November 12, 2021 Edition

California Clarifies Expectations for Administering COVID-19 Boosters

This week, senior officials clarified the state’s expectations for local health jurisdictions and providers in administering COVID-19 vaccine boosters. In a letter from CDPH Director and State Public Health Officer Dr. Tomás Aragón, vaccine providers throughout the state are instructed to:

  • Proactively outreach to patients who are age 65 and older, have underlying medical conditions, or received the Johnson & Johnson vaccine (single dose).
  • Allow patients to self-determine their risk of exposure; do not turn a patient away who is requesting a booster if the patient is 18 or over and has met the six-month original vaccination series time period for the Moderna or Pfizer vaccine or if it has been at least two months since their Johnson & Johnson vaccine.
  • For pharmacies, prioritize Long Term Care facility partnerships to provide COVID-19 vaccine boosters to those in Skilled Nursing Facilities and Assisted Living Facilities.

Further, CDPH reminds all providers to not miss any opportunity to vaccinate the unvaccinated or provide boosters by offering vaccine during routine or non-routine visits to medical offices, clinics, pharmacies, and hospitals. The full letter is available here.

California Health and Human Services Agency (CalHHS) Secretary Dr. Mark Ghaly during a press conference in Los Angeles County with Governor Gavin Newsom on Wednesday also reiterated the state’s clarification, encouraging residents to receive a COVID-19 vaccine or booster when they are eligible. Additional information from the Governor’s Office is available here.

Newsom Issues Executive Order to Support Health Facilities Ahead of Winter

On Wednesday, Governor Gavin Newsom issued Executive Order N-21-21 extending provisions implemented to expand the state’s health care workforce during the pandemic, allowing health care workers from out-of-state to provide services in California, and enabling certain medical personnel to continue supporting the state’s COVID-19 response, including administering vaccines. The order additionally continues flexibility for health care facilities to plan and adapt their space to accommodate patients and allow alternate areas to be used for vaccination efforts at clinics and other health facilities.

Notably, the executive order extends California’s state of emergency due to COVID-19 originally proclaimed on March 4, 2020, through March 31, 2022.

Additional information from the Governor’s Office is available here.

Appeals Court Stays Federal Vaccine Mandate for Large Employers, Litigation Continues

Recall, last week, the Department of Labor (DOL) Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard relative to COVID-19 protections and precautions for employers with 100 or more employees, including a requirement for employers to verify that employees are fully vaccinated or complete regular weekly testing.

Shortly after the order was issued by OSHA, at least 27 states filed lawsuits challenging the mandate’s statutory and constitutional legality. On Saturday, the Fifth U.S. Circuit of Appeals in New Orleans granted an emergency stay of the OSHA rule which would have required employees to be vaccinated or test by January 4, 2022.

The Biden-Harris Administration late Monday filed a response to the court’s stay, arguing that maintaining the stay would “endanger many thousands of people” and expressing the Administration’s intent to defend the OSHA requirements. The Administration notes that OSHA has the “authority to act quickly in an emergency where the agency finds that workers are subjected to a grave danger and a new standard is necessary to protect them.”

Given the number of challenges filed against the OSHA emergency temporary standard in multiple circuit courts, federal law requires that all cases be consolidated and heard by one federal appeals court chosen by lottery. The lottery is anticipated to occur as early as next week, and the case may end up before the U.S. Supreme Court.

The full Fifth Circuit stay order is available here. As the litigation continues its way through the court system, additional information and announcements are expected over the coming days and weeks.

Biden-Harris Administration Announces Additional Investments in COVID-19 Response

This week, the Biden-Harris Administration announced a series of new investments of American Rescue Plan Act (ARPA) funds to continue support of the country’s response to the COVID-19 pandemic. The funding announcement, according to the White House, is a direct response to the recommendations advanced by the COVID-19 Health Equity Task Force which delivered its final report to the White House Office of COVID-19 Response this week.

Recall, President Joseph R. Biden, Jr., on the first full day in office, created the Health Equity Task Force to identify health equity issues uncovered and exacerbated by the COVID-19 pandemic. Notably, the White House indicates over 80 percent of the Task Force recommendations have already been fulfilled and the Biden-Harris Administration is committed to embedding the recommendations into initiatives and programs throughout the federal government.

To accomplish many of the recommendations set forth by the Task Force, the Biden-Harris Administration announced a total $785 million investment across the following areas:

  • Nearly $240 Million to Expand Community-Based Public Health Workforce – The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), will invest nearly $240 million into a new program to provide education and on-the-job training to build the pipeline of public health workers in underserved communities. This program will support apprenticeship programs at over 500 health care and public health sites nationally, including emergency departments, health centers, state and local public health departments, mobile health clinics, shelters, housing programs, and other locations where high-risk populations access care and receive services. Funding is anticipated to support a pipeline program for 13,000 community health workers and paraprofessionals from underserved communities.
  • $210 Million to Build Preparedness and the Public Health Workforce Among Tribal Communities – The Indian Health Service (IHS) will invest $92 million to hire school nurses to provide critical testing, contact tracing, case management, and overall school health to support Bureau of Indian Education (BIE) K-12 schools, $67 million to enhance public health capacity and emergency preparedness for IHS and Tribal Nations, $45 million to expand loan repayment and support IHS’s ability to recruit and retain professionals, and $6 million to support core surveillance and epidemiology activities for American Indian and Alaska Native populations.
  • $150 Million for People with Disabilities and Older Adults – The Administration for Community Living (ACL) within HHS is investing $150 million for its disability and aging networks to increase the public health workforce with disability and aging expertise and to collaborate with public health systems to support the health and safety of people with disabilities and older adults who are at heightened risk for severe illness from COVID-19.
  • More than $140 Million to CBOs for Vaccine Outreach – HRSA will award an additional $66.5 million as part of the community-based organization (CBO) vaccine outreach initiative established earlier this year. This funding has allowed CBOs to hire local community outreach workers to educate individuals, provider resources, and address barriers to getting vaccinated in underserved areas. HRSA will also invest another $77 million for additional CBOs to hire community workers for vaccine outreach and engage in other efforts to build vaccine confidence.
  • $35 Million for CDC Workforce Diversity – The U.S. Centers for Disease Control and Prevention (CDC) will invest $35 million to expand activities in recruitment and pipeline programs to support diversity, equity, and inclusion in public health workforce and increase awareness and interest in public health among underrepresented groups.

Additional information from the White House is available here.

HHS to Invest $650M in COVID-19 Rapid Diagnostic Testing

The U.S. Department of Health and Human Services (HHS) this week announced it will invest $650 million from the American Rescue Plan Act (ARPA) to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests.

HHS notes as at-home testing increases, the need for follow-up testing in health care settings will also grow. This investment is intended to ensure confirmatory tests conducting at a health facility will be readily available across the country. HHS will use the $650 million in funds to ramp up U.S. domestic manufacturing capacity, minimizing reliance on imports from overseas and sustaining long-term manufacturing throughout 2022. The funding will also support purchasing raw materials and finished tests to increase domestic supplies of diagnostic tests.

Additional information is available here.

FEMA Extends Full Reimbursement for COVID-19 Response

This week, President Joseph R. Biden, Jr. directed the Federal Emergency Management Agency (FEMA) to extend the federal government’s 100 percent reimbursement of eligible COVID-19 emergency response costs incurred by states, tribes, and territories through April 1, 2022. The extension of FEMA reimbursement also includes 100 percent federal reimbursement for National Guard personnel deployed to assist in COVID-19 response.

Recall, President Biden issued an order on his second day in office directing FEMA to cover full state emergency costs in responding to the COVID-19 pandemic. The reimbursement order was extended in August through the end of the year amid the COVID-19 delta variant surge experienced this summer.

The full directive extending reimbursement to April 2022 is available here.

Pfizer-BioNTech Seek Approval for COVID-19 Boosters for All Adults

This week, Pfizer and BioNTech formally requested the U.S. Food and Drug Administration (FDA) to authorize their COVID-19 mRNA vaccine booster to all adults ages 18 and older. According to the companies, the request is based on efficacy and safety data from a randomized, controlled trial with more than 10,000 participants, showing efficacy of 95 percent or better for people receiving the booster.

Recall, Pfizer and BioNTech made a similar request in September, but the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) instead limited booster eligibility to people older than 65 years and younger people at an increased risk of severe COVID-19 due to underlying medical conditions, an occupation, or living situation.

The FDA has not yet scheduled a VRBPAC meeting for this month, and reports indicate the FDA may move forward on a Pfizer-BioNTech booster decision this month without seeking input from VRBPAC.

The full Pfizer-BioNTech request announcement is available here.

Biden Announces Intent to Nominate Califf as FDA Commissioner

Today, President Joseph R. Biden, Jr. announced his intent to nominate Dr. Robert Califf as the Commissioner of the U.S. Food and Drug Administration (FDA). According to the White House, Dr. Califf is a recognized expert in clinical trial research, health disparities, health care quality, and cardiovascular medicine.

Dr. Califf previously served as FDA Commissioner in 2016-17 after being confirmed by the U.S. Senate on a 89-4 vote with bipartisan support. Califf is currently a professor of medicine at the Duke University School of Medicine and also works as Head of Clinical Policy at Verily Life Sciences. He has led many landmark clinical trials and is only of the most frequently cited authors in biomedical science with more than 1,200 publications in peer-reviewed literature.

Dr. Califf will take over from Dr. Janet Woodcock who has served in the commissioner role on an interim basis during the past year. President Biden, in announcing his nomination of Dr. Califf, applauded Dr. Woodcock’s work and called on the U.S. Senate to swiftly confirm Dr. Califf to the new position.

Additional information is available here.

U.S. Surgeon General Issues Toolkit to Address Health Misinformation

U.S. Surgeon General Dr. Vivek Murthy this week released the “Community Toolkit for Addressing Health Misinformation,” intended to help Americans navigate the serious threat of health misinformation, particularly mis- and disinformation online.

Recall, this summer, Dr. Murthy issued the first Surgeon General’s Advisory of the Biden-Harris Administration warning Americans about the urgent threat of health information and calling for a  whole-of-society approach to addressing it.

The Surgeon General’s toolkit provides specific guidance to individuals, health care professionals and administrators, teachers and school administrators, and faith leaders to understand, identify, and stop the spread of health misinformation in their communities. Resources in the toolkit include:

  • A health misinformation checklist to help evaluate the accuracy of the health-related content;
  • Tips on how individuals can talk to loved ones about health misinformation
  • An outline of common types of misinformation and disinformation tactics; and
  • Reflections and examples of times individuals may have encountered misinformation.

The Surgeon General’s Office notes that during the COVID-19 pandemic, health misinformation and disinformation have threated the U.S. response to COVID-19 and continue to prevent Americans from getting vaccinated, prolonging the pandemic and putting lives at risk.

Additional information, including the full community toolkit, is available here.

Over 200 Hospitals Join New HHS Material and Infant Care Collaborative

The U.S. Department of Health and Human Services (HHS) Office of Women’s Health (OWH) this week announced that over 200 hospitals nationwide are now participating in the HHS Perinatal Improvement Collaborative. The participating facilities comprise a network of hospitals from all 50 states focused on improving maternal and infant health outcomes by reducing disparities and evaluating how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.

The new collaborative was developed as part of the HHS Maternal Morbidity and Mortality Data and Analysis Initiative which seeks to enhance maternal health data, improve performance, and strengthen evidence-based practices to improve maternal and infant health outcomes. Each participating hospital will capture more than 150 measures to understand clinical and non-clinical factors that impact overall maternal and infant health outcomes with an overarching focus on health disparities.

Additional information, including a listing of participating facilities, isavailable here.

CDC, WHO Find Global Progress Against Measles Threatened During COVID-19 Pandemic

The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) this week released a new report finding that progress toward measles elimination worldwide continues to decline, posing increased risks for measles outbreaks. During 2020, the CDC and WHO report that more than 22 million infants missed their first dose of the measles vaccine – three million more than in 2019, marking the largest increase in two decades and creating dangerous conditions for outbreaks to occur.

Compared with the previous year, reported measles cases decreased by more than 80 percent in 2020. However, measles surveillance deteriorated with the lowest number of specimens sent for laboratory testing in over a decade. Weak measles monitoring, testing, and reporting jeopardize countries’ ability to prevent outbreaks, according to the CDC and WHO. Major measles outbreaks occurred in 26 countries and accounted for 84 percent of all reported cases during 2020.

First-dose measles vaccine coverage fell in 2020 and only 70 percent of children received their second dose, well below the 95 percent coverage needed to protect communities from the spread of the measles virus. Further, the CDC and WHO note that 24 measles vaccination campaigns in 23 countries originally planned for 2020 were postponed because of the COVID-19 pandemic, putting at risk more than 93 million people for the disease.

Additional information from the CDC is available here. The full CDC-WHO report is available here.

CDC NIOSH to Host Panel on Protecting Health Worker Mental Health

The U.S. Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) will host a special virtual event with NIOSH Director Dr. John Howard, U.S. Surgeon General Dr. Vivek Murthy, and other national experts from labor and medicine on the mental health of the nation’s health care workforce. The event will be held on Thursday, November 18 from 11:30 am-12:30 pm PT.

As noted by the CDC, health workers face many on-the-job challenges that can lead to work-related stress. For many of the more than 20 million health workers in the U.S., the COVID-19 pandemic has contributed to new and worsening mental health concerns, including burnout, compassion fatigue, depression, anxiety, substance use disorders, and suicidal ideation.

The panel will:

  • Discuss the current crisis and the impact of the pandemic
  • Explore specific challenges facing the nation’s health workers and what is needed to design a better work experience for this workforce
  • Highlight current efforts and introduce NIOSH’s five-part plan to address the growing public health crisis

Additional information, including registration, is available here.

LAO Issues Analysis of California’s HCBS Spending Plan

The California Legislative Analyst’s Office (LAO) recently published an analysis of the state’s Home- and Community-Based Services (HCBS) spending plan as part of its broader 2021-22 California Spending Plan analysis series. The LAO’s analysis details the temporary increase in Medicaid federal share of cost for HCBS, eligibility requirements for states to draw down increased federal medical assistance percentages (FMAPs), and California’s recent HCBS plan submission to the federal government.

The LAO further provides a summary of the federal responses received to the state’s initial HCBS plan. DHCS submitted a revised spending plan to the federal government in mid-September, and the state still awaits federal approval on its revised plan.

Additional information, including the full analysis from the LAO, is available here.

CDPH Violence Prevention Initiative Publishes Reports on Firearms, Violent Deaths

The California Department of Public Health (CDPH) Injury and Violence Prevention Branch recently released a series of resources and information on firearm storage practices and violent deaths in California.

The first report, “California Household Firearm Storage Practices, 2017-2019,” uses data from the 2017-2019 California Behavioral Risk Factor Surveillance System (BRFSS) and finds that one in five California adults reported a household firearm. Of those who reported a firearm, one in ten reported storing the firearm unsafely (loaded and unlocked). CDPH notes that easy access to loaded firearms may contribute to firearm injuries through unintentional or impulsive discharge. Unsafe firearm storage was most commonly reported among older adults, males, veterans, and those without children in their household.

CDPH Injury and Violence Prevention Branch also released a series of new injury data briefs and an infographic produced from the California Violent Death Reporting System (CalVRDS). The briefs cover suicide, homicide, firearm-related deaths, and violent deaths involving multiple victims using data from 2018. Each brief summarizes vital statistics data and supplemental data from coroner or medical examiner and law enforcement reports to identify trends and circumstances in violent deaths in California. The resources include:

Additional information about the CDPH Injury and Violence Prevention Branch is available here.