Any site that tests a patient specimen to diagnose, prevent or treat disease is a laboratory under CLIA, even if it runs one rapid strep test and charges nothing for it. Of the 285,940 labs outside New York and Washington, 233,448 hold a Certificate of Waiver (CMS, September 2026).
A waiver is the lightest certificate: one form, the CMS-116, sent to the state agency, and a fee paid on pay.gov. Since March 1, 2026 CMS sends fee coupons and certificates by email only.
Which certificate do you need?
| Certificate | Allows | CMS fee (October 2026) |
|---|---|---|
| Certificate of Waiver | Only tests FDA has categorized as waived. | $248 for two years |
| Provider-Performed Microscopy (PPM) | Nine microscopy procedures personally performed by a physician or other practitioner the rule names, plus waived tests. | $297 for two years |
| Certificate of Registration | Temporary, for a nonwaived lab until its compliance survey or proof of accreditation. | $123 |
| Compliance or Accreditation | Moderate and high complexity testing, surveyed every two years by the state agency or an accrediting organization. | By test volume |
Fees set by CMS-3326-F, effective January 27, 2024. The 2019 fee schedule still posted on cms.gov is out of date.
Changes that need a notice
Tell the state agency within 30 days of a change in ownership, name, location or director. A waiver or PPM lab must notify it before running any test outside its certificate. Using a waived test in a way its instructions do not allow makes it high complexity.
Watch for look-alike invoices
On October 7, 2026 CMS warned labs about third-party mailings styled as bills or invoices. Official CLIA communications come only from CMS or your state agency, and your fee is paid on pay.gov from the coupon CMS emails you. We never send invoices for government fees.
Want us to prepare it?
A Certificate of Waiver application is $399 per site, or $549 with a compliance binder; five sites are $1,599. You pay CMS and the state directly. See every price, or check your state’s requirements.
Questions
- Do waived tests need a CLIA certificate?
- Yes. The CMS-116 says it plainly: waived tests are not exempt from CLIA. A site that runs only waived tests needs a Certificate of Waiver, follows each test’s instructions and lets inspectors in.
- Can one certificate cover all our locations?
- Usually not. Each fixed location needs its own certificate. The three exceptions are mobile or temporary testing sites, limited public-health testing by not-for-profit or government labs, and a hospital campus under common direction.
- Who signs the CMS-116, and who pays CMS?
- The lab’s owner or director signs; the form carries the lab’s attestation and its consent to inspection. CMS emails the lab a fee coupon and the lab pays on pay.gov. We prepare the application and never collect the CMS fee.
- Does a telehealth company need a certificate?
- Not to order tests that a lab runs, or for patients who self-test with an FDA home-use test. It does when its staff perform or interpret a test, and the lab that processes mailed-in specimens needs its own certificate.
Sources: CMS-116, CLIA Quick Start Guide, 42 CFR 493.35, CMS laboratory statistics. Not affiliated with CMS, CDC, FDA, any accrediting organization or any state agency.