ICD Scrutiny: Study Quantifies Significant Off-Guideline Implant Activity
This article was originally published in The Gray Sheet
Executive SummaryThe implantable defibrillator sector took another potential hit last week with findings that more than 20% of patients treated with the devices for primary prevention of sudden cardiac death should not receive them under current guidelines.
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The Department of Justice says the additional 51 hospitals that settled with the government on charges of billing for ICD implants outside of Medicare coverage guidelines represent the "final stage" of a long-running investigation. DoJ previously identified another 457 hospitals that have settled. Hospitals payments tied to the investigation total $273 million.
More than 400 hospitals settled with the Justice Department following a five-plus year investigation into ICD implants performed during post-heart attack and post-surgery periods when Medicare policy states the devices generally should not be put in.
The agency affirms the evidence in favor of implantable defibrillators for primary prevention of sudden cardiac death is strong for patients with reduced left-ventricular ejection fraction, but does not support resynchronization ICDs for this population.