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As specified in regulations at 419.66(b)(1) through (3), to be eligible for transitional pass-through payment under the OPPS, a device must meet the following criteria: If required by FDA, the device must have received FDA approval or clearance and FDA marketing authorization (except for a device that has received an FDA investigational device exemption (IDE) and has been classified as a Category B device by FDA), or meet another appropriate FDA exemption
Inclusion would allow licensed pharmacists and physicians to use them in patient-specific compounded prescriptions
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10.1016/j.tem.2019.07.006 109 TeplovaI.LozyF.PriceS.SinghS.BarnardN.CardiffR
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