Elective Replacement Interval
The current National Coverage Determination for defibrillators does not contain any reference to coverage for generator change outs when batteries reach their elective replacement interval (ERI). The absence of this verbiage has been a long-time concern of mine that was recently elevated to the point that incorporating it into my recommendations to Medicare was a top priority..
Medicare Administrative Contractors recently published Local Coverage Articles for pacemakers. The contractors specifically outlined coverage for pacemaker generator change out in these policies. It is probably safe to assume that the omission of generator change out from the ICD policy was an oversight. However, recent assumptions regarding grey areas of Medicare device policy have been very costly to physicians and hospitals. Not too long ago, physicians and hospitals across the country were penalized for implanting dual chamber pacemakers when Medicare asserted that their coverage policy only permitted single chamber devices..
My concern regarding defibrillator generator change outs comes from the fact that defibrillators frequently improve ejection fraction and heart failure classification to the point that patients no longer meet the published indications. Similar to dual chamber pacemakers, physicians generally assume that generator change outs are covered. But that is not explicitly stated in the current ICD coverage policy. Most patients need to have class II or III heart failure and an ejection fraction of 35% or less. Technically, Medicare could assert that someone with a 40% ejection fraction or class I heart failure does not qualify for a new generator even if they had a 20% ejection fraction and class III heart failure when the chronic system was inserted.
I have not heard of anybody getting penalized for defibrillator generator change outs. I'm only showing my pessimistic side to illustrate why I prioritized the following recommendation to Medicare during their open public comment period for defibrillators indications:
"The current coverage policy does not address when it is appropriate to perform a generator change out and it does not list battery depletion (elective replacement interval) as an indication for a generator change out. This is problematic because 6 of the 9 indications are contingent on the patient having a reduced ejection fraction. It is common for patients to experience improvement in cardiac function and an increased ejection fraction shortly after having a defibrillator implanted. When these generators reach their elective replacement indicator, the patient no longer has an ejection fraction that falls below the 30 – 35% measure outlined in the policy."
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