(1) Alternative Pathway for Certain Transformative New Devices For applications received for new technology add-on payments for FY 2021 and subsequent fiscal years, a medical device designated under FDA's Breakthrough Devices Program that has received FDA marketing authorization will be considered not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS, and will not need to meet the requirement under 412.87(b)(1) that it represent an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries
The unfortunate truth is that big risk signals (lets say the kind you get from drinking antifreeze) can be spotted from the anecdotal experience of people in the world just trying things, but small-but-serious risk signals (lets say cardiovascular disease with tofacitinib) are really hard to identify without a proper trial or a proper observational study
Lactic acid production by tumor cells, as a byproduct of aerobic or anaerobic glycolysis, has also been shown to play a vital role in the M2-like polarization of TAMs, which is mediated by HIF- 1 (294)
Provides baseline data relevant to inflammation, immune status, and overall systemic health before any new compound exposure
