FDA Approval: SARCLISA (ISATUXIMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA761113 · Hematology
CriticalSarclisa (isatuximab) is an injectable CD38-directed cytolytic antibody approved for multiple myeloma, administered via intravenous injection and billing under Medicare Part B. As a hospital or office
View alertFDA Approval: BESREMI (ROPEGINTERFERON ALFA-2B) — Type 1 - New Molecular Entity
Policy FDA-BLA761166 · Hematology
CriticalBesremi (ropeginterferon alfa-2b) is a subcutaneously administered injectable approved for polycythemia vera, supporting a Part B billing pathway as a physician-administered drug. As an orphan drug in
View alertFDA Approval: ARGATROBAN (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA209552 · Hematology
HighThe recent FDA approval of Argatroban as an injectable drug suggests it will likely be assigned a J-code for billing under Medicare Part B. Since it is an anticoagulant, providers may receive pass-thr
View alertFDA Approval: ARGATROBAN IN DEXTROSE (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA201743 · Hematology
HighArgatroban in dextrose is an injectable medication that is likely to receive a J-code assignment for Medicare billing. Since it falls under Part B, billing may involve ASP+6% reimbursement if it meets
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