CMS Announces Medicare Coverage for Short-Term COVID-19 Therapy

CMS announced that Medicare coverage will now extend to monoclonal antibodies for coronavirus treatment in certain cases.

Monoclonal antibodies are lab-constructed antibodies, the National Institute of Health (NIH) has explained. They prevent viruses from entering the cell and starting the infection. These antibodies are delivered through infusion.

According to the NIH, monoclonal antibodies can provide short-term protection from coronavirus until a vaccine is successful and distributed.

The Food and Drug Administration (FDA) issued an emergency use authorization of monoclonal antibodies the day before the CMS announcement. Eli Lilly and Company is the pharmaceutical manufacturer producing the authorized therapy.

“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 CMS Administrator Seema Verma.

“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.”

At first, monoclonal antibodies will go to healthcare workers. Medicare will cover the infusion process, but healthcare workers will pay for the product itself.

When Medicare beneficiaries begin to receive monoclonal antibody infusion, they will see no copayment and no deductible for the infusion.

For Medicare Advantage beneficiaries, providers will send the claim for the infusion directly to Original Medicare.

CMS will set the Medicare price for monoclonal antibodies similar to the way it set the Medicare payment rate for the future coronavirus vaccine. For example, it may set the price at 95 percent of the average wholesale vaccine price.

The agency promised to provide billing and coding guidance soon.

“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 announcement stated.

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.

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.”

The FDA has specified that emergency use authorization is distinct from traditional FDA approval.

Medicare beneficiaries who can receive the infusion therapy for monoclonal antibodies, known as bamlanivimab, would have to fall under the specifications that FDA has outlined.

“Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization,” the FDA specified. “This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

Importantly, this treatment cannot be applied to beneficiaries who are hospitalized or who need oxygen therapy.