Clinical Laboratory Improvement Amendments (CLIA) fees are being increased for the first time in 20 years, according to a holiday week notice from the Centers for Medicare & Medicaid Services (CMS).

CLIA Fees Based on 1992

CMS wants a 20 percent increase for laboratories seeking a CLIA certificate. The agency explained that the program and workload cost assumptions on which the current fees are based date to 1992. The agency claimed current fees no longer support the program but the price boost will sustain the program through 2021.

CMS is soliciting public comments about revisions to the CLIA fee methodology, but the the fees increased December 28. The table below reflects the national average of compliance fees for each classification of laboratories (schedules) that requires inspection. The table represents the national average for each schedule for the current Compliance Fees (noted with a “c”) as paid biennially by laboratories that hold a CoC and the national average for each schedule for the new Compliance Fees (noted with a “n”) that will be paid biennially by laboratories that hold a CoC.

The following table shows  the current and new Certificate Fees, which reflects the 20 percent increase across all schedules, with the exception of fees for the issuance of a CoR.

Table 7 depicts the current and new Certificate Fees, which reflects the 20 percent increase across all schedules, with the exception of fees for the issuance of a CoR.

CLIA Self-supporting

Enacted in 1988, the CLIA statute applies to all laboratories performing tests on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment or assessment of health. The law mandates the program be self-supporting.

Laboratories must obtain a CLIA certificate from CMS. In addition to the certificate fee, there may be additional fees, such as inspection fees for non-accredited laboratories. Fees are assessed every two years.

CLIA-exempt procedures and their codes are updated yearly.