The Department of Justice has reached 70 settlements involving 457 hospitals in 43 states for more than $250 million related to cardiac devices that were implanted in patients in violation of Medicare coverage requirements, the Department of Justice announced Friday.
Among the Kentucky hospitals included in the settlements are Baptist Health Lexington, Saint Joseph Hospital and Saint Joseph Hospital East in Lexington, and Saint Joseph London.
Baptist Health Louisville and Baptist Health Paducah were also among the Kentucky hospitals, the Justice Department said.
"While recognizing and respecting physician judgment, the department will hold accountable hospitals and health systems for procedures performed by physicians at their facilities that fail to comply with Medicare billing rules," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's Civil Division.
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An implantable cardioverter defibrillator, or ICD, is an electronic device that is implanted near and connected to the heart. It detects and treats chaotic, extremely fast, life-threatening heart rhythms, called fibrillations, by delivering a shock to the heart, restoring the heart's normal rhythm.
Only patients with certain clinical characteristics and risk factors qualify for an ICD covered by Medicare.
Medicare coverage for the device, which costs about $25,000, is governed by a National Coverage Determination (NCD). The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty.
The medical purpose of a waiting period — 40 days for a heart attack and 90 days for bypass/angioplasty — is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary.
The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions. The Department of Justice alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the NCD.
The claims resolved by these settlements are allegations only and there has been no determination of liability.