December 26, 2021

The Nuts and Bolts of the New Mandatory Vaccine Rules

By Patrick Stanley

Several clients have reached out over the past few weeks to ask us whether the new mandatory COVID vaccination requirements apply to their dental practices.

The federal government has issued two sets of rules in recent weeks, one from OSHA and one from the Centers for Medicare and Medicaid Studies (“CMS”). Both sets were released on November 4, 2021, and require that the vaccination process be started by December 6.[1]

The new vaccine rules apply to two types of employers: (1) all companies with more than 100 employees, and (2) health care facilities that are certified by Medicare or Medicaid

for health and safety. Private dental offices are not Medicare/Medicaid certified facilities, so even if a dentist accepts Medicare or Medicaid payments, the vaccine rules will not apply.

Several states have already sued the federal government over these new mandates, and some of the rules have been temporarily blocked from going into effect until these lawsuits are resolved. Dentists who may be subject to the rules should monitor these cases closely and may want to continue preparing as though the rules will be enforced in December.

Below is a summary of how the rules work, if upheld in their current form.

The OSHA Rules: The 100 Employee Test

The new OSHA rules apply to companies with 100 or more employees, regardless of the nature of the business.[2] If you cross the 100-employee threshold, you will be required to implement a mandatory written vaccination policy. The policy must include procedures for reporting vaccination status and the options available for employees who refuse to be vaccinated.[3]

Under the OSHA rules, employers do not have to fire employees who refuse to be vaccinated. Instead, they must have weekly COVID testing and wear a face covering at all times while they are working. Employers who fail or refuse to comply with the requirements can face penalties ranging from around $10,000.00, up to more than $100,000.00.

One gray area is how dentists who are part of a DSO will be treated, and whether OSHA will count all employees from various practices under the DSO toward the 100-employee total. OSHA has not addressed that issue directly, so there is no definitive answer, but it will likely depend on the nature of the DSO structure.

The most likely outcome is that the dentist and any staff members employed by the practice would be counted separately from the DSO employees.[4] However, if staff members are employed by the DSO directly, rather than by the practice, they could be counted with all other employees of the DSO and may be subject to the rules. Consequently, you should review your financial records and DSO agreement to make sure you know which company is actually the legal “employer” of staff members.

The CMS Rules: Certified Health Care Facilities Only

The CMS rules only apply to facilities that have to have their health and safety conditions certified by Medicare and Medicaid.[5] These are largely institutional health care providers like the following:

  • Hospitals
  • Ambulatory Surgery Centers
  • Long Term Care Facilities
  • Rehabilitation Facilities
  • Indian Health Service Clinics

Private dental and physician offices are not required to be certified, so they will not be covered under the CMS rules.[6]

Lawsuits Have Stalled, And May Kill, The Rules

Although the rules were originally set to require vaccination by early December, their future is in doubt. Shortly after they were released, several states filed lawsuits challenging both the OSHA and CMS rules. A federal court has already blocked the OSHA rules from taking effect until further notice.[7] Another federal court is considering whether to block the CMS rules, and will likely rule before the December 6 deadline.[8]

One other point to keep in mind is that states can also issue their own vaccination mandates. Some states, like California and New York, have already imposed vaccine requirements for healthcare workers. Arizona currently does not have any such requirement in place.

DISCLAIMER: This is a fluid situation. The information in this article has been prepared for informational purposes only and does not constitute legal advice. Anyone reading this article should not act on any information contained therein without seeking individualized professional counsel from an attorney. The author and publisher shall not be responsible for any damages resulting from any error, inaccuracy or omission contained in this publication.

Patrick is a partner with the Scottsdale based law firm of Comitz | Stanley, practicing in healthcare and insurance law. / 480.998.7800.

[1] The full OSHA vaccine mandate regulations are located at 86 FR 61402 and the full CMS vaccine mandate regulations are located at 86 FR 61555.

[2] In determining whether you meet the threshold, there are a couple of important things to keep in mind. The OSHA rules include part-time employees in determining whether an employer reached the 100-employee threshold, and counts the total number of employees at all locations. See 86 FR at 61513. However, the OSHA rules do not include independent contractors or any workers supplied by a staffing agency in the total employee count.

[3] A template for the written policy can be found at:

[4] The typical DSO structure involves two or more separate legal entities: a practice entity (a P.C. or a PLLC), owned by the doctor, and the DSO entity, like Heartland, Pacific Dental, or Affordable Care, who provide the administrative support. OSHA has not issued guidance on these types of relationship, but an analogy could be made between DSOs and a business franchise relationship. OSHA has determined that in business franchises, the individual franchise’s employees are counted separately from the franchisor. So, while McDonalds as a franchisor would be subject to the OSHA rules, an individual franchise that has less than 100 employees would not be. Although it is uncertain how OSHA might ultimately rule on the issue, a similar argument could be made in the DSO context: If the DSO has more than 100 employees, it would be covered, but an individual office with far fewer employees would not be. This is just an argument, though, and until OSHA issues guidance on the issue, it remains uncertain how this will be answered.

[5] See 86 FR at 61607. More specifically, dental offices are not regulated under the “Conditions of Participation” that regulate the health and safety of certain types of health care organizations. The COVID rules issued by CMS only apply to those entities that must meet these “Conditions of Participation.”

[6] CMS designates 21 different types of facilities as requiring certification for health and safety. If you are uncertain about whether you are required to implement a vaccination policy, you can look at the complete list at

[7] Texas v. OSHA, United States Court of Appeals for the Fifth Circuit, Case No. 21-60845.

[8] Missouri v. Biden, United States District Court for the Eastern District of Missouri, Case No. 4:21-cv-01329.