Medicare and Medicaid facilities required to immunize the workforce
On November 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding the vaccination of staff at facilities participating in Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose by December 5, 2021 and complete a full vaccination by January 4, 2022.
The vaccine rule that was also released on November 4, 2021 by the Occupational Safety and Health Administration (OSHA) does not apply to employees of healthcare entities that are covered by the CMS IFR. However, employees of healthcare providers who are not subject to the CMS IFR may be subject to the OSHA vaccine rule if the facility has more than 100 employees. For more information on the OSHA vaccine rule, please click here.
Rationale for the rule
CMS cited a number of reasons for IFR, including the risk unvaccinated staff pose to patients, with reports of individuals forgoing healthcare due to fears of contracting COVID-19 from staff at the hospitals. healthcare facilities, healthcare operations disrupted due to infected staff and low vaccination rates among healthcare staff.
Scope of coverage
The IFR requirements apply to healthcare facilities that participate in Medicare and Medicaid and that are subject to conditions or participation requirements, including, but not limited to:
Outpatient surgical centers;
Hospitals, such as acute care hospitals, mental hospitals, hospital swing beds, long-term care hospitals, and children’s hospitals;
Long-term care facilities;
Home health agencies;
Comprehensive outpatient rehabilitation facilities;
Critical access hospitals;
Home infusion therapy providers; and
Federally qualified rural health clinics / health centers.
While the IFR does not apply directly to physician offices, which are not regulated by the CMS terms or participation requirements, physicians may nonetheless be required to vaccinate due to their relationships with others. health care entities. For example, the IFR requires hospitals to implement policies and procedures to ensure that “people who provide care, treatment or other services under contract or other arrangement” are fully immunized.
IFR requires vaccinations for staff providing patient and client care inside and outside facility, such as home care, home infusion therapy, palliative care, and therapy staff. CMS’s immunization requirement also extends to all staff who interact with other staff, patients, residents or clients, at any location, not just those entering facilities. . However, staff who provide 100% remote services, i.e. staff who never come into contact with other staff, patients, residents or clients – are not subject to IFR vaccination requirements. In addition, suppliers and suppliers are not required to ensure compliance with the IFR vaccination of one-off vendors, volunteers, or professionals, such as (a) those providing one-off non-health-related services (for example annual elevator inspectors), b) those who perform exclusively off-site services (for example accounting services), or (c) delivery and repair personnel.
Definition of complete vaccination
CMS considers “full vaccination” to be 14 days after receiving a single dose vaccine (such as the Johnson & Johnson vaccine) or 14 days after the second dose in a two-dose primary series (such as Pfizer or Moderna). Currently, CMS does not require the additional (third) dose of mRNA vaccine for moderately / severely immunocompromised individuals or the “booster dose” in order for staff to be considered “fully immunized”. In addition, CMS considers that people receiving heterologous vaccines (doses of different vaccines) meet the definition of “fully vaccinated” as long as they have received a combination of two doses. In order to assess compliance, CMS requires providers and suppliers to securely track and document the immunization status of each staff member as well as vaccine exemption requests and results. The IFR does not specify that weekly testing, masking and social distancing are an alternative to vaccination, which means employers must ensure that all employees are (1) fully vaccinated or (2) exempt in under an authorized exemption.
The IFR explicitly provides that employers must continue to comply with anti-discrimination laws and civil rights protections that allow employees to request and receive exemption from immunization due to a disability, medical condition. or a sincere religious belief or practice. Exemptions should be granted to personnel with known health problems for which a vaccine is contraindicated as a reasonable accommodation under the Americans with Disabilities Act. For exemptions for sincere religious belief or practice, CMS encourages healthcare entities to refer to the Equal Employment Opportunity Commission Compliance Manual on Religious Discrimination. Despite the option to provide an exemption, CMS states that exemptions may be granted to staff only to the extent required by law, and that exemption requests should not be provided to those seeking only to escape vaccination. . CMS also notes at length that the Food and Drug Administration considers approved vaccines to be safe. As a result, CMS is unlikely to be willing to excuse vendor and vendor non-compliance due to employee refusal to get vaccinated due to safety concerns.
While the IFR does not identify specific penalties for non-compliance, CMS should use enforcement tools such as civil monetary penalties, denial of payment for new admissions, or termination of the Medicare provider contract. / Medicaid. CMS will use state investigative agencies to review IFR compliance through standard recertification investigations and complaint investigations. Non-compliance with the IFR will be addressed through the established classification channels for “immediate danger”, “condition” or “standard” deficiencies.
Although CMS recognizes that some states and localities have established laws to prevent mandatory compliance with vaccine mandates, CMS ultimately views the supremacy clause of the United States Constitution as preempting national laws and incompatible localities as applied to Medicare and Medicaid certified providers and providers.
© 2021 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume XI, Number 309