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After consideration of the public comment we received and our ( review of the application, we have determined that the SCOUT MD TM Surgical Guidance System meets the newness criterion at 419.66(b)(1)

Section 1833(t)(8)(C)(ii) of the Act specifies that the Secretary must reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed a specified percentage

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Model utilities, disutilities, and the costs of serious adverse events were sourced from published literature

This composite hydrogel can promote the viability and adhesion of rat ADMSCs