COVID-19 Overview | Health Policy | Patient Management | Practice Finances The Ending of the COVID-19 Public Health Emergency—FAQs THE ENDING OF THE PUBLIC HEALTH EMERGENCY The Public Health Emergency (PHE) officially ended on May 11, 2023, marking the end of a 3-year worldwide pandemic. What does this mean for your medical practice? Curi has created a FAQ document to help guide you through the information. Much of this information is based on the Department of Health and Human Services (HHS) Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap. VACCINES & TREATMENTS Does the Centers for Disease Control and Prevention (CDC) still encourage vaccines? Yes. To help keep communities safe from COVID, HHS remains committed to providing COVID vaccines and treatments. Access to vaccines and treatments, such as Paxlovid and (Molnupiravir) Lagevrio™ (see Curi’s Molnupiravir oral treatment consent) will still be available to the general public. COVID vaccine-specific information can be accessed at these links: Interim COVID-19 Immunization Schedule U.S. COVID-19 Vaccine Product Information Can our practice still offer COVID vaccines that have an Emergency Use Authorization (EUA) status? The Food and Drug Administration’s (FDA) EUAs for COVID vaccines will not be affected. Existing EUAs for COVID vaccines will remain in effect under, Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met. The following COVID vaccines, are currently authorized under an EUA by FDA and will continue to be available for use in the United States: mRNA vaccines Moderna COVID vaccine, Bivalent Pfizer COVID vaccine, Bivalent Protein subunit vaccine Novavax COVID Vaccine, Adjuvanted The monovalent formulations of the two mRNA COVID vaccines (COMIRNATY/Moderna COVID Vaccine and SPIKEVAX/Pfizer COVID Vaccine) should no longer be used for COVID vaccination. All currently available mRNA COVID vaccines in the United States are formulated as a bivalent vaccine based on the original COVID strain and the Omicron variants. Janssen COVID vaccine is no longer available in the United States. None of the currently FDA-authorized COVID-19 vaccines are live-virus vaccines. Will FDA-approved EUA products such as tests and treatments be affected by the ending of the PHE? No. The ending of the COVID PHE will not affect the FDA’s ability to authorize various products, including tests and treatments for emergency use. Existing EUAs for COVID products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met. Now that the PHE has expired, how does this affect telehealth? MEDICARE Major Medicare telehealth flexibilities will not be affected. The vast majority of current Medicare telehealth flexibilities will remain in place through December 2024. The Centers for Medicare and Medicaid Services (CMS) has addressed Many questions related to waivers and other flexibilities and can be found in the CMS FAQs. Other questions related to physicians and other clinicians (including audio only telehealth visits) can be found on this additional CMS Fact Sheet. A list of services payable under the Medicare Physician Fee Schedule when furnished via telehealth can be viewed here. This resource provides an overview of the federal telehealth waivers that were made in response to COVID post-PHE. MEDICAID States have a great deal of flexibility with respect to covering Medicaid and the Children’s Health Insurance Program (CHIP) services provided via telehealth. Telehealth flexibilities vary by state: some are tied to the end of the COVID PHE, some are tied to state PHEs and other state emergency declarations, and some had been offered by state Medicaid and CHIP programs long before the pandemic. After the end of the federal PHE, Medicaid and CHIP telehealth policies will continue to vary by state. To learn more about state Medicaid flexibilities and returning to operations post pandemic, click here. CONTROLLED SUBSTANCES The temporary rule issued jointly between the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) states: The full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will remain in place through November 11, 2023. Additionally, for any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will continue to be permitted via a one-year grace period through November 11, 2024. In other words, if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024. GUIDANCE FOR HEALTHCARE WORKERS What does the end of the PHE mean to healthcare workers? The Centers for Disease Control and Prevention (CDC) is shifting from an emergency response to incorporating COVID into sustainable public health practice. GENERAL The CDC recommends returning to routine (pre-pandemic) infection prevention practices. This is inclusive of: encouraging everyone to remain up to date with all vaccines (such as flu and COVID); establishing processes to identify and manage individuals with suspected or confirmed infections (such as flu and COVID); implementing source control measures when appropriate; making personal protective equipment (PPE) available when necessary; following guidelines for environmental infection control (such as physical barriers when necessary and adequate ventilation systems); testing for infection when appropriate (such as flu and COVID); and taking necessary precautions for positive tests. These are two recent questions from our member practices. Do we still have to screen for COVID? No. There are no current screening requirements. However, practices should take appropriate measures to identify potentially infectious patients or healthcare workers to avoid unnecessary exposures. For example, a simple question asking if the patient has been sick recently during the check-in process and training healthcare workers to report any symptoms or exposures to infectious illnesses. See this CDC guidance document to address infection prevention (updated 5-8-2023). The recommendations in this guidance continue to apply after the expiration of the federal COVID PHE. What do we do now if a patient or healthcare personnel has been exposed to COVID? If a COVID infection is suspected in a patient who presents for care, follow the CDC’s Standard Precautions and Transmission-Based Precautions guidance. In general, asymptomatic healthcare personnel who have had a higher-risk exposure do not require work restriction, regardless of vaccination status, if they do not develop symptoms or test positive for COVID. For specific guidance, see CDC guidance document and Curi’s COVID process for exposures flowchart. News & Knowledge All Curi recommendations are based on current CDC criteria at the time of publication. CDC guidance for SARS-CoV-2 infection may, or may not, be adopted by state and local health departments to respond to rapidly changing local circumstances. Providers should always check with their local health department to see if the CDC’s guidance on any given topic has been modified (particularly if more restrictive) from the CDC’s recommended guidelines. Follow this link https://www.cdc.gov/publichealthgateway/healthdirectories/index.html for contact information to your state/local health department. If local recommendations vary from those of the CDC, and you are unsure what recommendations to follow, then it is safer to follow the more restrictive guidelines/recommendations.