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and Demonstrate a substantial clinical improvement, that is, substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment, or, for devices for which pass-through payment status will begin on or after January 1, 2020, as an alternative pathway to demonstrating substantial clinical improvement, a device is part of the FDA's Breakthrough Devices Program and has received marketing authorization for the indication covered by the Breakthrough Device designation

B12 injections provide a safe and effective alternative

B12 injections for fatigue and energy Correcting a B12 deficiency frequently resolves fatigue, since B12 is essential to red blood cell production and neurological function

The abdominal region is the preferred injection site, though thighs and upper arms are acceptable alternatives