The U.S. Food and Drug Administration has announced a recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume, indicating the test kits may produce “false positives” due to a manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA. Earlier this year, the Biden administration cut a $231.8 million deal with Ellume to boost the availability of the tests in the U.S. market.

Ellume says it has corrected the manufacturing problem and the FDA says it is continuing to monitoring the company’s efforts.

CMS released guidance on the American Rescue Plan’s requirement that state Medicaid and CHIP programs cover COVID-19-related treatments without cost-sharing. Beginning Mar 11, 2021, state Medicaid programs are required to cover treatments for COVID-19, including specialized equipment and therapies, preventive treatments and treatments for “long COVID-19.” States must also cover the treatment of conditions, without cost sharing, that may seriously complicate the treatment of COVID-19 (like cardiovascular diseases, chronic lung diseases, and cancer) if these services are already included in the state plan or a waiver.

To ensure that all state plans reflect the statutory requirements, states must submit a Medicaid state plan amendment attesting to coverage of these treatments without cost-sharing.

On Thursday, November 4, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) with the goal of minimizing COVID-19 transmission in the workplace. The ETS is for employees of large employers (100 or more employees).

Who is covered by the ETS? The ETS applies to employers in all workplaces that are under OSHA’s authority and jurisdiction, including the health care industry. However, this standard does not apply in settings where employees provide health care services or health care support services when subject to the requirements of the CMS health care ETS.

Are remote workers subject to the requirements? The ETS does not apply to employees who do not report to a workplace where other individuals are present. However, even though the employee does not report to the workplace, the individual counts toward the count of employees.

When is this rule effective? The ETS is effective immediately upon publication in the federal register. The deadline to be vaccinated from COVID-19 is January 4, 2022. By that point, workers must be fully vaccinated, completing a two-dose regimen of either Pfizer or Moderna vaccines, or the single-dose Johnson & Johnson vaccine.

Do you have to be vaccinated to comply with this regulation? No, you do not. However, if an employee decides to not be vaccinated by January 4, 2022, the employee must provide weekly test results to their employees at their own expense. Additionally, workers who remain unvaccinated will be required to wear a mask at work.

Information an employer must supply. The ETS requires employers to provide employees information in understandable language and literacy about: 1) information about the requirements of the ETS and workplace policies and procedures; 2) the CDC document “Key Things to Know About COVID-19 Vaccines,” 3) information about protections against retaliation and discrimination; and 4) information about laws that provide for criminal penalties for knowingly suppling false statements or documentation.

Is this rule being challenged in court? Yes, on Friday, November 5, 2021, 26 states filed suit challenging the ETS regarding COVID-19 vaccination and testing requirements issued by OSHA. In response, a federal appeals court halted the vaccine mandate for businesses. Timeline for when this rule will be litigated remains unclear, but that this time there has been no change to the January 4, 2022, effective date.

Thank you for your interest in in the COVID-19 Omnibus Vaccine Rule (IFC-6). The recent stakeholder call had a limit of 10,000 participants and we exceeded that number. Please accept our apologies.

CMS has posted the presentation slides and a recording of the stakeholder call for your convenience.

To view the slides, visit: https://www.cms.gov/files/document/covid-19-health-care-staff-vaccination-ifc-6-national-stakeholder-call-slides.pdf

To view the video, visit: https://www.youtube.com/watch?v=xHA0zY1aC-Y

In addition to the resources above, CMS has prepared a frequently asked questions document, available here: https://www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.pdf

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) is promoting the latest recommendations provided by the Centers for Disease Control and Prevention (CDC), to prepare healthcare workers to begin vaccinating children 5 to 11 years old. HHS Secretary Xavier Becerra issued this statement on the landmark moment to increase children’s protection during this pandemic.

The spread of the Delta variant resulted in a surge of COVID-19 cases in children throughout the summer. Vaccination, along with other preventative measures, can protect children from COVID-19 using the safe and effective vaccines already recommended for use in adolescents and adults in the United States.

OMH continues to focus on raising awareness about the importance of getting the COVID-19 vaccine. We encourage you to promote the latest CDC recommendations (English|Spanish) and other languages visit the OMH website (English|Spanish) for guidance on establishing vaccine confidence, and combatting vaccine hesitancy, especially among racial and ethnic minority groups.

The Biden-Harris Administration is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. The emergency regulation issued by the Centers for Medicare & Medicaid Services (CMS) protects those fighting this virus on the front lines while also delivering assurances to individuals and their families that they will be protected when seeking care.

“Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combatting the pandemic and the constantly evolving challenges we’re seeing,” said CMS Administrator Chiquita Brooks-LaSure. “Today’s action addresses the risk of unvaccinated health care staff to patient safety and provides stability and uniformity across the nation’s health care system to strengthen the health of people and the providers who care for them.”

The prevalence of COVID-19, in particular the Delta variant, within health care settings increases the risk of unvaccinated staff contracting the virus and transmitting the virus to patients. When health care staff cannot work because of illness or exposure to COVID-19, the strain on the health care system becomes more severe and further limits patient access to safe and essential care. These requirements will apply to approximately 76,000 providers and cover over 17 million health care workers across the country. The regulation will create a consistent standard within Medicare and Medicaid while giving patients assurance of the vaccination status of those delivering care.

Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.

CMS accelerated outreach and assistance efforts encouraging individuals working in health care to get vaccinated following the Administration’s announcement that it would expand the requirement for staff vaccination beyond nursing homes to include additional providers and suppliers. Since the Administration’s announcement, nursing home staff vaccination rates have increased by approximately nine percentage points – from 62 to 71 percent. This increase is encouraging, and this regulation will help to ensure even greater improvement in the vaccination rate among health care workers.

CMS will ensure compliance with these requirements through established survey and enforcement processes.  If a provider or supplier does not meet the requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance before additional actions occur. CMS’s goal is to bring health care providers into compliance.  However, the Agency will not hesitate to use its full enforcement authority to protect the health and safety of patients.

The requirements apply to: Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly, Hospitals, Long Term Care facilities, Psychiatric Residential Treatment Facilities, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Home Health Agencies, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services), Community Mental Health Centers, Home Infusion Therapy suppliers, Rural Health Clinics/Federally Qualified Health Centers, and End-Stage Renal Disease Facilities.

CMS is taking necessary action to establish critical safeguards for the health of all people, their families, and the providers who care for them. CMS knows that everyone working in health care wants to do what is best to keep their patients safe. Yet, unvaccinated staff pose both a direct and indirect threat to the very patients that they serve. Vaccines are a crucial scientific tool in preserving and restoring efficient operations across the nation’s health care system while protecting individuals. This new requirement presents an opportunity to continue driving down COVID-19 infections, stabilize the nation’s health care system, and ensure safety for anyone seeking care.

To view the interim final rule with comment period, visit: https://www.federalregister.gov/public-inspection/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination.

To view a list of frequently asked questions, visit: www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.docx.

The Ad Council, COVID Collaborative and rural organizations including the American Farm Bureau Federation, the Cooperative Extension System, the National Association of Farm Broadcasting and the National Association of Community Health Centers (NACHC) have collaborated to develop a series of public service announcements that highlight rural voices and stories involving COVID-19 in order to increase public confidence in vaccination. The summary discusses the importance of local perspectives to building community trust, as well as the impacts of the pandemic in rural areas.

Learn more.

The AgriSafe Network is a nonprofit organization that provides information and training on injury and disease related to agriculture.  Their health professionals and educators created a social media toolkit that aims to provide clear messages about COVID-19 vaccination for agriculture, forestry, and fishing workers.

See Reaching Farm Communities for Vaccine Confidence for more information.