CMS policy driving consensus around moderate use of Boston Scientific's Watchman: Survey

Watchman implant--Courtesy of Boston Scientific

A survey by BMO Capital Markets found that most physicians are abiding by CMS' National Coverage Decision when it comes to implantation of Boston Scientific's Watchman implant to prevent stroke by closing the heart's left atrial appendage.

The federal agency initially gave Boston Scientific ($BSX) a scare when its draft decision offered Medicare coverage only to those patients contraindicated for blood thinning warfarin. In February it released a final draft that provides reimbursement for patients suitable for short-term warfarin, "but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making."

In the BMO survey of 26 physicians, 62% responded that they "will limit use of Watchman who are indicated to be non-compliant or have side effects with long-term anti-coagulant therapy," MD+DI reports. In other words, the majority will essentially follow CMS' National Coverage Decision issued in February, up from 44% who responded that way in April.

Physician opinion seems to be reaching a consensus at the middle ground, the survey indicated, for the percentage of respondents who are quite enthusiastic about the device fell, as did the percentage who are quite skeptical.

Note that the FDA's indication for use is a little broader than CMS' requirement for reimbursement, only calling for Watchman patients to have an "appropriate rationale to seek a non-pharmacologic alternative to warfarin." But CMS' call for shared decision making gives physicians a good deal of flexibility, though the need for documentation adds slightly to the administrative burden.

None of the docs said they will take advantage of FDA's open-ended label and maximize its usage under the indication (down from 10% of respondents in April), while the percentage who said the device would "will transform patient care" fell to 19%.

Meanwhile, the proportion who said they will only use the device only in patients who would otherwise receive a standard surgical LAA closure declined from 20% to 15%. Boston Scientific hopes the transcatheter device expands the use of LAA closure by eliminating the need for open heart surgery; typically, the procedure is performed surgically only when the chest must be cut open for other reasons as well.

"With every new technology, the pendulum tends to swing to an extreme point early on (as pent-up excitement elicits an expectation for high-levels of product adoption) and later returns to the middle as physicians identify the appropriate patients," BMO's Joanne Wuensch wrote in a research note accompanying the survey, according to MD+DI. "The same might be true with Watchman, as there has been a shift over the past several surveys demonstrating a higher percentage of the cohort expecting their penetration to be less than initially thought."

Ultimately, the Watchman's role within the broader stroke prevention paradigm vis-à-vis warfarin and newer blood-thinning drugs will determine its rate of adoption. Going forward, additional data and studies will play a greater role in shaping opinion than now-fairly-well-established federal guidelines for usage and reimbursement.

to get to this point, the device has had to overcome an FDA rejection in 2010, and another regulatory delay in 2014.

Although warfarin is considered a very effective medication, Boston Scientific argues that the risk of excessive bleeding from long-term use and noncompliance mean that another treatment option is needed. The Watchman, and left atrial appendage occlusion more generally, will be discussed at the upcoming meeting of the American College Cardiology in Chicago. FierceMedicalDevices will be in attendance. 

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