Fact sheet

Medicare Program: CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) OF 1988 FEES (CMS-3356-NC)

Medicare Program: CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) OF 1988 FEES (CMS-3356-NC) 

Overview

On December 28, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a notice with comment period [CMS-3356-NC].  This notice with comment period increases fees for laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The CLIA statute requires CMS to impose user fees to cover the general costs of administering the CLIA program.

This fact sheet discusses why CMS is increasing the CLIA fees for the first time in 20 years. 

CMS performs monthly monitoring of incoming CLIA user fee collections and compares them with the corresponding level of CLIA obligations and expenditures, including State Survey Agency (SA) costs and CMS administrative costs. The fee schedule currently in use was based on assumptions made in 1992 about program operations and workload. Based on the agency’s financial data review, we project that a 20 percent fee increase will sustain and maintain the CLIA program through FY 2021.  CMS is required to update the program’s fee schedule because current fees are no longer sufficient to cover costs of the CLIA program.  This fee increase helps ensure the CLIA program can continue to be self-sustaining, as required by provisions of the law. 

This user fee increase is effective upon publication of this notice. CMS is soliciting public comments on revisions to the CLIA fee methodology.   

Additional Background 

On October 31, 1988, Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (Pub. L. 100–578), which replaced in its entirety section 353 of the Public Health Service Act (PHSA). The CLIA statute applies to all laboratories that perform tests on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment, or assessment of health. Section 353(m) of the PHSA requires the Secretary to impose certain fees.  

In order for laboratories to perform testing, they must obtain a CLIA certificate from CMS.  CLIA certificates are issued on a fee-basis to cover general costs of administering and operating the national CLIA program. In addition to certificate fees, there can be additional fees, including inspection fees for non-accredited laboratories.  Both fee types are assessed and billed on a two-year cycle. The total amount of user fees must be sufficient to cover all costs of administering the CLIA program. 

In January 2018, CMS issued a Request for Information to solicit public comments on the increasing CLIA fees. Many commenters were receptive to the increase in CLIA fees, noting there had not been an increase since 1997. 

This notice with comment period increases the “Certificate Fees” and “Additional Fees” to cover the cost of implementing the CLIA program and to ensure CLIA administrative functions and laboratory surveys can continue to be funded at a level that is reasonable and ensures accurate and reliable testing.  

This increase to the CLIA fees helps ensure the CLIA program can continue to be self-sustaining, as required by law. 

CMS will take public comments for consideration in potential future rulemaking. The notice with comment period can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection 

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