Articles Tagged with Part D

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On November 8, 2016, the United States Attorney’s Office for the Southern District Florida announced the conviction and sentencing of two defendants in a Medicare Part D fraud case.

What is Medicare Part D?

As most people know, Medicare is a federally funded program that provides free or below-cost healthcare benefits to certain individuals, primarily the elderly, blind, and disabled.  Medicare offers different types of benefits through program “parts.” Part D of Medicare, known as the Medicare Part D program, subsidizes the costs of prescription drugs for Medicare beneficiaries in the United States.

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Improper Off-Label Usage of Prescription Drugs

Broadly speaking, “off-label” drug use occurs when a doctor prescribes a medication for a condition or ailment that is not specifically approved by the FDA.  When the FDA approves a drug, the manufacturer is required to submit studies showing that a drug works for a specific condition and that it is safe.  Sometimes, however, a drug is shown to have beneficial effects on a condition, but the FDA will not approve the drug for that specific use.  For instance, I take a drug for migraine headaches that has only officially been approved for treatment of clinical depression.  This is considered “off-label” use.

No law prevents a physician from writing a prescription for an off-label use, and private insurance companies (my own included) frequently pay for drugs even when used for an “off-label” purpose.  Nevertheless, “off-label” drug use presents the potential for fraud.  Drug companies are barred by the FDA from marketing a drug for off-label use – for obvious safety reasons.