Check Your State's Pandemic Plan to Make Sure 1135 Waivers Line Up Locally

The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities related to requirements under the Conditions of Participation (CoP) and other regulations.

This article was originally published June 22, 2021 on PSQH

If your healthcare organization has taken advantage of federal 1135 blanket waivers during the national public health emergency (PHE), be sure to review the use of those waivers as you prepare for survey to check if any were inconsistent with requirements under your state emergency or pandemic plan.

The blanket waivers will remain in effect as long as the PHE declaration remains in force, and CMS surveyors and accreditation organizations (AO), in general, will be held to allowing those blanket waivers, says Darra James Coleman, special counsel with the law firm Nexsen Pruet in South Carolina.

However, some of the waivers could be superseded by requirements set by state or local authorities having jurisdiction, if that is stated in that particular waiver and is included in your state’s emergency or pandemic plan, she notes.

Following the PHE’s initial declaration in March 2020 and several extensions, Health and Human Services (HHS) Secretary Xavier Becerra reauthorized the PHE declaration on April 21. By law, that means the declaration is good for another 90 days—in this case through July 20—unless otherwise stated by the secretary.

In January, HHS Acting Secretary Norris Cochran notified the nation’s governors earlier this year that HHS would give them at least a 60-day notice before declaring an end to the PHE.

Waivers provide flexibility with some CoPs

The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities related to requirements under the Conditions of Participation (CoP) and other regulations.

CMS has said that although the waivers are in effect through the term of the PHE, once that ends, so do the waivers. CMS also has stated that hospitals could be held accountable for any backlog of maintenance, testing, or fire safety requirements that were specifically waived by the 1135 declarations.

It’s worth noting, says Coleman, that the federal PHE is different from any emergency declarations by individual states, which set their own emergency requirements. Even at a federal level, the president’s declaration of an emergency is different from the HHS secretary’s authority to declare a PHE.

Meanwhile, states can set their own emergency requirements in an emergency preparedness or pandemic plan.

It can all be confusing, Coleman says, especially as some states are declaring the pandemic emergency to be over and lifting social distancing, masking, or other public safety precautions.

Those are different from specific pandemic-related regulations or other requirements for healthcare providers, which may remain in place unless otherwise stated by local or state officials, she notes.

In reviewing the 1135 waivers, hospitals should remain aware that a few of the federal blanket waivers say the specific flexibility is allowed “so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan,” says Coleman.

That means as the end of the PHE approaches, hospitals “need to be very familiar with their own state’s emergency preparedness or pandemic plan” to ensure they are in compliance.

Waivers can vary

Not every waiver has the phrase about not being inconsistent with a state’s emergency preparedness plan, adding to the confusion.

As an example, under anesthesia services, the 1135 waiver states: “CMS is waiving requirements under 42 CFR §482.52(a)(5), §485.639(c) (2), and §416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician in paragraphs §482.52(a)(5) and §485.639(c)(2). CRNA supervision will be at the discretion of the hospital and state law. This waiver applies to hospitals, CAHs, and Ambulatory Surgical Centers (ASCs). These waivers will allow CRNAs to function to the fullest extent of their licensure, and may be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.”

If a surveyor were to find an inconsistency, they are required to defer to the state’s requirements as long as those requirements are part of the state’s preparedness plan, Coleman says. If your hospital is unsure, check your state’s emergency preparedness or pandemic plan and go with that, she says.

Remember, you did not have to make a specific request to CMS to qualify for the blanket waivers, says Gayle Nash, RN, MPH, president of Nash Healthcare, a compliance consulting firm headquartered in El Paso, Texas.

The Joint Commission and other accreditation organizations have said that surveys are resuming as normal, meaning they will be unannounced and on-site. This applies unless the hospital is in the middle of a COVID-19 patient surge, its incident command center is still active to deal with the PHE, and it is considered unsafe to go on-site.

Surveys resuming

However, by late April such incident command activation was unnecessary in many parts of the country, observes Nash.

“Many hospitals are not utilizing their incident command as they now have well-defined processes in place for screening, isolating, and treating patients,” says Nash. “It is common to see hospitals continue to include COVID-19 patient numbers and also patient location in the daily safety huddles, leadership reports, [and] of course infection prevention surveillance rounds, but the incident command is not needed in many cases for daily management of COVID patients.”

Nash is among several consultants from across the country who have been busy helping hospitals and other organizations prepare for upcoming accreditation visits, many of which are overdue after surveys were suspended at the start of the pandemic.

“As we travel from hospital to hospital, week after week, the level of hospital staff resiliency is remarkable,” says Nash. “The nurses say, ‘We are following our policies, using proper PPE, cleaning and disinfecting properly, and working closer as a team to manage COVID-19 patients.’ We also see the volume of infectious patients are becoming less, although occasionally there are small surges.

“In these surge cases, staff are now used to using alternative sites to manage COVID-19 patients, and some hospitals based upon need are keeping these alternative sites open and available,” says Nash.

Note that accreditation organizations will be following CMS’ lead as surveys return to normal.

DNV Healthcare told the Accreditation & Compliance Center that “The Public Health Emergency is a distinctly federal concept and the current PHE is national, affecting providers participating in federal health benefit programs, so we follow the same procedures everywhere.”

DNV also said its surveyors would be referring to the CMS document found at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/1135-Waivers-At-A-Glance.pdf. So you might want to as well.

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