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Discussing the CLOSURE I trial, Rick Lange and David Hillis point out that enrollment was slow because of frequent off-label use of PFO closure devices outside the trial, at a cost of about $800 million over 9 years (on a procedure that had no demonstrable benefit and increased risks). They ask: Should third-party payers withhold reimbursement for unproven device therapy unless it's part of a randomized trial?
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