§1320e–1 Limitations on certain uses of comparative clinical effectiveness research

Summary

The Secretary may only use findings from comparative clinical effectiveness research to decide Medicare (subchapter XVIII) coverage if the decision comes from an open, repeated process that invites public comment and looks at effects on different groups of people. Those findings cannot replace or change items or services already judged reasonable and necessary, and they cannot be the only reason to deny coverage. The Secretary must not treat life extension for older, disabled, or terminally ill people as worth less than for others. The research also cannot be used to push people away from choosing a treatment because of how they value longer life versus risk of disability. The Patient-Centered Outcomes Research Institute must not use dollars-per-quality-adjusted-life-year (QALY) or similar measures that lower the value of a life because of disability as a cutoff for what care is cost‑effective or recommended, and the Secretary cannot use such measures for Medicare coverage, payment, or incentives. Comparative clinical effectiveness research: studies that compare how well treatments work. QALY: a dollars-per-quality‑adjusted‑life‑year measure that can reduce value because of disability.