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CMS Proposes 20 Percent Increase to CLIA Lab User Fees

by | Aug 17, 2022 | News, Open Content

A new rule proposed by the agency would also mean new fees for follow-up and complaint surveys.

On July 22, CMS published a new proposed rule (Search for “CMS-3326-P”) that would implement key changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees regulations. The agency is proposing to do four things to increase CLIA user fees:

1. Impose a 20 percent across the board increase to existing CLIA fees paid by participating labs;

2. Imposing new fees for:

  • Follow-up surveys to confirm correction of deficiencies
  • Review and approval of testing when a lab adds a new testing specialty or subspecialty
  • Complaint surveys when the findings are substantiated
  • Desk reviews to ensure successful lab proficiency testing
  • Issuing revised or replacement certificates.

3. Charge a one-time $25 certificate fee increase on Certificate of Waiver (CoW) labs to recover the cost of categorizing waived tests (simple tests) by the FDA at the end of the public health emergency; and

4. Increase the user fee every two years based on the Consumer Price Index-Urban (CPI-U) to account for inflation, if needed to meet CLIA program obligations.

Find out more about the proposed rule in this article from the September 2022 issue of National Lab Reporter, posted in advance of digital PDF publication.