The Centers for Medicare & Medicaid Services requires healthcare employees to receive COVID-19 vaccinations by Jan. 4, 2022. Weekly testing is not an option.

  • The rule says little on specific penalties for noncompliance.
  • Expect more litigation regarding vaccination exemptions.
  • Employers may use the rule to overcome vaccine hesitancy.

The Centers for Medicare & Medicaid Services’ (CMS) highly anticipated interim final rule requiring healthcare workers to be vaccinated against COVID-19 will bring new obligations for healthcare employers, but it also might help overcome the objections of some employees.

The rule was released along with OSHA’s interim final rule requiring vaccination or weekly testing for COVID-19 for employers with 100 employees or more, which also may apply to certain healthcare employers covered under the CMS rule, says Carly O. Machasic, JD, attorney with Clark Hill in Detroit.

The main difference between the two vaccination mandates is there is no weekly testing option for healthcare workers, she says. The rule is expansive in terms of scope and covers a wide range of workers in healthcare settings that receive Medicare or Medicaid reimbursement, including, but not limited to, hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, Machasic says. The categories of individual workers covered by the rule also are broad and include not only licensed practitioners, but students, volunteers, trainees, administrative staff, leadership, and any other individuals providing care, treatment, or other services, regardless of clinical responsibility, relationship to patient care, or work location.

The only exception is for individuals who work 100% remotely or provide one-off non-healthcare-related services.

“While healthcare employers have known for months that this vaccination mandate was coming, we now finally have answers about the timeline for compliance,” Machasic explains. “Within 30 days of the announcement, covered healthcare employers must require workers to receive their first dose.”

January Deadline

A statement released by the White House explains healthcare employees will need to receive their final vaccination dose — either their second dose of Pfizer or Moderna, or single dose of Johnson & Johnson — by Jan. 4, 2022.

“OSHA also is clarifying that it will not apply its new rule to workplaces covered by either the CMS rule or the federal contractor vaccination requirement. Both OSHA and CMS are making clear that their new rules pre-empt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks, or testing,” the statement says.

The requirements were originally set forth in President Biden’s Path Out of the Pandemic COVID-19 Action Plan in September 2021, Machasic says.

“Many of the covered healthcare facilities were among the first to require COVID-19 vaccinations for employees by their own volition, but now requiring COVID-19 vaccinations will be a condition of federal funding under Medicare and Medicaid,” she says.

The White House indicated the goal is to “create a consistent standard across the country, while giving patients assurance of the vaccination status of those delivering care.”

Expect Progressive Enforcement

In the rule, CMS also emphasized the purpose is to protect patients and those who receive care and services by healthcare workers, Machasic says. The vaccination mandate is expected to affect more than 17 million healthcare workers.

CMS has indicated affected healthcare employers should expect a “progressive pattern of enforcement and remedies,” Machasic notes.

“The rule is largely silent on specific penalties for noncompliance but indicates that interpretive guidance will be released on this issue. The rule states that CMS will consider all penalties available under federal law, including civil penalties and disenrollment,” she says. “Unfortunately, the rule offers little guidance in terms of handling requests for religious accommodation. While CMS makes clear that healthcare employers are expected to provide medical and religious accommodations consistent with federal anti-discrimination laws and must document the process and decision, CMS does little to address the procedure for handling exemptions, particularly given the unique environment of healthcare.”

Healthcare facilities that have already implemented vaccine mandates have seen a flood of exemption requests, particularly for religious reasons, Machasic says. In the past, healthcare facilities have not seen anywhere near the same volume of accommodation requests with other vaccination programs, like annual influenza vaccination, which has been standard for healthcare workers.

Many healthcare employers have taken the position that any accommodation request requiring exemption from the COVID-19 vaccination by frontline workers is an undue burden and poses a direct threat to the health and safety of patients and other frontline workers, given the nature of the pandemic and particularly the delta variant, Machasic says. CMS merely refers to updated guidance issued recently from the Equal Employment Opportunity Commission (EEOC) on religious objections to COVID-19 vaccine mandates.

“Notably, in that updated guidance, the EEOC did indicate that employers working with ‘medically vulnerable individuals’ may take that into consideration when determining whether an employee’s request for an exemption from the mandate is an undue burden,” Machasic says.

More Vaccine Litigation Likely

Litigation over religious accommodations related to vaccination exemption has largely been dormant until the COVID-19 pandemic, Machasic says. Now, there are several pending lawsuits against healthcare facilities that likely will flesh out an employer’s obligation relating to exemptions.

“With the broad-sweeping nature of this rule, we would expect to see more litigation on this front into 2022,” Machasic says. “But this does little to help healthcare employers now as they review religious exemption requests.”

Regarding medical accommodations, Machasic says the rule is more explicit regarding what information employers are required to gather from individuals seeking a medical exemption, including specific information about the contraindication for the specific COVID-19 vaccine. Up to now, many employers have been using more generic medical accommodation paperwork, Machasic says, but the rule requires healthcare employers to take a more targeted approach to requests for medical accommodation.

With healthcare workers in short supply, Machasic says the potential loss of workers because of a vaccination mandate is top of mind for healthcare employers.

“In its commentary, CMS acknowledges this issue. However, CMS emphasizes that many large healthcare systems among the first to implement vaccine mandates have largely seen widespread compliance, not mass resignation,” she says. “Many healthcare facilities cannot absorb even a relatively small decrease in staff, so staffing will remain an ongoing concern for many healthcare employers. Healthcare employers are hopeful that consistency among the industry with respect to vaccine mandates will offset the impact that voluntary mandates may have had prior to the rule. Simply, if healthcare workers want to stay in the industry, vaccination is required.”


  • Carly O. Machasic, JD, Clark Hill, Detroit. Phone: (313) 309-6996.