For several years, CMS granted a special easier review path for new devices that had breakthrough status, and who wanted NTAP (hospital extra payment) or the equivalent in OPPS.
In Inpatient rulemaking released around August 1, CMS didn't kill the BT pathway, but gaved it a timed closure date. You still get the easy road if you get BT from FDA by 9/30/2026, and if you get FDA approval by 5/1/2028.
9/30/2026 isn't coincidental, it gives you 60 days notice from August 1, and it is the day before the new Fiscal Year for FY policymaking.
Steve Farmer, a physician who held a senior role at CMs, discusses in detail at Linked In. And, they link to an even longer article.
https://www.linkedin.com/posts/activity-7493659447328927744-fBZl
For even more detail:
