A top CMS official had a simple message for device makers Monday at the annual MedTech Conference hosted by AdvaMed.
Simple to the point of shocking.
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Here’s what Tamara Syrek Jensen, director of the coverage and analysis group at the Centers for Medicare and Medicaid Services, told the packed audience:
What is the problem you are trying to solve – so if you are heart failure, what is your treatment? What are you trying to solve? What is the evidence you have demonstrating that you are resolving that problem? And make sure that when you are talking about evidence with us, make sure you tell us the truth. Just be honest.
Let me repeat the last part: And make sure that when you are talking about evidence with us, make sure you tell us the truth. Just be honest.
In a few minutes, Jensen returned to that theme of speaking truthfully.
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“So again, when you come talk to us, let’s just have an open, honest conversation,” she said. “At least that’s my preference.”
In the question and answer session, I got up and asked her for clarification saying “it seems like you have encountered dishonest device manufacturers. Can you share?”
To which the room exploded with laughter and Jensen responded, “So many times. Oh gosh, I took a meeting just last week” to which the room laughed some more.
She added that while she couldn’t elaborate specifically, it was likely a case of “sugarcoating the data,” but “when you dig a little bit deeper you can tell perhaps that it isn’t necessarily how it was being portrayed.”
Jensen went on to say that the agency is more interested in hard data rather than marketing.
“I really, really enjoy all of your glossy brochures. They are really pretty. You’ve done a really really nice job with all of them. In the end it doesn’t matter to us. We really want to look at the ugly data. I know for many people that might be boring, but for us, it is exhilarating to take a look at that.”
Jensen added that if device makers think that the data is not as good, there are still pathways that CMS can recommend to get reimbursement. So, please work with us.
The advice about honesty was part of a broader panel discussion on what kinds of evidence commercial and government payers look for. This comes at a time when reimbursement has become the latest challenge that healthcare companies of every stripe are facing in their quest to bring their new-fangled inventions to the market.
But the fact that Jensen had to come out in a public forum and ask companies to fairly and honestly and truthfully portray the data/evidence backing up the product they hope to introduce in the market was — at the least — striking. And the fact that truthfully representing data is not the industry default but some type of fake-it-till-you-make-it attitude has afflicted so many is — frankly — disturbing.
You would think the Theranos saga would be a cautionary tale. That was no laughing matter.
Photo: marchmeena29, Getty Images
