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The tradeoff is that low doses (2.5 mg = 12.5 units) fall between the unit markings on most insulin syringes, requiring patients to estimate halfway between the 12 and 13 marks

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To reflect relevant product characteristics, we are finalizing to group skin substitutes that are not drugs or biologicals (that is, biological products licensed under section 351 of the PHS Act) using three CMS payment categories based on FDA regulatory pathways (PMAs, 510(k)s, and 361 HCT/Ps) to set payment rates