The federal Centers for Medicare and Medicaid Services (“CMS”) issued its long-anticipated rule (“CMS Rule”) on November 4 regarding vaccination requirements for medical facilities receiving Medicare and Medicaid funds. Most provisions of the rule will be effective December 5, 2021, unless operation of the rule is enjoined by a federal court challenge.
The vaccine requirement will cover approximately 17 million health care workers in 76,000 health care facilities across the country.
Unlike the OSHA rule covering private employers, also issued on November 4, the CMS Rule does not allow for weekly Covid testing as an alternative. The only persons excluded from the vaccine requirements are those with documented medical reasons why they cannot take a vaccine or persons who have demonstrated that getting the vaccine would impose upon a sincerely held religious belief. In both of those cases, accommodations must be provided unless the accommodation would cause an undue hardship to the employer.
The CMS Rule covers all of the following facilities that are certified to accept Medicare and Medicaid reimbursement: hospitals, ambulatory surgical centers, hospices, psychiatric residential treatment facilities, skilled nursing facilities (“nursing homes”), assisted living facilities, long-term care facilities, intermediate care facilities for individuals with intellectual disabilities, home health agencies, comprehensive outpatient rehabilitation facilities, clinics, public health agencies which provide outpatient physical therapy, community mental health centers, home infusion therapies suppliers, rural health clinics, federally qualified health centers, and end-stage renal disease facilities.
Although the list above is very comprehensive, the CMS Rule does not apply to health care entities that are not regulated by CMS, such as physician offices. Nor does it apply to non-hospital ambulatory settings where all non-employees are screened for Covid prior to entering and are prohibited from entry if they exhibit Covid symptoms.
The CMS Rule leaves health care facilities responsible for processing exemption requests arising out of medical conditions or sincerely held religious beliefs. Those who receive such an exemption will not need to be tested regularly, but will be required to observe masking and social distancing rules.
Because the CMS Rule does not provide for a testing option in lieu of vaccine, the only way to avoid a vaccine in most segments of the health care industry is to obtain a valid medical or religious exemption. Employers are required to have processes in place to consider such exemptions and will be held responsible for prohibiting abuse of those exemption rules.
Non-compliance can result in the draconian penalty of termination from participating in Medicare and Medicaid reimbursement payments. Senior administration officials stated that such a penalty would be a “last resort” for facilities that have been notified, given the opportunity to make corrections, and choose not to do so. Lesser penalties could include civil monetary penalties or short-term denial of Medicare or Medicaid reimbursements.
The CMS Rule applies to workers, whether employees or contractors, at all impacted facilities, regardless of clinical responsibility or patient contact. It also includes students, trainees, and volunteers, as well as individuals who provide care, treatment, or other services (whether medical or non-medical, and regardless of direct patient contact) at the facility. Individuals who provide services 100% remotely, such as fully remote telehealth or payroll services, are not subject to the CMS Rule, nor are persons who have extremely limited contact in a facility, such as a person who does an annual elevator inspection or a person who is called in for a few hours for an emergency repair (although such persons must be masked at all times).
Employers are required to maintain documentation evidencing proof of vaccination, such as copies of a vaccination card. Additionally, requests for exemptions based on medical or religious grounds must be documented and evaluated on a case-by-case basis. Medical exemptions must be accompanied by supporting documentation signed by a licensed practitioner acting within the scope of his or her practice. Reasonable accommodations are required for employees with valid exemptions, but accommodations will not be required if such an accommodation would impose an undue hardship on the employer.
With respect to timing, December 5 is the deadline for all employers to have implemented policies and procedures to ensure compliance with the CMS Rule, and for all employees to have received at least their first dose of the vaccine or have requested a lawful exemption. After that date, non-complying employees are not permitted to provide services for the facility. By January 4, 2022, all applicable staff must have received their final vaccination dose except those who have been granted exemptions.
Business groups and state attorneys general have indicated they may challenge the CMS Rule and other vaccine mandates in federal courts. If successful, such lawsuits could delay or even eliminate compliance obligations. Until a court rules otherwise, however, parties should plan to face compliance obligations on December 4.
At this point, it is unclear whether fully vaccinated workers will still be required to wear masks and engage in other protective measures. On the one hand, the CMS Rule says that fully vaccinated workers will not need to wear masks and distance themselves “in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present.” Little guidance is provided, however, on what constitutes a “well-defined area.” Moreover, in most medical settings, there is a risk that patients or unvaccinated exempt co-workers may be infected, and one can only speculate as to how this rule will be administered.
For more information on the application of the CMS rule or any other issue relating to the pandemic, reach out to Critchfield’s attorneys.