|The Watchman device--Courtesy of Boston Scientific|
In a win for Boston Scientific ($BSX), the Centers for Medicare & Medicaid Services backed off its proposal to contraindicate usage of the Watchman left atrial appendage closure device in warfarin patients as a condition for reimbursement under its Coverage with Evidence Development program.
The agency's November draft decision sent Boston Scientific stock down 4% because it was narrower than the FDA-approved indication for use of the implant to reduce the risk of stroke. But the final decision "provides wide latitude in deciding who can get the device and rules around post-approval registries, physician requirements, and additional clinical studies were as expected. The approval adds a very sturdy support to BSX's guidance for Watchman and Structural Heart broadly," Jefferies equity analyst Raj Denhoy wrote.
Among the conditions for CMS coverage are "a formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF (non-valvular atrial fibrillation) prior to LAAC." The decision must be documented in the medical record, and includes patients who are suitable for short-term warfarin but deemed "unable to take long term oral anticoagulation following the conclusion of shared decision making."
"We are very pleased CMS has established national coverage for this life-changing therapy for Medicare beneficiaries who have a reason to seek an alternative to long-term anticoagulation," said Boston Scientific CEO Mike Mahoney, in a statement. "The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry."
Indeed, the Watchman garnered the support of several medical societies during the 30-day public comment period, which followed November's initial decision. A total of 191 mostly supportive comments were received. In addition, the Society for Cardiovascular Angiography and Interventions, the American College of Cardiology, and the Heart Rhythm Society in December released a statement with several suggestions for simplification of the post-market registry, MedPage Today points out.
And Boston Scientific said that several private payers like BlueCross Blue Shield recently updated their policies to cover implantation of the Watchman. CMS' decision should encourage other insurers to offer broad coverage of the Watchman as well. Regardless, the vast majority of Watchman patients receive Medicare.
Following the disappointing draft, Boston Scientific reaffirmed its believe that the Watchman can become a $500 million device assuming a 2% penetration rate among the eligible population. The new development will only make it more likely that the goal is achieved.
CMS' ruling will delight others as well, most notably St. Jude Medical ($STJ). Some on Wall Street said a negative decision would deter the company from try to bring its competing, CE-marked Amplatzer Amulet device to the U.S. Denhoy said the company will begin FDA trials for approval later this year. The company will randomize against the Watchman, so the trial should produce some very interesting data.
Meanwhile, MedPage Today says the post-market registry may include SentreHeart's Lariat LAAC device. CMS said that it met with SentreHeart officials to discuss the Lariat procedure on June 6. The device turned out to have undisclosed risks that resulted 6 patient deaths, and an FDA letter advising against use of the device for left atrial appendage closure. The company is currently conducting an FDA clincal trial to earn that indication.
The device industry is increasingly complaining about CMS' penchant for excluding patients from reimbursement who are eligible for a device under the FDA-approved indications for usage, giving Boston Scientific's victory additional significance. It signals flexibility and responsiveness to public comment on the part of CMS.
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Editor's Note: Inaccurate information about the Lariat's indication has been removed.