The CMS' final coverage rule on Boston Scientific's cardiac device the Watchman does not include language requiring patients and physicians consult on the benefits and risks of the device, disappointing advocates who were hoping to empower patients.
In its proposed coverage decision last year, the CMS stated the patient and provider must use an “evidence-based decision tool” to determine the appropriateness of anticoagulation therapy. It urged conversation and consultation regarding the benefits and harms of Watchman.
However, when the CMS finalized its decision for Medicare coverage for the device this month, the requirement that the patient and doctor discuss the benefits and risks of device had been removed.
Michael Weinstein, a JPMorgan Analyst who specializes in cardiovascular medical technology, noted the change in a Feb. 9 investor's note as a “less restrictive” requirement on shared decisionmaking.
Informed Medical Decisions Foundation, a Boston-based organization that advocates for evidence-based shared decisionmaking between doctors and patients, found the final wording vague and said it hoped future coverage decision on products would more clearly stress shared decisionmaking.
Others said they were not so sure that the section had been weakened, and in fact felt that it may have been strengthened.
While the risk portion was removed, the CMS wrote in its final decision that there had to be a formal shared decisionmaking interaction with an independent non-interventional physician on oral anticoagulation and that that meeting must be made and documented in the medical records. The goal being to determine if there is another blood thinner besides warfarin that the person could take instead of getting Watchman.
About 2.7 million Americans have the condition that causes irregular and rapid heart rates. Many are prescribed warfarin to ward off stroke. But some patients who take the blood thinner suffer severe bleeding as a side effect. Watchman has been touted by cardiologists as a game changer for these patients.
“We believe non-interventionalists are likely to guide patients to consider new oral anticoagulants and ensure (Watchman's) use truly as second-line therapy, and prevent against over usage,” Kristen Stewart, an analyst at Deutsche Bank, said in a Feb. 9 note.
Others agreed and noted that the CMS likely took out the risk discussion language because it's assumed such a conversation would already take place, said Dr. Matthew Wynia, director of the center for bioethics and humanities at the University of Colorado.
Dr. Peter Goldbach could see it both ways. He agreed that the meeting with the non-interventional physician was a strong step, but didn't understand why the risk section had to be cut.
He serves as chief medical officer at Health Dialog Services Corporation, a subsidiary of Rite Aid Corporation, a population health management solutions company.
“It is puzzling that CMS requires that this interaction addresses solely the anticoagulation option,” Goldbach said. “There is no clearly stated similar requirement that patients are presented evidenced based information on the risks and benefits of the device.”
For the past 30 years there has been a movement to develop educational materials that empower patients to engage in shared decisionmaking with their physicians.
The aids include a description of the benefits and harms of a product or procedure.
Great Britain and Canada are far ahead of the U.S. in the use of aids.
More than a decade ago, researchers in the two countries spearheaded the creation of the International Patient Decision Aid Standards Collaboration, which has created standards for their content and development that include conflict-of-interest rules.
That's important since self-interested parties—such as devicemakers—could influence the aids by providing financial support to companies creating them.