CMS mandate on vaccines for health workers

The Centers for Medicare & Medicaid Services (CMS) has issued an Interim Final Rule (IFR) establishing COVID-19 vaccination requirements for staff employed at Medicare and Medicaid certified providers and providers.

The IFR requires that covered personnel be fully vaccinated against COVID-19 by January 4, 2022, or have received an approved religious or medical exemption or deferral by that date.

Overview

In the preamble to the IFR, CMS states that covered providers and providers must comply with federal anti-discrimination laws, including the Americans with Disabilities Act and Title VII of the Civil Rights Act, and, therefore, may be required to grant an exemption from the vaccination requirement as an accommodation under these laws.

The IFR provides, in part, that:

  • Covered providers and providers must implement mandatory vaccination policies that include a process by which staff can request an exemption from the vaccination requirement for medical or religious reasons in accordance with applicable federal law;

  • There is no “test” option;

  • Only religious or medical exemptions are allowed, and such requests must be submitted by December 5, 2021;

  • Covered personnel (except for those who have pending applications for, or who have been granted medical or religious exemptions from the IFR vaccination requirements, or those for whom COVID-19 vaccination should be temporarily delayed, as recommended by the CDC, in due to precautions and clinical considerations) must receive their first dose of a series of multi-dose COVID-19 vaccines by December 5, 2021, and all covered personnel must be fully immunized by January 4, 2022, or have received a religious exemption or medical approved. Employees who have received their last dose of vaccine but are not yet 14 days after vaccination by January 4, 2022 will be considered compliant;

  • Covered providers and providers should securely track and document the immunization status of every staff member, including those for whom there has been a temporary delay in immunization; and

  • Covered providers and providers must implement a process to ensure additional precautions to prevent the transmission and spread of COVID-19 for all staff who are not fully vaccinated against COVID-19.

Covered health entities

The IFR applies to the following Medicare and Medicaid certified providers and providers:

  • Outpatient surgical centers;

  • Hospices;

  • Residential psychiatric treatment establishments;

  • All-inclusive care programs for the elderly;

  • Hospitals (acute care hospitals, mental hospitals, hospital swivel beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals and rehabilitation hospitals / inpatient rehabilitation facilities);

  • Long-term care facilities, including skilled nursing facilities and nursing homes, generally referred to as nursing homes;

  • Intermediate care establishments for people with intellectual disabilities;

  • Home Health Agencies;

  • Comprehensive outpatient rehabilitation facilities;

  • Critical access hospitals;

  • Clinics, rehabilitation agencies and public health agencies as providers of outpatient physiotherapy and speech therapy services;

  • Community mental health centers;

  • Home infusion therapy providers;

  • Rural health clinics / federally approved health centers;

  • End-stage renal disease establishments;

The requirements do not apply directly:

  • Offices of physicians not regulated by CMS;

  • Organ procurement organizations; and

  • Portable X-ray suppliers.

However, the IFR preamble clarifies that staff working for these organizations may be indirectly subject to the requirements if they are under contract with other health entities that are subject to CMS vaccine requirements. For example, if a staff member of an organ harvesting organization goes on-site to a covered hospital to perform services, they are likely indirectly covered.

Covered staff

In most settings, the vaccination requirement applies to all staff, regardless of clinical responsibility or patient contact. All current and new staff who provide care, treatment or other services to the facility or its patients are covered. The IFR also applies to non-employees, such as students, interns, volunteers, and people who provide care, treatment or other services to the facility or its patients as part of a contract or other arrangement.

There is a limited exception to the vaccination requirement for staff who provide fully remote services, such as telehealth or fully remote payroll services. However, vaccination is compulsory for staff who principally provide services through telecommuting, but may occasionally meet colleagues who will enter a health facility or site of care for their professional responsibilities.

Penalties for non-compliance

CMS will issue interpretative guidelines, including investigative procedures, to govern enforcement. Depending on the level of non-compliance, covered providers and providers may face civil monetary penalties, denial of payment for new admissions, or termination of the Medicare / Medicaid provider contract.

Next steps

The IFR was published in the Federal Register on November 5, 2021, and comments will be accepted for 60 days, until January 4, 2022, but the IFR will go into effect immediately, with key compliance deadlines of December 5, 2021 and January 4, 2022, as noted below- above. There is no sunset provision.

In the meantime, covered providers and suppliers should:

  • Review existing vaccine policies, if applicable, to determine additional compliance requirements, particularly with respect to specific guidelines and rules regarding religious or medical exemptions;

  • Develop policies and exemption forms and procedures to meet tight deadlines; and

  • Train managers and human resources staff on these requirements, including issues relating to religious and medical exemptions that may arise.

Many questions remain unanswered, including the application of the IFR in jurisdictions where mandatory vaccines are prohibited. The preamble to the IFR states that the IFR takes precedence over these national or local laws. Likewise, the IFR provides that any exemption for religious or medical reasons must be based on federal law, regardless of the applicability, if any, of state religious or medical accommodation standards. Employers should seek legal advice on these and other difficult issues.

Jackson Lewis PC © 2021National Law Review, Volume XI, Number 309

About Yvonne Lozier

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