Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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Articles and Reports
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Continuum Settles Reverse False Claims Case
From - National Intelligence Report
Facing the uncertainty of trial, Continuum has officially settled reverse false claims allegations for…
OIG Report Indicates Limited Success for Senior Medicare Patrol
From - National Intelligence Report
An Office of Inspector General report detailing results of 2015 enforcement efforts by the Senior Medicare Patrol (SMP) show success but not overwhelming recoveries. However, the report cautions that…
Program Integrity Saves Medicare $42 Billion
From - National Intelligence Report
In a new report to Congress, the Centers for Medicare & Medicaid Services reports the Program Integrity activities have saved Medicare and…
Democratic Committee Leaders and CMS Present Latest Challenges to Theranos
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FCA Penalties Nearly Double Under DOJ’s Interim Final Rule
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Lab Implicated in Long-Running Kickback Case Pleads Guilty, Forfeits Assets
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Department of Justice Nearly Doubles FCA Penalties
From - National Intelligence Report
June 30, the Department of Justice (DOJ) published an Interim Final Rule in the Federal Register that has significant ramifications for enforcement under the…
Largest Strike Force Takedown in History Charges 300 Individuals
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