One PHE Declared as Another is On Its Way Out—Maybe

By A.J. Plunkett

Hospitals are now battling both monkeypox and COVID-19 as twin health emergencies, but CMS has signaled that the waivers and flexibilities allowed for almost three years may be almost up.

On August 4, two days after appointing a national monkeypox response team, U.S. Department of Health and Human Services Secretary Xavier Becerra declared the infectious disease a U.S. public health emergency (PHE). Cases are now being reported in all U.S. states and some territories.

The number of cases in the U.S. as of late August accounted for more than a third of cases worldwide. The World Health Organization declared the disease a global health threat on July 23.

As with COVID-19, the monkeypox PHE will last for the duration of the emergency, or 90 days with the possibility for extension.

The immediate impact of the monkeypox declaration was to allow the federal government to increase the availability of testing, vaccines, and treatments, according to HHS.

The CDC continues to regularly update its guidance for healthcare professionals, including infection control measures such as when and how to isolate patients and how to monitor potentially exposed healthcare personnel (HCP).

The guidance emphasizes that “correct and consistent use of PPE when caring for a patient with monkeypox infection is highly protective and prevents transmission to HCP,” writes the CDC.

“However, unrecognized errors during the use of PPE (e.g., self-contaminating when removing contaminated PPE) may create opportunities for transmission to HCP. Therefore, in the absence of an exposure described below, HCP who enter a contaminated patient room or care area while wearing recommended PPE, should be aware of the signs and symptoms of monkeypox; if any signs or symptoms of monkeypox occur, HCP should notify occupational health services for further evaluation and should not report to work (or should leave work, if signs or symptoms develop while at work).”

The guidance and other information offered by professional organizations such as the Association for Professionals in Infection Control and Epidemiology, as well as consultants, outlines donning and doffing of PPE, handling of lab specimens, and hazardous waste management.

COVID-19 PHE may end soon

Meanwhile, COVID-19 is still a very real problem, although deaths and hospitalizations were trending down in late August.

Following the COVID-19 PHE declaration in early 2020, HHS issued several blanket waivers for hospitals and other providers. Many of the waivers remain in place, while some have been revoked as the need has diminished. The online list of COVID-19 waivers was last updated in mid-August.

CMS has now issued what it calls a road map for hospitals and other healthcare organizations to wind down from PHE operations.

Announcement of the road map began with a reiteration of a promise made by the previous administration that states and healthcare organizations will be given advance notice that the PHE is ending.

“Throughout the COVID-19 public health emergency (PHE), CMS has used a combination of emergency authority waivers, regulations, enforcement discretion, and sub-regulatory guidance to ensure access to care and give health care providers the flexibilities needed to respond to COVID-19 and help keep people safer. Many of these waivers and broad flexibilities will terminate at the eventual end of the PHE, as they were intended to address the acute and extraordinary circumstances of a rapidly evolving pandemic and not replace existing requirements,” according to a CMS blog posting by Jonathan Blum, the agency’s chief operating officer and principal deputy administrator; Carol Blackford, director of the Hospital and Ambulatory Policy Group; and Jean Moody-Williams, deputy director of the Center for Clinical Standards and Quality.

“To minimize any disruptions, including potential coverage losses, following the end of the PHE, HHS Secretary Becerra has committed to giving states and the health care community writ large 60 days’ notice before ending the PHE. In the meantime, CMS encourages health care providers to prepare for the end of these flexibilities as soon as possible and to begin moving forward to reestablishing previous health and safety standards and billing practices.”

Notice that the blog says “eventual end of the PHE.” Since the COVID-19 PHE was renewed on July 15, it currently continues for 90 days, which would make its end point October 13. If it is renewed again, the new 90-day end point would be January 11, 2023. It’s unclear when the 60-day notice would be taken into account.

Whenever the PHE ends, CMS and accrediting organizations (AO) have always made clear that hospitals would be held accountable for having any required equipment testing and inspections, or other pandemic exceptions, at the next survey.

CMS is exploring whether some waivers and flexibilities, such as those regarding telehealth, may be kept or modified for use after the COVID-19 PHE.

However, in a separate document published August 18, CMS discussed the hospital waivers and flexibilities and made clear which ones would end along with the PHE.

For instance, for hospitals who extended their Medicare certification coverage to alternate care sites or were able to bill certain telehealth services at an inpatient rate, those flexibilities end with the PHE.

Any waivers regarding placement of alcohol-based hand rub dispensers, staff orientation to fire drills, or construction of temporary walls also will end, among others.

The requirements for emergency exercises remain flexible, but only as long as hospitals have their emergency command centers active.

CMS has also put together a resource for states to prepare for what it calls the unwinding of COVID-19 and considerations for whatever is the next pandemic.

Impact of the PHEs

All told, though, the end of one PHE and the start of another may not impact a lot of organizations come survey time.

Consultants and AOs have noted that many hospitals have declined to take the COVID-19 waivers because the specter of playing catch-up was not worth the trouble or because they have already stood down their emergency command operations.

Monkeypox is still lower on the priority list as well, says Steven A. MacArthur, a senior consultant with Chartis Clinical Quality Solutions in Danvers, Massachusetts.

“While monkeypox has graduated to PHE level, I think for many, if not most, hospitals, this one is going to sit at No. 3 or lower on the hierarchy,” says MacArthur. “COVID is still much more of a player than monkeypox, and there are still weather-related PHEs in the mix, as well as the opioid crisis, none of which seem to be going anywhere.”

Violence, both in the healthcare workplace and brought in with mass casualty events, is also a problem, he says.

“I think the management of violence, regardless of PHE status, is likely to supersede monkeypox as a hospital focus. I do think they’re trying to get out and stay out in front of monkeypox—I don’t think the feds want to have another pandemic on their hands if they can help it. I think moving forward, they will tend to err on early identification of PHEs, at least in terms of emerging infectious diseases (EIDs), pretty much as soon as something is found to be transmissible. Fortunately, at least for the moment, monkeypox is not quite so easily spread.”

Hospitals do need “to continue to monitor CDC recommendations for monkeypox and (potentially) any other EIDs. It probably makes sense to make it an agenda line item for the committees charged with managing infection prevention and control and emergency management,” he advises.

“I don’t think it needs to rise to the level of organizational leadership unless there are cases in the community. Again, so far the spread is slower, but there’s no reason to think that things couldn’t accelerate, so a regular ‘touch’ [at a committee level] makes good sense to me,” says MacArthur.

A.J. Plunkett is editor of Inside Accreditation & Quality, an HCPro publication.