Clinical laboratories and hospitals and systems that own them say the CMS has failed to add enough nuance to the enforcement framework that protects its process for making sure that labs are proficient.
In response to lobbying from the industry, Congress acted last year to give the CMS more discretion to determine when labs were intentionally undermining a system in which the CMS sends labs samples to test in the same manner they would test actual patient samples.
But the industry argues that the way the CMS has carried out that mandate still leaves them vulnerable to extreme penalties for minor and unintended infractions. The American Hospital Association said in a comment letter that the policy would have “a devastating impact on the patients served by large national health systems that often own and operate many laboratories in many locations.”
The changes to enforcement provisions under a 1988 law called the Clinical Laboratory Improvement Amendments, or CLIA, were wrapped into a proposed rule that primarily establishes a prospective payment system for federally qualified health centers. The CMS released the draft policy in September, and the comment deadline was Nov. 18.
A common complaint about the penalties for testing violations is that labs often inadvertently violate the law because they automatically send positive samples to other labs for confirmatory testing.
Yet labs found to be intentionally sending those samples to other labs temporarily lose their federal certification, and their owners are temporarily banned from owning certified labs.
The CMS proposed two lesser levels of sanctions and would reserve the most severe penalties for cases in whichlabs repeatedly refer the samples elsewhere or report others’ results as their own.
The American Clinical Laboratory Association argues in its letter that “it is conceivable that two, minor innocuous mistakes could result in these draconian sanctions.”
The ACLA also argues that the application of those more lenient sanctions primarily turns on the dates when errors are discovered rather than the circumstances.
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