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The largest US physician organization has created a billing code for what's expected to be the nation's third COVID-19 vaccine, moving ahead of an anticipated regulatory filing for emergency clearance of the product.
The American Medical Association (AMA) on Tuesday said the Current Procedural Terminology (CPT) code set has been updated to include the Johnson & Johnson (J&J) /Janssen vaccine, which has been assigned the code 91303.
New Brunswick, New Jersey–based J&J is awaiting phase 3 data from a study of its single-dose vaccine, which could be available as early as late January, a company spokesman told Medscape Medical News on Wednesday.
If the vaccine continues to appear to be safe and effective, J&J will file with the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of the vaccine "shortly" after seeing these data. The FDA in December granted EUAs for two COVID-19 vaccines — the first from the Pfizer-BioNTech collaboration and the second from Moderna Inc.
J&J's single-dose vaccine would mark "a big change" from the Pfizer-BioNTech and Moderna vaccines, which are given in two-dose regimens, noted AMA President Susan R. Bailey, MD, in a statement.
"The change will place greater importance on accurately reporting COVID-19 immunizations by vaccine type and dose to ensure patients complete the appropriate immunization schedule," Bailey said. "Unique CPT codes that clinically distinguish each COVID-19 vaccine provide the needed informational precision to ensure optimal vaccine distribution and administration."
The New England Journal of Medicine published interim phase 1/2a trial results January 13 for J&J's vaccine. After a single vaccination, neutralizing antibodies against COVID-19 were detected in more than 90% of study participants at day 29, Jerald Sadoff, MD, and coauthors reported.
It is expected that an EUA clearance for the single-dose J&J product might significantly boost the overall number of immunizations available against COVID-19, Medscape Medical News reported.
The AMA also created CPT codes for the Pfizer-BioNTech and Moderna vaccines before the FDA granted EUAs for them.
Kerry Dooley Young is a freelance journalist based in Washington, D.C. She earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.
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Cite this: J&J COVID Vaccine Gets Unique CPT Code Even Before FDA Filing - Medscape - Jan 22, 2021.