The Centers for Medicare & Medicaid Services (CMS) is proposing to change the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for 2020 and it could affect a medical group or facility’s bottom line.

CLIA Analyte Additions

The notice of proposed rulemaking includes the addition and deletion of analytes – or the components being studied – requiring proficiency testing and updates criteria for acceptable performance under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

CMS proposes adding 29 analytes so Subpart I of the regulations, based on the following criteria:

1. Current availability of proficiency testing (PT) materials
2. Number of proficiency testing programs that can provide analytes
3. Volume of patient testing performed nationwide
4. Impact on patient health and/or public health
5. Cost and feasibility of implementation

For microbiology specialties and subspecialties, CMS said the proposed rule requires updates to specify broad categories of tests when proficiency testing is required to allow for flexibility of new technologies currently in use and those that may be developed in the future.

CMS’ proposed rule amends regulations to reflect how moderate and high complexity laboratories that are also performing waived tests are subject to compliance with PT referral requirements found at 42 CFR §493.801(b)(1) through (6). This change is to align the regulations with the CLIA statute (42 U.S.C. 263a (i)(4)), allowing CMS to apply sanctions to those laboratories performing waived testing found participating in PT referral.

Labs Affected by Proposed CLIA Rule

CMS said there are 246,143 CLIA-certified laboratories, of which 36,777 are required to enroll in a CMS-approved proficiency testing program and comply with the proficiency testing regulations. The Clinical Laboratory Improvement Advisory Committee (CLIAC), is the federal advisory committee charged with providing regulatory and laboratory quality advice to the CLIA program and made recommendations for proficiency testing that included the following:

• Updating the list of required proficiency testing analytes;
• Revising scoring criteria for acceptable performance;
• Updating requirements for microbiology to include broad categories of organisms rather than a list of specific organisms; and,
• Clarification of requirements that address proficiency testing referral.