On May 30, 2022, Politico published an article with the headline:  America’s Hospital Regulator Wasn’t Designed for a Pandemic.”  The crux of the article: “[T]he Centers for Medicare and Medicaid Services is ill-equipped to enforce its rules.”  This matters for hospitals and other healthcare facilities still grappling with masks and vaccines.

Five interesting takeaways from the article are outlined below.

  1. Everyone seems to know religious exemptions are a soft spot in vaccine enforcement.

In the article, a nurse from Georgia boasts: “I don’t really truly have a religious exemption.”  For this nurse, opting out of vaccination with a religious exemption was easy: “With the click of a button, [the nurse] said she lied to her employer, claiming on a one-sentence administrative form that her religion prohibited vaccination.”

Throughout the fall and winter of 2021, healthcare employers struggled with how to review and evaluate religious exemption requests from employees.  Then, on December 28, 2021, guidance for regulators, and CMS clarified their intended approach to verifying religious exemption requests: “Surveyors will not evaluate the details of the request for a religious exemption, nor the rationale for the hospital’s acceptance or denial of the request. Rather, surveyors will review to ensure the hospital has an effective process for staff to request a religious exemption for a sincerely held religious belief.”  This process-based enforcement mechanism gave healthcare employers wide latitude—and scarce guidance—to use when evaluating employees’ religious exemption requests. They could question the veracity of the sincerely held religious belief, place patient safety above the need for a religious exemption, or simply allow employees to click a button and provide a single sentence to claim a religious exemption.

CMS’ approach created a conundrum for healthcare employers seeking to comply with CMS’ vaccine mandate while avoiding religious discrimination claims from employees.  Litigation where employers have rejected religious exemption requests is starting to make its way through the courts, and even circuit courts of appeal are starting to weigh in.  Some healthcare employers who denied religious exemption requests based on patient safety concerns are now reevaluating those exemption requests, given the changing nature of the threat from COVID.  For example, some facilities are recalling nurses and other professionals who were placed on unpaid leave when their religious exemption requests were rejected.

The article from Politico exposes the soft spot in vaccine enforcement that everyone knows.  CMS, however, reserved the right in the interim final rule to revisit compliance requirements for documenting religious exemption requests: “We decided to establish minimal compliance burdens for both categories of exemptions. This decision on the evidentiary standards could be revisited should an abuse problem arise on a significant scale.”

Could articles like this in Politico make it easier for CMS to revisit religious exemption enforcement?

  1. Healthcare Facilities are Required to Impose Additional Infection Control Measures for Unvaccinated Staff.

Healthcare facilities covered by CMS’ interim final rule are required to provide infection control measures specifically aimed at unvaccinated staff.  If the facility requires all staff to wear N95 facemasks, and there are no additional precautions taken for staff who are not vaccinated, the facility is likely out of compliance.  CMS and The Joint Commission expect more.

There must be additional precautions specific to unvaccinated staff, even if the facility already undertakes significant infection control measures for all.  For example, if all staff is required to wear N95 facemasks, perhaps unvaccinated staff could still be required to undergo weekly COVID testing.  The weekly COVID testing would be the additional infection control measure that is required.

While the Politico article only had one sentence addressing this issue, it is common for healthcare employers to overlook this requirement of the interim final rule.  When the state surveyor, The Joint Commission or CMS come knocking on your door, they are going to ask you to identify the additional infection control measures you take with respect to the unvaccinated staff.   Facilities must have something to point to.

  1. State Surveyors, CMS and The Joint Commission Are Out Surveying.

CMS told Politico that it had cited 69 hospitals for not complying with the mandate.  The Joint Commission declined to indicate how many hospitals or other facilities it had cited but did note that “it has seen an uptick.”

It has now been almost six months since the interim final rule was effective for most healthcare facilities across the country.  Enforcement efforts have begun, and employers would do well to engage in a self-audit of their compliance with the interim final rule.  A self-audit done under an attorney-client privilege should protect it from prying eyes of government regulators.

  1. Masks Are Still Required in Healthcare Facilities.

Perhaps the most fascinating aspect of the Politico article was the idea that the Politico report “Caught CMS by surprise” with respect to masking in healthcare facilities.  The reporter noted that although a CMS official said hospitals still require masks, “several patients and health workers” told Politico that masks were not required at their facility.

The CDC continues to recommend masking for “everyone in a healthcare setting,” regardless of vaccination status.  The color-coded community levels that the CDC rolled out in late March 2022 do not apply to healthcare.  Facilities looking to do away with masks should engage legal counsel to review the most up-to-date requirements and to evaluate the risks of going without masks.

CMS was apparently surprised by the lack of masking in covered facilities, and you can expect they will be paying extra attention to that issue now that Politico has identified it.

  1. On Wisconsin.

Finally, tying into that masking requirement, Politico named a patient from rural southwest Wisconsin.  She has two immunocompromised children but said her primary hospital does not require staff or visitors to wear masks.  She recalled encountering 30 unmasked people in a waiting room.  “This is insanity,” she told Politico.  “We need CMS to step up.”

This article could lead to increased enforcement action by CMS.  Without a doubt, though, there are people like the patient from the great State of Wisconsin who will be complaining to a CMS, OSHA or other enforcement agency near you.

A self-audit is an appropriate step to take to prepare for what may be increased enforcement activity.