Brief Blog: Big News: CMS Releases Innovative Coverage Rule; Breakthrough Devices

 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.

I've head the theory this morning that CMS seems to remark at one point in this proposal that it doesn't include "diagnostics," yet the regulation is about "devices" and "devices" at FDA includes "diagnostics" already.[*]  To be continued.   If the rule does include diagnostics under the umbrella of devices, then it provides a huge incentive to get FDA approval/clearance, if it is of the breakthrough type.   Even though just days ago HHS ruled that FDA can't require review of LDTs (here).  Whew.

For some 2019 background, see a 12/2019 House bill that would have effected coverage of innovative devices, here.  

For a March 2020 article about coverage & breakthrough devices, prior to today's new-news, here.

[*]

The rule is for breakthrough devices, which for FDA explicitly includes both interventional devices and diagnostic devices (and diagnostics include both lab test diagnostics and diagnostic machines like MRI).   On page 15, CMS asks the public if "the pathway should also include diagnostics or drugs" implying it doesn't include diagnostics or drugs as-is.  However, the regulation as proposed is automated CMS coverage for FDA breakthrough devices, which includes diagnostics both in theory and in practice.   And despite a sentence or two adverse to Dx in the Rule, the accompanying CMS Fact Sheet says that the rule does include diagnostics (here).

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For deep background, CMS tried to define Reasonable and Necessary way bacck in 2000 (here), as discussed in a Health Affairs article by Sean Tunis & Jeff Kang here.