The Centers for Medicare & Medicaid Services (CMS) issued a final rule to revise the proficiency testing (PT) regulations of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Laboratories that conduct testing for any of the analytes or microbiology subspecialties listed in the CLIA regulations under subpart I will be impacted by this final rule. This includes laboratories that participate in PT referral involving waived testing.


The revisions include the addition and removal of analytes or tests that require PT, as well as updates to the criteria for acceptable performance and administrative processes for CLIA PT programs (§§ 493.2 and 493.801 through 493.959). These updates take effect on July 11, 2024, two years from the date of the final rule’s publication in the Federal Register.


The revisions also include an update to the regulations so they align with the statute (42 U.S.C. 263a (i)(4)), which does not exclude waived tests from the ban on improper PT referral. On August 10, 2022, 30 days after the date of the final rule’s publication in the Federal Register, the regulations pertaining to laboratories performing tests of moderate and high complexity that also perform waived testing and PT enrollment (§§ 493.20 and 493.25) will go into effect.


In response to the Feb. 4, 2019, proposed rule, CMS received 107 public comments from individuals, PT programs, accreditation agencies, professional associations for laboratories, and corporations, which prompted CMS to change or remove a number of provisions in the final rule. “Commenters were generally supportive of the proposed changes, and some noted that these changes would increase flexibility and be a positive change for both laboratories and PT programs, especially in the specialty of microbiology,” CMS states.


In a conclusion in the Federal Register, CMS states that the estimated total cost for laboratories to participate in PT for analytes and tests in the final rule will range from $26 million to $94 million. “Although the effect of the changes will increase costs, implementation of these changes in this final rule will increase the confidence of laboratory professionals and the end-users of test results, including physicians and other health care providers, patients, and the public, in the reliability and accuracy of test results,” the agency writes.