TAG:
clia numbers
UnitedHealth to Start Gene Test Pre-Approval
CEO SUMMARY: With programs now at the nation’s two largest insurers, is it possible to argue that prior-authorization is going mainstream? Some observers say, yes, as THE DARK REPORT predicted. What is certain is that starting Nov. 1, UnitedHealthcare is requiring prior authorization fo…
Existing CLIA Language Drives PT Enforcement
CEO SUMMARY: Revocation of a lab’s CLIA license as penalty for inadvertent errors in handling proficiency tests (PT) is not a new problem. As explained here, most clinical laboratories have appropriate protocols for handling PT samples. But, when errors occur, the Centers for Medicare &…
Labs Should Prepare for Tighter CLIA Enforcement
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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