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Are Part D beneficiaries denied 'off-label' drugs?

Contemporary Long-Term Care Weekly, August 9, 2007

A Medicare patient advocacy group blasted the Medicare Part D prescription drug program this week, saying patients who need "off-label" drugs for treatment of pain and other conditions are often denied access, according to USA Today.

"Off-label" is a common industry term referring to a drug used to treat a condition for which it is not specifically approved by the U.S. Food and Drug Administration. Under Part D's current regulation, insurers can deny Part D beneficiaries such drugs even with prescriptions. Medicare allows pateints to obtain off-label drugs if the drugs are listed in one of the specific drug reference guides for their condition.

But Robert Hayes, president of the Medicare Rights Center, insisted CMS institute more exceptions to the rule, as is common practice with state Medicaid programs, reported USA Today. The most commonly requested off-label drugs include painkillers such as Actiq and Fentora, the anti-nausea drug Zofran, and also Lotronex, a bowel symptom drug geared to women but also sought by men, reported the newspaper.

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