Clinical Laboratories Face 20% Increase in CLIA Fees

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CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications. 

The American Hospital Association (AHA) has objected to the latter change.

The proposal was published in the Federal Register on July 26. According to the federal Centers for Medicare and Medicaid Services (CMS), the rule, if finalized, would do the following, among other changes:

  • Institute a 20% across-the-board increase on existing fees.
  • Establish a biennial increase of CLIA fees for follow-up surveys, substantiated complaint surveys, and revised certificates.
  • Revise personnel regulations under CLIA to address obsolete regulations and incorporate changes in technology.

$22.5 Million Annual Increase

With the 20% increase in fees, and an additional increase to account for inflation, CMS expects the CLIA program to raise $15.8 million. Additional proposed fees would account for another $6.7 million, bringing the total amount to $22.5 million in added revenue each year.

“We believe this would stabilize the CLIA program and allow us to use the inflation factor for future biennial increases,” CMS wrote in the Federal Register.

In a separate fact sheet on the proposed rule, the agency said that, without the fee increases, the CLIA program will no longer be financially self-supporting by the end of fiscal year 2023.

Nurse Qualifications Debated

The proposed rule seeks to add doctoral, master’s, and bachelor’s degrees in nursing to qualify testing personnel for high and moderate complexity testing. CMS pointed to point-of-care testing as a standard that illustrates the evolving nature of testing personnel requirements.

“We recognize that in many healthcare systems, nurses perform the majority of the point-of-care testing in many different scenarios (for example, bedside, surgery centers, end-stage renal disease facilities),” CMS wrote. “We do not have any reason to believe that nurses would be unable to accurately and reliably perform moderate and high complexity testing with appropriate training and demonstration of competency.”

CMS acknowledged that it has received blowback from some in the healthcare industry regarding prior statements supporting nursing degrees within CLIA.

The AHA has taken umbrage with the testing personnel proposal.“The types of laboratory tests classified by CMS as high complexity require a level of knowledge, training, and result interpretation that we believe exceeds the typical nurses training—even at the doctoral and master’s [degree] levels,” the AHA wrote in a letter to CMS.

The comment period on the proposal was scheduled to close on Aug. 25, but there were requests for CMS to extend that period by an additional 30 days to allow more time for comments from the clinical lab industry. 

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