LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It
False billing of urine drug tests (UDTs) continues to be a focus for enforcement agencies in 2023, here’s how to avoid compliance issues.
Hospitals Sue CMS Over ‘Two-Midnight’ Rule
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CMS Divides PT Sanctions Into 3 Categories, Limits Reach of Ban
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Feds Charge 90 With Health Fraud in Latest Strike Force Takedown
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LDT Guidance Unlikely to Be Released Anytime Soon
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
FDA Official Defends Plan to Issue Guidance for LDTs
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Florida Health Care Execs Facing Charges Over Fake Lab Billings
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Enforcement Trends — Labs Continue to Be a Focus
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