After literally 4-5 years of rumor mill and dsicussion, CMS has finally released a proposed rule on innovative coverage ideas for FDA breakthrough devices, as well as an effort to "define reasonable and necessary" - something President Trump asked the agency to do in an 2019 executive order.
- The proposed rule will be HERE. See my early cloud copy here.
- The CMS press release is here.
- The press release is quite detailed.
- The rule has been in draft form since at least 12/2019 here.
- See my review backwards to 2016, which I blogged in 8/2019, here.
- Early press coverage at Mass Devices here. At 360Dx here. At WSJ here. At Becker's here.
- Subscription-only coverage at Politico Pro here.