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Off-Base: The Exclusion of Off-label Prescriptions from Medicare Part D Coverage

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Publication Date: August 2007

Publisher(s): Medicare Rights Center

Topic: Health (Pharmaceutical services)

Type: Report

Coverage: New York


The Medicare prescription drug benefit (Part D), implemented in 2006, has left many people who enrolled in the benefit without coverage for the prescriptions they need. Among those in the situation of being better off before the Medicare drug benefit came along, are the many people with Medicare whose doctors have prescribed medically necessary medications for "off-label" uses. Drugmakers seek Food and Drug Administration (FDA) approval for specific uses of their products and conduct trials to test their drugs' safety and effectiveness in patients with specific conditions. If the FDA approves the drug for those conditions, the drug manufacturer has to sell the medications with a label that lists the FDA-approved uses for that drug. Any use outside of that is referred to as off-label.

Regulations issued last year by the Bush administration prohibit Part D coverage of off-label prescriptions, unless the prescribed use is supported in one of three specific medical compendia, which print overviews of new uses of medications supported by surveys of clinical studies and peer reviewed medical literature. If it is not, Part D plans cannot cover the drug regardless of the extent of medical necessity and proof showing the effectiveness of the drug for that use.

Often individuals taking off-label prescriptions have tried treatment after treatment to no avail -- sometimes experiencing debilitating side effects over a period of years. They, along with their doctors, are thrilled to finally find a medication that eases their discomfort--or, in some cases, preserves their lives--only to discover that even though the drug is on their Medicare Part D plan's formulary, it cannot be covered for them. When coverage of such medicines stops, people face increased suffering that frequently also increases the costs to Medicare because of their resulting need for more drastic medical care, such as emergency hospitalizations.