Government fee guide · 2026
CLIA waiver cost in 2026: the federal fee, state fee examples and how you pay
The federal Certificate of Waiver fee is $248 for two years. That is the CMS certificate fee, not the full cost of setting up testing. Your state may require a separate registration or license, and exempt state programs use a different route.
Sources: CMS — CLIA certificate fee schedule · CMS — apply for a CLIA certificateCheck my test menuThis educational guide summarizes the linked sources. It does not confirm approval, legal compliance, eligibility or waived status for a specific device. Confirm your facility's route, exact test systems and current agency notice before paying or testing.
The $248 fee buys a two-year federal certificate
The CMS schedule effective January 27, 2024 still lists $248 for waived laboratories in the sources checked for this 2026 guide. It is a biennial certificate fee, not a charge per test or patient. Under 42 CFR 493.638, the fee covers certificate issuance and administration, including review of whether the listed tests fit the certificate.
Sources: CMS — CLIA certificate fee schedule · 42 CFR 493 Subpart F — certificate and inspection feesNo additional routine compliance-survey fee for a waiver
A Certificate of Compliance has an additional fee for routine compliance inspections; a Certificate of Accreditation has separate validation fees. A Certificate of Waiver is not subject to the routine inspection fee, and CMS says waiver laboratories are not routinely surveyed. Inspections are still possible, and substantiated complaint investigations or related actions can create charges under 42 CFR 493.645(b).
Sources: CMS — CLIA Certificate Fee Schedule (Updated 2024) · CMS — CLIA Laboratory Quick Start Guide · 42 CFR 493 Subpart F — certificate and inspection fees · 42 CFR 493 Subpart B — waiver requirements and durationApply first, then pay CMS using the emailed coupon
- For the federal route, send the completed CMS-116 to the appropriate state agency. Do not send money with the application.
- Wait for the CMS fee notification by email. It supplies the laboratory's CLIA identification number and the amount due.
- Go to Pay.gov, search for CLIA and use the CLIA number on the invoice. CMS accepts ACH, debit and credit cards.
- Keep the payment confirmation and the issued certificate. Payment alone is not the certificate; CMS instructs new applicants to receive the certificate before beginning testing.
The federal payment is to CMS through the U.S. Treasury's Pay.gov platform. Since March 1, 2026, CMS requires electronic fee coupons, electronic certificates and Pay.gov payments; federal paper checks are no longer accepted. Keep the laboratory's email current with its state agency. State-license payment instructions are separate.
Sources: CMS — apply for a CLIA certificate · CMS — Form CMS-116 (04/2026) · CMS — CLIA paperless fee coupon, payment, and certificate FAQState fees: check the credential, route and billing period
These examples come from documented state fees in the linked guides. Some are additional charges; others belong to a separate state program. This is not a complete national fee list. An omitted state does not mean a $0 fee.
| State guide | Documented state charge | What the amount covers |
|---|---|---|
| California | $155 | Waived Clinical Laboratory Registration: initial and annual renewal fee effective January 1, 2026. Separate from the federal CLIA fee. Any card merchant charge is extra.Sources: CDPH LFS — 2026 Clinical Laboratory Annual Licensing Fees (FeeSchedule2026) · CDPH LFS — Fee Schedule and Online Payment FAQs |
| Washington | $130 initial in the current filing period; $260 full biennial fee | State Medical Test Site (MTS) waiver license. The $130 prorated fee applies to applications submitted July 1, 2026–June 30, 2027; the license expires June 30, 2027. Washington's exempt state program replaces the federal certificate route: do not add the $248 federal waiver fee.Sources: Washington State Department of Health — Medical Test Site Application Packet, DOH 505-192/193/194/195 (July 2026) · Washington State Legislature — WAC 246-338-990, Fees · CMS — List of Exempt States under CLIA, August 15, 2025 |
| New York | $200 if the CLEP Limited Service Laboratory route applies | Non-refundable initial registration or reapplication fee for CLEP LSL. This is a different route from federal CLIA through POLEP for qualifying physician offices. Do not treat $200 as a surcharge for every New York office; a POLEP state surcharge was not established by the reviewed sources.Sources: NYS DOH Wadsworth Center — Limited Service Laboratories · NYS DOH — DOH-4081 Initial Limited Service Laboratory Registration Application (6/25) · NYS DOH Wadsworth Center — POLEP Initial Application |
| Pennsylvania | $100 initial permit fee | Separate from federal CLIA. Annual state licensure fees are $100 per listed category; the applicable categories and any proficiency-testing charges determine the invoice. The initial $100 is not a flat renewal total.Sources: Pennsylvania — In-State Clinical Laboratory Permit Application Packet Checklist (integrated, pp.1-2) · Pennsylvania — Instructions for the Application Process and Demographic Changes (REV 10/2025) |
| Maryland | $0 state licensure application fee | The state application says there is no fee for this licensure. Waived-only applicants use Schedule B for excepted tests. A state application is still required; the federal CLIA fee is separate.Sources: Maryland OHCQ — State Compliance Application (04.23.2026-A) |
Budget separately for kits, quality control and people
The federal fee covers certificate administration. It does not buy test kits, an analyzer, controls, quality-control supplies, maintenance, staff training or director and consultant services. Keep those operating costs separate from government fees when comparing your total testing budget. This is WaivedLab planning guidance, not a regulatory requirement.
Where waiver application budgets go wrong
- Choosing a kit by test name alone. Check the exact system in the FDA CLIA database; a waiver certificate does not make every version of a test waived.
- Budgeting for one certificate before resolving the sites. Federal rules generally require a separate application for each testing location, with specified exceptions.
- Leaving the director line unresolved. CMS-116 identifies the director; CMS sets no federal education or experience qualifications for a waiver-only director, but state requirements need separate review.
Renew every two years and review changes separately
A federal Certificate of Waiver is valid for no more than two years. The current renewal certificate fee is $248. Use the amount and due date on the CMS notice. CMS says waiver renewal fee coupons are sent approximately six months before expiration; that is a notice schedule, not a processing guarantee.
Sources: CMS — CLIA certificate fee schedule · CMS — CLIA paperless fee coupon, payment, and certificate FAQ · 42 CFR 493 Subpart B — waiver requirements and duration · 42 CFR 493 Subpart F — certificate and inspection feesRead the CLIA waiver renewal guide. If the director, location, owner or tests changed, review changes to an existing filing as well. An inquiry through WaivedLab does not renew a certificate.
CLIA waiver cost: frequently asked questions
How much does a CLIA license cost?
For a federal Certificate of Waiver, the CMS certificate fee is $248 for two years under the schedule checked October 31, 2026. Other certificate types have different fees. State registrations or licenses and your testing costs may be separate; exempt state routes need their own fee check.
Sources: CMS — CLIA certificate fee schedule · CMS — apply for a CLIA certificateHow much is a CLIA waiver renewal?
The current federal Certificate of Waiver renewal fee is $248 for the two-year cycle. Pay the amount on your CMS renewal notice by its due date. State renewals follow their own fee schedules, and a changed or expired filing may need additional review.
Sources: CMS — CLIA certificate fee schedule · CMS — CLIA paperless fee coupon, payment, and certificate FAQ · 42 CFR 493 Subpart B — waiver requirements and duration · 42 CFR 493 Subpart F — certificate and inspection feesDo I send payment with Form CMS-116?
No. Submit the application to the appropriate state agency, then use the CLIA number and fee amount on the CMS emailed coupon to pay CMS through Pay.gov. Since March 1, 2026, federal CLIA payments must be electronic; paper checks are no longer accepted. Separate state payments can have different instructions.
Sources: CMS — Form CMS-116 (04/2026) · CMS — apply for a CLIA certificate · CMS — CLIA paperless fee coupon, payment, and certificate FAQDoes a waiver have a routine inspection or compliance fee?
A Certificate of Waiver is not subject to the additional fee for routine compliance inspections under 42 CFR 493.643(a), and CMS says waiver laboratories are not routinely surveyed. This does not prevent inspections. Complaint investigations and related actions can generate charges under 42 CFR 493.645(b).
Sources: CMS — CLIA Laboratory Quick Start Guide · 42 CFR 493 Subpart F — certificate and inspection fees · 42 CFR 493 Subpart B — waiver requirements and durationDoes the federal fee include state licenses, test kits or a laboratory director?
No. The federal fee covers certificate administration, not your clinic's operating budget. Plan separately for any state credential, test kits and equipment, controls and quality-control supplies, staff and any director or consultant services. Check the actual state route and exact test system before estimating a total.
Sources: 42 CFR 493 Subpart F — certificate and inspection fees · CMS — apply for a CLIA certificate · FDA — CLIA categorized test-system searchConfirm the test menu and state route before estimating a total
Start with the checker, then read your state guide. The fictional sample packet shows how forms, test-system review and fee notes can be organized for client review and signature.
Run the checkerNot legal or medical advice. WaivedLab prepares documents; the client reviews and signs. Any WaivedLab transmission requires separate written authorization for the exact packet, destination and channel. No approval or agency timeline is promised.
Sources checked 2026-10-31
Official CMS, FDA, federal regulation and state-agency sources. Amounts describe the cited billing period and route; confirm the current agency notice before paying.