Medicare ordered to pay for off-label drugs

Washington -- A federal judge has ruled that the Medicare program must cover off-label use of drugs when treatment is medically necessary, even when the use is not described in an official medical compendium.

The March 7 ruling settles a 2007 lawsuit filed by the Medicare Rights Center in New York against the Dept. of Health and Human Services on behalf of two Medicare patients, Judith M. Layzer, who since has died of ovarian cancer, and Ray J. Fischer, who has muscular dystrophy.

"This is a victory for our plaintiffs and sets an important precedent for all people with Medicare," said Joe Baker, the center's president. "Since the start of the Medicare drug benefit, the Medicare Rights Center has received calls from consumers who have struggled to obtain coverage of off-label, medically necessary drugs. This ruling brings us closer to removing a sizable obstacle to coverage of these drugs."

In Layzer's case, Cetrotide (cetrorelix acetate), which is used to prevent premature ovulation during fertility treatments, was prescribed to control her cancer and prevent her tumors from hemorrhaging. But her Medicare Part D plan denied her coverage of the drug, because the prescribed use could not be found in the Food and Drug Administration-approved labeling or in any of three compendia used as guides for off-label coverage.

Judge Harold Baer Jr. for the U.S. District Court of the Southern District of New York reversed the denials and ordered that Layzer's estate be reimbursed for the money Layzer had to pay out of pocket for the drug. He found the agency's denials "rested on an unsound interpretation of the law" because there is no compendium requirement for off-label coverage.

The ruling comes after one of the plaintiffs received some legislative relief in 2009. That's when Layzer first obtained coverage for her treatment through a provision of the Medicare Improvements for Patients and Providers Act. The law clarified that Medicare must cover off-label use of cancer drugs when the drug has FDA approval and is either supported by one or more compendia, or the drug plan determines that the use is medically accepted based on clinical evidence in peer-reviewed journals or other publications approved by the HHS secretary.

However, the provision did not apply to noncancer drugs. The Medicare Rights Center and other organizations have asked Congress to change this by further clarifying the coverage guidelines to go beyond cancer treatments.

Reps. Mac Thornberry (R, Texas) and Russ Carnahan (D, Mo.) have introduced a bill to do just that. The Part D Off-Label Prescription Parity Act would allow Medicare coverage of off-label use of noncancer medications when supportive clinical evidence exists in peer-reviewed medical journals and other literature.

"This legislation takes a balanced approach to addressing patients' treatment needs while ensuring that safety and efficacy are taken into account when determining if Medicare Part D should cover a requested off-label drug," Baker said.