Melinta Therapeutics announced two important milestones for KIMYRSA™ (oritavancin), a lipoglycopeptide antibiotic that was launched in July. The Centers for Medicare & Medicaid Services (CMS) has issued a permanent product-specific J-code (J2406) for KIMYRSA Injection effective October 1, 2021. CMS has also granted transitional pass-through status for KIMYRSA in the Hospital Outpatient Department (HOPD) setting of care. KIMYRSA delivers a complete course of therapy for acute bacterial skin and skin structure infections (ABSSSI) in a single, one hour, 1,200 mg infusion. The U.S. Food and Drug Administration approved KIMYRSA on March 12, 2021, for the treatment of adult patients with ABSSSI caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). The unique J-code enables reimbursement for KIMYRSA in all outpatient treatment settings. Pass-through status is intended to protect Medicare beneficiaries’ access to innovative drugs, such as KIMYRSA, and ensures that KIMYRSA will be reimbursed at average sales price for three years, regardless of changes for other drugs.2 Drugs with pass-through status are not subject to the payment reduction applicable to drugs purchased through the 340B program.