Operation Warp Speed and Preparing for COVID-19 Vaccine
As a COVID-19 vaccine becomes closer, the big questions are who will get it and when? There has been some talk about it being widely available very soon, but most of the potential vaccines are not in clinical trials yet. Once a vaccine (or vaccines) becomes available, though, distribution should happen very quickly.
Massive Effort to Develop a Vaccine
Operation Warp Speed (OWS) is a government program consisting of a partnership between several Department of Health and Human Services (HHS) agencies. It includes the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA), and Food and Drug Administration (FDA). The Department of Defense (DoD) is also part of the operation.
OWS oversees the nearly $10 billion allocated to various pharmaceutical companies for the development and production of a vaccine. Unlike coronavirus tests, which are very limited, HHS reported that 14 vaccine candidates have been chosen and are under development (over 100 were proposed).
The plan is to narrow that number down to about seven promising candidates for clinical trials.
Funding many different developers is an effort to speed up success and also allows for several different technologies to be used, including viral vector, nucleic acid, and protein subunit vaccines.
It is the administration’s assertion that individuals will have low or no out-of-pocket costs for the coronavirus vaccine, but like flu vaccines and COVID testing, it is likely that insurers and government health care payers will be charged.
Medical billers and coders will need to stay aware of any new codes issued by the Centers for Medicare & Medicaid Services (CMS) and American Medical Association (AMA).
Insurers may also have their own submission requirements and limitations on what they will cover, so again, billers must make sure that all claim submissions meet any requirements specific to vaccines.
Because of the rush to get the vaccine delivered, as soon as an approval or emergency use authorization (EUA) is issued, there will likely be medical codes submitted for use, but these may not be effective immediately.
For billing purposes, it is important to make sure the date of the service is after the code becomes effective, or the claim will be denied, even though the code would be correct should the vaccine be given on the date that the claim is sent in.
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