On July 22, the Centers for Medicare & Medicaid Services (CMS) released the proposed 2023 CLIA Fees; Histocompatibility alternative Waived Testing Sanctions regulation, signaling a change in the CLIA fee schedule. These proposed CLIA fee schedule changes include histocompatibility requirements, personnel requirements, and allowing for alternative sanctions for waived testing. The CAP will advocate against changes in the proposed regulation and changes to laboratory director requirements.

The proposed 2023 CLIA regulation does ask for changes to laboratory director qualifications, particularly around doctorate level scientists, such as consideration of the doctor of clinical laboratory scientist (DCLS). For instance, the proposed regulation includes defining the doctorate-level degree by providing an educational requirement of three years and asking the community to determine the degree as a DCLS or PhD. Additionally, the proposed regulation will allow non-scientific degree individuals to qualify for roles within CLIA if they meet a qualification algorithm. This would apply to technical supervision, testing personnel, and laboratory director roles.

Other key changes proposed by the CMS include:

• Creating a new fee structure that would consider travel and inspection costs.
• Establishing a new category for nurses as testing personnel and respiratory therapists as testing staff to oversee blood gas labs.
• Updating the histocompatibility requirements to reflect current-day practices primarily related to crossmatching.
• Allowing alternative sanctions for waived laboratories (including civil monetary penalties, a directed plan of correction, and onsite monitoring).

The proposed regulation combines proposals from a 2019 CLIAC report and the Centers for Disease Control and Prevention request for information released in 2018. Many changes aligned with the CAP’s advocacy efforts in histocompatibility, separate testing categories for nursing, and alternative sanctions for waived testing.

The CAP will respond to the proposed rule within the 60-day deadline.