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Commenters further stated that CMS lacks explicit statutory authority to redefine ASP inputs in this manner because section 1847A of the Act ties ASP to sales to purchasers, not payments to non-purchasing service providers, and the Congress has not directed manufacturers to add specific manufacturing costs into ASP
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The multifactorial pathophysiological mechanisms of diabetic wounds, including chronic hyperglycemia, oxidative stress, persistent inflammation, impaired angiogenesis, and altered cellular function, further aggravate these harms [8]
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