CLIA Fees Increase 20 Percent

CLIA Fees Increase 20 Percent

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.

 
Laboratory classification (schedules) Current average (c) New average (n)
LVA $300 $360
A 994 1,192
B 1,325 1,591
C 1,657 1,988
D 1,947 2,336
E 2,237 2,684
F 2,527 3,032
G 2,817 3,380
H 3,107 3,728
I 3,397 4,076
J 3,673 4,408

The following table shows national average of Additional Fees for each schedule of accredited laboratory. This table represents the national average fees for each schedule for the current Additional Fees (noted with a “c”) as paid biennially by laboratories that hold a CoA and the national average for the new Additional Fees (noted with a “n”) that will be paid biennially by laboratories that hold a CoA.

Laboratory classification (schedules) Current average (c) New average (n)
LVA $15 $18
A 50 60
B 60 80
C 83 99
D 97 117
E 112 134
F 126 152
G 141 169
H 155 186
I 170 204
J 184 220

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.

Type of CLIA certificate Laboratory schedule Current fee New fee
Certificate of Waiver (CoW) Not applicable $150.00 $180.00
PPM Not applicable 200.00 240.00
CoC and CoA LVA 150.00 180.00
CoC and CoA A 150.00 180.00
CoC and CoA B 150.00 180.00
CoC and CoA C 430.00 516.00
CoC and CoA D 440.00 528.00
CoC and CoA E 650.00 780.00
CoC and CoA F 1,100.00 1,320.00
CoC and CoA G 1,550.00 1,860.00
CoC and CoA H 2,040.00 2,448.00
CoC and CoA I 6,220.00 7,464.00
CoC and CoA J 7,940.00 9,528.00

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.

Brad Ericson

Brad Ericson

Director of Publishing at AAPC
Brad Ericson, MPC, CPC, COSC, has been director of publishing since 2007. Before AAPC he was at Ingenix for 13 years and Aetna Health Plans prior to that. He has been writing and publishing about healthcare since 1979. He received his Bachelor's in Journalism from Idaho State University and his Master's of Professional Communication degree from Westminster College of Salt Lake City.
Brad Ericson

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Brad Ericson, MPC, CPC, COSC, has been director of publishing since 2007. Before AAPC he was at Ingenix for 13 years and Aetna Health Plans prior to that. He has been writing and publishing about healthcare since 1979. He received his Bachelor's in Journalism from Idaho State University and his Master's of Professional Communication degree from Westminster College of Salt Lake City.

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