Thought Leadership / News
November 16, 2021 
 Thought Leadership
CMS Vaccination Rule - What Healthcare Providers Need to Know

Gray Reed Legal Alert

On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS), through its broad statutory authority to establish health and safety regulations, issued an interim final rule requiring that certain Medicare and Medicaid-certified providers and suppliers (Covered Facilities) put into place COVID-19 vaccination policies and procedures, which must require that all applicable staff be fully vaccinated against COVID-19 by January 4, 2022 (CMS Vaccination Rule). With the newly established compliance deadline looming, this alert provides the fundamental issues that healthcare providers need to know.

I am a healthcare provider that accepts Medicare. Am I a Covered Facility that is subject to the CMS Vaccination Rule?

Maybe, depending on your provider type. The following provider and supplier types are Covered Facilities subject to the CMS Vaccination Rule:

  • Ambulatory Surgical Centers (ASCs)
  • Hospices
  • Psychiatric residential treatment facilities (PRTFs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Hospitals (acute care hospitals, psychiatric hospitals, long term care hospitals, children’s hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation hospitals)
  • Long Term Care (LTC) Facilities, including SNFs and NFs, generally referred to as nursing homes
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
  • Home Health Agencies (HHAs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services
  • Community Mental Health Centers (CMHCs)
  • Home Infusion Therapy (HIT) suppliers
  • Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)
  • End-Stage Renal Disease (ESRD) Facilities

The CMS Vaccination Rule does not apply to other healthcare providers or supplier types, such as physician offices. However, if you are a physician admitting or treating patients in person within a Covered Facility, you will be subject to the Covered Facility’s vaccination policy. To date, however, there has been no ruling on the legality of the CMS Vaccination Rule by any court.

I am a Covered Facility. Are all of my staff members subject to the CMS Vaccination Rule?

Not all, but most. The CMS Vaccination Rule casts a wide net and requires that a Covered Facility’s vaccination policies and procedures apply to all employees, licensed practitioners, students, trainees, volunteers, and any individuals who provide care, treatment, or other in-person services for the Covered Facility and/or its patients, under contract or other arrangement.  The Rule is not limited to staff members who provide clinical services, but also applies to administrative and other staff who may interact with clinical staff or patients. Frequency of interaction with clinical staff or patients does not matter when determining whether a staff member is covered by the Rule. The only staff members who are not subject to the CMS Vaccination Rule are individuals who provide services 100 percent remotely.

I am not a Covered Facility, but I am a healthcare provider that provides services to a Covered Facility. Am I subject to the vaccination requirement?

Most likely. Although you are not directly subject to the vaccination requirement, you will be subject to the vaccination policies and procedures of the Covered Facility to which you provide services. For example, if you are a physical therapy provider that contracts with a hospital to provide services to hospital patients, the individual physical therapy providers who provide services at the hospital (or at a remote location of a hospital) would be included in “staff” of the Covered Facility for whom full COVID-19 vaccination is required.

Can Covered Facilities grant exceptions to the vaccination requirement?

Yes, the policies and procedures adopted by the Covered Facility must include a process by which staff may request an exemption based on applicable federal law. Specifically, CMS requires that the policies and procedures address exemptions to staff members with recognized medical conditions for which vaccines are contraindicated (as a reasonable accommodation under the Americans with Disabilities Act) or sincerely-held religious beliefs, observances, or practices (established under Title VII). In considering exemptions or accommodations, employers must address such requests on a case-by-case basis. As healthcare providers, employers must also ensure that they minimize the risk of transmission of COVID-19 to at-risk individuals, consistent with their obligation to protect the health and safety of patients.

Is a Covered Facility allowed to test staff rather than require vaccination?

No. The CMS rule does not provide an alternative to vaccination.

Are there any pending challenge to the CMS Vaccination Rule?

As of November 10, 2021, one lawsuit has been filed challenging the CMS Vaccination Rule. The lawsuit, brought by 10 states, questions CMS’s authority to implement the mandate for healthcare workers and argues that the Rule will further exacerbate the current shortage of healthcare workers. 

What should Covered Facilities do to prepare for the CMS Vaccination Rule?

Covered Facilities need to implement policies and procedures that comply with the mandates of the CMS Vaccination Rule. Covered Facilities also need to be mindful that vaccination records must be kept confidential and stored outside of employees’ personnel files. Finally, Covered Facilities should consider creating an employee portal or secure email account to receive employee vaccination records.  The CMS Vaccination Rule is technical, and employers should consult Gray Reed’s Healthcare or Labor and Employment Department for specific questions concerning implementation.