FDA Simplifies COVID-19 Vaccines

On April 18, 2023, the FDA authorized an amendment to the Emergency Use Authorization (EUA) for COVID-19 bivalent vaccines for all patients ages 6 months and older. Monovalent COVID-19 vaccines offered through Pfizer-BioNTech and Moderna are no longer authorized in the United States

Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNACOVID-19 Vaccines

The amended EUA provides the following information:

- Patients who had a monovalent COVID-19 vaccine only may receive one bivalent vaccine

- Unvaccinated patients may receive one bivalent vaccine

- Most patients who have already had one dose of bivalent are considered fully vaccinated at this time. The FDA may revise this decision after the FDA Advisory Committee meeting in June

Exceptions to this include:

- Patients aged 65 or older ? may receive an additional bivalent vaccine at least four months following the first

- Patients with immunocompromised conditions ? may receive an additional bivalent vaccine at least two months following the first with additional doses as determined by the healthcare provider The FDA states there are additional considerations for patients aged 6 months ? 4 years

The FDA offers additional recommendations for children ages 6 months through 5 years depending upon previous COVID-19 vaccination administrations

CorroHealt h invit es you t o check out t he m lnconnect s page available from t he Cent ers For Medicare and Medicaid (CMS). It 's chock full of new s and inform at ion, t raining opport unit ies, event s and m ore! Each w eek PARA w ill bring you t he lat est new s and links t o available resources. Click each link for t he PDF!

Thursday, May 4, 2023

New s

- FAQs on CMSWaivers, Flexibilities, and the End of the COVID-19 Public Health Emergency

- Guidance for the Expiration of the COVID-19 Public Health Emergency

- COVID-19 Over-the-Counter Tests

- Medicare Diabetes Prevention Program: Public Health Emergency Flexibilities Continue through December 31

- Transplant Eco-System: Role of Data in CMSOversight of The Organ Procurement Organizations

- Expanded Home Health Value-Based Purchasing Model: April Newsletter & Performance Reports

- Religious Nonmedical Health Care Institution Benefit & COVID-19 Vaccines

- Clinical Laboratory Fee Schedule 2024 Preliminary Gapfill Rates: Submit Comments by June 26

- Mental Health: Recommend Medicare Preventive Services

Claim s, Pricers, & Codes

- COVID-19: Reporting CRModifier & DRCondition Code After Public Health Emergency Update

- Claim Status Category & Claim Status Codes

Event s