This is a crude auto transcript, but you can get an idea what the AI generated Google Podcast with two voices, is like.
##
Speaker 1 0:00
Okay, so listeners, imagine this.
You're waiting for a new knee replacement, right? And you hear about this incredible new implant, yeah, gets people back on their feet faster. Wow, less pain, wow, maybe you even get to ditch the cane sooner, yeah, life changing stuff, right?
Speaker 2 0:19
Absolutely, exactly formillions of people. These, these medical breakthroughs, are the difference between just getting by and and truly thriving.
Speaker 1 0:27
But here's the thing, getting that game changing tech from a scientist slab into your doctor's hands, right? That's a journey. It is. And and Medicare, they're like the gatekeepers, right? They are. Coverage decisions have huge ripple effects,
Speaker 2 0:41
no doubt about it. Yeah, and in the past, frankly, it's been slow. It has a bit like watching a snail race when you need a cheetah.
Speaker 1 0:50
That's putting it mildly, which is why your deep dive today is so timely.
Yes, we're digging into a brand new program from CMS, okay, the Centers for Medicare and Medicaid Services called the transitional coverage for emerging technologies pathway,
Speaker 2 1:05
TCET, for short. There we go. And while the name might not exactly roll off the tongue, right, the potential impact is enormous. Yeah, we could be talking about a future where Medicare beneficiaries have much faster access to the medical innovations that matter most.
Unknown Speaker 1:21
Okay, so less jargon, more impact. Exactly
Unknown Speaker 1:24
I like it. Yes,
Speaker 1 1:25
we've got CMS own fact sheet from August and a super recent Webinar Transcript from September 2024 Okay, to guide us. Great. You ready to break this down? Let's do it all right, so first things first, okay, what exactly is this TCE pathway, and why should you, the listener care?
Speaker 2 1:42
So in a nutshell, TCE is all about speed, okay, on giving some much needed clarity to device manufacturers, okay, all while keeping patient safety front and center,
Speaker 1 1:53
because who wants to wait years for a treatment that could drastically improve their life, right? Especially if it's already gotten the green light from the FDA Exactly.
Speaker 2 2:01
That's where the transitional part comes in. Okay? Tcet aims to finalize Medicare coverage decisions within six months of the FDA approval.
Speaker 1 2:11
Six months, yeah, that's practically warp speed compared to how long things usually take. It really is wow. But it's not just about speed. It's about setting clear expectations. Okay? Now device manufacturers will know exactly what kind of evidence CMS needs to grant coverage right from the get go.
Speaker 2 2:27
So less guesswork for the manufacturer, right?
Speaker 1 2:30
More potential for them to focus on developing those breakthrough devices. Exactly makes sense to me, yeah, but this can't be for just any new medical device, right? Right? My new fitness tracker that tracks how many steps they take a day. Probably won't make the cut.
Unknown Speaker 2:43
You're right, probably not.
Unknown Speaker 2:45
So how does CMS decide which devices get to ride the tcet Fast Track?
Speaker 2 2:51
The fact sheet lays out some specific criteria. Okay, first and foremost, yeah, we're talking about devices with that FDA breakthrough device designation, things that represent a major leap forward in medical technology. Okay?
Speaker 1 3:05
So, like cutting edge implants, AI powered diagnostics, gene therapies, right? That sort of thing, precisely.
Speaker 2 3:10
Okay. It has to be a potential game changer. Got it, and the device also has to fall under what Medicare considers a benefit category, meaning it's something they're already set up to cover in some form, which makes
Speaker 1 3:24
sense. They can't just start covering every experimental medical gadget under the sun,
Speaker 2 3:28
exactly, right? And, of course, there's also a bit of a legal checklist, okay? The device can't already be covered by a Medicare national coverage determination, right? Or be specifically excluded by law. So
Speaker 1 3:40
it's got to be groundbreaking, fit into their existing system and not be something they've already made a decision on, right? Got it, yeah, but even if a device ticks all those boxes, it doesn't automatically get a free pass to coverage, right?
Speaker 2 3:52
You're catching on, okay? CMS still has rigorous standards to uphold, right? They need to be certain that the device is safe and truly benefits the Medicare population, which
Speaker 1 4:04
is reassuring, because we wouldn't want to rush potentially risky technology to patients just for the sake of speed. Absolutely
Speaker 2 4:11
not right, and that's why data collection is so crucial here. Okay, tcet emphasizes gathering real world evidence through what they're calling fit for purpose studies.
Speaker 1 4:22
Fit for purpose, huh? Yeah, so not your average research study, then Exactly,
Speaker 2 4:26
okay. It means the study design is tailored to answer the specific questions that CMS has about a device's effectiveness and safety for the Medicare population, which,
Speaker 1 4:38
let's be honest, that's not always the same as the people who participate in those initial clinical
Speaker 2 4:42
trials. Very true, right? Medicare beneficiaries tend to be older, right? Have more complex medical histories, yeah, and they might use a device differently than someone younger and healthier, right? These fit for purpose studies help fill in those real world gaps.
Speaker 1 4:56
So CMS is making sure that the device. Is really beneficial for the people who rely on Medicare the most. Yes, that makes a lot of sense, but this sounds like a massive undertaking. It is. Are they going at it
Speaker 2 5:08
a lot at all. CMS is really emphasizing collaboration here, okay, working closely with the FDA, device makers, researchers, and even gathering public input throughout the whole process, collaboration,
Unknown Speaker 5:21
the magic word, there you go. Why is that so important in this case?
Speaker 2 5:26
Because getting these innovative technologies into the hands of patients who desperately need them requires a team effort. Okay? The FDA focuses on initial safety and effectiveness, right? But then CMS has to figure out how that translates to coverage within the complex world of Medicare, it's like
Speaker 1 5:44
a relay race. Dropping the baton at any point means the patients lose out.
Speaker 2 5:49
That's a great analogy, right? Tcet is designed to create a smooth handoff, making sure everyone is on the same page from the get go,
Speaker 1 5:56
I see. So it's about communication and coordination, yes, speaking of which, yeah, what does the actual TCE process look like for a device manufacturer? So is it a mad dash to file paperwork once the FDA gives the thumbs up?
Speaker 2 6:10
Not quite. Okay. The Webinar Transcript highlighted some key stages. Okay, it actually starts way before the device is even close to hitting the market. We're talking 18 to 24, months ahead of their anticipated FDA approval. Wow. That's when CMS encourages manufacturers to send a letter of intent, so like a heads up, yeah, like a heads up, giving CMS a sneak peek at what might be coming down the pipeline.
Speaker 1 6:34
Smart. But when do things get really serious? About 12 months
Speaker 2 6:39
before they expect FDA approval, okay, manufacturers can formally nominate their device for the TCE pathway
Speaker 1 6:45
a full year out. That's when things get real. Yes. Then what if
Speaker 2 6:50
CMS thinks the device is a good fit for tcet? They move on to what's called the evidence preview, okay, think of it like a deep dive into all the existing data,
Unknown Speaker 6:59
so like a scientific research montage? Yes, okay. They're combing
Speaker 2 7:03
through clinical trials, studies, all that good stuff. Exactly. They work with an independent contractor to conduct a thorough literature review, looking at everything available. Okay? And the manufacturer isn't just sitting on the sidelines during this right. They're encouraged to provide their own list of relevant studies and even comment on the draft evidence preview,
Unknown Speaker 7:23
a true team effort to make sure they have all the right information.
Speaker 2 7:26
Yes, and once that evidence preview is finalized, CMS has a sit down with the manufacturer to discuss next steps.
Speaker 1 7:34
Okay? So it's like a matchmaking meeting where they figure out if they're truly a good fit for a coverage decision. You
Speaker 2 7:39
got it okay now, yeah, there are a few possible outcomes from this meeting. Okay, in the best case scenario, yeah, the evidence of the preview is already strong enough, and they fast track a national coverage determination, the
Unknown Speaker 7:52
golden ticket to Medicare coverage, exactly, right?
Speaker 2 7:55
But let's be real, yeah, with cutting edge technology, there are often some gaps in the evidence, especially when it comes to how it works for the specific needs of the Medicare population,
Speaker 1 8:07
right? Because even the most promising devices need time to prove themselves in the real world, right? What happens, then? Does the device get put on hold? Not
Speaker 2 8:15
necessarily. Okay. This is where the evidence development plan comes in. Okay? If both CMS and the manufacturer agree that more data is needed, they collaborate to develop a plan for gathering it
Speaker 1 8:27
so it becomes a not yet, yeah, but with a clear roadmap for how to get there, you got it, okay,
Speaker 2 8:33
and that roadmap often involved those fit for purpose studies we discussed earlier, tailored to answer CMS specific questions, but the device's effectiveness for Medicare beneficiaries. So
Speaker 1 8:44
even if a device doesn't have mountains of data at launch, tcet provides a clear pathway to gather it, while still potentially offering some level of coverage. Exactly that seems like a pretty big deal for patients. It
Speaker 2 8:57
means that instead of waiting years for more data to come, right? Medicare beneficiaries might be able to access these potentially life changing technologies much sooner. This
Unknown Speaker 9:10
is all sounding very promising, yeah, but I have a feeling there might be a catch. Well, there
Speaker 2 9:15
is a slight caveat. Okay, what's the catch while coverage is possible during this evidence gathering phase, it's usually time limited, okay, tied to the timeline of the evidence development plan.
Unknown Speaker 9:27
Ah, so it's like a trial period for the device to prove its worth, precisely,
Speaker 2 9:30
okay? And during that time, yeah, the manufacturer needs to stay in close contact with CMS, okay, providing regular updates on the evidence they're gathering. Okay? No ghosting allowed, definitely not right.
Speaker 1 9:42
So once that evidence, development plan is completed and the new data is in, what happens, does CMS make the final decision? Exactly, okay, they
Speaker 2 9:51
conduct a comprehensive review of everything, yeah, and decide about long term coverage. Okay, so
Speaker 1 9:56
it's a multi stage process, a lot of back and forth. Yeah? But the end goal is to reach a point where they have enough data to make a truly informed decision. You got it right,
Speaker 2 10:06
and that's the beauty of tcet. Okay? It's not just a one time yes or no right, but an ongoing dialog where CMS and manufacturers work together to make sure that Medicare beneficiaries have access to the most innovative and beneficial medical technologies available that
Speaker 1 10:23
all makes sense, yeah, but what about those devices that don't end up going down the TCE path? Are they just out of luck when it comes to Medicare coverage? Not
Speaker 2 10:31
at all. Remember, tcet is completely voluntary, right? It's a new option, but manufacturers can choose to stick with the traditional pathways for getting Medicare coverage.
Speaker 1 10:41
So it's like having an extra option, right? A potential shortcut, exactly, but not the only way to get to the destination you got it, okay? And
Speaker 2 10:48
even if a device doesn't qualify for TCA initially, right, it doesn't mean CMS will never cover it. Okay? They're constantly reevaluating technologies as new evidence comes to light. Okay,
Speaker 1 11:01
that's good to know, yeah, so there's still hope, even if a device doesn't fit the TCE mold right away, exactly.
Speaker 2 11:07
The key takeaway here is that CMS is clearly committed to giving Medicare beneficiaries access to innovative medical technologies. TCE is just one piece of the puzzle. All
Speaker 1 11:19
of this is super helpful, but it also sounds like a ton of work for CMS, it is. Have they said how they're gonna handle what's probably gonna be a massive influx of applications they
Speaker 2 11:31
have? Okay, from what I understand, they're very aware of the potential workload, right? And are taking steps to streamline everything. Okay, bringing in extra resources, working on better coordination with the FDA, that sort of thing. That's good
Speaker 1 11:43
to hear, yeah, because efficiency is key if you want to keep up with the crazy fast pace of medical innovation these days. Absolutely
Speaker 2 11:50
right? And speaking of keeping up, yeah, remember those deadlines we talked about earlier?
Unknown Speaker 11:55
You mean the ones for manufacturers to submit their nominations? Exactly,
Speaker 2 11:58
yes. October 31 2024 is the cutoff for that first TCE review cycle. Wow. The
Unknown Speaker 12:06
clock is tipping. It is what happens after that. Then
Speaker 2 12:09
CMS will be reviewing nominations every quarter. So
Speaker 1 12:12
this is really just the beginning. It is a start of what could be a major shift in how new medical technology reaches the people who need it most, right? But it's not all smooth sailing from here, right? Of course, it's not all gonna be sunshine and instant cures, right? This new pathway could bring some challenges too, couldn't it? Of
Speaker 2 12:32
course, whenever you're talking about increasing access to cutting edge technology, right, the question of cost always comes up, yeah, will this lead to a spike in Medicare spending, or could it actually lead to savings down the road, if these new devices prove to be more effective and efficient, right? These are questions that we'll be grappling with as TCE evolves. It's like
Speaker 1 12:55
that classic saying you have to spend money to make money, right? Right? Only in this case, it's more like you have to spend money to potentially save money and hopefully improve lives in the process,
Speaker 2 13:08
exactly, right? And it's not just about the bottom line either, right? We also need to make sure that these technological advancements are truly accessible to all Medicare beneficiaries, right? It shouldn't matter where they live, their income level, any of that, right? We don't want to create a system where only certain groups benefit from these breakthroughs. Yeah,
Speaker 1 13:28
a two tiered healthcare system would be the opposite of what we're aiming for, exactly. So equity is a huge factor here. Absolutely.
Speaker 2 13:34
Yeah, these are complex issues Without Easy Answers, right? But they're conversations that we need to be having now proactively, yeah, as we move forward with tcet, definitely
Speaker 1 13:44
food for thought. Yeah. So where does that leave us? Is it all just a big question mark, or can we allow ourselves a little bit of optimism about the future of TCE?
Speaker 2 13:54
I think cautious optimism is the perfect way to put it okay. TCT has the potential to be a win win, both for patients who are understandably eager for the latest and greatest treatments, right, and for a healthcare system that's always trying to keep pace with scientific progress, right?
Speaker 1 14:09
Which, let's be honest, feels like it's happening at lightning speed these days. It is. It is no kidding. What makes me optimistic is that CMS seems committed to doing this the right way. Yeah. Transparency, collaboration, letting the data guide their decisions. I agree, yeah. And
Speaker 2 14:25
the fact that they're actively encouraging public feedback throughout this process, that's huge, yeah, it shows that they're really invested in getting this right, yeah, and
Speaker 1 14:35
that's where you, the listener come in. Yes, our deep dive today has hopefully given you a solid understanding of what TCE is all about, right, and what it could mean for the future of healthcare, yeah, but this is just the beginning. Is still curious. Keep learning, share what you've learned with others, yes, and if you're passionate about a particular medical technology, mm. Or if you have personal experience that could be valuable, right? Make your voice heard during those public comment periods. Yes, very important. Your insights and experiences could genuinely help shape the future of healthcare for millions of people. They really could, who knows, maybe that life changing medical device we talked about at the beginning, the one that could mean getting back on your feet faster after surgery or getting access to a revolutionary new treatment, maybe it'll be available to you or someone you love sooner than you think that's right, thanks in part, to TCE and the people who helped shape it. I truly hope so. Stay curious out there.
Transcribed by https://otter.ai
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.