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.