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Weekly News, Analysis, and Commentary

Legal & Regulatory Features & News

Source: U.S. Navy photo by Mass Communication Specialist Seaman Apprentice Matthew Bookwalter and Wikimedia Commons
Source: U.S. Navy photo by Mass Communication Specialist Seaman Apprentice Matthew Bookwalter and Wikimedia Commons

POD Defender Puts DOJ on Ropes

The government’s healthcare cop, the DOJ, says Reliance Medical violated the Anti-Kickback Statue of the False Claims Act. Rubbish, says Reliance’s lawyer, Pat Hooper who beat the DOJ the last time they went after physician owned entities. He says the government’s just coming back for a second bite of the apple. Read how he is defending his clients and PODs.

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First PODS Prosecuted

Image created by RRY Publications, LLC
Image created by RRY Publications, LLC

The government has fired the first legal shot against physician-owned distributors (PODs) by filing a False Claim lawsuit against Reliance Medical, two PODs and Aria Sabit, M.D., an investor in the PODs. The suit says the group sailed outside Safe-Harbor waters and therefore filed false Medicare claims. The government wants its money back.

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The Social Media Advantage for Post Market Device Performance Data – Part II

Data Mining / Source: Wikimedia Commons and Marksenizer
Data Mining / Source: Wikimedia Commons and Marksenizer

The current adverse event reporting system clearly has its flaws. Can social media make a difference? This week, in Part II, our guest authors take a deeper dive into the pros and cons of the MAUDE, MedWatch and social media data bases as a source of information. And have specific recommendations.

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More Cases Emerge From FBI’s California “Spinal Cap” Investigation

Image created by RRY Publications, LLC / Source: Wikimedia Commons
Image created by RRY Publications, LLC / Source: Wikimedia Commons

More cases are emerging from the FBI’s “Spinal Cap” investigation. Now the allegations are around unapproved spine devices, bribed docs and elected officials, and tragically, a dead baby. It all started with the flawed California workers’ comp law and the ways in which administrators, surgeons and companies tried to game the system.

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Social Media Trumps Peer-Review Journals?-Part I

Diagram of a Social Network / Source: Wikimedia Commons and Katherine Willis
Diagram of a Social Network / Source: Wikimedia Commons and Katherine Willis

Social media is proving to be a better and faster source of medical device and drug post market approval performance than either the FDA or, depressingly, the community of peer-review journals. How does this new tool work? Is it a force for good or ill? The McAfees have an answer.

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