Final CMS Decision Memo for Watchman Dumps Controversial Warfarin Contraindication


In what may prove to be the removal of a key barrier to the expanded use of the Watchman left atrial appendage closure device in patients with nonvalvular atrial fibrillation, the Centers for Medicare & Medicaid Services (CMS) has backed off on a number of controversial criteria it had initially proposed as essential in order for device implantation to be covered.

In its final national coverage determination memo released late yesterday, the CMS stipulated that for patients’ procedures to be paid for through the federal agency, they must meet 4 criteria related to stroke risk score, patient care, and study inclusion, all under the umbrella of “evidence development.” But the requirement that appears to have been one of the most volubly protested in the open public comment period that followed the publication of the agency’s proposed coverage plan last year—that patients have a contraindication to warfarin—has been removed.

That requirement would have explicitly contradicted the Watchman’s FDA-approved indicationsfor use—themselves based on the inclusion criteria used in the pivotal trials—that stipulate patients must “deemed by their physicians to be suitable for warfarin.”

Many of the letters sent during the period of public comment on the proposed coverage expressed concerns and “deep disappointment” over the warfarin contraindication. Apparently, the CMS listened. In wording released yesterday, the agency now says coverage will be offered if the patient meets all other criteria and has “suitability for short-term warfarin but [is] deemed unable to take long term oral anticoagulation following the conclusion of shared decision making, as [left atrial appendage closure] is only covered as a second-line therapy to oral anticoagulants.”

All left atrial appendage closure procedures—the Watchman (Boston Scientific) is currently the only FDA-approved device—will only be covered by the CMS under the paradigm related to “items or services that are reasonable and necessary for research.” As such, the proposed coverage had set out the requirements for a mandatory registry of these procedures. This registry requirement appears in the final memo, but with somewhat relaxed parameters. Patient follow-up was reduced from a minimum of 5 years to 4 and the requirement of a parallel arm of “contemporaneous patients followed on oral anticoagulant therapy to serve as noninterventional controls” has been dropped.

However, the final decision memo—but not the earlier proposal—extends coverage to patients participating in new FDA-approved randomized controlled trials. Specifically, such a trial would need to be a randomized comparison of left atrial appendage closure to medical therapy with the primary endpoint of ischemic stroke and systemic embolism and a secondary endpoint of cardiovascular mortality and all-cause mortality.

Such a trial, presumably, would help answer one of the lingering concerns from the pivotal randomized trials of the Watchman device, namely, the higher rate of ischemic stroke among device-treated patients as compared with controls in both PREVAIL and PROTECT AF.

Also of note, the final decision memo contains greater specificity surrounding the level of stroke risk required of patients being considered for device closure, but drops the bleeding risk consideration set out in the proposed decision memo. The proposed coverage had referred to “a high CHADS2 or CHA2DS2-VASc score,” which echoes the language in the FDA approval, and “high HAS-BLED score”. In its final decision, however, the CMS document drops any mention of a high HASBLED score, but specifies a CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3.

Those cut points—as well as proposed revisions tackling the issue of “warfarin contraindication” were set out in a letter jointly sent to the CMS on behalf of Society for Cardiovascular Angiography and Interventions, American College of Cardiology, and Heart Rhythm Society during the open public comment period.

 

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Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…

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