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CMS Proposes Adding 29 New Analytes in Update of CLIA Proficiency Testing Rules

NEW YORK (360Dx) – A proposed rule to update Clinical Laboratory Improvement Amendment (CLIA) proficiency testing rules for the first time since they were introduced in 1992 would add 29 new analytes to the list of analytes that require proficiency testing.

There are currently 81 analytes on the list of regulated analytes requiring proficiency testing. Along with the addition of 29 new analytes, the proposed rule from the US Centers for Medicare & Medicaid Services also recommends the elimination of five analytes from the regulated analyte list that are no longer commonly used, for a net gain of 24 analytes. The US Department of Health and Human Services (HHS) estimated the overall impact of adding the proposed analytes to be in the range of $26 million to $114 million in the first year, in cost for labs that are currently required to participate in proficiency testing. As of January 2017, 36,777 of the 246,143 CLIA certified laboratories are required to participate in HHS approved proficiency testing programs, according to HHS.

Proficiency testing providers have argued in recent years that an update to the CLIA rules regarding proficiency testing is long overdue. Last year, when CMS published a request for information seeking public comment related to CLIA personnel regulations, proficiency testing referrals, histocompatibility requirement and fees, several proficiency testing providers commented on the need to update proficiency testing requirements even though that was not one of the issues CMS specifically requested comment on.

"Medical laboratory testing and methods are far more advanced than when CLIA was established 30 years ago. The largest example of this is that the regulated analyze test list is extremely outdated," the American Academy of Family Physicians, which is also a proficiency testing provider, wrote in a comment letter at the time.

HHS acknowledged this issue in announcing the proposed rule.

"Many tests for analytes for which PT was not initially required are now routine in clinical use. For example, tests for cardiac markers, such as troponins, and the hemoglobin A1c tests commonly used to monitor glycemic control in persons with diabetes were not routinely performed prior to 1992," the proposal states.

The process for revising CLIA proficiency testing rules has been years in the making. The Clinical Laboratory Improvement Advisory Committee (CLIAC) working with HHS held meetings with members of the laboratory community in 2008 and 2010 to gather input on modernizing the regulations. CLIAC then collaborated with CMS and the Centers for Disease Control and Prevention to review industry recommendations and develop a method for modernizing the rules, according the proposed rule.

In selecting analytes to add to the list, CMS and CDC considered several factors. The agencies identified analytes that were already offered by at least three proficiency testing programs, believing that this "would provide a sufficient number of programs to offer immediate access to PT by laboratories." CMS and CDC then narrowed the list to analytes that had estimated national testing volumes of at least 500,000, then added an additional 10 analytes that were below the 500,000 national testing volume threshold but were "determined to be clinically important."

CMS and CDC further reduced the list based on "evidence available as to patient and public impact for each analyte" as well as based on assessed feasibility of proficiency testing.

In addition to changing the list of regulated analytes, the proposed rule recommends significant changes to microbiology proficiency testing, which does not specify required analytes. The proposed rule recommends certain categories, or steps within microbiology testing processes, that might require proficiency testing. The proposal also recommends a list of types of microorganisms that might be included in HHS-approved PT programs over time.

The proposed rule also makes numerous recommendations related to the criteria governing how proficiency testing is performed.

Comments to the proposed rule must be submitted by April 5.