The playwright George Bernard Shaw is credited with having said, “the single biggest problem in communication is the illusion that it has taken place,” a remark device makers might apply to their interactions with FDA and the Centers for Medicare & Medicaid Services.
Those two agencies might have similar observations about device makers, too.
Still, we’ve all discovered it’s not always easy to communicate clearly, especially when complex matters are at hand. So let’s dig into the story behind a recent development at FDA and a long-standing communication hurdle between CMS and device makers.
FDA recently issued a draft standard operating procedure for its communiqués with device makers regarding how recent evidence might affect the agency’s expectations of device applications. The draft SOP is interesting in two ways.
One of these is that it is a re-draft of a 2011 version that described two types of communications, the notice-to-industry (NTI) letter and the immediately-in-effect (IIE) letter.
The NTI letter – which would have functioned to communicate an emerging consideration rather than an immediate change – does not appear in this latest draft. To make matters more interesting, the agency does not explain the omission. Will FDA take up the NTI letter in a separate draft SOP? It’s not clear.
What we do know, however, is that FDA will use the IIE letter to let industry know when the existing standards for safety and/or efficacy for a device/indication simply don’t cut it. Industry would have 60 days to argue, but the terms of the IIE letter would go into force 90 days after the comment period closes.
The second reason this new draft SOP is interesting is that the often-contentious relationship between industry and agency makes one wonder why FDA opted to let the NTI letter slide, especially since it’s a vehicle for giving device makers the heads-up when such changes might be in the offing.
As matters stand, the net effect is that FDA has restricted its options to an 11th-hour approach to informing device makers that the regulatory standards for device applications have changed – to the complete exclusion of something more proactive.
Defining your terms; substantial clinical improvement
The new technology add-on payment mechanism has been in play at CMS for nearly a decade, and device makers generally like the program because it gives them a reason to innovate, including when that innovation carries a higher price tag than the current standard of care. The benefit for patients is that they have access to devices that do the job a lot better than that standard of care. One of the things a device maker has to demonstrate to qualify for a new tech add-on payment is that the offering renders “substantial clinical improvement” over the current suite of offerings.
Device makers will say this term of art is sufficiently fuzzy that it’s tough to plan trials around it. So a device maker might ask why there’s no standard metric for “substantial clinical improvement.”
We might assume there are a couple of obvious reasons for this. One is that poorly met needs will always draw more leniency from both FDA and CMS. The same goes for patients in dire straits.
Another problem is that it’s no mean feat to come up with a rubric that works across device types and across disease states. There’s also this question of a “level playing field.” By that I mean device makers might react badly if CMS told industry that one device type has to offer a 15% reduction in morbidity (to pick a number out of thin air), then propose an entirely different standard for another device type.
Like it or not, CMS and industry are stuck with the task of making up the meaning of “substantial clinical improvement” as they go along. It’s ugly and messy, but it’s probably the least obnoxious of their options.