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Federal Court suit filed to lift Medicare

coverage bar on off-label, “medically necessary” drugs... Plaintiff fights nearly two years for off-label prescription drug supported in peer-reviewed medical literature and by array of medical experts

New York, NY –The Medicare Rights Center filed suit in federal district court today, asking a judge to declare unlawful the Bush Administration’s refusal to allow Medicare coverage of a broad range of medically necessary “off-label” drugs.

“Too many people are being forced to go without needed medications because of the Bush Administration’s misreading of the Medicare Part D statute,” said Robert M. Hayes, president of the Medicare Rights Center, a national consumer advocacy group.  “The administration is defying the intent of Congress, and keeping people from the medicine they need by its refusal to allow coverage of prescriptions that patients’ doctors insist are needed.”

Medicare Part D is outpatient prescription drug coverage only available through private insurance companies.

According to the suit filed in federal district court in Manhattan, “Many people with Medicare were actually better off before the drug benefit was introduced” in 2006.

The suit attacks the administration’s regulations that bar private drug plans from covering medically necessary prescriptions that are not approved for a specific use by the Food and Drug Administration. The complaint notes that in the United States over 20 percent of prescriptions written for the 500 most commonly used drugs are for off-label uses.

“Without coverage of off-label prescriptions,” the suits alleges, “people face increased suffering. And Medicare often bears increased costs because of the need for more drastic care, such as emergency hospitalizations, that results when people do not receive the medicines that they need.”  

The plaintiff, a 66-year-old widow, was first diagnosed with ovarian cancer in 1971. She had a recurrence in 1987, and has been taking Cetrotide, a commonly prescribed medication, since 1999 to treat and limit her cancer. Prior to January 2006, the drug was covered by the plaintiff’s employer’s insurance plan.  After the implementation of the Medicare drug benefit, her retiree drug coverage was moved to a Medicare Part D private plan, and within weeks the plan denied coverage of Cetrotide, stating that the drug was “not covered under Medicare Part D.”

The case brings three counts against the defendant, Health and Human Services Secretary Michael O. Leavitt:

·        That he has failed to ensure prescription drug coverage for a person with Medicare who is entitled to such coverage;

·        That he has failed to prevent the denial of coverage of a medically necessary, covered Part D drug; and

·        That his actions are arbitrary and capricious.  

The suit seeks reimbursement of the more than $100,000 the plaintiff has paid out of pocket to date.

A copy of the complaint filed in federal district court in Manhattan today is available at 

www.medicarerights.org/Off_Label_Complaint_Nov2007.pdf.   

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