‘Layer Upon Layer of Regulation’: Breaking Down the CMS Vaccination Mandate

Since the Centers for Medicare & Medicaid Services (CMS) released its interim emergency regulation relating to the federal government’s vaccine mandate last Thursday, more clarity has come to the surface.

Specifically, CMS has made clear what health care providers are included, what individuals can be exempt and how the mandate will be enforced.

What came as somewhat of a surprise was the fact that home- and community-based services (HCBS) providers were not included in the mandate. It instead only applies to providers regulated under the CMS Conditions of Participation (CoPs), which includes home health agencies, and, overall, nearly 76,000 providers and 17 million health care workers.

No one knows the exact thought process behind that decision for CMS, Darby Anderson, the chief strategy officer at Addus HomeCare Corporation (Nasdaq: ADUS) and vice chairman of the Partnership for Medicaid Home-Based Care (PMHC), told Home Health Care News.

“I assume it was a decision of where to draw the line,” Anderson said. “Using CoPs makes sense, as it is a clear way to define the service and personnel providing it consistently across states which have varied definitions on HCBS personnel types. It is helpful from the perspective of allowing waivers and testing options to keep staff employed.”

Because of the enormous complexity that goes into an interim emergency regulation like this one, leaving out HCBS providers allowed CMS to be more concrete with its guidelines.

But between the CMS mandate, the Occupational Safety and Health Administration’s (OSHA) coinciding guidelines for private businesses and state mandates, there is a lot for providers to sort through.

“It is layer upon layer of regulation and requirements that are not always easy to understand,” Emina Poricanin, managing attorney of Poricanin Law, told HHCN.

The CMS mandate doesn’t just apply to patient-facing workers, but full-time telework staff are exempt. It also does not allow for opt-outs, where an individual can instead be tested weekly in lieu of being vaccinated.

That could potentially squeeze some workers out of home health care and other health care settings. It could also give providers not included in the emergency regulation an edge, if they are OK with employing unvaccinated workers.

Along with HCBS providers, assisted living facilities, group homes and physician’s offices are not subject to the mandate.

Speaking at the 2021 Credit Suisse Healthcare Conference on Monday, Encompass Health (NYSE: EHC) President Mark Tarr suggested the loss of some clinicians from the health care workforce is inevitable.

“We continue to look at the details of the president’s mandate that came out last week from CMS, … and we obviously will comply with the mandate,” Tarr said. “I do think that we will see – now that it’s clear that this is the direction – a higher percentage of our staff go out and get the vaccination. But we will have a percentage of our staff that decide that they’re going to leave the health care practice because they don’t want to get vaccinated, so that’s unavoidable.”

What could exacerbate that departure from the field is the inability to opt-out of the vaccine and instead receive weekly testing.

“Having experience in a state like New York, which also does not allow for a weekly test-out option or a religious exemption in its mandate, I have mixed feelings about CMS’ regulation,” Poricanin said. “Not allowing weekly testing as an opt out takes away options for employees who do not wish to be vaccinated. But on the other hand, it helps employers who – in some states – might be required to pay for the time employees spend getting tested on a weekly basis.”

Employers will, however, have to pay for time off for employees to get vaccinated and for any sickness that derives from the process.

The CMS mandate – unlike the ones in Maine and New York – is also allowing more flexibility around religious exemptions.

“Many employees will flock to these exemptions and submit requests, professing to have sincerely held religious objections to the mandate,” Poricanin said. “From my experience, I expect that employers who are short-staffed – as most of them are – will accept these religious exemption requests and allow the non-vaccinated caregivers to work. The religious exemption will open the door for many employees to maintain their employment and avoid vaccination.”

The barrier to compliance

According to CMS, providers must do three things in order to be considered in compliance with its emergency regulation.

First, providers must implement a process or plan for vaccinating all eligible staff. They must also have a plan for how they’re handling exemptions and accommodations for workers who are exempt. Lastly, providers must outline how they plan on tracking and documenting staff vaccinations.

Workers need to have received one shot of a two-dose vaccine or one dose of the Johnson & Johnson (NYSE: JNJ) vaccine by Dec. 5. They must be fully vaccinated by Jan. 4 of 2022. Booster shots are not yet included in the mandate’s guidelines, but are strongly encouraged by CMS.

For those who do seek exemption status – either for religious or medical reasons – they must go through a process that’s required to be put in place by the provider.

If they are citing medical grounds, workers must provide documentation from a licensed practitioner. That documentation must include a signature from the practitioner, as well as the reason why the vaccine would be bad for their health and a recommendation from the practitioner specifically saying that the worker should not receive the vaccine.

On the religious grounds end, providers must “ensure all requests for religious exemptions are documented and evaluated in accordance with applicable federal law and as a part of the facility’s policies and procedures,” according to CMS.

The latter is far more likely to keep unvaccinated workers in home health than the former. It’s also still unclear how strict the threshold for religious exemptions will be, and which party will be the deciding factor: the provider or the government.

As for oversight overall, CMS says that it will be working with both state survey agencies and accrediting organizations to assess compliance. Those agencies will be conducting on-site reviews of agencies through recertification surveys and complaint surveys.

If a provider is found not to be in compliance with the mandate, they will be given an opportunity to return to compliance. After that, however, CMS may use enforcement remedies such as “civil monetary penalties, denial of payment and even termination from the Medicare and Medicaid program.”