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New Vaccine Requirement for Select CMS-Participating Facilities

Client Alert

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.


Supreme Court Rules that Employers Must Show Substantial Increased Costs to Legally Decline Employees’ Religious Accommodation Requests

On June 29, 2023, the Supreme Court ruled in Groff v. DeJoy that under Title VII of the Civil Rights Act of 1964 (“Title VII”) employers must show, in order to decline religious accommodations, that the burden of granting religious accommodations to employees will result in substantial increased costs in relation to the conduct of an employer’s particular business, thus amending the prior, simple standard of a “de minimis” undue hardship.

Recent HIPAA Breach Settlements - Lessons Learned

According to the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), the consequences for providers may include settlements of $30,000 to $240,000. OCR recently released two settlements for improper breaches of protected health information (PHI) that are good examples of the major monetary penalties that can result from common HIPAA mistakes.

Supreme Court Issues Major False Claims Act Decision

Telehealth Flexibility Updates: HIPAA, DEA, and CMS

The Covid-19 Public Health Emergency (PHE) officially ended on May 11, 2023. But what does that mean for telehealth, a field that expanded exponentially during the PHE? Fortunately, many of the flexibilities will remain intact, at least temporarily. This client alert presents a brief overview of the timelines that providers need to follow, but for a more comprehensive review of telehealth flexibilities and when they will end

WEBINAR SERIES RECAP | Ending the Public Health Emergency + Post-Pandemic Check-Up

Some may take the position that the rest of the country already returned to a new “normal” following the COVID-19 pandemic.  But healthcare providers continue to implement COVID protocols and navigate the ever-changing healthcare regulations at both the federal and state levels.  It is important for healthcare providers to take time for a “Healthcare Check-Up” with the start of 2023 and the ending of the Public Health Emergency (“PHE”).