New COVID-19 Booster Dose & The Final Frontier of the PREP Act

On February 28th, the CDC endorsed an additional updated 2023-2024 COVID-19 vaccine dose for adults 65 years or older due to the increased risk of serious COVID-19 outcomes in that patient population. The approval of an additional dose brings the question of what submission clarification code (SCC) may be required. Coinciding with the transition from US government supplied COVID-19 (EUA) vaccines, commercially available vaccines no longer required an SCC due to their approval as a single-dose vaccine. Now that an additional dose has been approved, it remains to be determined if payors will want an SCC. Many payors (e.g., OptumRx and Medi-Cal) still have the SCC requirements for the original series in their Provider Manuals. In addition, the American Medical Association (AMA), the entity that supplies CPT codes for medically based services, has deactivated CPT codes associated with specific COVID-19 dose vaccines (i.e., First, Second, Third, Booster).

As a reminder, the Public Readiness and Emergency Preparedness (PREP Act) was amended by Secretary Becerra for the eleventh time on May 12, 2023. As stated on the Administration for Strategic Preparedness & Response’s (ASPR) PREP Act Questions & Answers webpage, the amended PREP Act “authorize[s] pharmacists to continue to administer COVID-19 and seasonal influenza vaccines to individuals aged three and above and order and administer COVID-19 tests in accordance with an FDA license, approval, or authorization through December 31, 2024.” Ultimately, this means that under the changes made in the Eleventh Amendment of the PREP Act, there will be liability protections in place for COVID-19 vaccines and tests, along with seasonal influenza vaccines through December 31, 2024.

PAAS Tips:

  • The CDC has a useful website to determine what vaccination and dose a particular patient needs based on their vaccination history
  • Recall the billing units for COVID-19 vaccines are in mL and the correct days’ supply is 1
Meredith Thiede, PharmD