Calculation of CLIA User Fees

CLIA USER FEES AS OF JANUARY 8, 2019

Lab Schedule # of Specialties Annual Test Volume Certificate Fee  Avg.
Compliance Fees
Waived N/A N/A $180
PPM N/A N/A $240
Low Vol A N/A Less than 2,000 $180 $360
Sched A 3 or Less 2,000-10,000 $180 $1,192
Sched B 4 or More 2,000-10,000 $180 $1,591
Sched C 3 or Less 10,001-25,000 $516 $1,988
Sched D 4 or More 10,001-25,000 $528 $2,336
Sched E N/A 25,001-50,000 $780 $2,684
Sched F N/A 50,001-75,000 $1,320 $3,032
Sched G N/A 75,001-100,000 $1,860 $3,380
Sched H N/A 100,001-500,000 $2,448 $3,728
Sched I N/A 500,001-1,000,000 $7,464 $4,076
Sched J N/A Greater than 1,000,000 $9,528 $4,408

Effective March 6, 2019, the new vendor (US Bank) and mailing address for CLIA Coupon Payments:

CLIA Laboratory Program
PO.Box 3056
Portland, OR 97208-3056

  1. The Certificate of Registration Fee is set at $100.00 for all laboratory types, regardless of number of tests performed.  Please note anytime a change in type of certificate is requested (i.e., downgrading from a certificate of compliance or certificate of accreditation to a certificate of waiver or certificate of provider performed microscopy), the laboratory is billed the $100.00 registration certificate and issued a new registration certificate even if it is an already established laboratory.  The same is true for any laboratory wishing to upgrade its certificate status from waived or PPM to the compliance or accreditation level.
  2. For facilities requesting a certificate of waiver (COW), the laboratory pays a $180.00 fee for the certificate of waiver. The laboratory is then billed $180.00 every two years for the COW.
  3. For facilities requesting a provider performed microscopy certificate (PPM), the laboratory pays $240.00 for the PPM certificate fee.  The laboratory will be billed $240.00 every two years as long as it maintains its PPM status.
  4. For facilities requesting a certificate of compliance (COC), the laboratory pays the initial $100.00 registration certificate fee.  The laboratory will then be billed a compliance fee based on the total annual volume of tests performed in the moderate and high complexity level categories. Note from Table “CLIA USER FEES AS OF JANUARY 8, 2019” that CMS has established eleven different schedules, Low Volume A through Schedule J, based on total volume of laboratory testing.  After the facility has paid the compliance fee, the laboratory will be scheduled by the State Agency for an inspection.  After the inspection has occurred and a completed final package has been entered into the computer system, the laboratory will be billed the corresponding certificate fee, also based on total annual testing volume, and this figure can be found under column 1 “Certificate Fee.”  Please note CMS bills the compliance fees a year in advance of when the inspection is due and then bills the certificate fee upon completion of the inspection.  The CLIA certificate is good for a two-year cycle, however the laboratory will receive a bill from CMS on an annual basis (compliance fee, then certificate fee).
  5. For facilities requesting a certificate of accreditation (COA), the laboratory pays the initial $100.00 registration certificate fee.  The laboratory will be billed a fee by whatever accrediting agency the facility has selected.  After the accrediting agency has completed its inspection and submitted its data to CMS, the laboratory will receive a bill from CMS for its certificate of accreditation.  The certificate of accreditation fee is based on the annual testing volume reported by the laboratory to the accrediting agency at the time of the inspection. This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.