The Centers for Medicare and Medicaid Services (CMS) issued its highly anticipated vaccine mandate for health facilities today. The CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (“the CMS Rule”) implements mandatory vaccine requirements announced by the Biden Administration in September – and sets the first of several deadlines for December 5.
How do I know if the CMS Rule applies to my facility?
The CMS Rule applies to providers and suppliers regulated under the CMS Conditions of Participation. This includes Hospitals, Ambulatory Surgical Centers, Long Term Care facilities, Home Health and Hospice Agencies, Rural Health Clinics, and Federally Qualified Health Centers.
In general, the CMS Rule does not apply to physician offices, but may apply in limited circumstances, such as clinics which are provider-based or provide physical therapy or speech pathology services that are subject to the CMS Conditions of Participation.
Even if the CMS Rule does not apply, you may be covered by the Federal Contractor Mandate or the mandate issued by the Occupational Safety and Health Administration. You can find out more about those rules here.
What steps are necessary for a covered health facility to comply?
Covered health facilities must have a policy in place 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 December 5, 2021. All eligible staff must be fully vaccinated by January 4, 2022.
Health facilities must also develop a plan for permitting exemptions in alignment with federal law – which are limited to (1) recognized medical conditions and (2) strongly held religious beliefs, observances, or practices. The CMS Rule does not provide for any other exemption, such as an allowance to submit negative weekly tests or proof of the presence of COVID-19 antibodies.
Health facilities should also ensure they have a plan in place for tracking and documenting staff vaccinations, as well as mitigating any risks to patients from employees granted a religious or medical accommodation.
Notably, the CMS Rule supersedes any state law it is in conflict with – for example, any state law that prevents health facilities from requiring vaccines or requires additional exemptions other than medical or religious exemptions to be implemented.
Who must be vaccinated?
Any staff member on site at a covered health facility who provides patient care, or interacts with staff who provide patient care, must be vaccinated. The CMS Rule also applies to staff who perform duties offsite and to certain non-staff who enter into a CMS regulated facility (for example, a physician who is a member of the Medical Staff of the facility). The CMS Rule does not apply to full telework staff.
How will the CMS Mandate be enforced?
State surveying agencies and Accrediting Organizations will review compliance with the CMS Rule during regularly conducted surveys. If a covered health facility is not in compliance with the CMS Rule, it will be cited for non-compliance and will have an opportunity to return to compliance before additional actions occur. For covered health facilities that do not come into compliance, the CMS Rule carries the weight of Civil Monetary Penalties, denial of payment, and, as a last resort, termination from the Medicare and Medicaid programs.
Amie K. Wilcox's practice is focused in the area of healthcare where she works primarily on various corporate and compliance matters. She drafts and reviews policies to ensure compliance with federal healthcare regulations such as HIPAA, Stark I and Stark II, Anti-Kickback and Medicare/Medicaid reimbursement.
Disclaimer: The information included here is provided for general informational purposes only and should not be a substitute for legal advice nor is it intended to be a substitute for legal counsel. For more information or if you have further questions, please contact one of our Attorneys.