Moderna bivalent COVID-19 vaccine for children under six is available for ordering through the Health Center COVID-19 Vaccine Program. However, due to limited availability nationwide, Pfizer-BioNTech bivalent COVID-19 vaccine for children under five is not available for ordering. A new supply of Novavax is now available to order, with a cap of 100 doses per site and an expiration date of April 30. A few important reminders:

• The monovalent formulation of COVID-19 vaccine products is authorized for the primary series only. Please order only what you anticipate using over the next 7-10 days and track your supplies to assess the need and adjust current ordering patterns to avoid stockpiling.
• Moderna has recently expanded expiration dates for the monovalent vaccine for children under six. Always check the Pfizer BioNTech and Moderna expiry dates for the products in your inventory before wasting them.
• The Emergency Use Authorization (EUA)-labeled Pfizer adult (12+) monovalent vaccine is no longer available to order. Health centers requiring the Pfizer adult (12+) monovalent vaccine should order the Biologics License Application (BLA)-labeled (COMIRNATY) product (NDC 00069-2025-10).
• Centers for Disease Control and Prevention (CDC) released a fact sheet for single-dose vials of the updated Pfizer BioNTech COVID-19 vaccines for people 12 years and older.
• ASPR updated the Federal Response to COVID-19: Therapeutics Clinical Implementation Guide, a comprehensive review of available COVID-19 therapeutic treatment options and key prescribing, implementing, and administering information.

Earlier this week, the Centers for Medicare & Medicaid Services released a fact sheet with updates to policy on vaccines, testing, and treatments; telehealth services; continuing flexibilities for healthcare professionals; and expanded hospital capacity through care in a patient’s home.  Last week, the agency provided updates specific to Rural Health Clinics and Critical Access Hospitals, describing the Medicare and Medicaid waivers and flexibilities that have been terminated, made permanent, or that will end with the public health emergency (PHE) on May 11, 2023.

As part of the Centers for Medicare & Medicaid Services’ (CMS) ongoing efforts to provide up-to-date information to prepare for the end of the Public Health Emergency (PHE) for COVID-19, which is expected on May, 11, 2023, we are providing a new overview fact sheet on CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.  COVID-19 efforts have been a significant priority for the Biden-Harris Administration, and with the use of whole-of-government approach, the country is in a better place. Over the next several months, CMS will work to ensure a smooth transition back to normal operations.

The CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency provides clarity on several topics including:

• COVID-19 vaccines, testing, and treatments;
• Telehealth services;
• Health Care Access

In the coming weeks, CMS will be hosting stakeholder calls and office hours to provide additional information. Please visit the CMS Emergencies Page for continuous updates regarding PHE sunsetting guidance as information becomes available to the public.

COVID-19 survivors have a 66% higher risk of developing type 1 or type 2 diabetes following their diagnosis compared to those who were not infected with the coronavirus, according to a study by Penn State College of Medicine researchers published Monday. The researchers found that SARS-CoV-2 — the virus that causes COVID-19 — binds to an enzyme receptor found on the surface of many organs and tissues, including cells found in the pancreas, small intestine, and kidneys, affecting insulin levels. Read more.

There are fewer COVID-19 deaths and infections in areas of the country where there is a Community Health Center according to findings from NACHC and the Morehouse School of Medicine’s National COVID-19 Resiliency Network (NCRN). Health centers, which serve nearly 29 million Americans in nearly 1400 communities, are a critical component of the national vaccination strategy launched by the Biden Administration to ensure equity in the fight against COVID-19. Health centers have been vaccinating people who have been disproportionately affected by the pandemic — essential workers, agricultural and migrant workers, public housing residents, the elderly, and people experiencing homelessness. To date, health centers have provided more than 19 million COVID-19 vaccinations, with over two in three shots at a health center administered to people of color. The joint analysis from NACHC and Morehouse School of Medicine’s NCRN compared the rate of infection and mortality from COVID-19 in areas with a health center and areas without, determining that there are 200 fewer cases of infection and nine fewer deaths per 100,000 people.

On January 30, 2023, the Biden-Harris Administration announced its intent to end the national emergency and public health emergency (PHE) declarations related to the COVID-19 pandemic on May 11, 2023. The Centers for Medicare & Medicaid Services has resources available to help you prepare for the end of the PHE, some of which have been updated based on recent action by Congress .

On December 29, 2022, H.R. 2716, the Consolidated Appropriations Act (CAA) for Fiscal Year 2023 was signed into law. This legislation included an extension of the major telehealth waivers and the Acute Hospital Care at Home (AHCaH) individual waiver that were initiated during the PHE.

We will continue to execute the process of a smooth operational wind down of the flexibilities enabled by the COVID-19 emergency declarations. The following materials reflect recent changes and are currently available on the CMS Emergencies Page:

• Provider-specific fact sheets for information about COVID-19 Public Health Emergency(PHE) waivers and flexibilities: https://www.cms.gov/coronavirus-waivers
• CMS 1135 Waiver / Flexibility Request and Inquiry Form: https://cmsqualitysupport.servicenowservices.com/cms_1135
• Acute Hospital At Home: https://qualitynet.cms.gov/acute-hospital-care-at-home

Updates will continue to be provided as we approach the end of the PHE. We encourage you to regularly visit the CMS Emergencies Page for the most up to date information.

HRSA released their Health Center COVID-19 Holiday Ordering Schedule on Dec. 13. All ordering will be disabled and no deliveries will be made during the weeks of Dec. 18 and Dec. 25. Regular ordering cadence will resume the week of Jan. 1. Additionally, BD Veritor Point-of-Care (POC) products have been exhausted at this time. Other distributors for these test strips can be found on the website Ordering & Reimbursement | BD Veritor™ Plus System.

Researchers used funding from the NIH-supported RADx-UP program to better understand barriers in underserved communities – rural and urban, as well as racial and ethnic minority populations – in Kansas.   The most commonly reported barrier was fear of lost income or employment resulting from quarantine.  Common barriers reported in both rural and urban communities were access issues, such as lack of transportation and lack of support for languages other than English.  Three subthemes appeared to be dominant in rural counties. Under the theme of “political beliefs,” the subtheme “politicization of COVID-19 mitigation and response efforts” was an identified barrier for most rural counties.  See Approaching Deadlines below for a RADx-UP opportunity that closes in January.

HRSA will distribute funding to health centers to support community-based vaccination events and outreach focused on underserved populations

The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced a new $350 million initiative for HRSA-supported health centers to increase COVID-19 vaccines in their communities, with a specific focus on underserved populations. This funding will support health centers administering updated COVID-19 vaccines through mobile, drive-up, walk-up, or community-based vaccination events, including working with community-based organizations, and other efforts to increase the administration of COVID-19 vaccines.

“Community health centers save lives,” said HHS Secretary Xavier Becerra. “We will continue to reach, vaccinate, and protect our most vulnerable people across the country working together with community health centers and community-based organizations. We have seen COVID infections increase in prior winters, and it does not have to be that way this year. We now have updated COVID-19 vaccines to protect communities against the Omicron strain. Our message is simple: Don’t wait. Get an updated COVID-19 vaccine this fall. It’s safe and effective.”

“As community-based organizations that have built deep relationships with their patients and neighborhoods, health centers are uniquely positioned to increase COVID-19 vaccinations,” said HRSA Administrator Carole Johnson. “These funds will ensure that people who live in underserved communities have access to updated COVID-19 vaccines this winter through community-based vaccination events hosted by health care providers and organizations they trust.”

The Expanding COVID-19 Vaccination initiative will provide resources directly to health centers throughout the country to increase COVID-19 vaccinations this winter by addressing the unique access barriers experienced by the underserved populations that health centers serve. HRSA anticipates these efforts will also increase flu and childhood vaccinations through combined vaccination events. All HRSA-funded health centers, as well as health center look-alikes that received American Rescue Plan funding, will be eligible. These funds build on the previous investments made to HRSA-funded health centers to combat COVID-19 and will help even more Americans have access to updated COVID-19 vaccines. To date, health centers have administered more than 22 million vaccines in underserved communities across the country, of which 70 percent to patients of racial and ethnic minorities.

To facilitate access to COVID-19 vaccination, the initiative will foster new and strengthened coordination, with community-based organizations that provide childcare, early childhood development, housing, food, employment, education, older adult, or behavioral health services. Health centers will be encouraged to support mobile, drive-up, walk-up, or community-based vaccination events; extend operating hours, outreach, and off-site vaccination locations to expand opportunities for COVID-19 vaccination; and support  access to COVID-19 vaccination by expanding transportation, translation, education, and interpretation services.

The nearly 1,400 HRSA-funded community health centers serve as a national source of primary care in underserved communities, providing services through more than 14,000 sites across the country. They are community-based and patient-directed organizations that deliver affordable, accessible, and high-quality medical, dental, and behavioral health services to more than 30 million patients each year, with specific initiatives intended to reach people experiencing homelessness, agricultural workers, and residents of public housing.

In 2021, HRSA-funded health centers provided care for one-in-five residents in rural areas and one-in-eleven people nationwide. One-in-three health center patients are living in poverty, and nearly two-thirds are racial/ethnic minorities.

Learn more about the Health Center Program: https://bphc.hrsa.gov/about-health-centers/health-center-program-impact-growth

Read the White House FACT SHEET: Biden Administration Announces Six-Week Campaign to Get More Americans their Updated COVID-⁠19 Vaccine Before End of the Year.