Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the brakes to accelerating use of the device.
The CMS proposal would restrict coverage to cases in which Watchman is implanted in a research setting, specifically clinical trials and registries. The proposal states up front that coverage for the device outside of the research setting is not warranted because the evidence has not demonstrated that use of the device is “reasonable and necessary.” The proposal thus leads the way for Watchman to follow the path of percutaneous valve repair in which CMS reimbursement has been restricted to use within carefully defined research protocols.
In addition, the CMS proposal would restrict coverage to patients who have a contraindication to warfarin. It appears likely that this detail will be modified before the final determination is published in February, however, since the FDA indication for Watchman states that eligible patients should be “deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin.” In its long and torturous path to approval one of the most vexing problems was the difficulty in defining the patient population who might benefit from the device.
Wells Fargo analyst Larry Biegelsen wrote that he expects that there will be “an outpouring of pressure from the key medical societies” during the comment period aimed at amending the NCD. Almost certainly CMS will need to modify or elaborate on the warfarin contraindication. I suspect that the medical societies like the ACC will seek to work with CMS, FDA, and Boston Scientific to set up and oversee the registries and trials required by the NCD. In a roundup of analysts comments on StreetInsider, an Evercore analyst estimated that that there are now about 400 sites in the US that currently perform TAVR and should be prepared to meet the NCD criteria.
Although implementation of the NCD could well curtail short-term use of Watchman, it is also possible that the mandated research programs, if positive, could help drive long term acceptance of the device. Of course, if negative they could also have the opposite effect.