Check your state's pandemic plan to make sure 1135 waivers don't conflict with those requirements
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May 13, 2021
by A.J. Plunkett (email@example.com)
If your healthcare organization has taken advantage of federal 1135 blanket waivers during the national public health emergency (PHE), be sure to review 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 is in effect, and CMS surveyors and accreditation organizations (AO), in general, will be held to allowing those blanket waivers, says Darra James Coleman, special counsel with Nexsen Pruet law firm in South Carolina.
The 1135 blanket waivers apply to requirements for federal programs. However, some of the waivers could be superseded by requirements set by state or local authorities having jurisdiction, if that is stated in a particular waiver and is included in your state’s emergency or pandemic plan, she notes.
Secretary of Health and Human Services Xavier Becerra reauthorized the PHE on April 21. By law, that means the PHE 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 that he would give them at least a 60-day notice before declaring an end to the PHE.
The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities from requirements under the Conditions of Participation and other regulations.
CMS has said that while the waivers are in effect through the term of the PHE, once that ends, so do the waivers and 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 the federal level, the president’s declaration of an emergency is different from the HHS’ Secretary’s authority to declare a public health emergency and issue 1135 blanket waivers.
Remember states can set own requirements
Meanwhile, the states can set their own emergency requirements in an emergency preparedness or pandemic plan.
It can be confusing, Coleman says, especially as some governors are declaring the pandemic emergency to be over and lifting social distancing, masking or other public safety guidelines.
Those guidelines 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 public health officials, she notes.
In reviewing the 1135 waivers, hospitals should remain aware that some 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.
Not every waiver has the phrase, 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 survey were to find an inconsistency between the 1135 waiver used in this example and state restrictions, they are required to defer to the state regulatory requirements, Coleman says. If your hospital is unsure whether an 1135 waiver is consistent with your state law, check your state’s emergency preparedness or pandemic plan and go with that, she says.
Incident command centers slowly closing
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 triennial surveys are resuming as normal, meaning they will be unannounced and on site, unless the hospital is in the middle of a COVID-19 patient surge, has its incident command center still active to deal with the PHE and it considered unsafe to go on-site.
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, 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 AOs will be following CMS’ lead as surveys return to normal.
DNV Healthcare told the Accreditation & Quality 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.