Amid Class 2 Watchman Recall, CMS Proposes Limits on Coverage

Deborah Brauser

November 13, 2015

SILVER SPRING, MD — Both the Centers for Medicare and Medicaid Services (CMS) and the US Food and Drug Administration (FDA delivered announcements this week about the left atrial appendage (LAA) closure device known as the Watchman (Boston Scientific).

The device was approved by the FDA in March of this year for stroke prevention in patients with atrial fibrillation (AF). However, the CMS announced on Tuesday that there's enough evidence to show that use of the LAA-closure device is not "reasonable and necessary" for managing patients who are treatable with warfarin and so should not be covered by Medicare [1].

Instead, the organization recommends that reimbursement should cover only Watchman procedures in patients not receiving warfarin, according to a proposed decision memo.

In addition to warfarin nonuse, the CMS also proposed six other conditions that need to be met for coverage, including that the patient have a high CHADS2 or CHA2DS2-VASc score and a high HAS-BLED score, that the hospital where the procedure is done follows specific institutional requirements, that the procedure is performed by highly experienced physicians (including having completed manufacturer-provided safety training), and that the patient be enrolled in a national registry.

The CMS plans to make a final determination and issue a final decision memorandum after reviewing public comments.

In other news, the FDA announced a class 2 recall for the device's implant and delivery system because of blood leakage risks[2,3].

The agency reported that an "urgent field correction" was sent out by the manufacturer in late August about this issue, which discussed safety concerns and included instruction updates.

In its recall, the FDA noted that if the Watchman's hemostasis valve is "tightened with the dilator in place," it could lead to cross-threading and inadequate valve sealing. The field correction "reinforces the directions for use and gives further guidance on correct use of the hemostasis valve, minimizing potential for undesired blood leakage," said the agency.

A class 2 designation signifies that use of a product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

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