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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66

Q: When will I see results

A few commenters expressed concern about the measure scoring methodology, specifically, the complexity of the reporting requirements and the actionability of the data

While the evidence supporting an association between PD and vitamin B12 deficiency is limited, the findings that those with low B12 levels at the time of Parkinsons diagnosis went on to have worse postural stability and gait issues is a useful take away finding

The VitB5 of all study subjects was within the normal range (Fig