte.
Health Information Privacy (HIPAA), HHS: HHS Office for Civil Rights information on HIPAA rules, compliance guidance and enforcement.
OSHA Publications: OSHA's library of workplace safety and health publications.
OSHA State Plans: information on OSHA-approved state workplace safety and health programs.
CDC resources on CLIA
CDC's overview of the CLIA program: CDC explains that CLIA applies to every U.S. site that tests human specimens to assess health or to diagnose, prevent, or treat disease. It also explains that CDC supports the program alongside CMS and FDA.
CDC on CLIA test complexity categories: CDC explains how FDA scores tests as moderate or high complexity using seven criteria. It also notes that lab-developed or modified tests default to high complexity, and that moderate and high complexity standards differ only in personnel requirements.
CDC on waived tests: CDC notes that waived tests are simple and low-risk but not error-proof. Errors can happen when the manufacturer's instructions are not followed.
CMS resources for clinical labs
Medicare Claims Processing Manual, Ch. 16 (Laboratory Services): CMS billing rules for lab tests, including CLIA numbers on claims and waived-test billing.
CMS MLN006270: CLIA Program & Medicare Lab Services: Explains that Medicare pays only for tests within the lab's CLIA certificate type.
Related SLC guides: - Medicare lab billing basics - Medicare Clinical Laboratory Fee Schedule (CLFS) - PAMA reporting for clinical laboratories - Medicare lab NCDs and LCDs
CLIA waiver application FAQs
How much does a CLIA Certificate of Waiver cost? The CMS fee schedule (updated 2024) lists $248 for a two-year Certificate of Waiver. You pay on pay.gov after you get your emailed fee coupon.
Can I apply for a CLIA waiver online? You complete the fillable CMS-116 PDF electronically and send it to your State Agency using the method it accepts. Fees must be paid online at pay.gov as of March 1, 2026. Certificates arrive by email. The CMS sources reviewed here don't describe a federal portal for submitting the application.
Which sections of the CMS-116 do I fill out for a waiver? Sections I–VI and IX–X, with "Certificate of Waiver" checked in Section II. Skip Sections VII and VIII.
Where do I send my CLIA waiver application? Send it to the CLIA State Agency for the state or territory where your lab is physically located, not to CMS headquarters. In Arizona, that's the ADHS Office of Laboratory Licensing and Certification (CLIAAZ@AZDHS.GOV). Labs in New York and Washington, which are CLIA-exempt states, work with their state licensure program.
Do I need a CLIA number before I apply? No. Leave the CLIA Identification Number blank on an initial application. The number is assigned when the form is processed.
Will my waived lab be inspected? CMS lists Certificate of Waiver labs as not routinely surveyed. By signing the CMS-116, though, you agree to inspection at any reasonable time.
Do waived tests really need a CLIA certificate? Yes. In the form's words, "Waived tests are not exempt from CLIA," even if you perform only one test or don't charge for it.
Get your waiver application right
Sound Lab Consultants helps waived sites across the country confirm their test menus, complete the CMS-116, and plan an upgrade when they're ready for non-waived testing. Learn more about our CLIA consultant services.
Book a free consultation. We can review your CMS-116 before you submit it.
Sound Lab Consultants (SLC) is a nationwide laboratory consulting network. Mailing address: PO Box 2135, Chandler, AZ 85244.
Sources: Form CMS-116 (03/24) and Instructions; CMS CLIA Certification Quick Start Guide (March 2026); CMS Paperless FAQ; CMS Apply for a CLIA Certificate page; CMS CLIA Certificate Fee Schedule (updated 2024); CMS CLIA State Agency Contacts; 42 CFR 493.15.