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In order to evaluate substantial clinical improvement over currently available treatments to meet the transitional pass-through payment criterion at 419.66(c)(2), we stated that we consider supporting evidence, preferably published peer-reviewed clinical trials, that demonstrates improved clinical outcomes, such as reduction in mortality, complications, subsequent interventions, future hospitalizations, recovery time, pain, or a more rapid beneficial resolution of the disease process comparing the nominated device to the standard of care (88 FR 81733)

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Multivariable analyses for major complications identified old age, open surgery, and visceral fat as independent risk factors, while subcutaneous fat area on preoperative CT scan was independent protective factor

The 'why' behind your research dictates the 'when' of your administration