In our recent alert on the various federal and state vaccine mandates that may be applicable to Health Care and Human Services Agencies in New York State, we noted that the Centers for Medicare & Medicaid Services (CMS) recently issued its Interim Final Rule (CMS Rule), which added certain health care providers, specifically Intermediate Care Facilities (ICFs), that were not previously encompassed under the New York State health care vaccine mandate. On November 19, 2021, and with minor revisions on November 23, 2021, the NYS Office for People With Developmental Disabilities (OPWDD) issued its guidance to ICFs, including OPWDD’s Developmental Centers (DCs), specialty hospitals, and Article 16 Clinics. OPWDD confirmed that these covered facilities must abide by the CMS Rule, which requires that eligible employees receive their first shot of the two-dose COVID-19 Pfizer-BioNTech or Moderna vaccine series or the single-dose shot of the Johnson & Johnson vaccine by December 6, 2021, and their second shot of the two-dose vaccines by January 4, 2022. The CMS Rule provides for vaccination only; that is, it does not allow for a weekly test-out option, and it only allows for limited exemptions for medical reasons or Title VII accommodations.
Covered Staff
The OPWDD guidance specifically notes that the CMS Rule requires all employees, including nondirect support staff, such as maintenance, security, and administrative staff working in the location and those who “regularly work” in the facilities subject to the CMS Rule, to be vaccinated. Those staff who “regularly work” at a subject location include staff that rotate or cover work assignments at these locations, are included on a scheduled basis, or as part of a group of work support assignments. Moreover, any sites or programs that share space with the ICFs, DCs, or Article 16 Clinics, must also abide by the CMS Rule’s vaccination requirements for each staff member. To ensure compliance, we recommend that the vaccine requirement includes all staff who may have a work-related reason to visit a covered location.
Facilities and Programs Not Subject to CMS Rule
OPWDD confirmed that the CMS Rules does not apply to the following OPWDD Medicaid-funded programs:
- Home and Community Based Services (HCBS) Facilities, including Individualized Residential Alternative (IRA) Residential Habilitation Facilities, Family Care, Day Habilitation, Community Habilitation, Supported Employment, and other HCBS programs
- Care Coordination Organizations (CCOs) and Health Homes
- Crisis Services for Individuals with Intellectual and/or Developmental Disabilities (CSIDD)
- Independent Practitioner Services for Individuals with Developmental Disabilities (IPSIDD)
- Programs that are 100 percent state funded
Many agencies not covered by the CMS Rule are 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 ETS has been stayed pending court challenges. No court has, as of this writing, ordered a stay of the CMS Rule, but there are lawsuits pending. Unless and until a ruling is made that affects the CMS Rule, covered health care entities are expected to comply.
Enforcement
CMS has stated that it will work directly with state survey agencies to monitor compliance. Agencies can expect surveyors to review the COVID-19 vaccination policies and procedures and assess staff vaccination status. All enforcement remedies will be available to ensure compliance, including civil monetary penalties, denial of payment for services, and termination from Medicare and Medicaid programs. CMS has stated that its goals are to bring facilities into compliance and that termination from the programs would generally occur only as a final measure after providing facilities an opportunity to come into compliance.
Continued Developments
NYS Governor Hochul has previously indicated that the state will consider expanding its health care vaccine mandate to reach some of the Medicaid-funded programs that are not subject to the NYS vaccine rule. Barclay Damon attorneys will continue to closely follow developments relating to vaccine requirements for Health Care and Human Services providers in New York State. Meanwhile, agencies should continue to monitor guidelines from state and local authorities.
If you have any questions regarding the content of this alert, please contact Margaret Surowka, counsel, at msurowka@barclaydamon.com, or another member of the firm’s Health & Human Services Providers Team.
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.