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Keeping up with the changes to the COVID vaccines has certainly been a rollercoaster ride and we now have two new twists to this exciting ride. Twist one comes from the FDA who recently pulled the emergency use authorization (EUA) for the monovalent Moderna and Pfizer-BioNTech mRNA vaccines, and instead authorized the bivalent boosters for all doses starting at age 6 months. Twist two is found in the changes taking place as part of the official end to the COVID Public Health Emergency (PHE) beginning May 11, 2023. Buckle up and let’s look at how this changes things.
End of the Monovalent COVID-19 Vaccines
On Tuesday, April 18, 2023, the FDA announced the revision of the EUAs for the Moderna and Pfizer-BioNTech mRNA vaccines so that only a single dose of the bivalent form is now accepted as being fully vaccinated. “At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
On May 1, 2023, the AMA announced that retroactively (back to the date of the FDA announcement),, the following codes are no longer authorized for use: 0001A, 0002A, 0003A, 0004A, 0011A, 0012A, 0013A, 0051A, 0052A, 0053A, 0054A, 0064A, 0071A, 0072A, 0073A, 0074A, 0081A, 0082A, 0083A, 0091A, 0092A, 0093A, 0094A, 0111A, 0112A, 0113A 91300, 91301, 91305, 91306, 91307, 91308, 91309, 91311. That’s a pretty big change.
Officially, these codes are not being removed (deleted) from the CPT codeset at this time, however, some of the guidelines have been revised to reflect these changes.
Vaccines and the End of the PHE
So what does this mean for coverage of the COVID vaccines? An announcement by HHS stated (emphasis added) that “Vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service for most private insurance plans and will be fully covered without a co-pay. Currently, COVID-19 vaccinations are covered under Medicare Part B without cost sharing, and this will continue. Medicaid will continue to cover all COVID-19 vaccinations without a co-pay or cost sharing through September 30, 2024, and will cover ACIP-recommended vaccines for most beneficiaries thereafter.”
According to the Department of Labor, “While many plans must continue to cover COVID-19 vaccines at no cost to employees from an in-network provider, the requirement to cover COVID-19 vaccines out-of-network will generally lapse after the end of the COVID-19 public health emergency.”