The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance.
Interesting item #1: The passage stating that CMS is examining the question of “whether local contractors should have the discretion to apply CED in local coverage” is pretty close to an earthquake.
I’m assuming that most CED trials will have to span more than one Medicare carrier’s jurisdiction, which suggests a patchwork of CED coverage or a need to get multiple carriers on board with a single CED protocol. This might be the worst idea since pet rocks and it’s exceedingly difficult to imagine anyone would want to go this route. Is there a reason not to believe this is CMS’s way of saying: “Come to Baltimore and talk to us about your novel and expensive offerings, not the local carriers”?
Interesting item #2: CMS states that the authority to invoke CED “has existed for more than a decade but has been applied sparingly.” The document states also that CMS “believes that the lessons learned during the initial implementation of CED can inform its more frequent use.”
Interesting item #3: The draft acknowledges that there may be a problem with the fact that coverage of an item or service ends after the CED study ends. CMS suggests sponsors might develop “integrated research strategies during the planning of CED studies” that would allow the use of “practical observational studies to close outstanding evidence gaps and allow coverage” after a randomized, controlled CED trial ends. The fly in the paste here is that this would call for “an interim analysis, based on pre-agreed public criteria … to open or close enrollment in the follow up study.”
So how long will this interim analysis take? That’s how long coverage would be absent.
There’s a lot more to the guidance than is covered here, but a cynic’s guide to the galaxy might state that the agency’s proclaimed interest in using CED more frequently comes with CMS’s unstated but widely suspected effort to draw a tighter noose around Medicare medical device spending. Beyond that, the difference between the old CED and the new CED might be “lots and none at all,” as Bilbo Baggins told the trolls.
FDA-to-CMS trial transition: strictly incidental?
Up to now, the vast majority of Medicare coverage decisions have taken place at the local level, but clearly the ratios are going to change. CMS also seems to argue that its cooperation with FDA is incidental to the CED process. The draft CED guidance states that the agency sees the “alignment of CED with an FDA post-approval study requirement” as nothing more than “an example of a CED application rather than a new CED paradigm.”
I wonder if device makers with first-of-a-kind devices will believe that, given the talk about integrated research strategies, practical observational studies and gaps in coverage after the CED study is over. These “practical observational studies” are yet another clinical study requirement, and device makers are not going to ignore the need to mesh their FDA trial mandates with those of CMS in order to keep the number of studies down to a manageable number. Not if they want to keep investors on board, anyway.
This is anything but a mere “example of a CED application,” and a lot closer to “a new CED paradigm” as best as I can tell. If I’m not mistaken, it’s called “parallel review.”