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On November 4, 2021, the Centers for Medicare and Medicaid (“CMS”) released a new rule requiring certain healthcare facilities to implement policies requiring employees to be vaccinated against COVID-19. It does not matter if a staff member does not perform patient treatment services, they must still be vaccinated if an employee of an applicable facility.

Particularly, staff at these facilities should be given at least the first dose of an accepted vaccine within 30 days of November 5, 2021. Phase 2 will require staff to have their second dose within 60 days of November 5, 2021. Acceptable vaccines include, and at this time are limited to, Pfizer, Moderna, and Johnson & Johnson.

Applicable Facilities

The new requirement does not apply to all facilities that provide healthcare services, but rather only those facilities that are regulated by CMS as one of the following:

• Ambulatory surgical centers;
• Hospices;
• Programs of all-inclusive care for the elderly;
• Hospitals;
• Long-term care facilities;
• Psychiatric residential treatment facilities;
• Intermediate care facilities for individuals with intellectual disabilities;
• Home health agencies;
• Comprehensive outpatient rehabilitation facilities;
• Critical access hospitals;
• Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech language pathology services);
• Community mental health centers;
• Home infusion therapy suppliers;
• Rural health clinics/federally qualified health centers; and
• End-stage renal disease facilities.

While a facility may render some of the services listed above, that does not necessarily mean that a facility is required to comply with the rule. For example, if a facility provides care for psychiatric patients, the rule still may not apply if the facility is not regulated by CMS as a psychiatric residential treatment facility.

Additionally, while many facilities identify as “clinics,” the rule states that there are only approximately 5,000 clinics who are Medicare and Medicaid-certified rural health clinics and federally qualified health centers. Therefore, without this qualification, the rule will not apply.

However, facilities who are not required to comply with this new rule should note that their facility may still need to follow the OSHA COVID-19 Employer Emergency Temporary Standard, which requires employers with more than 100 employees to be vaccinated, or undergo regular testing, among other requirements. For more information, read this client alert by BMD Healthcare Litigation Member Stephen Matasich. 

Staff Exemptions

Staff who work full-time remotely do not need to be vaccinated under the new rule.

However, staff members are still able to seek either bona-fide religious or medical exemptions to exclude them from the vaccine requirement. For those that are given an exemption, the facilities must ensure that reasonable accommodations are given to the employee, while still minimizing the risk of the spread of COVID-19. CMS refers to the Equal Employment Opportunity Commission’s (“EEOC”) website for further guidance on this topic.

Compliance/Discipline

Those facilities who do not comply with the new rule within the specified timeframe will be subject to civil monetary penalties, denial of payment, and, in extreme circumstances, exclusion from Medicare and Medicaid. CMS plans to oversee facilities through state surveyors, and has noted that interpretive guidelines outlining how surveyors will determine compliance will be published in the future. However, CMS has already stated that reviewing records of staff vaccinations, staff interviews, and review of facility vaccine policies and procedures are among some of the procedures that will be used to detect noncompliance.

Questions

If you have any further questions about the new rule or are unsure of whether it is applicable to your facility, please contact Labor + Employment Partner Bryan Meek at bmeek@bmdllc.com (330.253.5586) or Healthcare and Hospital Law Member Amanda Waesch at alwaesch@bmdllc.com (330.253.9185).

Bryan and Amanda will be hosting an informative webinar on Wednesday, November 17 at 2 PM ET to discuss who the new rule applies to, and if so, what steps should be taken to comply. Click here for more information and registration.