CTP Evidence Standards Causing Industry Confusion

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• CMS (US) — 93% revenue reduction: Manufacturers report that drastic reimbursement cuts make funding new product research unsustainable, leading to delayed or canceled 3–4-year development plans and reduced availability of low-cost innovations.
• LCD evidence standards unclear: CMS has not specified whether acceptable evidence must be RCTs vs real-world evidence, the required treatment effect size, or standardized measures (e.g., Braden Scale), and some CMS-approved products no longer exist on the market.
• Feasibility concerns for small/mid-sized companies: With <12 months to generate evidence—vs typical 18–24 months for RCT recruitment—many companies cannot conduct trials, especially given limited site availability and costs; CMS expectations diverge from FDA requirements under PHS Act §361, creating regulatory conflict.

Please note: This content is a direct transcript, capturing the authentic conversation without edits. Some language may reflect the flow of live discussion rather than polished text. 

Well, it's interesting. The recent changes and the regulatory environment we find ourselves in is specific to research and innovation on new products. You can't expect companies to have 93% fewer revenues and still be able to fund their research. So with Venture (Medical), we have a three- or four-year plan for three different products to be studied to be released into the U.S. market. And some of those are going to have to be put on hold. We're going to have to actually delay products that could really help patients at a low cost in favor of those that might be more lucrative for us. And so I think a lot companies are really looking at shelving research on new products because the revenue that would drive them perform that research is just drying up with the stroke of a pen.
 
To answer whether the requirements clinical data by CMS and the LCDs is feasible or not, you first have to ask the question: What are those requirements? CMS has not been clear. They have talked about the Braden scale, HQAs put out, that really doesn’t give any specificity to whether these need to be randomized controlled trials, whether they can also include real-world evidence, which is the opposite of that, which they talk about as well. They don't talk about what kind of treatment difference they're looking for or how great that might need to be. And if you look at the covered list of products that they say meet their evidentiary standards, not one of them meets all the standards that they profess to adhere to. So, and then you've got products that they've approved of that aren't even marketed anymore. 
 
So I think the overall industry is very confused. And for a small- and mid-sized business, you know, there's only a certain number of clinical trial sites that are out there that can recruit patients fast enough to get a randomized controlled trial done in 18 to 24 months. And they gave us less than 12 months to get evidence in. So a small- and a mid-sized business probably isn't going to have the clout with those clinical research organizations to get the trials done, even if there were more time allotted.

So I would say that this is a major source of frustration and confusion among industry and just shows that CMS has been a little bit out of touch with this issue and doesn't really know how to prescribe how to evaluate clinical evidence, which is really the purview of FDA, and it doesn't really make sense that they are prescribing clinical evidence when FDA is saying it's not needed, both in the regulatory process to launch our products under the PHS Act, subsection 361, and in their recent commentary about biosimilars, saying that it's not necessary to have these clinical trials. So they're, in its essence, countermanding FDA. And some would say inappropriately. 
 
And so they've put small- and medium-sized businesses into a box where we can't get the trials done. We can't afford to do the trials. We can't get them done at the time allotted. But we also don't know what the trials are supposed to do exactly. And it's, we find it entirely inappropriate that that the requirements are made of only one item that is an incident 2 item now onto the physician fee schedule. So it's a supply when no other supply items in the physician fee schedule are required to have any sort of randomized controlled trial for a physician to select it for use. 
 
So I think that regulators could align better with practitioners and industry on clinical requirements by actually letting FDA figure out what requirements they want for approval and then potentially looking for post-marketing data, which is more real-world evidence. Randomized controlled trials really don't give an accurate picture of how well a product works in situ, actually in use in the field. They say nothing about how they work once against, well against each other. They have varying exclusion criteria, which can make the data mean one thing or another, depending on how it's construed. And really, I think that they could, meaning CMS could, give more action than just the voice they've given to real world evidence and there's plenty of it out there and we're developing more of it all the time.