On August 26, 2021, the New York State Department of Health’s Public Health and Health Planning Council (PHHPC) approved emergency regulations that institute a broad vaccine mandate for New York healthcare facilities. These emergency regulations supersede and go beyond earlier vaccine directives aimed at healthcare workers. Specifically, on August 16, then-New York Governor Andrew Cuomo announced that New York healthcare workers would be required to be vaccinated against COVID-19. On August 18, the Department of Health issued a Summary Order on vaccination affecting certain types of healthcare facilities. The new emergency regulations impose a mandate that extends beyond general hospitals and long-term care facilities, which would have been covered by the Summary Order, to many other types of healthcare providers (Covered Entities).  The emergency regulations also preclude any potential exemption from the vaccine mandate for sincerely held religious beliefs, an option that was previously contained in both the Summary Order and the initial version of the emergency regulations.  The mandate implemented by the emergency regulations took effect immediately upon their filing with the New York Secretary of State on August 26, 2021.

Who is Covered by the Emergency Regulations?

Covered Entities

The emergency regulations apply to each of the following categories of healthcare providers licensed by the State of New York pursuant to the Public Health Law or Social Services Law:

• general hospitals and nursing homes (which are subject to an earlier deadline described below);
• diagnostic and treatment centers, including without limitation community health centers and other federally qualified health centers, dental clinics and dispensaries, midwifery birth centers, and rehabilitation clinics;
• certified home health agencies, long-term home healthcare programs, acquired immune deficiency syndrome (AIDS) home care programs, licensed home care service agencies, and limited licensed home care service agencies;
• home and in-patient hospices; and
• adult care facilities.

Personnel

All individuals who are employed by, or otherwise affiliated with, a Covered Entity, regardless of whether they are paid, will be subject to these emergency regulations.  This includes medical and nursing staff, contract staff, students, volunteers, and anyone else who engages in activities such that if they were infected by COVID-19, they could potentially expose other covered personnel, patients, or residents.

When Do Personnel of Covered Entities Have to Be Vaccinated?

Personnel must receive their first COVID-19 vaccine dose, or have a documented approved medical exemption, by the dates below or they cannot be permitted to work.  Personnel must then become fully vaccinated within the timeline recommended for the vaccination they received in accordance with applicable federal guidelines and recommendations.  The deadlines are:

• by September 27, 2021: personnel in general hospitals and nursing homes must receive their first dose.
• by October 7, 2021: all remaining personnel in Covered Entities must receive their first dose.

Exemptions

Medical Exemptions

Personnel may present a certification from a licensed physician or certified nurse practitioner (not from any other medical provider) documenting that the COVID-19 vaccine is detrimental to their health based upon a pre-existing condition.¹  The certification must contain the nature and duration of the medical exemption and be maintained by the Covered Entity for production to the Department of Health upon request.  The state has described Covered Entities as “gatekeepers” which must scrutinize such requests to ensure that any granted exemptions comport with generally accepted medical standards.  Healthcare providers who are found to have issued certifications beyond the intended limited scope for exemption (such as for people who have experienced medical contraindications to a previous dose of the COVID-19 vaccine or other limited allergies) may be referred to the Office of Professional Medical Conduct, although the Department of Health has not explained how those providers will be identified and/or reported.  The state did not speak to acceptable accommodations for employees who are granted medical exemptions, but these may include routine COVID-19 testing, additional personal protective equipment, leaves of absence, or reassignment to isolated or remote work.

Religious Exemptions

Critically, the emergency regulations do not allow for any religious exemptions to the vaccination mandate.  While such an exemption was contained in the Summary Order and in the initial proposed emergency regulations, the Department of Health explicitly stated during the August 26, 2021 hearing that Covered Entities will no longer be permitted to provide religious exemptions to personnel covered by the COVID-19 vaccine mandate, and the emergency regulations supersede the August 18, 2021 Order for Summary Action issued to hospitals and nursing homes that provided for religious exemptions.  It seems this change was brought about by feedback in the healthcare community about a significant rise in purported religious objections to COVID-19 vaccination.  In response to prior health crises, such as a 2019 measles outbreak in the New York City area, state and local departments have similarly done away with religious objections to vaccinations.  In addressing the PHHPC at the emergency hearing, counsel for the Department of Health stated that removal of this exemption will not conflict with any federal statutes because the agency is not “Constitutionally required to provide a religious exemption,” pointing to existing requirements for measles, mumps and rubella vaccinations for New York healthcare employees and students in public and private schools.  While this conclusion may be challenged on constitutional grounds in future litigation, until otherwise ordered New York Covered Entities may not allow for religious exemptions.   

Documentation

By the applicable dates set forth above, Covered Entities must maintain the following documentation:

• A vaccination policy that ensures compliance with the emergency regulations, which must be presented to the Department of Health upon request;

• For all healthcare personnel, acceptable records of COVID-19 vaccinations, containing the manufacturer, lot number(s), date(s) of vaccination, and vaccinator or vaccine clinic site, such as:
  
  • CDC COVID-19 vaccine card or other record prepared and signed by the licensed health practitioner who administered the vaccine;
  • Official records from a foreign nation, NYS Countermeasure Data Management System (CDMS), the NYS Immunization Information System (NYSIIS), City Immunization Registry (CIR), a Department-recognized immunization registry of another state, or an electronic health record system; or
  • Any other documentation determined acceptable by the Department of Health.
• Certifications of medical exemptions and any reasonable accommodations granted, as discussed above; and
• COVID-19 vaccination data consisting of the following:
  
  • Number and percentage of personnel who have been vaccinated;
  • Number and percentage of personnel with granted medical exemptions; and
  • Total number of covered personnel.

Union Considerations

Notably, the state’s directive likely removes any decisional bargaining obligation under the National Labor Relations Act about vaccine mandates affecting employees represented by a labor organization. Employers must still be mindful of “effects” bargaining obligations that may exist and should be prepared to bargain over effects of the vaccine mandate if requested by the applicable collective bargaining representative. The most likely “effects” bargaining issue relates to the employment status of employees who refuse to be vaccinated. Also, regardless of whether there are decisional or effects bargaining obligations, employers should expect and respond to union requests for information (RFIs) about the employer’s vaccination-related policies. Vaccine-related RFIs should be analyzed under the same standard that the employer would apply to any other health and safety-type information request.

Enforcement

The Department of Health has not established how it will enforce this new mandate.  For now, it requires employers to self-enforce, including terminating personnel who fail to comply, and the agency can require production of the documents outlined above at any time.  The Department of Health has the authority to initiate enforcement proceedings for noncompliance with its regulations, which could result in monetary penalties.

Effective Dates

As stated above, the emergency regulations became effective on August 26, 2021 upon filing with the Department of State.  Due to their temporary emergency nature, the emergency regulations are set to expire on November 24, 2021, unless they are renewed, modified, or a notice of proposed rulemaking is issued for their permanent adoption.  Over the next 90 days, the Department of Health will review the feedback elicited during the August 26, 2021 PHHPC hearing, including requests for a “Dear Administration” letter for facilities to better explain the basis and application of the vaccine mandate to its personnel, and questions about resources for entities that are already suffering from worker shortages and low vaccination rates. We expect further guidance to be issued, in which event we will provide updates.    

Face Coverings

Effective August 27, 2021 and until further notice, NY’s Commissioner of Health has mandated the use of face coverings within Covered Entities’ healthcare settings in accordance with CDC guidance.  This applies to personnel as well as visitors, regardless of vaccination status.  The emergency regulations also require Covered Entities to make masks available to personnel at no cost.

What to Do Next?

In the meantime, Covered Entities should take steps to comply with the new mandate, including review and revision of existing vaccination policies, job descriptions and job postings, and implementation of a system to track and document vaccination data for presentation to the Department of Health upon request.  Employers are also reminded of Civil Service Law § 159-c (public employers) and Labor Law §196-c (private employers), which require up to four hours of paid leave for an employee to receive a COVID-19 vaccine injection. 

We encourage you to speak with employment counsel regarding these rapidly changing vaccination requirements.  We will continue to monitor developments and provide updates as additional information becomes available.