AHRQ Releases Draft Report on Implantable Defibrillators and Prevention of Sudden Cardiac Death


On March 21, 2013, the Agency for Healthcare Research and Quality’s (AHRQ) Technology Assessment Program released a draft technology assessment report regarding implantable cardioverter-defibrillators (ICDs) and the evidence for primary prevention of sudden cardiac death (SCD).  ICDs are battery-powered implantable devices that monitor heart rhythm and deliver therapy in the form of either antitachycardia pacing or electric shock when detecting a life-threatening ventricular arrhythmia.  A National Coverage Determination sets forth Medicare’s coverage policy for ICDs.  The policy identifies nine covered indications for ICD implantation, many allowing coverage of an ICD intended for  “primary prevention,” which means prevention of SCD of a patient with risk factors for ventricular tachyarrhythmia, but who has not had sustained ventricular tachyarrhythmia.  The policy was last updated in 2005.

AHRQ’s draft report analyzes the clinical effectiveness of an ICD for primary prevention and finds a high strength of evidence that ICD therapy benefits patients with covered indications. The report also finds that Medicare coverage policy is consistent with ICD clinical studies and professional practice guidelines, concluding that they “correlate with the coverage criteria set by CMS.”  The AHRQ draft report does not recommend any change in coverage policy. 

The draft report is available for public comment and peer review until April 8, 2013.  To view a copy of the draft report, click here.  To access the report on AHRQ’s website, where you can also submit comments, click here.

Reporters, Lynn M. Adam, Atlanta, +1 404 572 3528, ladam@kslaw.com, and Kerrie S. Howze, Atlanta, +1 404 572 3594, khowze@kslaw.com.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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