The Centers for Medicare & Medicaid Services has decided to cover Boston Scientific’s Watchman percutaneous left atrial appendage closure device under certain conditions.
Last week’s decision, which took effect immediately, provides consistent and uniform access to the device as a non-pharmacological treatment option for stroke risk reduction, the company says.
CMS adopted the majority of physician and professional medical society feedback received during a 30-day public comment period, specifically as it relates to patient coverage criteria and future data collection requirements, Boston Scientific says.
The final decision appears to remove the two biggest issues in the proposed version, including replacing the contraindication to warfarin with: “A suitability for short-term warfarin but deemed unable to take long term oral anticoagulation…” says Lawrence Biegelsen, a senior analyst with Wells Fargo Securities. This is consistent with the FDA label and should not be a barrier to adoption of Watchman. Also, he says, the final version removes the control arm from the registry, which will make implementation feasible.
Biegelsen says the decision is slightly more restrictive than the FDA label in terms of the patient population indicated for the device, but it is not expected to affect adoption.
While the label does not state a specific risk score in order to be eligible for the device, the decision states that a patient must have a CHADS2 score of 2 or greater or a CHADS2 VASc score of 3 or greater. Biegelsen points out the Prevail study only included patients with a CHADS2 score of 2 and above, so the device was not intended to be used in patients with a CHADS2 score below 2 because they are at a lower risk of bleeding.
Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the Watchman device. The remaining population is represented by private payers, Boston Scientific says. Prior to the CMS decision, a number of private payers, including several Blue Cross Blue Shield plans, have updated their policies to now cover the device.
The device — the first and only percutaneous LAAC therapy approved by the FDA — is indicated for patients with non-valvular atrial fibrillation who are at high stroke risk, suitable for warfarin and are seeking an alternative to long-term warfarin therapy. — Jonathon Shacat