Executive Summary

US surgeons have warned that they will be forced to stop performing accepted lifesaving procedures and instead use only "approved" - but more invasive, dangerous and costly - surgical techniques. At issue is a year-long US Department of Justice/Department of Health & Human Services Inspector General investigation into hospital billings for use of unapproved cardiac devices. The Justice Department issued 125 subpoenas last June, alleging that institutions charged Medicare and Medicaid programmes for these products even though US law forbids reimbursement until the devices are approved.