The Biden-Harris administration announced in September that all U.S. health care workers would be required to get vaccinated as part of its six-pronged national COVID-19 strategy.

Since then, the U.S. Centers for Medicare & Medicaid Services (CMS) has been putting together its guidance to help steer that process. The agency released its interim emergency regulation on Thursday morning.

“Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combating the pandemic and the constantly evolving challenges we’re seeing,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “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 Occupational Safety and Health Administration (OSHA) also released interim vaccine rules for companies with 100 or more employees on Thursday.

“COVID-19 has had a devastating impact on workers, and we continue to see dangerous levels of cases,” U.S. Department of Labor (DOL) Secretary Marty Walsh said in a statement. “We must take action to implement this emergency temporary standard to contain the virus and protect people in the workplace against the grave danger of COVID-19. Many businesses understand the benefits of having their workers vaccinated against COVID-19, and we expect many will be pleased to see this OSHA rule go into effect.”

The CMS emergency regulation affects all health care organizations that participate in the Medicare and Medicaid programs, including home health agencies and home- and community-based services (HCBS) providers. Overall, nearly 76,000 providers and 17 million health care workers will now have to adhere to the national requirement.


Since COVID-19 vaccines became available, in-home care workers have been among the least vaccinated of all health care workers, according to multiple studies and news reports.

Originally, the Biden-Harris administration called for all nursing homes to require staff vaccinations in order to receive Medicare and Medicaid funding. That announcement spurred immediate backlash from operators, who argued that such a targeted step would prompt facility-based workers to migrate to other settings, exacerbating staffing shortages in nursing homes.

“If the vaccine mandate is implemented poorly, hundreds of thousands of nursing home staff are going to leave,” Mark Parkinson, president and CEO of the American Health Care Association/National Center for Assisted Living (AHCA/NCAL), told Skilled Nursing News in August. “If it’s implemented thoughtfully, we can avoid that.”

The goal of Thursday’s emergency regulation is to “create a consistent standard within Medicare and Medicaid while giving patients assurance of the vaccination status of those delivering care,” CMS noted.

Per CMS guidance, providers covered by the 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 Dec. 5 of this year.

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 Jan. 4, 2022.

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“The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances or practices,” CMS stated. “Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.”

As of Thursday morning, the U.S. had 750,431 confirmed deaths due to COVID-19, according to Johns Hopkins University data. The nation has had over 46 million confirmed cases since the start of the pandemic in early 2020.

But after a late summer and fall surge in new cases linked to the more contagious Delta variant, the U.S. has generally seen new infections fall, apart from some persistent hotspots.

The federal government believes mandatory vaccination policies will keep numbers in check heading into winter.

The Nation Association for Home Care & Hospice (NAHC) has repeatedly expressed support for vaccinations, calling the vaccination of in-home care staff “a public health responsibility.”

“The rules issued today represent the difficult and complex outcome of efforts to address an extended pandemic that has taken many lives in this country, including those on the front lines of caring for COVID-infected patients in their homes,” NAHC President William A. Dombi said in a statement shared with Home Health Care News. “Home care providers have provided care to hundreds of thousands of patients with COVID and millions more throughout the pandemic with a keen focus on infection control.”

Organizations with vaccination requirements have seen vaccination rates increase by more than 20 percentage points and have routinely seen their share of fully vaccinated workers rise above 90%, according to CMS, citing an analysis of health care systems, educational institutions, public-sector agencies and private businesses.

Since CMS unveiled plans for required vaccinations in health care settings, vaccination rates among nursing home staff have increased from 62% to 71%.

“While we support the overall intent of this CMS policy, we are concerned that the execution will exacerbate an already dire workforce crisis in long-term care,” Parkinson said on Thursday. “A hard deadline with no resources for providers, or glide path for unvaccinated workers, is likely to push too many out the door and ultimately threaten residents’ access to long-term care.”

CMS plans to “ensure compliance” with 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,” the agency explained. “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.”

Publicly traded home-based care companies Addus HomeCare Corporation (Nasdaq: ADUS) and Amedisys Inc. (Nasdaq: AMED) both discussed workforce vaccinations during third-quarter earnings calls this week.

About 79% of Addus’ home health workers are vaccinated, with 71% of hospice workers vaccinated, according to the provider. About 56% of its personal care employees are vaccinated.

In New York, a market already impacted by a vaccine mandate, 93% of its caregivers are fully vaccinated or have received their first dose of a two-shot regimen.

“These various city and state mandates, as well as the potential of federal mandates, make it imperative that we focus on getting as many of our employees vaccinated as possible,” Addus Chairman and CEO Dirk Allison said Tuesday.

About 67% of Amedisys’ workforce is fully vaccinated, with another 5% or 6% of workers either partially vaccinated or planning to get vaccinated, according to the company’s COO, Chris Gerard.

“We’ve seen some state mandates come into play already that we’ve noticed kind of [accelerate] vaccination rates in those states, as the deadlines quickly approached,” Gerard said Wednesday. “And in fact, it hasn’t negatively impacted us in those states, where the mandates have come into effect, for the most part.”

CMS and OSHA will offer additional clarification and guidance in days to come.

In the meantime, NAHC believes it’s important to further consider what vaccine requirements will mean for home-based care organizations of all shapes and sizes.

“[We] remain concerned that the rules divide home care providers into two categories: those subject to the mandate and those that are not because of size or relationship to Medicare and Medicaid,” Dombi continued. “This may lead to staff separations and some access to care limitations. Nonetheless, the home care community remains committed to protecting its patients and staff.”

In-home care stakeholders have 60 days to submit formal comments on the emergency regulation, which will go into effect immediately and before any additional response is provided by CMS.

The comment period officially closes on Jan. 4, 2022.

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[Updated] CMS Releases Emergency Regulation Requiring COVID-19 Vaccinations for Medicare, Medicaid Providers – Home Health Care News