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Most CMS rules go through one cycle of comments; the MCIT rule has gone through three, garnering 115 comments in the third cycle just completed. Links provided.
I have also pulled about a dozen major comments and placed them in a cloud ZIP file for readers.
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What Happened?
As shown in the figure above, under the Trump Administration, CMS proposed "Medicare Coverage for Innovative Technologies" in September 2020 (85FR54327). The final rule was published January 14, 2021, effective March 15, 2021. It would have provided 4 years of coverage for new FDA cleared or approved "breakthrough devices" without requiring favorable LCDs or NCDs for coverage.
CMS, under the Biden Administration, delayed the rule (with comments opened) on March 17, and delayed it again on May 18. Finally, on September 15, 2021, CMS proposed a new final rule that would in effect simply revoke the January 2021 final rule, and a third comment period September 15-October 15, 2021.
Links
See the original January 2021 final rule here - the rule which is currently in place, but suspended until December. See the September 2021 rule here - the one whose comment period just closed. See the "unified agenda" showing all the different publications and comment dates, here. See the comments, 115 of them, for the comment period just closed, here.
Trade Press
See an October 2021 article in HealthCareDive by Nick Paul Taylor summarizing some of the major comments, such as AdvaMed's and MDMA's (Medical Device Mfgr Assoc). Here.
Next Steps
The current CMS administration will want to act on this rule and comment cycle by December 2021, when the "delay" of the Trump rule from January 2021 will expire.
To accomplish the MCIT by lawmaking on the Hill rather than by CMS policy action, bills like the "Ensuring Patient Access to Critical Breakthrough Products Act" are being introduced - here.
Zip File
I've made a search through the 115 comments for some names I recognized, and I've placed those comments in a cloud Zip file for readers - here. (4 mb).
Comments I pulled included AAMC, Abbott, ACLA, Advamed, AMP, BIO, C21M, DTA, Masimo, MDMA, Medtronic, Misonix, PCMA, PHRMA, PMC. With the keywords I used, I didn't find comments from CAP or AMA.
My "Informal" Comment Notes
I'll show you my scratchpad. I put some very informal personal notes on the comments in a separate webpage here. These are only informal notes and you should see the full association statements for their positions.
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Footnote.
My original September 2020 blog and links on the first Trump version of MCIT is here.
Some negative Op Eds appeared in December 2020 (and later); December blog here.
See my August 2019 blog on the history of Breakthrough coordination between CMS and FDA, going back to 2016 - here.
It would be helpful if Federal Register and Regulations.gov listed the comments by the submitter's organization, but they don't. When you click to see the 115 comments, all you see is screenfuls of the comment document index numbers, one after another. (It's even worse when there are 2000 comments).
