Healthcare facilities that do not fully vaccinate all eligible staff members by Jan. 4 may face fines or termination of their Medicare or Medicaid contract, CMS said during a Nov. 4 briefing on the new regulations.
While "termination is the ultimate last resort," CMS will use "full enforcement authority to protect patients," Lee Fleisher, MD, CMO and director of CMS' Center for Clinical Standards and Quality, said during the briefing.
Along with enforcement protocols, CMS also shared more details on the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule, including to what types of healthcare workers the standards apply and how it interacts with other federal vaccination rules.
Here are six questions about the regulations, answered.
What does the rule entail?
1. The interim final rule requires healthcare facilities to develop plans and processes to:
- Vaccinate all eligible staff
- Provide exemptions and accommodations as appropriate
- Track staff vaccination rates
2. By Dec. 6, facilities must have all plans in place, and healthcare workers must have received at least one vaccine dose. By Jan. 4, 2022, all eligible healthcare employees should be fully vaccinated.
3. The federal regulation does not include a testing option as an alternative to vaccination and does not add any new data-reporting requirements for facilities.
4. The regulation also preempts state laws and other federal regulation requirements for all facilities that participate in Medicare or Medicaid.
Which healthcare facilities does the rule apply to?
5. The requirement applies to about 76,000 healthcare providers and suppliers regulated by CMS' Conditions of Participation. CMS estimates the regulations will cover 17 million healthcare workers.
6. The regulations do not apply to:
- Religious nonmedical healthcare institutions
- Organ procurement organizations
- Portable X-ray suppliers
- Assisted living facilities
- Group homes
- Home and community-based services
- Physician offices
Which staff members must get vaccinated?
7. The vaccination requirements apply to all current and new eligible staff members, including facility employees, licensed practitioners, students, trainees, volunteers and contracted staff.
8. Staff members who provide duties off-site, such as home health or home infusion therapy staff, and individuals who enter a CMS-regulated facility, such as a physician with privileges at a hospital, must also be vaccinated.
9. The regulation does not apply to full-time telehealth workers or remote payroll services employees.
How does CMS define fully vaccinated?
10. CMS considers staff members fully vaccinated if it has been at least two weeks since they've received two doses of Pzifer or Moderna's vaccine or one dose of Johnson & Johnson's vaccine.
11. Staff members who've completed their vaccination series by the Jan. 4 deadline will be considered fully vaccinated, even if they have not yet completed the 14-day waiting period.
12. The regulation does not apply to booster doses.
How do exemptions work?
13. CMS requires healthcare facilities to offer religious and medical exemptions for staff in accordance with federal law.
14. Exempt staff should be provided with appropriate accommodations, such as an option for COVID-19 testing, physical distancing or placement in nonpatient care areas. Facilities have the authority to determine the best type of accommodation to ensure they minimize the risk of transmission to at-risk individuals.
15. The regulation does not include exemptions for staff who have COVID-19 antibodies.
How will CMS ensure compliance?
16. CMS will work with state survey agencies to conduct on-site compliance reviews for the requirements via recertification surveys or complaint surveys.
17. Accrediting organizations such as the Joint Commission will also assess facilities' compliance.
18. Facilities found out of compliance with the regulation will be cited and have an opportunity to comply. If hospitals fail to comply, CMS may use enforcement remedies, including civil monetary penalties, denial of payment and termination from the Medicare and Medicaid programs, as a final measure.
"CMS' goal is to bring healthcare facilities into compliance," the agency said. "Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance."
For more details on the regulation, click here.
This story was updated on Nov. 11.