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HHS
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…
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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