On August 26, 2021, the Public Health and Health Planning Council (PHHPC) approved an emergency rule expanding New York State Department of Health’s prior order mandating certain healthcare workers to receive their first COVID-19 vaccine dose by September 27. The emergency rule is effective immediately and will remain in effect for 90 days, subject to additional revisions and extensions.

Previously, in an order issued under Section 16 of the Public Health Law, New York State Department of Health (NYSDOH) applied the vaccine mandate to general hospitals and nursing homes, leaving out some key providers in the healthcare sector. The Section 16 order, which was vacated by NYSDOH on August 26, would have allowed for medical and religious exemptions; the new emergency rule has eliminated the religious exemption as a basis for avoiding the mandate.

In addition to general hospitals and nursing homes, the emergency rule expands the list of “Covered Entities” that must follow the mandate to include the following:

• Any facility or institution defined as a “hospital” under Article 28 of the Public Health Law, which includes ambulatory surgery centers and other diagnostic and treatment centers, among other categories;
• Agencies licensed under Article 36 of the Public Health Law, including certified home health agencies and other licensed and long-term home care services agencies and programs;
• Hospices; and
• Adult care facilities.

In comments during a webcast on August 26, NYSDOH legal counsel indicated that the definition of covered personnel in the emergency rule is modeled after the existing regulation for flu vaccinations (10 NYCRR 2.59) and is meant to encompass all categories of staff, regardless of whether they are patient-facing. Legal counsel indicated that the mandate would include anyone who enters a facility, except for patients and visitors. As such, workers at a general hospital or nursing home (including both paid and unpaid staff, students, volunteers, and those who work in Covered Entities as part of a contractual relationship (e.g. temp agency workers)), must receive a first dose of the vaccine by September 27. Personnel at Covered Entities newly added to the definition under the emergency rule have until October 7 to receive their first dose.

The directives associated with medical exemptions and the removal of the religious exemption raise questions for Covered Entities, which generally have to comply with employment discrimination laws, namely Title VII of the Civil Rights Law of 1964, the Americans with Disabilities Act and NYS Human Rights Law. In comments during the August 26 webcast, NYSDOH legal counsel indicated that the requirement was meant to mirror current Public Health Law requirements for vaccinations against measles and rubella, for which there is no religious exemption and a very narrow medical exemption. In particular, the elimination of a religious exemption is almost certain to bring legal challenges alleging infringement on religious freedoms.

Personnel requesting a medical exemption must include with their request a certification, issued by a licensed physician or certified nurse practitioner, that compliance with the vaccine mandate would be detrimental to the individual’s health based on a pre-existing health condition, in accordance with generally accepted medical standards (see, for example, the recommendations of the Advisory Committee on Immunization Practices of the U.S. Department of Health and Human Services).  Notably, physicians assistants are not explicitly named in the emergency rule as eligible to provide a medical exemption certification. In addition, the Covered Entity must have documentation of (and therefore should likely require the certification to contain) details as to the nature and duration of the medical exemption and must keep such documentation in the associated confidential personnel medical record.  Any reasonable accommodation granted based on a medical exemption must likewise be documented in the personnel record.  In comments during the August 26 webcast, NYSDOH legal counsel indicted that Covered Entities must “review and approve” requests for medical exemptions and may not simply rely on certifications provided by an individual’s personal physician. This suggests a more in-depth evaluation of the medical exemption than some Covered Entities anticipated and appears to be contrary to how most employers would typically process requests for accommodation.

The emergency rule requires Covered Entities to submit documentation to NYSDOH upon request including: the number and percentage of personnel who have been vaccinated; the number and percentage of personnel who have received a medical exemption; and the total number of covered personnel.

The emergency rule does not include specific penalties for non-compliance, but it is likely that violations will be subject to enforcement pursuant to Public Health Law § 12, which allows NYSDOH to impose a civil penalty up to $2,000 for a violation of any order or regulation where a civil penalty is not otherwise set by law. Penalties under Public Health § 12 may increase to $5,000 for subsequent violations of the same rule within a 12-month period, or $10,000 if the violation directly results in “serious physical harm to any patient or patients”.

In addition, President Biden announced on August 18 that CMS will issue new regulations requiring nursing home workers to be fully vaccinated as a condition of the nursing home receiving federal funding. As such, nursing homes serving Medicare and Medicaid beneficiaries face an additional penalty of loss of federal funding for failure to comply with the federal vaccine mandate, though the terms of mandate have not yet been announced by CMS.

We will continue to follow these developments. Please contact the attorneys in our Healthcare Industry or Labor and Employment Practice Area with any questions.