Observations about day two of the MDMA annual meeting
(Posted May 1, 2026, on LinkedIn)
The second day of the 2026 MDMA meeting featured a talk by CMS administrator Mehmet Oz. There was some expectation that Oz would have a lot to say about the Regulatory Alignment for Predictable and Immediate Device (RAPID) proposal, but he didn’t say as much as I’d hoped.
There are times when HHS officials time announcements about programs like RAPID to coincide with these events. CMS posted a press release about RAPID April 23 and said a formal announcement would appear in the Federal Register, but no luck yet. Just what the details will disclose about RAPID is anyone’s guess, but there seems to be a fair amount of skepticism about RAPID.
I’ve heard comments to the effect that RAPID is a rehash of existing program and is a new version of parallel review. One also has to wonder how investors will react. After all, many of their companies are still getting up to speed on the Transitional Coverage for Emerging Technologies (TCET) program, which CMS formally adopted in August 2024. That’s less than two years ago and CMS made clear that RAPID would at least temporarily supplant TCET.
Before TCET, we had Medicare Coverage of Innovative Technologies (MCIT), the subject of a final rule posted in September 2021. One might understand if small firms are scrambling to craft a coherent message to investors with all this programmatic churn. Yes, it’s great that CMS is paying attention to the valley of death between market authorization and payment, but how are manufacturers of FDA-designated breakthrough devices to plan when the environment is this unstable? And let’s not forget that CMS has proposed to do away with the alternative NTAP payment program in the inpatient draft for FY 2027, another dramatic turn for breakthrough devices.
The current edition of the Ensuring Patient Access Act also did not receive as much attention as I thought it might at the MDMA meeting. This bill would solve a lot of the problems encountered with an administrative approach to Medicare coverage of breakthrough devices, and it gives CMS another $10 million a year to handle the administrative load. The problem is that the annual $10 million appropriation disappears after year five. Count me among those who don’t understand Capitol Hill’s seemingly vacillatory approach to this question.
It doesn’t stretch the imagination to say that none of this is easy or we wouldn’t still be talking about it. After all, this all began at least as far back as 2018 with the Patient Access to Critical and Emerging Technologies (PACER) proposal. Perhaps the moral of the story is that this task is simply un-doable as an administrative matter and screams for legislation. Will the legislation for MDUFA VI put an end to this saga by incorporating the Ensuring Patient Access Act? We shall see, but I’m not particularly inclined to try and handicap that.
