Advocates sue over Medicare drug coverage exclusions

An activist group representing Medicare beneficiaries has filed a federal lawsuit against the Bush administration over its policy of not providing Medicare coverage for prescription drugs used for purposes not specifically approved by the Food and Drug Administration (FDA).

The Medicare Rights Center filed suit Monday in federal court in New York City against the Department of Health and Human Services and Secretary Mike Leavitt on behalf of a single beneficiary who has been denied coverage for a medicine approved for fertility treatment by the FDA that the patient has used to treat her cancer since 1999.

{mosads}The suit revolved around so-called “off-label” prescriptions, common in the medical profession, in which physicians prescribe drugs to treat conditions for which the FDA has not approved the medicines. Such prescriptions are based on the physician’s own clinical experience, published guidelines in pharmaceutical compendia or research findings in peer-reviewed medical journals. 

Physicians typically resort to off-label uses of medications when conventional therapies prove ineffective. Off-label prescribing differs from the use of unapproved experimental drugs because even though the medicines are not FDA-approved for the off-label indication, the drugs are FDA-approved for other uses.
In an August report, the Medicare Rights Center cited a study published in 2006 by the Archives of Internal Medicine, which determined that, in 2001, more than 20 percent of the prescriptions written for the 500 most commonly used drugs were for off-label indications.

Physicians generally oppose restrictions on off-label prescriptions because, in their view, these limitations interfere with doctors’ clinical judgments.

Official American Medical Association (AMA) policies on off-label prescribing, for example, are at odds with Medicare’s policy.

“A physician may lawfully use an FDA-approved drug product or medical device for an unlabeled indication when such use is based upon sound scientific evidence and sound medical opinion,” one policy reads in part. Another states, “When the prescription of a drug or use of a device represents safe and effective therapy, third party payers, including Medicare, should consider the intervention as reasonable and necessary medical care, irrespective of labeling, and should fulfill their obligation to their beneficiaries by covering such therapy.”

Nevertheless, the Medicare policy is not entirely out of line with limitations on off-label prescriptions established by health insurance companies, which vary in their policies for covering these medicines in the private market.

Under regulations promulgated by the Centers for Medicare and Medicaid Services (CMS), Medicare Part D prescription-drug plans are prohibited from covering off-label prescriptions unless the indication in question has been included in one of four official medical compendia, including those published by the AMA and the U.S. Pharmacopeia.

By contrast, Medicare will cover off-label uses of medicines when those uses are supported by peer-reviewed research if the drug is administered in a doctor’s office under Medicare Part B, which covers physician services.

According to the Medicare Part D manual issued by CMS in March, “indications are not ‘medically accepted’ if they are supported in peer-reviewed medical literature, but not yet included or approved for inclusion in one of the compendia. Therefore, the use of a drug for such indications would not meet the definition of a Part D drug and plans should deny payment.”

The Medicare Rights Center contends that this policy creates barriers to treatment for people with the most serious health conditions and interferes with the doctor-patient relationship.

“The exclusion from Medicare Part D coverage of off-label prescriptions that lack support in the compendia hurts the most vulnerable people with Medicare. The exclusion of these off-label prescriptions also conflicts with standard medical practice,” the complaint reads.

The named plaintiff in the case, represented by the Medicare Rights Center, is Judith Layzer, 66, of New York City. Layzer has been taking Cetrotide, a medicine ordinarily used for fertility treatments, since 1999 as part of a regimen against her ovarian cancer.

Prior to the implementation of Medicare Part D, Layzer received prescription-drug coverage through a health plan provided as part of the retirement benefits she receives from New York City, which paid for her Cetrotide. The city transitioned its retirees into a Part D plan in 2006, after which the plan denied further coverage.

After appealing the decision, Layzer’s Part D plan agreed to cover the Cetrotide, under the condition that she pay a large share of the cost. Between February 2006 and June 2007, Layzer paid $7,208 each month for her medication compared to the $40 or less she paid each month under her previous coverage.
A further appeal with a Medicare administrative law judge upheld the denial of coverage in February based on CMS regulations, despite the judge’s agreement that the medicine is considered effective against ovarian cancer. Layzer subsequently sought relief from the Medicare Appeals Council but the body has not acted on her request, the complaint states.

“Mrs. Layzer has exhausted her administrative remedies,” the complaint asserts to justify the filing of a lawsuit. In addition to seeking to force Medicare to allow her Part D plan to cover her medicines, the suit asks the court to require CMS to reimburse the more than $100,000 Layzer has already spent on the medicine.