Court Finds FDA Explanation of Knee Implant Reversal Lame

Last Friday the D.C. Circuit reversed a lower court ruling in favor of the FDA in a lawsuit over the agency’s reversal of its own earlier approval of a surgical mesh used in knee replacement surgery. The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in …

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Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer patients at risk. But Judge Reggie Walton made it clear that his dismissal was on purely …

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CMS Charges $13 Million Late Payment Fee on $1 Million Medicaid Overpayment

New York City’s Mt. Sinai Hospital refunded a one million dollar Medicaid overpayment. CMS said thanks for the repayment, but you still owe us a late payment fee: $13 million. To add insult to injury, the overpayments were inadvertent—the result of electronic coding errors on about 900 Medicaid claims. On …

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Whistleblower Defendant Blows Whistle on Whistleblower

Antonio Saidiani filed a whistleblower suit alleging that NextCare urgent centers and CEO Dr. Shufeldt had collected tens of millions of dollars in false Medicare claims. Antonio was in a position to know because he was that most dangerous of all whistleblowers: the fired ex-employee. NextCare entered into a …

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Did the Federal Court Protect the Wrong Doctor?

Last week in a medical malpractice case in Alabama, a federal court denied the plaintiff’s motion to compel production by a hospital of the defendant doctor’s personnel file. The plaintiff believed that the file could show that the hospital was negligent in hiring and supervising the doctor and might contain …

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OIG Warns Pharma Its Copayment Coupons May Aid Crime

Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers. There’s one big difference, though. If a senior citizen uses a coupon for Rice …

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