CMS Approves Coverage of COVID Antibody Treatment for Medicare Beneficiaries  

New COVID cases reported daily have more than doubled during recent weeks, since a more modest July surge.

As the nation’s COVID-19 pandemic continues to spiral out of control, federal authorities are racing to find ways to mitigate the spread.

The Centers for Medicare & Medicaid Services (CMS) announced last week that Medicare beneficiaries will be eligible to receive coverage of monoclonal antibodies to treat COVID, with no cost-sharing, during the duration of the current public health emergency (PHE). The coverage will apply to monoclonal antibody infusion of bamlanivimab, which received an emergency use authorization (EUA) from the U.S. Food and Drug Administration just days ago.

“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,” CMS Administrator Seema Verma said in a statement. “Our timely approach means beneficiaries can receive these potentially lifesaving therapies in a range of settings – such as in a doctor’s office, nursing home, (or) infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives.”

New COVID cases reported on a daily basis in the U.S. climbed to nearly 40,000 during an early-year surge affecting major metropolitan areas on both coasts, a figure that soared to 75,000 during a more widespread secondary surge occurring in July. But that metric has exploded during recent weeks, with a staggering record 184,000 new cases reported in the U.S. in one 24-hour period over the weekend.

As of the weekend, nearly 70,000 people nationwide were hospitalized with COVID – a figure greater than the capacity of more than half of NFL stadiums.

CMS in its announcement said it anticipates that the monoclonal antibody treatment will initially be given to healthcare providers at no charge, but it would cover any charges incurred going forward in other circumstances. When providers begin to purchase monoclonal antibody products, Medicare anticipates setting the payment rate in the same way it set the payment rates for COVID-19 vaccines – 95 percent of the average wholesale price for such vaccines in many provider settings, for example. This means that cases involving monoclonal antibody treatment will not be eligible for the enhanced payment established under the Medicare Inpatient Prospective Payment System (IPPS) in CMS-9912-IFC.

CMS added that it will issue billing and coding instructions for providers in the coming days.

“CMS anticipates the announcement today will allow for a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract, to administer this treatment in accordance with the EUA, and bill Medicare to administer these infusions,” the agency said in its announcement.

Under Section 6008 of the Families First Coronavirus Response Act (FFCRA), state and territorial Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP), through the end of the quarter in which the COVID-19 PHE ends, officials added. A condition for receipt of this enhanced federal match is that a state or territory must cover COVID-19 testing services and treatments, including vaccines and their administration, specialized equipment, and therapies for Medicaid enrollees without cost-sharing. This means that this monoclonal antibody infusion is expected to be covered when furnished to Medicaid beneficiaries, in accordance with the EUA, during this period, with limited exceptions.

To view the CMS Monoclonal Antibody COVID-19 Infusion Program Instruction, go online to https://www.cms.gov/files/document/covid-medicare-monoclonal-antibody-infusion-program-instruction.pdf.

The global COVID-19 pandemic has sickened nearly 55 million people worldwide, killing an estimated 1.3 million. The United States accounts for approximately 11.2 million cases and 250,000 deaths alone.