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Our attorneys stay on top of changes in legislation, agency regulations, case law, and industry trends—then craft timely legal alerts to keep clients up to date on legal developments important to their business.

November 24, 2021

State and Federal Regulations Require NYS Health Care and Human Services Facilities to Implement Vaccine Mandates

As noted in a prior legal alert, certain health care facilities will soon be, or in some cases already are, responsible for ensuring that nearly all staff members at their facilities are fully vaccinated. The New York Prevention of COVID-19 Transmission by Covered Entities Emergency Regulation (NY Vaccine Rule) was issued on August 26, 2021, and required covered health care entities to mandate vaccination for covered personnel. Recent court decisions and New York State Department of Health (DOH) guidance required the mandate to be implemented by November 22, 2021, for staff who had previously claimed religious exemptions. For those facilities not covered by the NY Vaccine Rule, the Centers for Medicare & Medicaid Services Interim Final Rule (CMS Rule) requires certain Medicare-participating providers to ensure eligible employees receive their first dose of a COVID-19 vaccine by December 6, 2021, and their second shot of a two-dose vaccine by January 4, 2022. Other health care facilities and Medicaid-covered human services programs are not covered by either mandate but may be covered by the emergency temporary standard (ETS) released by the Occupational Safety and Health Administration (OSHA) requiring COVID-19 vaccinations or weekly testing for workers at businesses with 100 or more employees. 

The absence of a religious exemption within the NY Vaccine Rule has been challenged in both federal and state court, and thus far, those courts have repeatedly ruled in favor of the DOH. More specifically, those courts have upheld the NY Vaccine Rule, requiring that covered health care facilities ensure all staff members, including those who were previously allowed religious exemption from the mandate, are now vaccinated, work remotely (if available), or obtain a medical exemption.  

All of the above-referenced government vaccine mandates are the subject of pending legal challenges. In fact, most recently, a federal appeals court enjoined enforcement of the OSHA ETS. Although no court has, as of this writing, ordered a stay of the CMS Rule, one of the lawsuits targeting that regulation was filed with the same federal appellate court that recently issued the injunction in respect of the OSHA ETS. But, unless and until any ruling is made that affects the CMS Rule or NY Vaccine Rule, covered health care entities will be expected to comply. The following are some of the requirements included in the CMS Rule regulations. 

Eligibility
The staff vaccination requirement under the CMS Rule applies to the following Medicare and Medicaid-certified provider and supplier types:

  • Ambulatory Surgery Centers
  • Community Mental Health Centers
  • Comprehensive Outpatient Rehabilitation Facilities
  • Critical Access Hospitals
  • End-Stage Renal Disease Facilities
  • Home Health Agencies
  • Home Infusion Therapy Suppliers
  • Hospices
  • Hospitals
  • Intermediate Care Facilities (ICFs) for Individuals With Intellectual Disabilities
  • Clinics
  • Rehabilitation Agencies
  • Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Psychiatric Residential Treatment Facility (PRTF) Programs for All-Inclusive Care for the Elderly Organizations (PACE)
  • Rural Health Clinics and Federally Qualified Health Centers
  • Long-Term Care Facilities

The NY Vaccine Rule encompasses facilities not included in the federal law, such as assisted living facilities and nursing homes. The NY Vaccine Rule additionally covers diagnostic and treatment centers, adult day health care programs, adult homes, enriched housing programs, residences for adults, AIDS home care programs, certified home health agencies, licensed home care service agencies, and long-term home care programs. Notably, the CMS Rule added Intermediate Care Facilities to the mandate, which were not covered by the NY Vaccine Rule.  New York State agencies that license and regulate other health care and Medicaid-based human services in programs and nonhospital settings are considering the applicability of the CMS Rule. We are aware that the NY Office of Addiction Services and Supports (OASAS) has completed its analysis of and indicated that community-based (nonhospital) inpatient detox programs, residential services programs, outpatient programs, and Opioid Treatment Programs (OTPs) are not required to comply with the CMS mandate and that NYS Governor Hochul’s office is reviewing that analysis.  

Private medical and therapist practices that are not subject to CMS health and safety regulations are not covered under either the CMS Rule or the NY Vaccine Rule.  

Procedures and Recordkeeping
Under all the vaccine mandates, health care employers must develop and implement a process for determining the vaccination status of all employees, including those who may be exempted from the mandate. The NY Vaccine Rule requires that the record contain the name of the manufacturer, lot number(s), date(s) of vaccination, and the vaccinator or vaccine clinic site. The CMS Rule says acceptable forms of proof of vaccination include Centers for Disease Control and Prevention (CDC) COVID-19 vaccination record cards or a legible photo of the card, documentation of vaccination from a health care provider or electronic health record, or a state immunization information system record. Although booster shots are not required under either regulation, the CMS Rule says providers and suppliers must have a process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC. 

Should any employee seek a medical exemption from the policy, the employer will need to adhere to specific requirements under the regulations. The NY Vaccine Rule states that if a licensed physician or certified nurse practitioner certifies that immunization with a COVID-19 vaccine is detrimental to an employee’s health based on a preexisting health condition, the nature and duration of the medical exemption must be documented. Additionally, the CMS Rule requires that all documentation confirming the recognized clinical contraindication to COVID-19 vaccines must be signed and dated by a licensed practitioner. The medical exemption forms also need to specify which of the vaccines are clinically contraindicated for the staff member, the reasons why, and a statement from the practitioner recommending that the employee be exempted based on recognized clinical contraindications. 

With regard to requests for reasonable accommodations, such as those based on a sincerely held religious belief, there is no specified procedure or documentation. Instead, entities are told to develop and implement a process for these requests. The CMS Rule simply requires that covered employers have a system in place to record the requests made, the decision made by the employer on the matter, and what, if any, accommodations are provided. 

The records required under these rules must be secured and kept confidential in accordance with applicable privacy laws and, according to the CMS Rule, stored separately from an employer’s personnel files. The federal regulation says appropriate places for vaccine status documentation include a facility’s immunization records, health information files, or other relevant documents.    

Future Developments
Although not all employers operating in the health care field are currently covered by either the state or federal regulations, that could change. New York State already expanded the scope of its regulation once in October to encompass more facilities within the Office of Mental Health network and NYS Governor Hochul has stated her intent to further expand it.   

Barclay Damon will be hosting a webinar on the requirements included in the CMS Rule and the NY Vaccine Rule in the near future. We will continue to follow these developments.
For more information on this topic, Barclay Damon recently published legal alerts on the new federal vaccine regulations and in response to updated guidance on addressing religious objections to COVID-19 vaccine mandates.

If you have any questions regarding the content of this alert, please contact Rob Thorpe, partner, at rthorpe@barclaydamon.com; Margaret Surowka, counsel, at msurowka@barclaydamon.com; Payne Horning, law clerk, at phorning@barclaydamon.com; or another member of the firm’s Labor & Employment Practice Area.

We also have a specific team of Barclay Damon attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and who are prepared to assist clients. Please contact Yvonne Hennessey, COVID-19 Response Team leader, at yhennessey@barclaydamon.com, or any member of the COVID-19 Response Team, at COVID-19ResponseTeam@barclaydamon.com
 

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