Published Online: Saturday, September 1, 2007
Medicare rules giving Part D drug plans the right to deny coverage for off-label prescription drugs are unfairly limiting the treatment options for millions of older Americans, critics of the program have charged.

In opening fire on those restrictions, officials at the Medicare Rights Center said that many seniors are able to obtain relief from pain or treat rare diseases by securing prescriptions for medicines approved by the FDA for other uses. Although this type of off-label drug use is widely accepted by patients and their physicians, the Medicare rules close the door on this practice, the critics maintain.

According to officials at the Medicare Rights Center, the off-label drugs most commonly denied by Part D insurers include painkillers such as oral transmucosal fentanyl citrate (Actiq) and fentanyl buccal tablet (Fentora), which have been approved for cancer-related pain but not for other types; ondansetron HCl (Zofran), an antinausea medication approved for chemotherapy patients; and alosetron HCl (Lotronex), a bowel-syndrome drug that the FDA has approved for women but that some men also have found useful.

Critics of the Part D restrictions contend that these rules have widespread implications for health care. According to the Medicare Rights Center, of all US prescriptions written for the 500 most commonly used prescription drugs, 1 in 5 today is for off-label use.

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