The home page for the final rule is here. CMS has released a "unpublished" early version (typescript); the final typeset version will be released August 17. The rapid version PDF is here. It tallies a hefty 2,593 pages.
The most newsworthy item is that CMS will pay for CART therapies (Kymriah, Yescarta) under standard "new tech" payment rules, which pay hospitals 50% of the extra cost - CMS will pay the hospital e.g. $80,000 of an extra $160,000 cost.
Overall, CMS had 15 new tech products under review, and while 4 dropped out for various reasons, it covered 10 of the remaining 11 candidates. Typically, CMS raises a lot of objections of variable cogency against the products' novelty or value in preliminary rulemaking but is less stringent in final decisions. However, I believe the win rate for industry is higher this year than usual.[*] CMS now liberally creates new tech ICD-10 procedure codes as needed to implement new tech payment rules.
CMS produced the final rule only 35 days after the comment period closed (June 25).
Biorobotic Medtech Wins NTAP for Prostate Surgical Treatment
A Bay Area medtech company, PROCEPT Biorobotics, won a New Technology Add-On Payment (NTAP) for its Aquablation procedure for treatment of BPH. (See pp. 752-782). The procedure is also up for a Category I CPT code in the 9/2018 AMA CPT meeting. Procept successfully raised $118M in February 2018.
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[*] In August 2015, there were only six applicants and four were rejected. Some organizations complained that CMS standards were unreasonably high (here).
