CLIA Fee Calculator
Pick your CLIA certificate type and, for a compliance or accredited lab, its annual test volume and number of specialties. You get what CMS bills for one two-year cycle: the certificate fee and, where it applies, the compliance survey or validation fee, line by line. Every amount is from CMS's fee schedule (updated 2024), read on 23 October 2026.
CLIA fee calculator — assaydeck.com
CMS fees for your CLIA certificate
From CMS's CLIA Certificate Fee Schedule (Updated 2024), final rule of 28 December 2023 (88 FR 89976), effective 27 January 2024.
Non-waived tests only, one per analyte; leave out QC, QA, PT and calculated values.
CMS fees for one 2-year cycle
$669
Certificate of Compliance. 1,800 tests a year counted. 3 or fewer specialties. Renewal.
| Fee | Amount |
|---|---|
| Compliance certificate fee | $223 |
| Average survey fee (compliance) | $446 |
| Total, one 2-year cycle (Low Volume A) | $669 |
Contact your State Survey Agency for the specific certificate and survey fees your laboratory needs to pay.
Fee sheet
- CertificateCompliance
- ScheduleLow Volume A
- Tests counted a year1,800
- Compliance certificate fee$223
- Average survey fee (compliance)$446
- Total, one 2-year cycle$669
- Replacement certificate$75
- Revised certificate$150
- Follow-up survey, per hour (FY 2024)$111.81
How to use it
- Pick the certificate type. Waiver and PPM pay one flat fee, so that is all you need to choose.
- For Compliance or Accreditation, enter the lab's non-waived tests for a year and how many specialties they fall in. Use the volume you put on Form CMS-116 if you have it.
- Choose renewal, or new lab if you are applying for the first time.
- Print the sheet for the budget file, or copy the lines into an email to the practice manager.
It opens on a renewing compliance lab with 1,800 tests a year: Low Volume A is the largest group of compliance labs, 5,876 of 15,201 (38.66%) in CMS's September 2026 count. Everything runs in this browser tab. Nothing you enter is sent to AssayDeck or stored.
What it calculates
CMS bills a CLIA certificate once every two years. A Certificate of Waiver is $248 and a Certificate for PPM procedures is $297, whatever the volume. Compliance and accreditation labs are placed in one of 11 schedules by annual test volume and, between 2,001 and 25,000 tests, by the number of specialties. The lowest is Low Volume A (Schedule V in the regulation). Each schedule has a certificate fee and a second fee:
- a compliance lab pays CMS's average survey fee, which funds its State Agency inspection;
- an accredited lab pays a much smaller validation fee, and its accreditor's own fees on top, which CMS does not set.
A new compliance or accreditation lab first pays the $123 registration certificate fee, once, and then the schedule's fees (CMS brochure). The calculator adds it when you pick “New lab”. Here is the whole schedule it reads, from CMS's CLIA Certificate Fee Schedule (Updated 2024):
| Schedule | Specialties | Tests a year | Certificate fee | Compliance: average survey | Accreditation: average survey |
|---|---|---|---|---|---|
| Low Volume A | any | 2,000 or fewer | $223 | $446 | $22 |
| Schedule A | 3 or fewer | 2,001–10,000 | $223 | $1,477 | $74 |
| Schedule B | 4 or more | 2,001–10,000 | $223 | $1,969 | $98 |
| Schedule C | 3 or fewer | 10,001–25,000 | $639 | $2,463 | $123 |
| Schedule D | 4 or more | 10,001–25,000 | $654 | $2,894 | $145 |
| Schedule E | any | 25,001–50,000 | $966 | $3,325 | $166 |
| Schedule F | any | 50,001–75,000 | $1,635 | $3,755 | $188 |
| Schedule G | any | 75,001–100,000 | $2,304 | $4,187 | $209 |
| Schedule H | any | 100,001–500,000 | $3,032 | $4,618 | $231 |
| Schedule I | any | 500,001–1,000,000 | $9,244 | $5,049 | $252 |
| Schedule J | any | more than 1,000,000 | $11,801 | $5,459 | $273 |
| Schedule J | any | each additional 500,000 | – | +$411 | +$21 |
CMS, CLIA Certificate Fee Schedule (Updated 2024), from the final rule of 28 December 2023 (88 FR 89976), effective 27 January 2024. Read 2026-10-23. The survey columns are averages, not fixed prices.
How test volume is counted
The schedule turns on one number, so count it the way CMS does. § 493.638(c)(1): “a test is a procedure or examination for a single analyte”, and tests run for quality control, quality assessment and proficiency testing are left out. § 493.638(b)(1) also leaves out waived tests.
Each profile (that is, group of tests) is counted as the number of separate procedures or examinations; for example, a chemistry profile consisting of 18 tests is counted as 18 separate procedures or tests.
The counting guidelines that ship with Form CMS-116 add the cases a bench argues about:
- Calculated values are not tests: A/G ratio, MCH and T7 are the form's own examples.
- A WBC differential counts as one test; each other measured CBC analyte that is ordered and reported counts separately.
- A culture counts once per test request per specimen, however many organisms are worked up.
- Urinalysis: the microscopic and the macroscopic each count as one. A dipstick counts once, whatever its pads.
- Histopathology counts blocks, not slides. Manual cytology counts slides, not cases.
- Allergen testing counts one test per allergen.
The form's lipid panel (total cholesterol, HDL, LDL, triglycerides) counts as 4. If your LDL is calculated rather than measured, ask your State Agency how to count it, since calculations are left out.
Specialties are the nine in § 493.638(c)(2): microbiology, serology (diagnostic immunology on the form), chemistry, hematology, immunohematology, pathology, radiobioassay, histocompatibility and clinical cytogenetics. Urinalysis, endocrinology and toxicology are parts of chemistry, not specialties of their own.
Worked example
A family practice runs moderate complexity chemistry on its own analyzer and holds a Certificate of Compliance. Its year, counted by the form's rules:
| What the lab runs in a year | Run | How it counts | Counted |
|---|---|---|---|
| Lipid panels (cholesterol, HDL, LDL, triglycerides) | 1,500 | 4 tests each, as the form counts a lipid panel | 6,000 |
| Microscopic urinalyses | 400 | 1 test each | 400 |
| Waived glucose meter and dipstick tests | 3,000 | waived: left out | 0 |
| Control runs and PT samples | about 900 | QC and PT: left out | 0 |
| Annual test volume for the fee | one specialty (chemistry, which includes urinalysis) | 6,400 |
6,400 tests in one specialty is Schedule A: a $223 certificate fee plus a $1,477 average survey fee, $1,700 for the two years. In its first cycle it would also have paid the $123 registration fee: $1,823. Accredited instead, the same lab pays $223 plus a $74 validation fee, $297, and then its accreditor's fees.
Now say it adds hematology, general immunology and bacteriology at the same total volume. Four specialties move it to Schedule B: $223 plus $1,969, or $2,192. Enter 6400, pick “4 or more” and the tool shows it.
Takeaway
Fees it leaves out
- A replacement certificate is $75; a revised certificate $150 (registration, compliance, PPM) or $95 (accreditation, waiver).
- Onsite follow-up surveys (including those for added specialties), substantiated complaint surveys and unsuccessful PT desk reviews are billed at the average State Agency hourly rate times the hours, travel included. For fiscal year 2024 that rate is $111.81.
- Your accreditor's fees, and any state licence fee. Neither is set by CMS.
CMS bills after the State Agency processes your form: a fee notice by email, paid on pay.gov by bank account (ACH), debit or credit card (CMS's apply page). The two-year cycle, invoice and lapse rules are in CLIA certificate renewal.
Check the bill, not only this page
What 42 CFR 493 says
- § 493.638(b)(1) HHS sets the certificate fee every two years and publishes changes in the Federal Register.
- § 493.638(b)(3) You pay the amount in the most recent notice at the time your application is processed.
- § 493.638(c)(3) There are 11 schedules, from Schedule V (not more than 2,000 tests) to Schedule J (more than 1,000,000).
- § 493.643 Compliance labs pay a separate fee for determining program compliance, also every two years.
- § 493.645(a)(1) Accredited labs share the cost of validation inspections: “5 percent of the same costs” as inspecting non-accredited labs of the same schedule, paid whether or not they get one.
The current amounts implement the December 2023 final rule, effective 27 January 2024. Not sure which certificate you need? Start with the CLIA certificate finder, then how to get a CLIA certificate and the CMS-116 walk-through.