Medicare beneficiaries will not have to pay out-of-pocket costs for coverage of monoclonal antibodies to treat COVID-19 during the public health emergency, CMS announced on November 10, 2020. The agency’s coverage will apply to bamlanivimab, Eli Lilly’s monoclonal antibody infusion, which received an FDA emergency use authorization on November 9, 2020. Antibodies are proteins produced by the immune system that protect the body by binding to specific targets. COVID-19 monoclonal antibodies are synthetic versions of antibodies that target the virus and are administered intravenously by infusion to treat mild to moderate COVID-19.
CMS anticipates that bamlanivimab and similar antibody products will initially be given to health care providers for free. CMS will not pay for monoclonal antibody products that providers receive at no charge. However, CMS will reimburse providers for the infusion of products provided for free. CMS anticipates that its announcement will allow home health agencies, freestanding and hospital-based infusion centers, and nursing homes and related entities to begin administering bamlanivimab and billing Medicare for these infusions.
In a Program Instruction released with the announcement of the CMS payment policy, CMS indicated that the initial Medicare payment rate for the infusion of the bamlanivimab product will be $309.60. The rate is based on one hour of infusion and post-administration monitoring in the hospital outpatient setting. The rate will be adjusted for geography. As additional monoclonal antibody products are approved, CMS may use a similar methodology to set the payment rate, based on the expected infusion time.
When health care providers begin to purchase monoclonal antibody products, CMS anticipates setting the payment rate in the same manner it set the payment rates for COVID-19 vaccines. In many provider settings, for example, reimbursement for COVID-19 vaccines is based on 95% of the average wholesale price. CMS has indicated that cases that include the use of monoclonal antibody COVID-19 products will not be eligible for the enhanced payment established under the Medicare Inpatient Prospective Payment System (IPPS) in CMS-9912-IFC. CMS plans to issue billing and coding instructions in the coming days. King & Spalding will continue to monitor this issue.
The CMS press release is available here. The FDA’s EUA for bamlanivimab is available here. The Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction is available here.