Long-term care staff must be fully vaccinated against COVID-19 by Jan. 4 under a new healthcare worker vaccination rule released early Thursday by the Centers for Medicare & Medicaid Services. 

Providers are required to establish a policy by Dec. 6 that will ensure all eligible staff have received the first dose of a two-dose vaccine regime, or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by the January deadline. The much-anticipated rule requires that all eligible staff receive either their two doses of Pfizer or Moderna or one dose of the Johnson & Johnson vaccine no later than the first Tuesday of 2022.

Since the White House announced in mid-August that a federal mandate would be imposed, nursing home staff vaccination rates have increased by approximately nine percentage points – from 62% to 71%, CMS noted Thursday.

“This increase is encouraging, and this regulation will help to ensure even greater improvement in the vaccination rate among healthcare workers,” an agency statement said.

CMS said it will compel compliance with the new 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 healthcare providers into compliance. However, the Agency will not hesitate to use its full enforcement authority to protect the health and safety of patients.”

Exemptions based on recognized medical conditions or religious beliefs, observances or practices will be allowed, but operators must develop their own processes for allowing those exemptions.

The emergency regulation is expected to be published in the Federal Register tomorrow but is available as a PDF now.

In addition, companies with more than 100 employees will also be mandated to require COVID-19 vaccinations for their workers or do regular testing by Jan. 4, the Department of Labor’s Occupational Safety and Health Administration announced early Thursday. The emergency temporary standard is designed to protect more than 84 million U.S. workers, officials said.

The mandates have been a bone of contention for many political and labor factions. The Jan. 4 deadline is expected to ease employer tensions through the year-end holiday retail and service seasons, but how much of a positive effect that will have remains to be seen. Vaccination rates have steadily climbed through the fall months, though not as quickly as most healthcare and administration officials had hoped.

A Department of Labor spokeswoman confirmed to McKnight’s early Monday that the administration’s review of the rule had cleared the Office of Management and Budget, meaning that it could be released at any time and become official once it is published in the Federal Register.

“COVID-19 has had a devastating impact on workers, and we continue to see dangerous levels of cases,” said U.S. Labor Secretary Marty Walsh in a statement accompanying Thursday’s announcement. “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 coronavirus has led to the deaths of 750,000 people in the U.S. alone, and the infection of millions more, making it the deadliest pandemic in the nation’s history, the Department of Labor noted.

“OSHA estimates that this rule will save thousands of lives and prevent more than 250,000 hospitalizations due to workplace exposure to COVID-19 over the course of the ETS,” its statement said.

The new CMS requirements will apply to approximately 76,000 providers and cover more than 17 million healthcare workers, the agency said. The regulation “will create a consistent standard within Medicare and Medicaid while giving patients assurance of the vaccination status of those delivering care,” it added.

Organizations that have vaccination requirements have seen their vaccination rates increase by more than 20 percentage points and have routinely seen their share of fully vaccinated workers rise above 90%, according to a recent White House report sharing an analysis of healthcare systems, educational institutions, public-sector agencies and private businesses.

“Unvaccinated staff pose both a direct and indirect threat to the very patients that they serve,” CMS said, adding that the new requirement “presents an opportunity to continue driving down COVID-19 infections, stabilize the nation’s healthcare system, and ensure safety for anyone seeking care.”

CMS has posted answers to frequently asked questions about the emergency regulation online.

Biden first announced plans for the staff vaccination mandate rule on Aug. 18. Originally, it applied only to nursing homes — which led operators to immediately criticize the move since it did not include other healthcare providers in the mandate, thus leaving them vulnerable to mass defections. CMS at the time said nursing homes could expect their interim rule to be issued in late September.

That timeline changed when Biden announced on Sept. 9 expanded the mandate terms to include home health agencies, hospitals and dialysis facilities, among others. The broader policy now encompasses patients of 50,000 providers and more than 17 million healthcare workers in Medicare- and Medicaid-certified facilities and settings. The release date for the Interim Final Rule with Comment Period, as a result, was targeted for mid- to late-October.

CMS earlier this month confirmed to McKnight’s Long-Term Care News that details on what would be required would hopefully be released in late October.

Agency officials could not comment on preparations for the new mandate since federal law prohibits them from talking about pending regulations during the rulemaking process. Officials, however, did say providers who fail to quickly comply with the rule likely wouldn’t be stripped immediately of their Medicare and Medicaid program eligibility. 

The new regulation will be “enforced in the same manner that is expected of all Medicare- and Medicaid-certified facilities with regard to compliance,” Jean Moody-Williams, deputy director for CMS’ Center of Clinical Standards and Quality, said during a nursing home stakeholder call in late August.

“We usually use a progressive pattern of enforcement and remedies, in which there’s notification. There could be civil monetary penalties, denial of payment, and ultimately, removal from Medicare/Medicaid programs,” Moody-Williams added. “Typically, that is not where we generally go first.” 

The day after CMS announced its original nursing home-only mandate, AHCA delivered the agency a six-point wish list to make it compatible for skilled nursing facilities. The first request was that the mandate be broadened to all healthcare providers, which the association proudly pointed out was done relatively quickly. But it knew of no other changes until today.

The group’s six-point plan was included in a letter to Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.

Highlights included a call to offer a daily COVID-19 testing alternative instead of a vaccination mandate for employees who refuse to get the shots, as well as a request of $25 million to restart an enhanced education program aimed at employees.

In its Aug. 20 letter, AHCA also asked for $3 billion from it to help with the expenses of paying for agency staffing if vaccine-averse employees leave and to administer a new wave of inoculations. 

The association also addressed one of the most galling aspects for operators: asking that providers be allowed to ask visitors about their vaccination and test results — and require vaccination or negative tests prior to visits.

This is a developing story. Please check back for more details.