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Medicare Drug Program News
Suit Filed to Lift Medicare Ban on Off-Label but
‘Necessary Drugs’
Medicare Rights Center says many with Medicare
better off before the drug benefit
 Nov. 26, 2007 - 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 - those not approved by
the Food and Drug Administration for the specific use prescribed.
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.”
“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.”
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.
Medicare Part D is outpatient prescription drug
coverage only available through private insurance companies.
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.
Editor’s Notes:
Medicare Rights Center (MRC) is the largest
independent source of health care information and assistance in the
United States for people with Medicare. Founded in 1989, MRC helps older
adults and people with disabilities get good, affordable health care.
520 Eighth Avenue, North Wing, 3rd Floor, New York, New York 10018 and
110 Maryland Avenue, NE, Suite 112, Washington, D. C. 20002 ∙
www.medicarerights.org
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