Press Release             

FOR IMMEDIATE RELEASE

Contact: Deane Beebe
Public Affairs Director
212-204-6219
E-mail
Medicare Rights Center

August 2, 2007

Americans with Medicare Private Drug Benefit Denied Access to Medications Prescribed for “Off Label” Use

Bush Administration’s Regulations Conflict with Standard for Medical Care, Consumer Group Reports

New York, NY – People with Medicare whose doctors prescribe medications for “off-label” use are denied coverage of these drugs due to the Bush Administration’s misinterpretation of Medicare law, a new report by the Medicare Rights Center says.

The Centers for Medicare and Medicaid Services (CMS) should adjust its regulations regarding off-label drugs, and if it fails to do so, Congress must clarify the language in the Medicare law so that its intent to cover “medically necessary” drugs for people with Medicare is explicit, the national consumer service organization recommends.

Medications are classified as “off-label” when they are prescribed to treat conditions other than those for which the Food and Drug Administration (FDA) approved the drug. Current Medicare drug benefit regulations categorically prohibit coverage of off-label prescriptions.

“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 M. Hayes, president of the Medicare Rights Center.

“Congress never intended to bar Americans with Medicare from getting the medically necessary drugs they need. The Bush Administration needs to revise off-label regulations quickly, so that no one is harmed any further,” said Mr. Hayes.

In “Off-Base: The Exclusion of Off-Label Prescriptions from Medicare Part D Coverage,” the Medicare Rights Center explains that off-label prescribing is common medical practice with over one in five prescriptions for commonly used drugs being prescribed for off-label use. People with cancer, HIV/AIDS, debilitating pain, mental health conditions, and rare and serious conditions are routinely prescribed “off label” medications.

The report contains case examples of people who had coverage for off-label drugs through Medicaid, state pharmaceutical assistance programs, pharmaceutical patient assistance programs or private insurance and lost it when they joined a Medicare private drug plan. Forty-two state Medicaid programs and nearly all private employer-based insurance plans cover “off-label” prescriptions.

In “Off-Base: The Exclusion of Off-Label Prescriptions from Medicare Part D Coverage,” the Medicare Rights Center discusses how the Medicare statute shows Congress’ intent to ensure access to medically necessary drugs for people with Medicare. The group recommends that Congress revise the language of the statute to more clearly allow for the consideration of other evidence of medical necessity in the appeals process, including peer-reviewed literature and someone’s medical history, if CMS does not reinterpret the current regulations.

“Off-Base: The Exclusion of Off-Label Prescriptions from Medicare Part D Coverage” is available online at http://www.medicarerights.org/Off-label_PartD_Coverage.pdf.

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