SPECIAL SECTION: Medicare D and Other Drug Coverage Updates

PART D FAILS TO COVER OFF-LABEL PRESCRIPTIONS

According to a recent report released by the Medicare Rights Center (MRC), there has been an upsurge in consumer complaints over the lack of Medicare Part D coverage for off-label prescriptions, which are drugs prescribed for uses other than their Food and Drug Administration (FDA)-approved indications.

The MRC report, entitled Off-Base: The Exclusion of Off-Label Prescriptions from Medicare Part D Coverage, explains that rules issued by the Bush administration dictate that Part D plans can cover doctor-prescribed off-label drugs only if their use is for a condition found in one of three major drug reference guides, called compendia.

However, off-label prescribing is a very common medical practice. According to a study published in the Archives of Internal Medicine, more than 20 percent of the 725 million prescriptions written for the 500 most commonly used prescription drugs in the United States are for off-label use, prescribed to treat such conditions as cancer, pain, HIV/AIDS, psychiatric conditions, and rare diseases.

“An off-label medication may be the only treatment that relieves a person’s debilitating pain, keeps someone out of the hospital or keeps someone alive,” said Robert Hayes, president of the Medicare Rights Center, which became aware of the problem as a result of consumer calls to its hotline.

Some of the drugs commonly left uncovered for off-label indications by Part D plans include the pain medications Actiq and Fentora, which are FDA approved for cancer-related pain but not covered for managing other types of pain; Zofran, which is covered for nausea in chemotherapy patients but not for others; and Lotronex, which treats irritable bowel syndrome in women, but is not covered for use by men.

According to the MRC report, patients who need off-label drugs for conditions not covered in the compendia have few choices to pay for drugs that can cost up to thousands of dollars per month.

MRC’s report contends that the Part D drug benefit should cover all “medically necessary” drugs. Coverage for drugs intended for noncompendia conditions should be based on “other evidence of medical necessity,” such as support in peer medical-reviewed journals.

-Adapted from: “Part D Fails To Cover Off-Label Prescriptions, Medicare Watch, a biweekly electronic newsletter of the Medicare Rights Center, Vol. 10, No. 17: August 21, 2007.

09/07