CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations

Yesterday CMS filed a proposed rule that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by CLIA.  Under current regulations, any laboratory that intentionally refers a PT sample to another laboratory for analysis will automatically lose its CLIA certificate for at least one year.  CMS has always interpreted the term “intentional” very broadly to mean an intention to act and thus has not considered the circumstances surrounding the referral of a PT sample when imposing revocation.  Even so, CMS recognizes in the Proposed Rule that revocation of the laboratory’s CLIA certificate in cases of certain PT referrals involving “reflex” or “confirmatory” testing may have adverse effects on patients and has therefore proposed an exception.  Described by CMS as “an infrequent and narrowly crafted carve-out from the long-standing interpretation of ‘intentional,’” the exception would apply only to a laboratory that refers a PT sample to another laboratory for “reflex” or “confirmatory” testing in accordance with the laboratory’s standard operating procedures for patient testing.  As long as the PT referral is not a repeat referral (i.e., no other PT referral occurred during the two survey cycles prior to the time of the PT referral at issue), CMS would consider the referral to be “improper” rather than “intentional” and would impose alternative sanctions, rather than revoke a laboratory’s CLIA certificate.