In this edition of The Rubrum Exchange, Carol Blackford, vice president of payment and healthcare delivery policy, and Tamara Syrek Jensen, vice president of federal policy, sat down to talk about what they’re watching for at MedTech 26.

What do you expect the big conversations at MedTech to be this year? 

Carol Blackford: The big question in medtech this year is how to keep bringing quality innovation to market on time in the current environment. From a market access and reimbursement lens, a lot of the conversation will be about demonstrating value and affordability. Those are two areas CMS has been focused on, and I think they’ll come up in every session and every conversation in the exhibit hall. 

We’ll also hear some concern about what the administration’s focus on program integrity could mean downstream for patients’ access to care. CMS is laser-focused on program integrity and has been aggressive about weeding out bad actors. Everyone is anxious to see what’s in the CRUSH proposed rule and whether specific items or services will be the next target. So: affordability, value and program integrity. 

Tamara Syrek Jensen: It’s all going to come back to how patients get access to new technologies, and the agency has given a lot of signals there. Take the RAPID program. Its foundation is building the evidence that leads to a national decision, and that’s a tremendous opportunity for anyone with Class II or Class III devices. The agency also removed the add-on payments, but I think RAPID will be the glide path to getting them back, so that evidence foundation really matters. 

Then, as Carol said, there’s fraud and abuse. The agency has many tools for that, including national coverage determinations and local coverage determinations. When you read the CRUSH rule, look closely at what the agency plans to do with lab testing in particular. I’m looking forward to all of those conversations. 

What do you think the conversation will be on the ground about RAPID? 

Carol Blackford: It will be a huge focus at the conference, and I think you’ll hear two competing points of view. Medtech manufacturers are concerned about what’s called the “valley of death,” the gap between FDA market authorization and Medicare coverage. We could do a whole separate session on that. 

RAPID is a nice step in the right direction because it gives more clarity about what it takes to move through FDA and into Medicare coverage. But some people worry it’s too narrow. You’ll hear that in the diagnostics conversations especially. There’s concern, and some confusion, in the diagnostics industry about why it hasn’t been included in the discussion of accelerated coverage. I’m sure that will come up on a number of the diagnostics panels. 

At the same time, there’s a lot of excitement about the clarity RAPID could bring, and about closer interaction and collaboration between FDA and CMS. So you’ll hear both sides. 

Tamara Syrek Jensen: That’s right. Change doesn’t happen fast; it happens in small steps. Because of Medicare Advantage, national coverage determinations matter more now than they did 20 years ago, since Medicare Advantage plans mustfollow an NCD. RAPID is one of those iterative steps. It isn’t the end, it’s the middle. 

Look at the history of coverage. In 1995, IDE studies were covered at local discretion. Now they are national, with one-stop shopping. Then came parallel review, MCIT, and TCET. RAPID is an attempt to rearrange those pieces so the process moves faster. But the agency is adamant, at least in the RAPID notice, that the foundation has to be value. To me, value means developing the right evidence to show how a technology improves Medicare patients’ lives. If a manufacturer can show what problem the technology solves and how it helps a Medicare patient, the path to coverage, coding and payment is much easier. 

That’s the whole philosophy of what we do at Rubrum, and it’s the philosophy of CMS too. When you put the pieces together, it fits: CMS removed the add-on payments because it didn’t see value, added RAPID because it wants value, and introduced CRUSH because it sees people taking advantage of the system. The agency is trying to bring all of those pieces together. 

What should attendees make time for at the conference? 

Tamara Syrek Jensen: What I enjoy most about the MedTech Conference is the connections with people. Come with your questions in mind and look for sessions that might answer them. And then have the conversations outside the sessions, because that’s where I learn the most. People will point you to where you need to go, whether you’re looking for an answer or just something new. 

When I was at CMS, I can’t tell you how often I’d have a hallway conversation and think, “That was a fabulous idea,” then bring it back and see how we could implement it. Sessions are also a good place to meet like-minded people who have the same question as you. If there isn’t an answer yet, maybe you can work out a solution together. 

Carol Blackford: There’s plenty of exciting new technology, and I’d encourage every attendee to walk the exhibit floor. The sessions have great, timely content on the issues we’re all working on, but the exhibit hall is where you see what’s coming to market. This year there’s a lot of interesting work in software, AI-enabled healthcare services, and claims processing technology. The exhibit hall is also where small medtech innovators pitch their products to more established companies, and those sessions are always fun to watch. 

Which sessions are you most looking forward to? 

Carol Blackford: FDA always does a great town hall. Michelle Tarver brings her staff to talk about what’s coming from FDA, and that session is always fantastic. 

This year there will also be a CMS Town Hall along the same lines, and I’d encourage everyone to attend. It’s an hour long, and you’ll hear directly from the people at CMS who write the rules and policies. The timing is perfect: the RAPID proposal comment period will have closed, and the final payment rules are about to land. The lineup includes Dr. Dora Hughes, CMS chief medical officer and head of CCSQ; Ryan Howe, Deputy Director for the Center for Medicare; and Janine Owo of the Center for Program Integrity. 

I’m also looking forward to Tamara’s session. And I always try to catch one or two of the patient-focused panels. Hearing from patients about innovations that have meaningfully improved their quality of life is a powerful reminder that the patient is at the center of everything we do. 

Tamara Syrek Jensen: I agree about both town halls. Carol and I have each done the CMS Town Hall a few times in our careers, and as a former CMSer, I always enjoyed them. The questions are key. I encourage people to ask them, because those are the things CMS staff bring back and say, “I got this question. Do we have an answer?” If you have a question, the town hall is the time to ask it. 

I’ll be speaking on a molecular diagnostics panel on Monday at 2 p.m. As Carol mentioned, this will be a big topic, especially why lab tests aren’t included in RAPID and what happens to lab diagnostics under MolDX. If lab tests aren’t part of RAPID, maybe the agency needs to do something within MolDX to speed things up, because there’s a waitlist there. We have a great panel, including Brian Carey and Dr. Bruce Quinn, a pathologist and former Medicare contractor medical director who has a lot to say about lab testing today. 

Any final advice for attendees? 

Carol Blackford: I’d emphasize a point Tamara made earlier. Before you arrive, decide on your top two or three policy questions and build your conference schedule around getting them answered. Spend as much time as you can in the hallways and on the exhibit floor and make time to connect with colleagues and with us. Stop by the Rubrum booth (#1133). We’ll be on the exhibit floor and at the sessions, and we’d love to connect. We love what we do, and we’re passionate about getting quality innovation to patients on time. Come check us out. 

Tamara Syrek Jensen: I couldn’t have said it better. Please reach out. I love seeing people in person, especially people I haven’t seen in a long time. 

Rubrum Advising helps innovators navigate the policy landscape shaping market access and reimbursement. To learn more about working with our team, drop us a line. 

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