Thought Leadership / News
January 25, 2022 
 Thought Leadership
CMS Vaccination Rule - What Healthcare Providers Need to Know (Updated 1/25/2022)

Gray Reed Legal Alert

UPDATE (1/25/22) – TEXAS ADDED: On January 19, 2022, a federal district court in Texas dismissed the State’s lawsuit,   lifting the injunction applicable to Texas and allowing CMS to enforce the vaccine mandate for healthcare providers nationwide. On January 20, 2022, CMS issued guidance setting out new compliance guidelines for Texas. All prior deadlines set for the other 49 states remain unchanged.

By February 19, 2022, Covered Facilities in Texas must:

  1. Require that 100% (as set forth below) receive the first dose of the COVID-19 vaccine (except those with a medical or religious exemption); and
  2. Enact policies to comply with the CMS interim final rule.

By March 21, 2022, Covered Facilities in Texas must ensure that 100% of covered staff are fully vaccinated (except those with a medical or religious exemption).

UPDATE (1/14/22) – ALL STATES EXCEPT TEXAS: On January 13, 2022, the U.S. Supreme Court held in a 5-4 decision that the CMS Interim Final Rule requiring the vaccination of certain healthcare workers can proceed. The Supreme Court’s decision stayed preliminary injunctions temporarily blocking the implementation of the CMS vaccine mandate in twenty-four states. Twenty-five other states were already subject to enforcement of the CMS vaccine mandate; Texas is currently the only state still subject to a preliminary injunction. Although the Supreme Court’s decision only stayed the preliminary injunctions and did not rule on the merits of the case, Covered Facilities (defined below) in all states—other than Texas—are now required to comply with CMS Interim Final Rule.

Before January 27, 2022, Covered Facilities must:

  1. Require that 100% of its covered staff (as set forth below) receive the first dose of the COVID-19 vaccine (except those with a medical or religious exemption); and
  2. Enact policies to comply with the CMS interim final rule.

Then, by February 28, 2022, Covered Facilities must ensure that 100% of covered staff are fully vaccinated (except those with a medical or religious exemption).

For the details of these requirements, please see the full article below. Gray Reed's Healthcare and Labor & Employment Departments will continue to monitor all developments and provide updates for employers and providers.

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.