The Centers for Medicare & Medicaid Services (“CMS”) Omnibus Interim Final Rule (“Final Rule”) takes effect November 5, 2021, and with it comes the requirement that Medicare and Medicaid-certified suppliers, providers, and their staff become vaccinated for COVID-19. As this new rule becomes a new reality, it is essential that all key stakeholders involved understand: who is impacted by the Final Rule, the Final Rule’s vaccination requirements, and how to determine who qualifies as exempt from the Final Rule’s vaccination requirement.

Who is Impacted by the Final Rule?

The Final Rule applies to Medicare and Medicaid-certified provider and supplier types that are regulated under the Medicare health and safety standards (collectively “facilities”). Hospitals, Hospice, Community Mental Health Centers, and Comprehensive Outpatient Rehabilitation Facilities are some of the types of facilities that will need to implement policies to ensure their staff complies with the Final Rule. The vaccination requirement applies to all staff, current and new, who provide care, treatment, or other services for the facility and/or its patients. This also includes individuals under contract (or other arrangements) to provide such treatment or services. Offsite staff members who interact with other staff, patients, residents, clients, or PACE program participants in homes, clinics, administrative offices, and beyond what is considered the formal clinical setting are also required to be vaccinated under the Final Rule.

What are the Final Rule’s Vaccination Requirements?

The Final Rule requires facilities to establish policies and processes that fulfill the vaccination requirement over two phases. Phase 1 requires that all staff at eligible facilities obtain the first dose of a primary series or a single dose COVID-19 vaccination prior to providing treatment and services for the facility and/or to patients, within 30 days after the Final Rule’s publication date, which is November 5, 2021. Phase 1 also requires that facilities have appropriate policies and procedures developed and in place. Phase 2 requires that, within 60 days after publication of the Final Rule, staff at eligible facilities complete the primary vaccination series. Staff who have completed the primary vaccination series by this date are considered to meet these requirements, even if they have not yet completed the two-week waiting period required for full vaccination. Facilities are required to implement processes to ensure they follow nationally recognized infection prevention and control guidelines intended to mitigate transmission of COVID-19 when they have staff that have not completed the two-week waiting period. For purposes of the Final Rule, an individual is fully vaccinated two or more weeks after they have completed a primary vaccination series for COVID-19. Vaccines that count toward the requirement include all vaccines licensed or authorized for emergency use by the Food and Drug Administration, vaccines listed by the World Health Organization for emergency use, and vaccines received during an individual’s participation in a clinical trial.

Who is Exempt or Excluded from the Vaccination Requirement under the Final Rule?

Staff with recognized medical conditions for which vaccines are contraindicated may obtain reasonable accommodations under the Americans with Disabilities Act, and staff with religious beliefs, observances, or practices established under Title VII of the Civil Rights Act of 1964 qualify for exemption under the Final Rule. The Final Rule preempts the applicability of any State or local law providing for exemptions to the extent the law provides broader exemptions than Federal law. Facilities have the flexibility and the responsibility to establish their own processes to allow eligible staff to obtain exemptions. Additionally, those excluded from the Final Rule include: individuals who provide services 100 percent remotely and who do not have direct contact with patients or other staff, Religious Nonmedical Health Care Institutions, Organ Procurement Organizations, and Portable X-Ray Suppliers. To ensure compliance, CMS works directly with state survey agencies, who are expected to conduct onsite compliance reviews of requirements.

Although the Final Rule will take immediate effect, stakeholders have 60 days to submit formal comment on this emergency regulation. This comment period officially closes on January 4, 2022, at which point CMS will consider and respond to comments as a part of potential future rulemaking, if needed.

If you have any questions regarding this Final Rule, please do not hesitate to contact any member of the Health Law Practice Group at Shipman.

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Photo of Joan W. Feldman Joan W. Feldman

Joan W. Feldman is Chair of the Health Law Practice Group and a member of the firm’s Management Committee. She regularly advises her clients on corporate governance, corporate and business issues and combinations (e.g., mergers, acquisitions, affiliations, joint ventures and physician/hospital strategic alliances)…

Joan W. Feldman is Chair of the Health Law Practice Group and a member of the firm’s Management Committee. She regularly advises her clients on corporate governance, corporate and business issues and combinations (e.g., mergers, acquisitions, affiliations, joint ventures and physician/hospital strategic alliances); state and federal regulatory issues, Medicare and Medicaid reimbursement, qui tam actions, fraud and abuse, corporate compliance (e.g., False Claims Act, Anti-kickback and Stark); data privacy and HIPAA, state and federal privacy matters; information technology and software licensing; medical staff governance and credentialing matters; medical ethics and end-of-life issues; and quality of care regulatory matters, developing quality improvement and assessment programs; clinical research matters; and state and federal licensure matters.

Photo of Stephanie Gomes-Ganhão Stephanie Gomes-Ganhão

Stephanie Gomes-Ganhão focuses her privacy practice on health care and insurance privacy matters, including counseling clients regarding compliance with HIPAA/HITECH, the federal regulations governing the confidentiality of substance use disorder patient records (42 C.F.R. Part 2), the Gramm-Leach-Bliley-Act (GLBA), the Telephone Consumer Protection…

Stephanie Gomes-Ganhão focuses her privacy practice on health care and insurance privacy matters, including counseling clients regarding compliance with HIPAA/HITECH, the federal regulations governing the confidentiality of substance use disorder patient records (42 C.F.R. Part 2), the Gramm-Leach-Bliley-Act (GLBA), the Telephone Consumer Protection Act (TCPA), and the Payment Card Industry Data Security Standard (PCI DSS).

Stephanie is also somewhat of a data breach response nerd and stays up to date on security breach trends. She regularly assists clients with establishing compliance programs for the early detection of data privacy concerns and guides clients through the data breach investigation and notification process when a breach has occurred. Stephanie’s complete biography can be found here.