A Shot Across the Bow

President Biden’s executive order heralding mandates for COVID-19 vaccination may not have teeth, but the overall direction of federal guidance has been made abundantly clear.

What does last week’s announcement that President Biden was “mandating vaccines” mean? 

Less than you might think. 

Executive orders may be inherently confusing, although perhaps it is just that media coverage of them is so poor. The headline in the New York Times was “Biden Issues Sweeping Mandates for Shots.” That isn’t true. 

As we have discussed in the past, executive orders cannot actually do much. Perhaps a good analogy is watching a coach call a play on the sidelines. We know the kernel of the idea, but it doesn’t really take shape until the play happens on the field. Last Thursday the President announced that he has instructed various government agencies to issue regulations. Until those regulations are effective, there has been no change in the regulatory environment. As of this moment, there are no federal requirements in place that weren’t there before the announcement. There is not yet a “sweeping mandate.”

That said, the announcement gives a pretty good sense of what is coming. The Centers for Medicare & Medicaid Services (CMS) was already working on an interim final rule that would have required skilled nursing facilities (SNFs) to require their staffs to receive COVID-19 vaccinations in order to satisfy Medicare’s Conditions of Participation (CoP). On Thursday, CMS announced that it would be expanding that regulation to cover all facilities certified to participate in Medicare and Medicaid. That means that organizations like hospitals, dialysis facilities, ambulatory surgical centers, and home health agencies will likely be required to vaccinate their employees. 

You might be wondering “does that mean if we lack evidence of vaccination for one employee, we can be ejected from the Medicare program?” And I am certain you are wondering “by what date must this occur?” We do not have answers to those or other questions, because we don’t have the regulations. CMS’s press release indicated that the interim final rule with comment period will be issued sometime in October. There is, of course, no guarantee that planned deadline will be satisfied. But it does appear that the requirement will apply only to healthcare entities that have CoPs. If you are with a healthcare organization that is not certified by Medicare, for example, a physician clinic or a physical therapy practice, this new CMS rule will not apply to you. I should clarify that since rural health clinics have CoPs, I assume the rules will apply to them, though the CMS press release made no mention of that. 

If you are in a “regular” physician clinic, the fact that these CMS rules won’t apply does not mean you will avoid a vaccine requirement. The action by CMS is not the only forthcoming rule. The president also instructed the U.S. Department of Labor to issue a rule that will apply to all employers with 100 or more employees. Larger clinics will presumably fall under that definition. Yet another rule will apply to government contractors, although I do not believe that very many healthcare organizations are considered government contractors. Participation in Medicare, by itself, does not seem to convert an entity into a government contractor. 

While we don’t know the details, the Administration is clearly sending a message to those who are unvaccinated. In the words of Blondie, one way, or another, I’m gonna find ya; I’m gonna get ya, get ya, get ya, get ya. Presumably sometime in the next month or so, there will be new rules explaining how that plan will impact healthcare organizations that have CoPs, and those that employ 100 or more people. 

Programming Note: Listen to healthcare attorney David Glaser’s Risky Business segment Mondays on Monitor Mondays, 10 Eastern.