The Medicare Rights Center has filed a federal lawsuit against the Department of Health and Human Services for denying Medicare coverage for a drug because it was prescribed on an off-label basis. The advocacy group filed its suit on behalf of Judith Layzer, 66, of New York City, who’s been taking Cetrotide, a med usually used for fertility treatments, since 1999 to fight ovarian cancer, according to the lawsuit (which you can read here).

The suit attacks the Bush administration’s regulations that bar private Medicare plans from covering medically necessary scrips that aren’t approved for a specific use by the FDA. 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 and states that “many people with Medicare were actually better off before the drug benefit was introduced” in 2006.

The advocacy group contends CMS policy is unfair because it prevents people from gaining needed treatments. “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 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.”

In Lazyer’s case, prior to January 2006, her med was covered by her employer’s insurance plan, but after the implementation of the Medicare drug benefit, her retiree coverage was moved to a Medicare Part D private plan. Within weeks, the plan denied coverage of Cetrotide, stating that the drug was “not covered under Medicare Part D.”

After some squabbling over Layer’s med, her Part D plan agreed to cover Cetrotide, but only if she paid a large share of the cost. From April 2006 to June 2007, Layzer paid $7,208 each month, compared with $40 or less she paid under her previous coverage. An appeal to a Medicare administrative law judge upheld coverage denial based on CMS regs, even though the judge agreed Cetrotide is considered effective against ovarian cancer. According to the lawsuit, the judge wrote that his own ruling was “frustrating” and “made no sense.” Besides asking Medicare to allow her Part D plan to cover her med, the suit asks for CMS to reimburse more than $100,000 Layzer has already spent on Cetrotide.

Interestingly, American Medical Association policies on off-label prescribing, for example, are at odds with Medicare’s policy, as The Hill points out. “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, The Hill writes. Under CMS regs, Medicare Part D drug plans are prohibited from covering off-label scrips unless the indication in question has been included in one of four official medical compendia, including those published by the AMA and the US Pharmacopeia.

By contrast, Medicare will cover off-label uses of meds when those uses are supported by peer-reviewed research if the drug is administered in a doc’s office under Medicare Part B, which covers physician services. As The Hill notes: The Medicare Part D manual issued by CMS in March says: “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.”

Want to read more about the debate over Medicare and off-label use? The advocacy group issued this report in August.