Emergency Use Authorization (EUA) for the Janssen Biotech Inc.’s COVID 19 Vaccine
The FDA has issued an Emergency Use Authorization (EUA) for the Janssen Biotech Inc.’s COVID 19 Vaccine for individuals 18 years of age and older, so Medicare will cover and pay for the administration of the vaccine when furnished in line with the EUA. You only bill for the vaccine administration codes when you submit claims to Medicare since the vaccines are free. To know more, read along!
The U.S. Food and Drug Administration (FDA) has, on the 27th of February 2021, issued an Emergency Use Authorization (EUA) for the Janssen Biotech Inc.’s COVID 19 Vaccine for individuals 18 years of age and older. So, Medicare will cover and pay for the administration of the vaccine when furnished in line with the EUA during the COVID-19 Public Health Emergency (PHE).
To get specific COVID-19 vaccine information, you may want to review payment and HCPCS Level I CPT code structure (COVID-19 Vaccines and Monoclonal Antibodies). You only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes, because the vaccines are free.
Summary of instructions for COVID-19 vaccination providers
The Janssen COVID-19 Vaccine is a suspension for intramuscular injection and is administered as a single dose (0.5 mL). Vaccination providers enrolled in the Federal COVID-19 Vaccination Program must report the following:
• All vaccine administration errors
• All serious adverse events
• Cases of Multisystem Inflammatory Syndrome (MIS) in adults
• Cases of COVID-19 that result in hospitalization or death following administration of the Janssen COVID-19 Vaccine
For instructions for the preparation and administration of the vaccine, go to this website — www.janssencovid19vaccine.com — to get the most recent information.
To get information on clinical trials that were used in testing the use of the Janssen COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov
Description of COVID-19
COVID-19, coined from coronavirus disease 2019, is an infectious disease caused by the novel coronavirus, SARS-CoV-2, which appeared in late 2019. The virus predominantly causes a respiratory illness but can affect other organs.
The severity of symptoms reported by people with COVID-19 varies widely, ranging from mild symptoms to severe illness, and they usually within 2 to 14 days after exposure to the virus. Some of the common symptoms of the disease include fever with chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, nasal congestion or runny nose, nausea, vomiting, and diarrhea.
https://www.fda.gov/media/146304/download
