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[352] For the reasons explained above, we do not believe gene therapies for hemophilia meet the definition of a clotting factor for purposes of Medicare payment, but even if they did, they still would not be eligible for the furnishing fee because the costs associated with furnishing these gene therapies would already be reflected in applicable administration codes paid under the Physician Fee Schedule

Avoid vigorous agitation or vortexing, which may compromise peptide integrity through mechanical stress

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The only human trial ever registered (NCT02637284) was cancelled in 2016 without publishing results

Instructions provided for self-injection technique