HHS subpoenas 132 hospitals in a false-billing probe. Hospitals say they don't understand Medicare policy, which generally forbids payment for services involving investigational devices.
American Hospital Association says many hospitals now exclude Medicare patients from device trials. Arguing patient care and research are threatened, industry groups lobby for legislative relief.
About 25 hospitals challenge the legality of Medicare policy in a lawsuit against HHS.
A whistleblower lawsuit is partially unsealed. It alleges systematic fraud by hospitals to obtain up to $1 billion in Medicare reimbursement.
Reversing policy, HHS announces Medicare will cover most devices in clinical trials.
An HHS official tells a Senate subcommittee that half of subpoenaed hospitals knew they were submitting claims for noncovered services and about 30 took steps to prevent detection. Meanwhile, Sutter Memorial Hospital in Sacramento, Calif., agrees to pay about $1.3 million to avoid prosecution under the False Claims Act.
U.S. District Court, Los Angeles, rules for the 25 hospitals, declaring the old Medicare policy void because it wasn't promulgated according to rulemaking requirements.