This article was updated on November 16, 2020.
As of yesterday, November 11, Medicare beneficiaries will receive coverage of monoclonal antibodies to treat COVID-19 with no cost-sharing during the public health emergency (PHE). The Centers for Medicare and Medicaid Services coverage of monoclonal antibody infusions applies to bamlanivimab, which the FDA approved for emergency authorization.
“Today, CMS is announcing a historic, first-of-its-kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost-sharing,” said Seema Verma, CMS Administrator. Verma added that she believed that the new initiative will benefit all freestanding and hospital-based infusion centers, home health agencies, and nursing homes.
According to CMS, the monoclonal antibody will be given to providers at no charge, at least at first. Medicare will not pay for the monoclonal antibody products that providers receive for free but will reimburse providers for the infusion costs. Again, this means that there will be no cost to Medicare beneficiaries and the antibody test providers will be reimbursed for infusion costs.
CMS provided the code for Medicare reimbursement or the monoclonal infusion. The Medicare reimbursement rate for monoclonal infusion is $309.60.
“This payment rate is based on one hour of infusion and post-administration monitoring in the hospital outpatient setting,” CMS explained in a fact sheet. “This rate will also be geographically adjusted. At a later date, we may use a similar methodology to determine the payment rate for the infusion of additional monoclonal antibody products based on the expected infusion time, consistent with the FDA emergency use authorization or FDA approval of such products.”
As providers start buying the monoclonal antibodies, CMS said it will likely set the payment rate in the same way it set the payment rates for COVID-19 vaccines.
“Our timely approach means beneficiaries can receive these potentially life-saving therapies in a range of settings – such as in a doctor’s office, nursing home, infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives,” said Verna.
What are monoclonal antibodies?
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells, according to CMS. Note: Bamlanivimab cannot be applied to beneficiaries who are hospitalized or who need oxygen therapy.
Click here to view the Monoclonal Antibody COVID-19 Infusion Program Instructions.
Medicaid programs also must cover monoclonal antibodies
Medicaid programs also must cover monoclonal antibodies as part of compliance with the Families First Coronavirus Response Act (FFCRA) coronavirus testing and treatment rules.
If state Medicaid programs do not cover monoclonal antibodies, with certain exceptions, then they may no longer qualify for the 6.2 percentage point Federal Medical Assistance Percentage (FMAP) boost for the public health emergency period.