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Topical numbing can be applied to the injection site

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These symptoms are more likely linked to the underlying condition causing the elevated B12 levels, rather than the high B12 levels themselves 17

We sought comments on whether these products should meet a substantial clinical improvement standard or whether, consistent with current pass-through policy, a device that has received marketing authorization for an indication covered by FDA's Breakthrough Devices Program would generally represent clinically-relevant innovation sufficient to qualify for a product-specific payment rate