Updated guidance on COVID-19 vaccines Week of 5/22

May 23, 2023

Impacted: All lines of business

May 24, 2023 

On May 12, 2023, the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC) issued an update to the COVID-19 Vaccine Interim Clinical Considerations. The guidance was updated to remove references to the Johnson & Johnson (J&J)-Janssen COVID-19 Vaccine. All remaining doses have expired, and the product is no longer available on the market.  In response to the removal of the J&J-Janssen vaccine from the ACIP/CDC COVID-19 Vaccine Interim Clinical Considerations, Prime made the following changes to the Prime Standard vaccine drug lists for all lines of business. 

Prime Standard COVID-19 vaccine list updates:    

Commercial, Medicaid and Medicare 

  •  J&J-Janssen COVID-19 Viral Vector Vaccine    
  • Removed from Prime Standard COVID-19 Vaccine Lists  
  • NDCs (59676058005, 59676058015)   
  • Following their removal from the drug lists, the J&J-Janssen COVID-19 vaccine will not be covered and will reject at point of sale. 

Note: Additional guidance is expected as we prepare for the transition from government supplied vaccines to a more traditional commercial process. Prime will continue to monitor and adjust if applicable.    

Review previous COVID-19 vaccine guidance

May 17, 2023 

As noted in our May 5, 2023 COVID-19 vaccine communication, Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC) have issued additional guidance for the immunocompromised population. People with moderate or severe immunocompromise may receive additional doses at the discretion of their healthcare provider. To accommodate the additional recommended doses, two more updates were made to Prime Standard COVID-19 Vaccine drug lists.

Prime Standard COVID-19 vaccine list updates – Bivalent formulations: 
Commercial

  • Pfizer-BioNTech COVID-19 mRNA Bivalent Vaccines
    • Increase age limit to 5 years to allow correct dosing for members who age from 4 to 5 years old during their vaccine series.
    • NDCs (59267060901, 59267060902)
  • Moderna COVID-19 mRNA Bivalent Vaccines
    • Increase quantity limit to 3 doses per rolling 365 days to allow for additional doses in the immunocompromised population.
    • NDCs (80777028302, 80777028399)

Medicaid
The same edits that were made for commercial apply to Medicaid. Both the age edit for the Pfizer-BioNTech Bivalent vaccine and the quantity limit for the Moderna Bivalent vaccine have been made to Prime’s standard Medicaid COVID-19 vaccine lists.

Medicare
The Pfizer-BioNTech Bivalent vaccine age limit increase has been made to Prime’s standard Medicare COVID-19 vaccine lists. Medicare does not have quantity limits on COVID-19 vaccines, so the increased quantity limit for the Moderna Bivalent vaccine does not apply.

Note: Additional guidance is expected as we prepare for the transition from government supplied vaccines to a more traditional commercial process. Prime will continue to monitor and adjust if applicable.

 

May 5, 2023

On April 18, 2023 the Food and Drug Administration (FDA) issued several updates to Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines.

There are two parts to this announcement:

  • The Pfizer-BioNTech and Moderna monovalent mRNA vaccines are no longer authorized for use in the United States.
  • The authorized Pfizer-BioNTech and Moderna bivalent mRNA vaccines should be used for all doses administered to individuals 6 months of age and older.

Following the FDA’s updates, the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC) also issued an update of the Interim Clinical Considerations for use of COVID-19 Vaccines on Saturday, April 22, 2023.

In response to the FDA and ACIP/CDC announcements Prime has made the following changes to Prime Standard Commercial and Medicaid COVID-19 vaccine drug lists.

Prime Standard (PS) COVID-19 vaccine drug list changes: 

Monovalent formulations:

  • All monovalent mRNA Pfizer-BioNTech and Moderna COVID-19 vaccines, including Comirnaty and Spikevax, were termed from the PS Commercial and Medicaid COVID-19 vaccine drug lists.
    • Medicare: Monovalent mRNA Pfizer-Biotech and Moderna COVID-19 vaccines, except Comirnaty and Spikevax, were termed from the PS Medicare COVID-19 vaccine drug list, pending further guidance from the Centers for Medicare & Medicaid Services (CMS).
  • Following their removal from drug lists, these monovalent mRNA products will not be covered and will reject at the point of sale.

Bivalent formulations: 

  • Prime updated quantity limits to 3 doses per rolling 365 days on the following;
    • Pfizer-BioNTech COVID-19 mRNA Bivalent Vaccines
      • NDCs (59267030401, 59267030402, 59267140401, 59267140402, 59267056501, 59267056502, 59267060901, 59267060902)
    • Moderna COVID-19 mRNA Bivalent Vaccines
      • NDCs (80777028205, 80777028299)
  • The following bivalent Moderna product is now authorized for use for those age 6 months and older. Prime will apply an age edit of 6 months and older accordingly when a RxClaim system enhancement has been implemented.
    • Moderna COVID-19 mRNA Bivalent Vaccine
      • NDCs (80777028205, 80777028299)

Note: ACIP and CDC are still finalizing a recommendation for the immunocompromised population. Prime will continue to monitor and will adjust QLs if applicable.

If you have additional questions, please reach out to your Prime Client Engagement representative.