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Following the approval by the U.S. Food and Drug Administration (FDA) of emergency use authorization for the investigational monoclonal antibody therapy, bamlanivimab, the Centers for Medicare & Medicaid Services (CMS) announced it will cover monoclonal antibody therapies, with no beneficiary cost-sharing for the duration of the COVID-19 public health emergency.
Bamlanivimab, which is authorized to treat certain patients with mild-to-moderate COVID-19 diagnosis, must be administered in settings where health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system if necessary.
CMS also said it anticipates that bamlanivimab and other, similar therapies will initially be given by drug makers to health care providers at no charge and will not pay for those monoclonal antibody products that providers receive for free. However, CMS will reimburse hospitals for the infusion of bamlanivimab at a rate of $309.60.
CMS also states that when providers begin to purchase monocolonal antibody products, it anticipates setting the payment rate in the same manner it uses to set COVID-19 vaccine payments. CMS provides additional details for providers about Medicare coding, payment, and billing for monoclonal COVID-19 products and their administration in its Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction.