Compliance

The “Final Say” on Vaccine Mandates in Covered Facilities

The U.S. Supreme Court has now given the Centers for Medicare and Medicaid Services the green light to enforce the Interim Final Rule in every state.


The U.S. Supreme Court said the Centers for Medicare and Medicaid Services (“CMS”) can now implement and enforce the vaccine mandate for Medicare- and Medicaid-certified facilities.

CMS issued an Interim Final Rule (“IFR”) last November requiring facilities subject to Medicare or Medicaid conditions of participation or conditions of coverage ensure all eligible staff are fully vaccinated against COVID-19. Many states challenged the IFR in federal court. The federal courts temporarily banned CMS from implementing or enforcing the IFR, and CMS asked the U.S. Supreme Court to review these decisions. The U.S. Supreme Court gave CMS the green light to enforce the IFR in every state.1

The IFR does not apply to most physician offices and practices. It applies only to facilities subject to Medicare and Medicaid conditions of participation or conditions of coverage.

This will include: ambulatory surgery centers, hospitals, hospices, community mental health centers, psychiatric residential treatment facilities, long term care facilities, comprehensive outpatient rehabilitation facilities, critical access hospitals, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, intermediate care facilities for individuals with intellectual disabilities, clinics, rehabilitations agencies, public health agencies that provide outpatient physical therapy, speech-language pathology services, organizations providing all-inclusive care for the elderly, and rural health clinics/federally qualified health centers.

Vaccination will likely be required for physicians and advanced practice professionals with privileges at hospitals or other facilities subject to the mandate. A summary of requirements and applicable state-specific compliance deadlines for covered facilities follows.

What is Required of Covered Facilities?

    • Covered facilities must have a policy and process to track and ensure all staff are vaccinated.

    • Covered facilities must have a policy and process which allows individuals to request religious or medical-based exemptions allowed by state or federal law.

    • The policy and process must incorporate secure and confidential documentation and maintenance of proof of the individual’s vaccination status. Acceptable documentation includes a vaccination card (or photo of card), state immunization information system record, or documentation from a health care professional or electronic health record. Proof of vaccination must be kept separately from the employee’s personnel file.

    • The facility’s policy and process must ensure compliance with nationally recognized infection prevention and control guidelines and precautions to mitigate the spread of COVID-19 for exempted staff who are not fully vaccinated.

Who Must be Vaccinated?

Facility staff providing any care, treatment, or other health care services, regardless of clinical responsibility or patient contact, must be vaccinated. This includes facility employees and contractors, licensed practitioners, students, trainees, volunteers, and individuals providing care, treatment, or other services for the facility and/or its patients.

Covered facilities can only exempt staff from the vaccination requirement when:

    • Reasonable accommodation is required for a disability; or

    • Vaccination would conflict with the individual’s sincerely held religious belief, observance, or practice; or

    • An individual establishes a recognized clinical contraindication by submitting a statement signed and dated by a licensed health care practitioner; or

    • An individual teleworks exclusively with no direct patient or staff contact.

CMS cautions that no exemption should be provided where not legally required under the Americans with Disabilities Act (“ADA”) or Title VII of the Civil Rights Act of 1964 (“Title VII”).

Medical or Religious Accommodations

A covered facility must have a policy and process allowing staff to request a religious or medical exemption. Under the process, the covered facility will document and evaluate each request in accordance with applicable federal laws (ADA or Title VII). Staff requesting a medical exemption must submit documentation signed and dated by a licensed practitioner acting within their scope of practice (who is not the individual requesting exemption) stating the:

    • Practitioner recommends exemption from the COVID-19 vaccination requirement,

    • Specific recognized clinical contraindications to the vaccination, and

    • The type(s) of COVID-19 vaccines contraindicated.

CMS refers covered facilities to guidance from the Equal Employment Opportunity Commission (“EEOC”). The EEOC Technical Assistance Questions and Answers, sections K and L, addresses the ADA, Title VII, and vaccines. Facilities should also consult legal counsel to ensure compliance when formulating a process for receiving and evaluating requests for accommodation. 

What are the Compliance Deadlines?

Requirements Arizona & Utah Compliance Deadlines2 Colorado & Nevada Compliance Deadlines3

Phase I

Policies/procedures developed and implemented

AND

All covered staff received first dose of multi-dose COVID-19 vaccine (or one dose of single-dose vaccine) or have requested or obtained qualifying exemption

2/14/2022 1/27/2022

Phase II

All covered staff received second dose of a multi-dose vaccine or obtained qualifying exemption

3/15/2022 2/28/2022

What are the Enforcement Details and What if Covered Facilities Do Not Meet Them?

Thirty days after the Phase I deadlines, federal, state, accreditation organization, and CMS-contracted surveyors will begin monitoring compliance during initial certification, standard recertification or reaccreditation, and complaint surveys. Ninety days after the Phase II deadlines, facilities that fail to maintain 100% compliance may be subject to enforcement action.

Policies and processes implemented, but less than 100% staff have received at least one dose (or requested or received exemption) by Phase I deadlines
Action 1: CMS issues written notice of non-compliance Action 2: No additional enforcement action against facilities with compliance levels at or above 80% with a plan for full compliance within 60 days Action 3: Facilities at less than 80% compliance risk additional enforcement action based on the type of facility/severity of deficiency, including plans of correction, civil monetary penalties, denial of payment, or termination
Policies and processes implemented, but less than 100% staff have received at least one dose (or requested or received exemption) by Phase II deadlines

Action 1: CMS issues written notice of non-compliance

Action 2: No additional enforcement action against facilities with compliance levels at or above 90% with a plan for full compliance within 30 days Action 3: Facilities at less than 80% compliance risk additional enforcement action based on the type of facility/severity of deficiency, including plans of correction, civil monetary penalties, denial of payment, or termination

Risk Management Recommendations

Covered facilities that slowed implementation during the IFR’s legal challenges should be working to meet the compliance deadlines applicable in their state. To meet the IFR requirements, covered facilities need a comprehensive written policy and process that:

    • Tracks the vaccination or exemption (medical, religious, or 100% telework) status of all individuals providing any care, treatment, or other services, regardless of clinical responsibility or patient contact.

    • Securely maintains acceptable documentation of staff’s vaccination status.

    • Incorporates receipt, evaluation, and appropriate documentation of requests for a medical or religious exemption.

    • Ensures and documents compliance with the CDC’s infection control recommendations.

    • Specifies precautions to limit the spread of COVID-19 for staff not fully vaccinated.

Where state or local laws contradict the IFR, the IFR is considered the higher authority. Covered facilities in states or locations with laws prohibiting vaccine mandates should consult with the office’s or practice’s business or corporate attorney to determine the best course of action.


1 Biden v. Missouri, Nos. 21A240 and 21A241. Technically, the ruling is not a final decision on the merits, and the case was returned to the lower federal courts for further proceedings and determinations.

2 Other states subject to this deadline include Alabama, Alaska, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, West Virginia, and Wyoming. Compliance deadlines are later for these states that challenged the IFR and obtained a preliminary injunction prohibiting enforcement. The injunction was effective until mid-January when the Supreme Court issued its ruling, so these states will need additional time to prepare for compliance.

3 Other states subject to this deadline include California, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, and Wisconsin.

 

The content of this publication or presentation is intended for educational purposes only; is not an official position statement of Mutual Insurance Company of Arizona (MICA); and should not be considered or relied upon as professional, medical, or legal advice or as a substitute for your professional judgment. Consult your attorney about your individual situation and the applicable laws. The authors, presenters, and editors made a reasonable effort to ensure the accuracy of the information at the time of publication or presentation but do not warrant or guarantee accuracy, completeness, or currency of such information. As medical and legal information is constantly changing and evolving, check for updated information and consult your attorney before making decisions.

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