R.S. v. Connecticut General Life Insurance Co./Cigna Medicare Rx (Docket No. M-11-1799)

The enrollee's Part D plan denied coverage of Geodon (ziprasidone) prescribed for an off-label use (mood and behavioral symptoms after a traumatic brain injury). The ALJ had ordered the plan to cover it; the Council took up review on its own motion and reversed, finding the plan wasn't required to cover the off-label use.ruleHHS Departmental Appeals Board, Medicare Appeals Council — R.S. v. Connecticut General Life Insurance Co./Cigna Medicare Rx, Docket No. M-11-1799 (Sept. 8, 2011)

An off-label use — a drug prescribed for something other than its FDA-approved indication — is a real, distinct category of Part D denial, separate from a formulary or tiering exception. Whether an off-label use is covered turns on whether it's supported by specific compendia or peer-reviewed medical literature, not simply on the prescriber's own clinical judgment.

This decision cuts against coverage — worth knowing honestly, not just citing decisions that favor an appeal. The real, practical takeaway is that an off-label request needs to point to the specific medical literature or compendium entry supporting that use, not just the prescriber's own say-so, if it's going to hold up on review.

Two real federal district court cases reached opposite conclusions on a closely related question — how strictly the "medically accepted indication" standard's own compendia requirement should be read: Layzer v. Leavitt, 770 F. Supp. 2d 579 (S.D.N.Y. 2011), and Kilmer v. Leavitt, 609 F. Supp. 2d 750 (S.D. Ohio 2009). Naming the specific compendium or literature your prescriber is relying on, rather than assuming any off-label use will be accepted, is the real lesson both cases point to.

The Council's own willingness to take up review on its own motion — reversing a decision that had actually favored the enrollee — is a reminder that a favorable ALJ ruling isn't always the final word. The plan or the Council itself can still seek further review of a legal question, not just the enrollee.

For an off-label request specifically, ask the prescriber directly which compendium (such as the AHFS Drug Information or DRUGDEX) supports the requested use for this condition, and ask that the supporting statement cite it by name — a general statement of clinical judgment, without that citation, is exactly the kind of gap this decision turned on.