On December 28th, the Centers for Medicare and Medicaid Services (CMS) published a final rule in the Federal Register, (CMS-3326-F), which introduces significant updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). While the regulations largely take effect January 27, 2024, certain provisions regarding personnel responsibilities and requirements will not be implemented until December 28.The Association for Diagnostics and Laboratory Medicine (ADLM) is currently reviewing the rule and has highlighted a number of key takeaways:
Revision of CLIA Fees and Funding
The rule implements a new process for CLIA funding which involves a biennial two-part increase in fees, addressing the need for ongoing financial support of the program. The revised fee structure also includes specific laboratory fees for follow-up surveys, substantiated complaint surveys, and revised certificates. Notably, there's a nominal increase in Certificate of Waiver (CoW) fees to cover administrative costs for test complexity determination for waived tests and systems.
Updates to Histocompatibility and Personnel Regulations
The rule also introduces several significant changes to personnel requirements under CLIA. The following summary outlines noteworthy highlights:
- Nursing Degrees and Laboratory Roles: The final rule addresses a proposed change that would have considered nursing degrees equivalent to biological science degrees for certain laboratory roles. This proposal faced significant criticism from ADLM and others in the clinical laboratory community when it was initially raised. In response, CMS has established a separate pathway and specific educational requirements for individuals with nursing degrees to become moderate complexity testing personnel. The rule clarifies that individuals with nursing degrees cannot qualify as laboratory directors, as nursing is not listed as a qualifying degree under the revised regulations.
- Acceptance of DCLS Degree for High Complexity Laboratory Director: The rule recognizes the Doctor of Clinical Laboratory Science (DCLS) degree as qualifying for the High Complexity Laboratory Director (HCLD) role. This inclusion met with resistance from ADLM and other laboratory professional societies, who raised concerns about whether degree holders could perform all the functions of a high complexity laboratory director. ADLM suggested that the Clinical Laboratory Improvement Advisory Committee (CLIAC) convene a session with stakeholders to discuss and resolve this matter.
- Master’s Equivalency for HCLD: The rule initially proposed allowing individuals with a "master’s equivalency" to qualify as HCLDs, provided they meet certain educational, training, and certification criteria. However, this suggestion faced criticism that a master's degree, even with additional qualifications, lacks the depth of research and analytical skills development found in doctoral programs. In response to strong opposition from ADLM and the broader healthcare community, this provision was not included in the final rule.
- Training and Experience Requirements: The final rule outlines additional new requirements and documentation for training and experience, focusing on roles involving moderate and high complexity testing.
- Adjustment of Qualifying Degree Types: The rule eliminates "physical science" as a qualifying degree type from the conventional list, which includes degrees in chemical, physical, or biological science or medical laboratory technology. In its place, CMS is developing an algorithm to assess coursework for individuals with non-traditional degrees.
- Standardization of Nomenclature: The rule moves toward standardization in nomenclature, adopting the "MLS" (Medical Laboratory Scientist) certification designation in place of the former "MT" (Medical Technologist) title.
Alternative Sanctions for Non-Compliance
The rule expands the range of sanctions that can be imposed on non-compliant laboratories operating under Certificates of Waiver. Previously, sanctions were limited to revocation, suspension, or limitation of a laboratory's CLIA certificate. The new rule allows for additional sanctions, such as civil monetary penalties, directed plans of correction, and onsite state monitoring. This measure aims to enhance compliance and accountability among laboratories, ensuring they adhere to high standards of operation and patient care.
In light of these substantial updates to the CLIA regulations under the final rule, ADLM is diligently reviewing the changes and will respond appropriately as warranted, ensuring that the best interests of both laboratory professionals and patients are upheld.
