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Calculation of CLIA User Fees


CLIA USER FEES AS OF JANUARY 01, 1998

Waived

N/A

N/A

$150

PPM

N/A

N/A

$200

Low Vol A

N/A

Less than 2,000

$150

$300

$15

Sched A

3 or Less

2,000-10,000

$150

$576

$29

Sched B

4 or More

2,000-10,000

$150

$767

$38

Sched C

3 or Less

10,001-25,000

$430

$959

$48

Sched D

4 or More

10,001-25,000

$440

$1,127

$56

Sched E

N/A

25,001-50,000

$650

$1,295

$65

Sched F

N/A

50,001-75,000

$1,100

$1,463

$73

Sched G

N/A

75,001-100,000

$1,550

$1,631

$82

Sched H

N/A

100,001-500,000

$2,040

$1,799

$90

Sched I

N/A

500,001-1,000,000

$6,220

$1,967

$98

Sched J

N/A

Greater than 1,000,000

$7,940

$1,967+

$98+

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 an initial $100.00 fee for the registration certificate and then pays an additional $150.00 fee for the certificate of waiver itself.  The laboratory is then billed $150.00 every two years for the COW.

3. For facilities requesting a provider performed microscopy certificate (PPM), the laboratory pays an initial $100.00 registration certificate fee and then pays an additional $200.00 PPM certificate fee.  The laboratory will be billed $200.00 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 1, 1998" that CMS has established eleven different schedules, Low Volume A through Schedule J, based on total volume of laboratory testing.  To determine the fee, locate the volume under the "Annual Test Volume" column and then find the corresponding compliance fee under column 2 "Compliance Fee."  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.  The laboratory can calculate the fee by adding the figures for the Certificate Fee from column 1 and the Accreditation Fee from column 3 from the table.  This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.


Last Updated: 06-13-2013

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