Governing Verification Risk in Outcome Based Payments for Gene Therapies

Abstract

Outcome-based payment agreements for gene therapies depend on institutional decisions where clinical evidence acquires financial consequences. Digital systems coordinate this sequence, but their reliability does not establish who is authorised to interpret an outcome, allocate missing evidence consequences, or revise a completed settlement. This article develops a legal account of verification risk: the risk that available evidence cannot support a sufficiently reliable and authorised determination of a contractual outcome. It distinguishes this risk from therapeutic underperformance and payment-execution error. Using the United States Cell and Gene Therapy Access Model as its principal institutional setting, the article examines the relationship between federal programme authority, state rebate agreements, and the HIPAA Privacy Rule. It recognises that the Model's design provides for reconciliation and appeals; the question is how these arrangements connect to subsequent corrections of clinical evidence. The article argues for a rebuttable contractual presumption of review where a correction is material to an existing payment condition, coupled with safeguards against retrospective alteration. It proposes a responsibility framework covering evidence production, outcome determination, settlement, and correction, testing it against hypothetical scenarios. The resulting contribution is a bounded account of financial finality: settlement should remain dependable while identified errors in its evidentiary basis remain capable of proportionate review. These proposals are contractual and programme-design recommendations, rather than claims that existing federal law requires a uniform reopening procedure.