Clarification: 1135 waivers, temporary suspension of rules during a disaster
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February 9, 2020
by Brian Ward
Joint Commission (TJC)–accredited hospitals and critical access hospitals must have a process in their policies for requesting an 1135 waiver from CMS, which is issued during a disaster or emergency when conditions necessitate modifying or temporarily lifting CMS requirements.
TJC’s recent clarification was to Emergency Management (EM) Standard EM.02.01.01, element of performance (EP) 14. The accreditor explained that surveyors don’t expect to review an actual 1135 waiver during survey; however, they will want to review your 1135 waiver request process and confirm that leadership is knowledgeable about the requirements.
With an 1135 waiver, a facility can modify:
- Conditions of Participation (CoP) or other certification requirements
- Program participation and similar requirements
- Preapproval requirements
- State licensing requirements for physicians and other healthcare professionals
- Emergency Medical Treatment and Active Labor Act (EMTALA) sanctions
- Stark self-referral sanctions
- Performance deadlines and timetable adjustments (these may not be waived)
- Limitations on payment to permit Medicare enrollees to use out-of-network providers in an emergency
While there’s no standardized application template for an 1135 waiver, there is specific information that hospitals need to include in their request:
- Provider name and type
- Full address: county, city, town, state
- Medicare provider number
- Name and contact information of the provider’s point of contact
- Consideration, such as the type of relief requested or regulatory requirement/reference to be waived
- Brief summary of why the 1135 waiver is needed
TJC provided an example summary as follows: “The critical access hospital is the sole community provider without reasonable transfer options at this point during the specified emergent event (such as flooding, tornado, fires, flu outbreak). The critical access hospital needs a waiver to exceed its bed limit by X number of beds for Y days/weeks (be specific).”
An 1135 waiver is approved for a maximum of up to 60 days and can only be issued under two circumstances: 1) when the Health and Human Services secretary declares a public health emergency (PHE), or 2) if the president declares an emergency using a Stafford Act declaration or the National Emergencies Act. Examples of 2019 PHEs are Hurricane Dorian in North Carolina, Typhoon Yutu in the Mariana Islands, and the national opioid crisis.
Kurt Patton, MS, RPh, is founder of Patton Healthcare Consulting and former director of accreditation services for TJC. When a facility submits a request for an 1135 waiver, he says that CMS isn’t likely to inspect your facility to verify the need.
“Time is of the essence when a regional disaster strikes, and CMS wants to ensure that patients are served as well as possible during that regional disaster,” Patton says. “Waiving some specific regulations is preferable to having the entire health system shut down because they are not able to offer perfect care during the crisis. The wait should be minimal, because CMS will already be aware that all of the greater Houston area is flooded and patients need to be accommodated. The HHS secretary can also issue a blanket waiver for a specific geographic area.”
However, an 1135 waiver can’t be extended unless there is a PHE still in effect and you can prove the waiver is still necessary. Nor is an 1135 waiver a blanket “get out of jail free” card for all standards. A list of specific requirements to be suspended or altered must be provided by the applicant along with an explanation of why the waiver is necessary.
In the chaos of an emergency, finding the time to go through your standards and requirements to decide the ones you’ll need waived isn’t feasible, Patton says. Therefore, as part of the 1135 waiver process, a facility should do some preplanning based on its annual Hazard Vulnerability Assessment (HVA).
“In that assessment, each organization identifies the most likely disasters and the emergency operations plan and twice yearly drills details [on] how you cope with those scenarios,” says Patton. “The hospital should know how floods, heating failure, tornadoes, snowstorms, etc. will affect them. The drill scenarios tell them the ‘workarounds and the relocations’ that need to be implemented.”
How much detail does TJC expect to be included in your 1135 request process?
Using your facility’s HVA and drill experience, Patton notes, you should have an idea what impact different disasters might have.
Facilities should already know, for instance, what the potential impacts of flooding at their main site would be compared to one of their remote clinics. They should also know what their alternative care delivery options are, explains Patton, and the emergency operations plan should be “succinct, but describe the anticipated process should disaster strike.”
“For example, the incident commander has a template 1135 waiver document that will be finalized during the recovery phase to maintain patient care services,” Patton says. “Based on impact and damage to our care delivery network, the template waiver request will be modified, specifically stating what the nature of the waiver request is and the waiver request signed by the CEO of the hospital. The template document already includes the email and fax numbers for CMS and it will be sent immediately after signature using the most effective method of communication available in our organization.”
The following list of websites was provided by The Joint Commission to give providers additional information and resources on 1135 waivers, including examples of recently approved 1135 waivers, checklists, and action plans: