COVID-19 Vaccine Updates; Janssen/Johnson & Johnson Vaccine Guidance

March 8, 2021

Below is a compilation of recent COVID-19 vaccine guidance and updates, including from the New York State Department of Health (DOH) and the Centers for Disease Control and Prevention (CDC) for the newly approved vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (referred to as the Janssen vaccine). New York State and other jurisdictions received a very limited initial supply of Janssen vaccine this week. DOH has instructed hospitals to use Janssen for vaccinating only the following populations:

New York State COVID-19 Vaccination Program Document Package

DOH updated the COVID-19 vaccination guidance (attached) to include the newly authorized single-dose Janssen vaccine for individuals 18 years of age and older. The packet includes:

  • Guidance for the New York State COVID-19 Vaccination Program (effective March 5, 2021)
  • Janssen Vaccine Emergency Use Authorization (EUA) Letter (New York State Health Commissioner letter issued March 1, 2021 – revised)
  • New York State COVID-19 Immunization Screening and Consent Form (current version from January 20, 2021)
  • Information for Health Care Professionals about the Screening Checklist for the COVID-19 Vaccine
  • New York State COVID-19 Vaccine Provider Storage and Handling Overview
  • New York State COVID-19 Vaccine Program Temperature Excursion Report
  • New York State COVID-19 Vaccine Program Guidance for Vaccine Transport and Tracking Sheet
  • New York State COVID-19 Vaccine Program Redistribution and Q&A

Janssen COVID-19 Vaccine Non-Patient Specific Standing Order

DOH also released a new non-patient specific standing order (attached) for the Janssen vaccine.

CDC Janssen Vaccine Guidance

The CDC has established its Janssen vaccine guidance page, which includes how to prepare and administer the vaccine, interim clinical considerations, storage and handling resources, and vaccine FAQs. The initial allocation of Janssen vaccine is very limited, with supply picking up later this month.

Storage and Handling Updates

The CDC Vaccine Storage and Handling Toolkit is now updated to include Janssen vaccine and reflect recent updates to Pfizer storage and handling guidance. The Pfizer vaccine factsheet was recently updated to indicate that undiluted frozen vials of Pfizer vaccine may be transported and stored at temperatures commonly found in pharmaceutical freezers for up to two weeks.

Janssen COVID-19 Vaccine Medicare Codes

During the COVID-19 public health emergency, Medicare will cover and pay for the administration of COVID-19 vaccines, including the newly authorized Janssen vaccine, when furnished consistent with the EUA. Please review the Centers for Medicare & Medicaid Services Medicare Billing for COVID-19 Vaccine Shot Administration toolkit and payment and Healthcare Common Procedure Coding System Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare (do not include the vaccine product codes).

McKesson Ancillary Supply Kit Issues

The US Department of Health and Human Services (HHS) is receiving reports of the malfunctioning of some products included in the COVID-19 vaccine ancillary supply kits, and GNYHA is aware that these issues are impacting some of our members. HHS contracts with McKesson Corporation for the production, storage, and distribution of vaccine ancillary supply kits, and HHS is directing any facilities experiencing issues to please share details directly with McKesson:

McKesson Customer Service

GNYHA’s COVID-19 Vaccination page includes a compilation of recent COVID-19 vaccine distribution program updates and guidance.

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