In November, the Centers for Medicare and Medicaid Services (CMS) issued a draft coverage policy for implantable cardioverter-defibrillator (ICD) implantation that would update the 2005 policy currently governing ICD implants for Medicare fee-for-service patients. The draft policy proposes to make updates to clinical indications, incorporate several exemptions for waiting periods, require a shared decision making interaction by an independent clinician using a tool, and to end the requirement for data collection.

The ACC submitted comments, in collaboration with the Heart Rhythm Society, recommending changes to portions of the draft policy. CMS will consider the public comments submitted regarding the draft, then issue a final NCD by Feb. 20, 2018. Those changes will be effective immediately, though contractors must await further technical instructions from CMS before updating their claims processing software.

"Ongoing collaboration and coordination among CMS, the U.S. Food and Drug Administration, the National Institutes of Health, the Agency for Healthcare Quality and Research and other federal agencies presents an opportunity to ensure funding and timely completion of well-designed studies to answer outstanding questions. The Societies support the coverage with evidence development paradigm to expedite earlier access to innovative technologies that are likely to show benefit for the Medicare population where there is incomplete evidence," write ACC President Mary Norine Walsh, MD, FACC, and George F. Van Hare, MD, FHRS, FACC, president of the Heart Rhythm Society. Read the full comment letter here.

Keywords: Fee-for-Service Plans, Centers for Medicare and Medicaid Services, U.S., Defibrillators, Implantable, Medicaid, Medicare, Government, Societies, Decision Making, Software, ACC Advocacy

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