Todd Shryock

 mandate for larger employers, but allowed a separate 

 to stand that applies only to healthcare workers at facilities the receive federal funding.

The 6-3 decision on the employer mandate blocks a rule issued by the Occupational Safety and Health Administration.

"OSHA has never before imposed such a mandate. Nor has Congress. Indeed, although Congress has enacted significant legislation addressing the COVID–19 pandemic, it has declined to enact any measure similar to what OSHA has promulgated here," the majority opinion stated.

For federally funded healthcare facilities, the court ruled 5-4 to uphold the rule administered by the Department of Health and Human Services.

"Both Medicare and Medicaid are administered by the Secretary of 

, who has general statutory authority to promulgate regulations 'as may be necessary to the efficient administration of the functions with which [he] is charged.' One such function — perhaps the most basic, given the Department’s core mission — is to ensure that the health care providers who care for Medicare and Medicaid patients protect their patients’ health and safety," the majority stated.

The rulings take effect immediately and will remain in place until legal challenges over their constitutionality are resolved through the justice system, and possibly through the Supreme Court.

The healthcare mandate applies to facilities that receive Medicare or Medicaid funds, requiring them to maintain a fully vaccinated workforce, with no testing alternative. The rule for health workers applies to more than 10.4 million workers.

The court’s ruling addressed only the issue of whether the states and business groups seeking to invalidate the mandates as unconstitutional can keep them from being carried out until courts determine the legality of the mandates themselves. Aside from the mandates, courts have widely upheld decisions by private companies to adopt their own vaccination and testing requirements, including those that are considered more restrictive.

The employer mandate would have been administered by OSHA, and the emergency temporary standard would have imposed penalties on U.S. employers with 100 or more workers that failed to ensure that all of their employees, aside from those who qualified for an exemption, were fully vaccinated for COVID-19, or tested for the virus, each week. Employers could choose whether to offer a testing option and wouldn't have had to pay for tests. Unvaccinated workers would have had to wear a mask at work.

This article was originally published on 

Articles

Employee mandate would have impacted 84 million workers. Healthcare mandate affects every facility that receives federal funding.

Supreme Court Ruling Blocks COVID-19 Vaccine Mandate for Employers

 is requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home 

 tests, starting January 15. Most consumers with private coverage will be able to go online, to a pharmacy or store, buy a test and have it paid for up front by their health plan or get reimbursed after submitting a claim.

The test kits must be FDA approved, and up to eight tests per month per individual are covered. The purchases will not require a doctor’s order and are without any cost-sharing requirements such as deductibles, co-payments or coinsurance, prior authorization, or other medical management requirements.

There is no limit to the number of tests covered if ordered or administrated by a health care provider following an individualized clinical assessment, including for those who may need them due to underlying medical conditions.

“This is all part of our overall strategy to ramp-up access to easy-to-use, at-home tests at no cost,” said HHS Secretary Xavier Becerra, in a statement. “Since we took office, we have more than tripled the number of sites where people can get COVID-19 tests for free, and we’re also purchasing half a billion at-home, rapid tests to send for free to Americans who need them. By requiring private health plans to cover people’s at-home tests, we are further expanding Americans’ ability to get tests for free when they need them.”

When plans and insurers make tests available for upfront coverage through preferred pharmacies or retailers, they are still required to 

 tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or the cost of the test, if less than $12). For example, if an individual has a plan that offers direct coverage through their preferred pharmacy but that individual instead purchases tests through an online retailer, the plan is still required to reimburse them up to $12 per individual test.

State Medicaid and Children’s Health Insurance Program (CHIP) programs are currently required to cover FDA-authorized at-home COVID-19 tests without cost-sharing. In 2021, the Biden Administration issued guidance explaining that State Medicaid and Children’s Health Insurance Program (CHIP) programs must cover all types of FDA-authorized COVID-19 tests without cost sharing under CMS’s interpretation of the American Rescue Plan Act of 2019 (ARP). Medicare pays for COVID-19 diagnostic tests performed by a laboratory, such as PCR and antigen tests, with no beneficiary cost sharing when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional.

The U.S. Department of Health and Human Services is providing up to 50 million free, at-home tests to community health centers and Medicare-certified rural health clinics for distribution at no cost to patients and community members. The program is intended to ensure COVID-19 tests are made available to populations and settings in need of testing.

Cost of At-Home COVID-19 Tests to be Covered by Group Plans, Insurance Companies

 shows that most are finding joy and staying resilient amid the pandemic as holidays approach. But health care providers should be aware that a sizeable minority are feeling high stress levels, including about their risk of getting COVID-19.

Women and those in their 50s and early 60s were more likely to report feeling a lot of 

, particularly among those who said their overall physical or mental health is fair or poor, and those with the lowest incomes.

The poll found that 27% of people over 50 said that just thinking about leaving their house caused them stress about the possibility of catching the coronavirus, while 58% said thinking about going to a crowded indoor space made them feel stressed for the same reason.

The poll is based at the University of Michigan 

Institute for Healthcare Policy and Innovation

 and supported by AARP and Michigan Medicine, U-M’s academic medical center.

“The clear differences in ability to find joy during these times, and in experiences of stress, based on health status, shows the importance of focusing on those in poor health,” said poll report 

 an assistant professor of epidemiology at the U-M School of Public Health, in a statement. “But for all 

, we know that alterations in daily life impact emotional and mental health, so finding safe ways to enjoy favorite activities is important.”

The poll was taken before widespread availability of booster doses of COVID-19 vaccine for older adults.

Fifteen percent of the older adults polled said they’ve become more resilient and able to “bounce back” or overcome challenges during the pandemic, while 71% said they are just as resilient as they were before the pandemic.

About half (47%) of poll respondents report a mixed experience of joy and stress

37% of older adults who say their health is poor reported feeling a lot of stress, compared with just 12% of those who say their health is excellent or very good.

62% of those who say their mental health is poor reported feeling a lot of stress, compared with just 8% of those who call their health excellent or very good.

26% of those in the lowest household income bracket said they feel a lot of stress, compared with 18% of those in the highest.

20% of older adults say they feel a lot of stress these days, while 38% said they have little to no stress. Those aged 50 to 65 were nearly twice as likely as those aged 65 to 80 to said they experience a lot of stress (25% vs. 13%).

17% of older adults polled said they feel little or no joy these days, but 53% said they feel some joy and 30% say they are feeling a lot of joy.

The most common sources of joy cited by poll respondents were being outdoors (87%), physical activity (72%), hobbies or projects (72%), being alone (58%) and pets (56%).

Relationships with others are important sources of joy, including friends (cited by 80% of poll respondents), children (70%), spouses or partners (64%) and co-workers (61%).

A nearly equal percentage said they got joy out of in-person and virtual connections with others, at 83% and 79% respectively. Other sources of joy: volunteering (43%) and faith-related activities (39%), social media (37%) and attending online events (22%).

Women and those in their 50s and early 60s reported the most stress about COVID-19

Patients at Higher Risk During the Holidays

PreHevbrio, a 3-antigen vaccine for adults formulated to prevent infection caused by all known subtypes of the 

The vaccine, developed by VBI Vaccines Inc. (Nasdaq: VBIV), a Cambridge, Mass., biopharmaceutical company, contains the S, pre-S2, and pre-S1 HBV surface antigens. It is the only approved 3-antigen vaccine for adults in the United States.

The approval was based on the results from two phase 3 clinical studies, PROTECT and CONSTANT. Data from the studies were published, respectively, in 

The Lancet Infectious Diseases in May 2021

The Journal of the American Medical Association Network Open in October 2021

. The studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.

PreHevbrio is expected to be available in the U.S. in the first quarter of 2022, and VBI has partnered with Syneos Health for the past two years to ensure commercial readiness.

"This is a substantial achievement that demonstrates the VBI team’s ability to progress vaccine candidates from the clinic through to approval,” Jeff Baxter, VBI’s president and CEO, said in a statement. “This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections. We would like to thank the study participants, clinical site investigators, our employees, and all who contributed to this achievement, and we look forward to working with public health and advocacy organizations as we join the fight against 

The Hepatitis B Foundation has a goal of eliminating HBV in the United States by 2030.

PreHevbrio is the only 3-antigen vaccine for Hepatitis B approved for adults