COVID-19 VEKLURYTM (remdesivir)
Following the recent statement from the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel about therapies for the COVID-19 Omicron variant, CMS created HCPCS code J0248 for VEKLURY™ (remdesivir) antiviral medication when administered in an outpatient setting.
COVID-19 Monoclonal Antibody Products
The FDA authorized the following investigational monoclonal antibody product under EUA for pre-exposure prophylaxis of COVID-19:
Important Update about Viral Variants
On April 16, 2021, the FDA revoked the EUA for bamlanivimab, when administered alone , due to a sustained increase in COVID-19 viral variants in the U.S. that are resistant to the solo product.
Medicare Coverage for COVID-19 Monoclonal Antibody Products
During the COVID-19 public health emergency (PHE), Medicare will cover and pay for these infusions (when furnished consistent with their respective EUAs) the same way it covers and pays for COVID-19 vaccines.
Coding for the Administration of COVID-19 Monoclonal Antibody Products
CMS identified specific code (s) for each COVID-19 monoclonal antibody product and specific administration code (s) for Medicare payment:
Medicare Payment for Administering COVID-19 Monoclonal Antibody Products
To ensure immediate access during the COVID-19 PHE, Medicare covers and pays for these infusions and injections in accordance with Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) .
Billing for Administering COVID-19 Monoclonal Antibody Products
Health care providers can bill on a single claim for administering COVID-19 monoclonal antibody products, or submit claims on a roster bill.
What are monoclonal antibodies?
Our bodies naturally make antibodies to fight infections. However, if you haven’t received the COVID-19 vaccine or had a previous COVID-19 infection, your body will not have antibodies designed to recognize a new virus like SARS-CoV-2.
How does monoclonal antibody therapy help?
Monoclonal antibody therapy is a way of treating COVID-19 for people who have tested positive, have had mild symptoms for seven days or less, and are at high risk for developing more serious symptoms.
Who is eligible for monoclonal antibody therapy?
Given that COVID-19 vaccination provides strong protection against severe disease and need for hospitalization, monoclonal antibody therapy is an option for certain high-risk patients with COVID-19.
What is the FDA approved monoclonal antibody?
Department of Health and Human Services (HHS), two different monoclonal antibody treatments have been authorized for emergency use by the FDA. One is bamlanivimab, and the other is a mixture of casirivimab and imdevimab. Over 600,000 such treatments have been shipped to U.S. health care facilities.
Is monoclonal antibody free?
The federal government is currently distributing monoclonal antibodies for free, but some health care providers may be charging patients for administering the treatment. These costs may be covered if the patient has insurance. If not, it is advised to ask the treatment facility if there will be any charges.
