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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.
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