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babylonsister Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Nov-28-07 12:43 PM
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Advocates sue * admin over Medicare drug coverage exclusions
Advocates sue over Medicare drug coverage exclusions
By Jeffrey Young
November 28, 2007

An activist group representing Medicare beneficiaries has filed a federal lawsuit against the Bush administration over its policy of not providing Medicare coverage for prescription drugs used for purposes not specifically approved by the Food and Drug Administration (FDA).

The Medicare Rights Center filed suit Monday in federal court in New York City against the Department of Health and Human Services and Secretary Mike Leavitt on behalf of a single beneficiary who has been denied coverage for a medicine approved for fertility treatment by the FDA that the patient has used to treat her cancer since 1999.

The suit revolved around so-called off-label prescriptions, common in the medical profession, in which physicians prescribe drugs to treat conditions for which the FDA has not approved the medicines. Such prescriptions are based on the physicians own clinical experience, published guidelines in pharmaceutical compendia or research findings in peer-reviewed medical journals.

Physicians typically resort to off-label uses of medications when conventional therapies prove ineffective. Off-label prescribing differs from the use of unapproved experimental drugs because even though the medicines are not FDA-approved for the off-label indication, the drugs are FDA-approved for other uses.

In an August report, the Medicare Rights Center cited a study published in 2006 by the Archives of Internal Medicine, which determined that, in 2001, more than 20 percent of the prescriptions written for the 500 most commonly used drugs were for off-label indications.

Physicians generally oppose restrictions on off-label prescriptions because, in their view, these limitations interfere with doctors clinical judgments.

Official American Medical Association (AMA) policies on off-label prescribing, for example, are at odds with Medicares policy.

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slackmaster Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Nov-28-07 12:47 PM
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1. This is a major problem - my mom is an expert
I'll pass the information on to her. Thanks!
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