Small Companies Are Not Immune From Prosecution – The Case Of Life Spine,…
n July 2019, the Department of Justice announced a False Claims Act suit filed against Life Spine, Inc., for violations of the…
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Yearly Archives
2019
Repackage Your CME Programs for MIPS Compliance
On September 16, 2019, Policy & Medicine editor Thomas Sullivan presented an interactive working session during the 17th…
The Chaos Over Drug Compounding Continues As Judge Throws Out Convictions…
A federal judge in Boston recently overturned the convictions of two former NECC executives who had been convicted of defrauding…
Pelosi Draft Plan Would Allow Price Negotiations on Select Drugs
A supposed draft plan summary to lower drug prices by House Speaker Nancy Pelosi has been circulating around Capitol Hill…
Opioid Case Tests The Boundaries Of Liability – Oklahoma, J&J And The…
The first opioid case to go trial has just concluded in Oklahoma with J&J as the sole defendant. This case is important for…
HHS OIG Posts Findings Following Opioid Prescribing Review
The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently posted its findings following a…
Florida AHCA Submits Concept Paper to HHS
Recently, the Florida Agency for Health Care Administration (AHCA) recently submitted a “concept paper” to the United States…
FDA Finalizes Revised Guidance on REMS Revisions and Modifications
The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation…
Industry Reaction Mixed to FDA Draft Guidance on Real World Data and…
In May, the US Food and Drug Administration (“FDA”) released a draft guidance outlining its current thinking on real-world data…
CMS to Host Public Meeting to Address Opioid Epidemic
On Wednesday, August 28, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will host a public meeting…