The 2014 scientific sessions hosted by the Heart Rhythm Society are over, and there was a lot of news coming out of San Francisco. One of the items that caught my eye was a consensus statement by HRS and a couple of other physician societies about appropriate use of implantable cardioverter defibrillators for populations not well represented in clinical trials. The first question that occurs to the casual observer is; how seriously will government take this consensus standard?
The background for this is in part the push by the Department of Justice to go after physicians and clinics that implanted ICDs outside of Medicare coverage policy, a move that ended in what seemed on the surface like a stalemate, but which was probably a win for electrophysiologists (EPs). At the 2013 HRS meeting, a group of EPs announced they were in pursuit of legislation that would exonerate cardiologists who implant ICDs outside of guidelines established by the Centers for Medicare & Medicaid Services. We might bear in mind that the House GOP alone has at least 19 members who are doctors, and they typically don’t take kindly to some efforts to restrict senior access to Medicare.
The consensus statement addresses a number of scenarios for implant outside coverage guidelines, but the natural question to ask is which of these are must-haves and which are nice-to-haves. One item we can safely assume is a must-have is the nagging question of implant within the first 40 days post-infarct.
This particular coverage question has rankled EPs for several years, but the consensus statement seems to offer more specificity about which patients in this group should receive this device within that 40-day window than perhaps was previously available. Will the specificity of the consensus document’s discussion on this and other recommendations mollify CMS and DoJ?
One answer to that question was provided by Fred Kusumoto, MD, of the Mayo Clinic (Jacksonville, Florida) during a press briefing at HRS 2014. Kusumoto said the physician societies had alerted CMS and DoJ to the work on the consensus statement, and that officials at CMS were at least open to the discussion. FDA, too, is apparently aware of these developments, and we might reasonably assume none of these federal agencies will simply ignore the document.
The next step is for someone to file a formal request for a re-opening of the current coverage policy. One might wonder if CMS and DoJ are wary of such an analysis with an interim director at the helm of the coverage and evidence group at CMS. Louis Jacques recently left the job to Tamara Syrek Jensen, who has been at CMS for some time and is probably quite capable of steering this kind of request appropriately. Still, given how charged the politics of this has been, some in government might push for a bigger name at the CAG than an “acting director,” a job Jensen has held before.
In any event, the current coverage policy is based on an analysis put into force in 2005, and everyone at CMS might be on board with the proposition that it’s time for another look. It may be too early to break out the champagne, but patients, doctors and device makers can probably expect at least some loosening of coverage conditions over the next year or so. That is unless CMS and DoJ want Congress breathing down their necks.