COVID-19 Resource Center

November 18, 2021

CMS ISSUES VACCINE MANDATE FOR FEDERALLY-REGULATED HEALTH CARE FACILITIES

On the same day that OSHA issued its recent Emergency Temporary Standard (“ETS”) requiring large (100 or more employees) private employers to mandate vaccination of their employees, The Centers for Medicare and Medicaid Services (“CMS”) issued its own emergency interim final rule requiring vaccinations for federally-regulated health care facilities.  It has subsequently been challenged, but no stay has yet been issued.

The new interim rule applies to virtually all health care facilities regulated by Medicare or Medicaid:

  • Ambulatory Surgical Centers (ASCs), 42 C.F.R. § 416.51;
  • Hospices 42 C.F.R. § 418.60;
  • Psychiatric residential treatment facilities, 42 C.F.R. § 441.151;
  • Programs of All-Inclusive Care for the Elderly (PACE), 42 C.F.R. § 460.74;
  • Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities), 42 C.F.R. § 482.42;
  • Long Term Care (LTC) Facilities (including Skilled Nursing Facilities [SNFs] and Nursing Facilities [NF]), 42 C.F.R. § 483.80;
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID), 42 C.F.R. § 483.430;
  • Home Health Agencies (HHAs), 42 C.F.R. § 484.70;
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs), 42 C.F.R. §§ 485.58 & 485.70;
  • Critical Access Hospitals (CAHs), 42 C.F.R. § 485.640;
  • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech language pathology services, 42 C.F.R. § 485.725;
  • Community Medical Health Centers (CMHCs), 42 C.F.R. § 485.904;
  • Home Infusion Therapy (HIT), 42 C.F.R. § 486.525;
  • Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs), 42 C.F.R. § 491.8; and
  • End-Stage Renal Disease (ESRD) Facilities, 42 C.F.R. § 494.30.

Employers covered by the new interim rule are required to institute policies mandating employees to undergo vaccination against COVID-19, subject to some limited exceptions.  Specifically, employees are required to have received their first dose vaccine shot by December 6, 2021, and to have received their second dose by January 4, 2022 (the rule does not mandate booster shots).  Employees covered include anyone that interacts with patients or other staff members (and so would include even non-clinical employees).  It also includes students, trainees, and other volunteers that interact with either patients or staff.  However, employees that either (1) exclusively provide telehealth or telemedicine services, or (2) who do not interact in any way with patients or other employees, are exempt from the vaccination requirements.  Employees may also seek exemptions from the vaccination requirement for medical conditions (which must be supported by documentation from a licensed practitioner) or sincerely held religious beliefs consistent with federal law.

The required policy must include procedures to ensure vaccination of covered employees, as well as a procedure for eligible employees to request appropriate exemptions (as outlined above).  Second, they must also include procedures for implementation of additional precautions intended to mitigate the transmission and spread of COVID-19 to individuals that are not fully vaccinated.  Third, the policies must include a process to securely track and document (1) the vaccination status of all covered employees, (2) any covered employee that has received a vaccine booster shot, (3) any delay in vaccination of employees, and (4) information provided by employees that have requested exemptions.  If employees have been granted exemptions, the employer must implement safeguards to mitigate the risk of transmission of COVID-19.

Unlike the OSHA ETS, there is NO testing alternative to the requirements of the CMS emergency interim final rule.

Following the issuance of the rule, Attorney Generals in ten states (Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire) filed a lawsuit in the U.S, District Court for the Eastern District of Missouri seeking to enjoin the rule.  The lawsuit alleges various violations of both statutory law and the U.S. Constitution.  A similar lawsuit was also filed in the U.S. District Court for the  Western District of Louisiana on November 15, 2021.

It is recommended that employers subject to this new emergency interim final rule begin preparation of the required policies and vaccination protocols now (notwithstanding the current pending lawsuits).  The timeline provided by CMS under the rule is short and covered employees should be advised of their requirements to become vaccinated and the details of the employer’s vaccination policies as soon as possible.

If you have any questions regarding the CMS emergency interim final rule, please contact our Employment Law Group at 1-888-488-2638 or email at EmploymentLaw@c-wlaw.com.