- Final rule Federal Register homepage here.
- Early-edition (inspection copy) of rule, here.
- Typeset Fed Reg publication August 16.
T2 Wins NTAP
CMS granted New Technology Add-On Payment status (NTAP) to the T2 Bacteria Panel, a molecular test for rapid pathogen identification in sepsis. Discussion, which is pretty grueling, having to block and tackle many CMS concerns, is at page 695-725. The add-on payment is capped at $97.
In other infectious disease news, some inpatient antibiotics also met NTAP criteria.
NTAP Rulebook Updated
CMS published and finalized some very lengthy policy initiatives for the New Tech review process, most notably, FDA Breakthrough Devices will automatically meet the "substantial clinical improvement" criterion for NTAP. (726ff).
New Breakthrough Rule About to Break Through
Entirely separate from this IPPS final rule, on August 2, some trade journal sources noted that a CMS rulemaking on other ways of handling Breakthrough Devices was at OMB review awaiting release. In fact, CMS and FDA have been discussing such a Breakthrough rule for a couple of years now.
No Change for CAR-T
CMS raised the NTAP percent payment from 50% to 65% in general, and 75% for certain new FDA approved antibiotics (QIDPs).
However, despite what was likely a mountain of comments, CMS makes no change to CAR-T policy.
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More on T2.
Overall, T2 Biosystems shares have slipped from $23 to 60 cents over five years. Market cap is about $27M, about the same as cash-on-hand. The stock was down 50% this week on weak revenue growth, independent to the after-market release of the CMS NTAP news.
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See the press release on the Final IPPS rule, here. For discussion of citations of President Trump by name in the materials, here.
No Change for CAR-T
CMS raised the NTAP percent payment from 50% to 65% in general, and 75% for certain new FDA approved antibiotics (QIDPs).
However, despite what was likely a mountain of comments, CMS makes no change to CAR-T policy.
___
More on T2.
Overall, T2 Biosystems shares have slipped from $23 to 60 cents over five years. Market cap is about $27M, about the same as cash-on-hand. The stock was down 50% this week on weak revenue growth, independent to the after-market release of the CMS NTAP news.
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See the press release on the Final IPPS rule, here. For discussion of citations of President Trump by name in the materials, here.
