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February 18, 2022

Eleventh Circuit Potentially Expands Medicare Part D Coverage for Off-Label Use of Prescription Medication

In an unpublished opinion issued on February 11, the Eleventh Circuit vacated an entry of summary judgment in favor of the Secretary of HHS and remanded with instructions for the district court to enter summary judgment in favor of a Medicare beneficiary who sought coverage under Medicare Part D for off-label use of a medication. HHS had argued that the beneficiary’s use was not expressly “supported by” one of three commercial drug compendia specified by 42 U.S.C. § 1396r-8(k)(6)—a requirement for off-label coverage. The court disagreed with HHS’s reading of the statute, concluding that the statute includes coverage for “off-label uses for which an approved medical compendium tends to show or helps prove the efficacy and safety of the prescribed off-label use.”