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.
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New Federal COVID-19 Vaccination and Testing Requirements
Requiring All Employers with 100+ Employees to Ensure their Workers are Vaccinated or Tested Weekly
The Department of Labor’s Occupational Safety and Health Administration (OSHA) is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work. OSHA will issue an Emergency Temporary Standard (ETS) to implement this requirement. This requirement will impact over 80 million workers in private sector businesses with 100+ employees.
Requiring COVID-19 Vaccinations for Over 17 Million Health Care Workers at Medicare and Medicaid Participating Hospitals and Other Health Care Settings
The Centers for Medicare & Medicaid Services (CMS) is taking action to require COVID-19 vaccinations for workers in most health care settings that receive Medicare or Medicaid reimbursement, including but not limited to hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies. This action builds on the vaccination requirement for nursing facilities recently announced by CMS, and will apply to nursing home staff as well as staff in hospitals and other CMS-regulated settings, including clinical staff, individuals providing services under arrangements, volunteers, and staff who are not involved in direct patient, resident, or client care. These requirements will apply to approximately 50,000 providers and cover a majority of health care workers across the country. Some facilities and states have begun to adopt hospital staff or health care sector vaccination mandates. This action will create a consistent standard across the country, while giving patients assurance of the vaccination status of those delivering care.
Requiring Vaccinations for all Federal Workers and for Millions of Contractors that Do Business with the Federal Government
Building on the President’s announcement in July to strengthen safety requirements for unvaccinated federal workers, the President has signed an Executive Order to take those actions a step further and require all federal executive branch workers to be vaccinated. The President also signed an Executive Order directing that this standard be extended to employees of contractors that do business with the federal government. As part of this effort, the Department of Defense, the Department of Veterans Affairs, the Indian Health Service, and the National Institute of Health will complete implementation of their previously announced vaccination requirements that cover 2.5 million people.
Calling on Large Entertainment Venues to Require Proof of Vaccination or Testing for Entry
The President’s plan calls on entertainment venues like sports arenas, large concert halls, and other venues where large groups of people gather to require that their patrons be vaccinated or show a negative test for entry.
See synopsis of full plan at https://www.whitehouse.gov/covidplan/
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COVID-19 Updates (09/10/2021)
Mu COVID Variant That May Resist Vaccines Found in 49 U.S. States
“Nebraska is the only state in the United States to have not detected a case of the Mu variant of COVID-19, which may render vaccines less effective. Since being first identified in Colombia in January, the Mu variant has spread to 41 countries, including the United States. Most prevalent in Hawaii and Alaska, the variant accounts for less than one percent of cases in the U.S., but its potential to be more transmissible or resist vaccines and natural immunity have health officials keeping tabs on the mutation.” Read full article on Newsweek website.
ANA Urges HHS to Declare Nurse Staffing Shortage a National Crisis
“The American Nurses Association (ANA), representing the interests of the nation’s 4.2 million nurses, urges the U.S. Department of Health and Human Services (HHS) to declare the current and unsustainable nurse staffing shortage facing our country a national crisis. In a letter to HHS Secretary Xavier Becerra, ANA calls for the Administration to acknowledge and take concrete action to address the current crisis-level nurse staffing shortage that puts nurses’ ability to care for patients in jeopardy.” Read full letter on Nursing World website
Breakthrough Infections Twice as Likely to Be Asymptomatic
Medscape Medical News reports, “People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study. Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases.” |
Moderna Covid-19 booster may come later than Pfizer and a 3-dose regimen may be best, Fauci says
By John Bonifield, CNN
Updated 10:57 PM ET, Sun September 5, 2021
Booster doses of Moderna's Covid-19 vaccine may be delayed from rolling out the week of September 20 as planned, Dr. Anthony Fauci said Sunday.
Fauci, President Joe Biden's chief medical adviser, said that while the administration's plan had been to roll out booster doses of both Pfizer and Moderna at the same time, that may not happen.
Fauci said vaccine maker Pfizer has submitted its information to the US Food and Drug Administration and "things look like they're ready to go," Fauci told CNN's Jim Acosta.
He said Moderna might be a little bit behind that, and if it is, rather than seeing a simultaneous rollout of both products, Moderna could be rolled out a week or two later.
"I don't think that is a major issue there, but we would have liked to have seen it happen all together, simultaneously. But ultimately the plan will be implemented, as was put forth," Fauci said.
Fauci said the plan is contingent first on the companies submitting the appropriate data to the FDA, and second, getting FDA approval and then a recommendation from the US Centers for Disease Control and Prevention's vaccine advisers.
Fauci said ultimately, it may turn out the proper Covid-19 immunization regimen is three doses.
"What we're observing now -- not only here in the United States but in other countries, including Israel and the UK -- (is) that the durability of the protection tends to wane, particularly in the context of the Delta variant," Fauci told CNN.
He explained how such waning can lead to both breakthrough infections and breakthrough infections that lead to hospitalizations.
"You look at the evidence from the cohorts here in the United States, there's no doubt that there is a diminution in the efficacy of the vaccine against infection, namely symptomatic infection. There's a slight suggestion in a couple of the cohorts that it also is true for a diminution of protection against hospitalization -- not profound, but the suggestion when you look at the data is there," he said.
"However, when you look at the Israeli data, and they are about a month or so ahead of us in every aspect of this -- vaccinations, boosters, etc. -- the data from the Israeli studies are that there's a rather substantial diminution in protection against infection and an unquestionable diminution in the protection against hospitalization."
Fauci said the good news is that data from Israel shows booster doses offer "profound" protection against infection and hospitalization.
"Importantly, their data also show that when you give those boosters you reconstitute, to an even higher level than before, the protection against both infection and hospitalization," Fauci said. "The boosters really jack up the response very, very high, and we hope that that response would be durable." |
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