Misdirected antibodies linked to severe COVID-19
National Institutes of Health (NIH) / By Sharon Reynolds
The severity of COVID-19 can differ drastically between individuals. Some people never know they’ve been infected, while others may end up needing intensive care or dying from the disease.
Several factors have been associated with severe COVID-19, including preexisting health conditions like obesity, diabetes, and high blood pressure. Men are more likely to die of the disease than women. And the risk of dying from COVID-19 increases with age.
Researchers around the world have been looking for other risk factors for severe or fatal infection with SARS-CoV-2, the virus that causes COVID-19. An international project called the COVID Human Genetic Effort has been searching for genetic and molecular differences that may increase the risk of severe COVID-19. The project is co-directed by Dr. Helen Su from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Dr. Jean-Laurent Casanova from Rockefeller University.
Two recent studies from the project, led by Casanova, found that some severe cases of COVID-19 could be linked to problems with immune-system proteins called type I interferons (IFNs). These IFNs are needed to fight off viral infections. In rare cases, genetic conditions blocked the production of these proteins. But more commonly, antibodies that mistakenly targeted the IFNs were found in the blood of people with severe or fatal COVID-19.
To better understand how common these autoantibodies are, Casanova and his colleagues screened for them in blood samples taken from more than 3,500 people with severe or fatal COVID-19 and more than 34,000 uninfected volunteers from 38 different countries. The new study was funded in part by several NIH components, primarily NIAID. Results were published on August 19, 2021, in Science Immunology.
The team found that 20% of people hospitalized with severe COVID-19 had high or intermediate levels of autoantibodies to type I IFNs. Autoantibodies were also found in at least 18% of people who died from the disease. In contrast, people with no or mild symptoms had very low levels of these autoantibodies. The researchers estimate that the autoantibodies may account for about 20% of total fatal COVID-19 cases.
The risk of having such autoantibodies increased with age. For example, while fewer than 10% of people under the age of 40 with severe COVID-19 had active levels of these autoantibodies, more than 21% of those over the age of 80 had them.
The researchers also found evidence of autoantibody production in uninfected volunteers. They were found in less than 1% of people between 18 and 69 years; in 2.3% of those between 70 and 79 years; and in 6.3% of those 80 years and older. This suggests that type I IFN autoantibodies existed before infection and become more common past age 70.
In a related paper published in the same issue of Science Immunology, the researchers identified another rare genetic defect that occurs only in men and results in disruption of IFN production. They estimated that this genetic risk factor accounts for at least 1% of cases of life-threatening COVID-19 in men under the age of 60.
“We can neatly explain much of severe COVID-19 as a net defect in type I IFN,” Casanova says. “To an extent never seen for any other acute infectious disease, these… studies collectively provide a molecular and immunological explanation for about 20% of critical cases.”
Autoantibodies against IFNs—at even very low levels—can be screened for in the clinic. Testing for these autoantibodies could help identify uninfected people who need aggressive preventive measures or infected people who need early aggressive treatment. |
$25.5 Billion in New COVID-19 Provider Funding Available
The U.S. Department of Health and Human Services (HHS), through the (HRSA) is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.
Providers, defined as any provider or supplier of health care, services, and support in a medical setting, at home, or in the community, will apply for both programs in a single application. HRSA will use existing Medicaid, CHIP and Medicare claims data in calculating payments. The application portal will open on September 29, 2021.
PRF Phase 4
75% of the Phase 4 payments will be based on lost revenues and expenditures between July 1, 2020, and March 31, 2021. The remaining 25% of payments will be utilized for bonus payments for providers who serve Medicaid, CHIP, and/or Medicare patients.
Medium and small providers will receive a base payment plus a supplement, with smaller providers receiving the highest supplement. Large providers will receive a minimum payment amount based on a percentage of lost revenues and COVID-related expenses. HHS will determine the exact amount of the base payments and supplements after analyzing data from all the applications received to ensure available funds are distributed equitably.
Rural
HRSA will make $8.5B in rural payments to providers who serve patients who receive Medicaid, CHIP, and/or Medicare services in a rural area as defined by the HHS Federal Office of Rural Health Policy. Search the Rural Health Grants Eligibility Analyzer to see what areas qualify as "rural" for the rural payments.
Phase 3 Reconsiderations
Providers who believe their Phase 3 payment was not calculated correctly according to this methodology will now have an opportunity to request a reconsideration. Further details on this Phase 3 reconsideration process are forthcoming.
Grace Period for Reporting Period 1
In order to help providers come into compliance with PRF Reporting requirements if they miss the September 30, 2021 deadline for the first PRF Reporting Time Period, HHS announced a final 60-day grace period for those who received a PRF payment between April 10, 2020 and June 30, 2020.
It’s important to note that the deadlines to use funds and the Reporting Time Period are not changing. However, HHS will not enforce actions for noncompliant providers during the grace period. More information on reporting is available on the HRSA website.
Additional Information:
Visit the HRSA website for more information about eligibility requirements, documents, and information providers will need to complete their application. |
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HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding
Combined application for American Rescue Plan rural funding and Provider Relief Fund Phase 4 will open on September 29
The Biden-Harris Administration announced today that the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic. This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children's Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.
"This funding critically helps health care providers who have endured demanding workloads and significant financial strains amidst the pandemic," said HHS Secretary Xavier Becerra. "The funding will be distributed with an eye towards equity, to ensure providers who serve our most vulnerable communities will receive the support they need."
Consistent with the requirements included in the Coronavirus Response and Relief Supplemental Appropriations Act of 2020, PRF Phase 4 payments will be based on providers' lost revenues and expenditures between July 1, 2020, and March 31, 2021. As part of the Biden-Harris Administration's ongoing commitment to equity, and to support providers with the most need, PRF Phase 4 will reimburse smaller providers—who tend to operate on thin margins and often serve vulnerable or isolated communities—for their lost revenues and COVID-19 expenses at a higher rate compared to larger providers. PRF Phase 4 will also include bonus payments for providers who serve Medicaid, CHIP, and/or Medicare patients, who tend to be lower income and have greater and more complex medical needs. HRSA will price these bonus payments at the generally higher Medicare rates to ensure equity for those serving low-income children, pregnant women, people with disabilities, and seniors.
Similarly, HRSA will make ARP rural payments to providers based on the amount of Medicaid, CHIP and/or Medicare services they provide to patients who live in rural areas as defined by the HHS Federal Office of Rural Health Policy. As rural providers serve a disproportionate number of Medicaid and CHIP patients who often have disproportionately greater and more complex medical needs, many rural communities have been hit particularly hard by the pandemic. Accordingly, ARP rural payments will also generally be based on Medicare reimbursement rates.
"We know that this funding is critical for health care providers across the country, especially as they confront new coronavirus-related challenges and respond to natural disasters," said Acting HRSA Administrator Diana Espinosa. "We are committed to distributing this funding as equitably and transparently as possible to help providers respond to and ultimately defeat this pandemic."
In order to expedite and streamline the application process and minimize administrative burdens, providers will apply for both programs in a single application. HRSA will use existing Medicaid, CHIP and Medicare claims data in calculating payments. The application portal will open on September 29, 2021. To help ensure that these provider relief funds are used for patient care, PRF recipients will be required to notify the HHS Secretary of any merger with, or acquisition of, another health care provider during the period in which they can use the payments. Providers who report a merger or acquisition may be more likely to be audited to confirm their funds were used for coronavirus-related costs, consistent with an overall risk-based audit strategy.
To promote transparency in the PRF program, HHS is also releasing detailed information - PDF (PDF - 175 KB) about the methodology utilized to calculate PRF Phase 3 payments. Providers who believe their PRF Phase 3 payment was not calculated correctly according to this methodology will now have an opportunity to request a reconsideration. Further details on the PRF Phase 3 reconsideration process are forthcoming.
Additionally, in light of the challenges providers across the country are facing due to recent natural disasters and the Delta variant, HHS is announcing today a final 60-day grace period to help providers come into compliance with their PRF Reporting requirements if they fail to meet the deadline on September 30, 2021, for the first PRF Reporting Time Period. While the deadlines to use funds and the Reporting Time Period will not change, HHS will not initiate collection activities or similar enforcement actions for noncompliant providers during this grace period.
For more information about eligibility requirements, the documents and information providers will need to complete their application, and the application process for PRF Phase 4 and ARP Rural payments, visit: https://www.hrsa.gov/provider-relief/future-payments.
Announcement posted on https://www.hhs.gov/about/news/2021/09/10/hhs-announces-the-availability-of-25-point-5-billion-in-covid-19-provider-funding.html |
Biden-Harris Administration to Expand Vaccination Requirements for Health Care Settings [Published by CMS]
New action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities
The Biden-Harris Administration will require COVID-19 vaccination of staff within all Medicare and Medicaid-certified facilities to protect both them and patients from the virus and its more contagious Delta variant. Facilities across the country should make efforts now to get health care staff vaccinated to make sure they are in compliance when the rule takes effect.
The Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC), announced today that emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. The decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19.
“There is no higher priority for us than patient health and safety. As the Delta variant strengthens, the Biden-Harris Administration is committed to doing everything we can to keep patients, and those who care for them, safe,” said U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra. “There is no question that staff, across any health care setting, who remain unvaccinated pose both direct and indirect threats to patient safety and population health. Ensuring safety and access to all patients, regardless of their entry point into the health care system, is essential.”
Nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant. CMS will continue to work closely with all Medicare and Medicaid certified facilities to ensure these new requirements are met.
“We know that those working in health care want to do what is best for their patients in order to keep them safe,” said CMS Administrator Chiquita Brooks-LaSure. “As the Delta variant continues to spread, we know the best defense against it lies with the COVID-19 vaccine. Data show that the higher the level of vaccination rates among providers and staff, the lower the infection rate is among patients who are dependent upon them for care. Now is the time to act. I’m urging everyone, but especially those fighting this virus on the front lines, to get vaccinated and protect themselves, their families, and their patients from COVID-19.”
CMS is developing an Interim Final Rule with Comment Period that will be issued in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements. Health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately. Facilities are urged to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.
Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSgov |
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