WASHINGTON, D.C. (November 4, 2021)—The Centers for Medicare & Medicaid Services issued an emergency regulation Thursday requiring about 17 million people working for some 76,000 health care providers—including those in home health, hospice and home infusion—to be at least partially vaccinated against COVID-19 by December 5, 2021. The administration announced in September that staff of providers participating in Medicare and Medicaid would need to be vaccinated; this regulation provides instructions about that rule.

“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,” CMS Administrator Chiquita Brooks-LaSure said in a news release. “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.”

CMS’s release cited the difficulties COVID-19 exposure has caused across the health care continuum, saying that “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.”

Along with hospitals, clinics, long-term care facilities and other locations, the requirements apply to hospices, home health agencies, public health agencies that provide outpatient physical therapy and speech-language pathology services, Programs of All-Inclusive Care for the Elderly (PACE), home infusion therapy suppliers and end-stage renal disease facilities.

National Association for Home Care & Hospice President Bill Dombi thanked CMS for providing guidance and said the industry would look for additional clarification going forward. 

“We have long supported COVID-19 vaccination of home care staff as a public health responsibility," Dombi said. “Patients served in home care are highly vulnerable to serious complications from Covid and vaccines are one crucial way of protecting them and others who can come in contact with home care staff.”

“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 frontlines of caring for COVID-infected patients in their homes," he said, but expressed concern that there is a division between providers who are subject to the requirements and those that aren't. 

The American Health Care Association and National Center for Assisted Living (AHCA/NCAL) also said the effort to vaccinate is a good one--but that this approach could "exacerbate an already dire workforce crisis in long term care."

"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," AHCA/NCAL President and CEO Mark Parkinson said in a statement. “Even a small percentage of staff members leaving their jobs due to this mandate would have a disastrous impact on vulnerable seniors who need around-the-clock care."

The unofficial version of the regulation posted on the Federal Register does not explicitly list home medical equipment or durable medical equipment (DME) providers, and the American Association for Homecare confirmed that DME providers are not included as covered entities. They could, however, be affected by a broader vaccination requirement also announced Thursday by the Occupational Safety and Health Administration that applies to all businesses with more than 100 employees. 

The CMS requirements state that:

  • Covered providers 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, 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 Jan. 4, 2022.
  • Exemptions may be provided 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.

The rule was issued as an emergency regulation, bypassing of the rulemaking process and going into effect November 5. Stakeholders have 60 days to submit formal comments, which CMS will consider and respond to as part of potential future rulemaking.   

CMS said it would use existing survey and enforcement processes to monitor compliance with the new requirement, and that providers found to be non-compliant will have opportunities to come into line.

“CMS’s goal is to bring health care providers into compliance,” the release read. “However, the Agency will not hesitate to use its full enforcement authority to protect the health and safety of patients.

In August, the Biden administration required nursing home staff to receive the vaccine. Since then, CMS said, nursing home staff vaccination rates have increased from 62% to 71%.

“This increase is encouraging, and this regulation will help to ensure even greater improvement in the vaccination rate among health care workers,” the news release read.

To view the interim final rule with comment period, click here.

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