CMS Proposes CLIA User Fee Increases & Letting Nurses Perform High Complexity Testing

On July 22, the Centers for Medicare & Medicaid Services (CMS) published a new proposed rule (CMS-3326-P) that would implement key changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees regulations. In addition to increasing and imposing new CLIA lab user fees, the proposed rule would allow individuals with nursing degrees to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here’s a briefing of what lab managers need to know about the proposed rule.

1. CLIA Lab Fee Increases

The CLIA program is funded via user fees assessed on certified labs. In 2018, CMS raised fees for the first time in 20 years. But funding shortfalls remain and, without an additional fee increase, the program will no longer be self-supporting by the end of fiscal year 2023, according to CMS. So, the agency is proposing to do four things to increase CLIA user fees:

(i)    Imposing a 20 percent across the board increase to existing fees;

(ii)   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 and
• Issuing revised or replacement certificates.

(iii)   Collecting 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

(iv)  Increasing 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.

2. Personnel Rules Changes

While the new fee structure is the centerpiece of the proposed rule, it’s the controversial changes to personnel qualifications (contained in Subpart M of the regulations) that have attracted the most attention. Because high complexity testing is more complicated, current educational requirements for assessing such testing are higher than for personnel assessing moderate complexity or waived testing. However, CMS suggests that educational requirements and degrees have changed a lot since these regulations were last updated in 2003.

Nowadays, nurses perform the majority of point-of-care testing in many different settings and scenarios, such as bedside, surgery centers, and end-stage renal disease facilities, reasons CMS. “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.” Besides, allowing nursing degree holders to perform high- and moderate-complexity testing “would decrease the burden on laboratories by allowing one individual to fulfill multiple responsibilities while still maintaining the laboratory’s ability to perform accurate and reliable testing,” the proposed rule explains.

Not surprisingly, elevating nurses to the realm of clinical laboratory scientists for purposes of CLIA high complexity testing doesn’t sit well with organizations representing the latter. While it’s true that nurses are often called on to perform point-of-care tests, professional organizations note that most of these are CLIA-waived tests. Allowing nurses to now do high complexity testing is a quantum leap that “recklessly disregards patient health,” according to the American Society for Clinical Pathology (ASCP).

“This would mean that individuals with a nursing degree would not be required to meet any coursework or clinical training requirements under CLIA,” notes the ASCP statement. “Nursing degrees typically require a fraction of the scientific coursework (about one-quarter) and laboratory training required by CLIA of laboratory testing professionals.”

Under the proposed rule, nursing degree holders wouldn’t be allowed to supervise or direct lab staff in a formal CLIA role, such as a laboratory director, technical consultants, technical supervisors, or general supervisors. Even so, ASCP has issued an action alert seeking to mobilize its members to press CMS to withdraw the proposal.

3. Elimination of Duplicative Histocompatibility Regulations

The proposed rule would remove specific regulations governing histocompatibility, i.e., lab testing performed on the tissue of different individuals to determine if a person is able to accept cells, tissue, or organs from another person, to the extent those requirements are already covered in the general requirements and laboratory director responsibilities. Example: CMS would eliminate specific quality control (QC) requirements related to both human leukocyte antigen typing and cross matching since a lab is required to have appropriate QC procedures and control materials under the general QC requirements and lab director responsibilities.

4. Alternative Sanctions for CoW Labs

Under current regulations, CMS can impose what are called alternative sanctions, i.e., directed plans of correction, civil money penalties, and state onsite monitoring, either instead of or in addition to principal sanctions for all CLIA certified labs, except CoW labs. In response to a January 2018 request for information, commenters said that imposition of alternative sanctions as opposed to principal sanctions for non-compliance should be an option for all CLIA-certified labs, including CoW labs. During the COVID-19 public health emergency, CMS included this regulatory change in an interim final rule, and now the proposed rule aims to make the change a permanent part of the CLIA regulations.

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This article originally appeared in G2 Intelligence, National Lab Reporter, September 2022, posted on August 11, 2022, in advance of PDF publication.