CMS seeks comments on changes to NCD for implantable cardioverter defibrillators

For the first time in over a decade, CMS has posted a decision memo with a 30-day public comment period for the National Coverage Determination (NCD) on implantable cardioverter defibrillators (ICD).

CMS posted a tracking sheet on coverage for ICDs May 30 and later released the decision memo following the first public comment period, which ended June 29 and brought in 36 comments, many of which recommended that the 2005 NCD for ICDs be updated. CMS is currently accepting subsequent public comments for 30 days following the release of the November 20 decision memo.

The decision memo includes the following proposed changes to the NCD for ICD:

• The addition of cardiac magnetic resonance imaging to the list of diagnostic imaging studies that can be used for evaluation of left ventricular ejection fraction
• Requiring a minimum of three months of optimal medical therapy for patients with severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history
• Requiring that certain patients take part in shared decision making prior to ICD implantation
• The removal of the Class IV heart failure requirement for cardiac resynchronization therapy patients
• The addition of an exception for patients who meet CMS coverage requirements for cardiac pacemakers and criteria for ICD
• The addition of an exception for patients who have an existing ICD and qualifying replacement
• The discontinuation of the current data collection requirement

For additional information, see the decision memo, which includes additional details on proposed changes as well as a the current NCD for ICDs as described in Section 20.4 of the Medicare National Coverage Determinations Manual and included in Appendix C of the decision memo.