On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more
2/1/2024
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Anti-Kickback Statute ,
Civil Monetary Penalty ,
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Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
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New Guidance ,
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Telehealth
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) continues to offer valuable insights to the healthcare industry as to how best to approach increasingly complex healthcare fraud...more
4/11/2023
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Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
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