TAG:
fda ldt guidance
New Twist: HHS Exerts Authority Over FDA on LDTs
CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…
LabCorp Now Larger than Quest, Two Labs Report 2015 Earnings
IN RECENT WEEKS, the nation’s two largest lab companies reported fourth quarter and full-year earnings for 2015. The earnings reports reveal how the paths of the two companies are diverging. The companies are diverging because of a major acquisition made in February 2015, by Laboratory Cor…
Official Makes Case in Favor of FDA LDT Guidance
IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed …
CURRENT ISSUE
Volume XXVII, Number 16 – November 16, 2020
UNWELCOME CHANGES to how labs do business are forcing labs to cope with high demand for COVID-19 testing while dealing with government and private payers interfering with normal operating procedures. Medicare has new requirements and payment rates for COVID-19 tests. Also reported here are UnitedHealthcare’s new Laboratory Test Registry Protocol, and California’s new COVID-19 testing laboratory that is diverting lab instruments, supplies, and test kits away from hospital and independent labs in the state.
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