On Sept. 9, 2021, President Biden announced his COVID-19 Action Plan – “Path Out of the Pandemic.” As part of this plan, the Centers for Medicare & Medicaid Services (CMS) was directed to issue emergency regulations requiring COVID-19 vaccination for workers in certain healthcare entities participating in Medicare and Medicaid, which would extend to more than 17 million workers. The anticipated critical component was a mandatory vaccine requirement that permitted medical and religious accommodations, but not a testing option unless the worker qualified for a medical or religious accommodation. Yesterday, CMS issued its long-awaited Interim Final Rule (IFR), and an FAQs document, requiring certain providers and suppliers to establish a policy ensuring eligible staff receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by Dec. 5, 2021, and the second dose of a two-dose COVID-19 vaccine by Jan. 4, 2022. As expected, workers at certified providers and suppliers have only two options – get vaccinated or qualify for a medical or religious exemption. According to the White House, the IFR will help provide patients with assurance about the vaccination status of their healthcare providers, create a level playing field for healthcare facilities, and help address challenges with staff sickness and quarantines.

The IFR is effective as of Nov. 5, 2021, and will be subject to a 60-day comment period. After formal comments have been submitted, CMS will consider and respond to the comments as it deems necessary.

Coverage

Which healthcare providers and suppliers are subject to the IFR?

Medicare- and Medicaid-certified providers and suppliers with compliance obligations pursuant to CMS Conditions of Participation (CoPs) and Conditions of Coverage (CoCs) are bound by the rule. Specifically, the rule applies to the following facilities:

• Ambulatory Surgery Centers (ASCs)
• Clinics, rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services
• Community Mental Health Centers (CMHCs)
• Comprehensive Outpatient Rehabilitation Facilities (CORFs)
• Critical Access Hospitals (CAHs)
• End-Stage Renal Disease (ESRD) Facilities
• Home Health Agencies (HHAs)
• Home Infusion Therapy (HIT) suppliers
• Hospices
• Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long-term care hospitals, children’s hospitals, transplant centers, cancer hospitals and rehabilitation hospitals/inpatient rehabilitation facilities)
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
• Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes
• Programs of All-Inclusive Care for the Elderly (PACE)
• Psychiatric Residential Treatment Facilities (PRTFs)
• Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)

CMS specifically excluded Religious Nonmedical Health Care Institutions, Organ Procurement Organizations and Portable X-Ray Suppliers. Healthcare workers providing services in Assisted Living Facilities, Group Homes, and Home and Community-based Services facilities are also not bound by these requirements. While providers working strictly in freestanding physician practices are not required to adhere to the rule requirements, physicians must meet the requirements if they provide services through the required provider types bulleted above (unless an exemption applies).

If the healthcare provider or supplier is subject to the IFR, which workers are covered by the vaccine mandate?

Current and new employees, licensed practitioners, students, trainees, volunteers, and individuals who provide services under a contract or other arrangement are covered by the IFR. This includes staff who perform duties within a healthcare facility, staff who routinely care for patients and clients outside the facility (i.e., home health), and other individuals who may encounter fellow staff who enter healthcare facilities or sites of care, such as in an administrative office or off-site meeting. Essentially, only individuals who provide services 100 percent remotely; ad hoc non-healthcare services, such as annual elevator inspections; or services that are exclusively off-site, such as accounting services, are exempt from the IFR.

Requirements

What are the details of the IFR and specifically the vaccine mandate?

The IFR is focused almost entirely on the vaccine mandate and related issues. It requires certain providers and suppliers to develop and implement policies and procedures to ensure staff are fully vaccinated against COVID-19 utilizing a two-phased approach. Phase 1 of the IFR requires that workers receive a first dose of the COVID-19 vaccine by Dec. 5, 2021. Phase 2 of the IFR requires that workers receive a second dose (of a two-dose COVID-19 vaccine) by Jan. 4, 2022. Staff who complete a COVID-19 vaccination series by Jan. 4, 2022, will have met the IFR requirements, even if they have not met the 14-day waiting period for full vaccination. Currently, the IFR does not require boosters or additional vaccination shots for purposes of compliance, and acceptable COVID-19 vaccines include any approved by the Food and Drug Administration or the World Health Organization. Workers who have had a positive COVID-19 test within 90 days may extend these deadlines in accordance with Centers for Disease Control and Prevention (CDC) guidelines.

What are the record-keeping requirements?

Further, proof of vaccination is required in the form of a CDC card (or photo of a CDC card), documentation from a healthcare provider or an electronic health record, a state immunization information system record, or a reasonable equivalent if the individual was vaccinated outside the United States. These records are to be kept in a facility’s immunization files, health information files or other relevant files, but like other medical records, vaccination documentation must be kept confidential and stored separately from an employer’s personnel files.

Are medical and religious accommodations required?

There is no option for unvaccinated staff to undergo daily or weekly testing in lieu of vaccination. However, employers are directed to comply with federal anti-discrimination laws, including providing appropriate accommodations for disability; medical conditions; or sincerely held religious beliefs, practices or observances. CMS encourages review of the Equal Employment Opportunity Commission’s guidance on exemptions and accommodations. Providers and suppliers also need to have a process for collecting and evaluating exemption requests, including appropriate documentation for medical exemptions as outlined by the IFR.

CMS advises that “[i]n granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID-19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients.” For those who meet the requirements of an exemption, facilities are directed to develop a process for implementing additional precautions in order to mitigate the transmission of COVID-19. This could be continuance of weekly testing or other COVID-19 safety guidelines for unvaccinated workers that were provided in the Occupational Safety and Health Administration (OSHA) emergency temporary standard (ETS) for healthcare providers published in June. The June OSHA ETS for healthcare providers still applies and should be followed in conjunction with the IFR.

State and Local Laws

Further, CMS takes the position that the IFR preempts any state or local law providing exemptions to the extent such laws provide broader exemptions than federal law or exemptions that are inconsistent with the IFR. CMS also takes the position that under the Supremacy Clause, the IFR preempts state or local laws that prevent providers or suppliers from complying with the IFR or mandating vaccination.

Enforcement and Penalties

With regard to enforcement, providers and suppliers may be cited for noncompliance by state CMS surveyors when state survey agencies conduct on-site compliance reviews of the IFR requirements either during the standard review recertification survey or on compliance surveys. The citations will be based on the severity of deficiency, scaled to three levels: immediate jeopardy, condition and standard. Providers and suppliers may be subject to enforcement remedies based on the level of noncompliance, such as civil monetary penalties, denial of payment for new admissions or termination of the Medicare/Medicaid provider agreement.

However, CMS has signaled that the goal is not to penalize every entity that does not meet 100 percent compliance within the dates prescribed. CMS has stated that “termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance” at all three levels. Also, CMS stated that “[its] goal is to bring health care facilities into compliance.” Hopefully, CMS takes into account healthcare facilities impacted by extreme labor shortages.

*             *             *             *             *

Healthcare facilities, providers and suppliers subject to the IFR should review and update their policies and procedures to ensure they are compliant with the new requirements in time for the first deadline, Dec. 5, 2021.