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A product included within the suite of cellular- and tissue-based products that aid wound healing

and where comorbidities are either not present or not addressed, and/or when the billing practitioner has not taken responsibility for ongoing medical care for that particular patient with consistency and continuity over time, or does not plan to take responsibility for subsequent, ongoing medical care for that particular patient with consistency and continuity over time (85 FR 84570 and 84571, 88 FR 78971)

Rather, the reconciled rebate amount is an update to the rebate amount owed to CMS by a manufacturer of a Part D rebatable drug