The Centers for Medicare and Medicaid Services (CMS) Emergency Preparedness Rule has been in effect for over a year now. During that time, the nation has seen catastrophic hurricanes, fires and tornados which caused damage to skilled nursing centers. CMS held a webinar in August to educate surveyors about the areas that needed better understanding – 1135 Waivers and E-tags.
The 1135 Waiver process begins with the Presidential declaration of emergency. The purpose of an 1135 Waiver is to ensure sufficient health care items and services are available to meet the needs of Medicare, Medicaid and CHIP beneficiaries and to ensure health care providers that provide such services in good faith can be reimbursed and not subjected to sanctions for noncompliance, absent any fraud or abuse. The 1135 Waiver has a limited duration. It will end no later than the termination of the emergency period, or 90 days from the date the waiver or modification is first published unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period. 1135 Waivers do not allow reimbursement for services otherwise not covered and do not allow individuals to be eligible for Medicare who otherwise would not be eligible.
The CMS Emergency Preparedness Rule requires the facility to demonstrate, in writing, that it has a policy and procedures which address the general awareness of the 1135 Waiver process. The surveyor must verify that the facility has a policy and procedures to address who to contact in the event an 1135 Waiver must be requested and the facility’s role in the provision of care and treatment at an alternate care site identified by emergency management officials.
The facility should have policies and procedures which address the knowledge of how to request a waiver; the circumstances when an 1135 Waiver might be granted based on the risk analysis; how they would operate under the granted waiver; how they would plan jointly on issues related to staffing, equipment, and supplies and having immediate access to the CMS 1135 website. The facility should also have in place policies and procedures which address emergency situations in which a declaration was not made and where an 1135 Waiver may not be applicable, such as during a disaster affecting a single facility.
The Emergency Preparedness Rule was published September 16, 2016, applies to all 17 provider and supplier types and was implemented November 15, 2017. Compliance with the Rule is required for participation in Medicare and Medicaid. If facilities are non-compliant, the same general enforcement procedures will occur as is currently in place for any other conditions or requirements cited for non-compliance. The facility will be surveyed on the Emergency Preparedness Rule in conjunction with survey.
Two tags that are sometimes confusing are E0001 verses E0004. There is a difference between the two tags. E0001 is the Emergency Preparedness PROGRAM. This will be cited if the facility has no elements of the Emergency Preparedness Plans, Policies and Procedures, Communication or Training and Testing Program. E004 is the Emergency PLAN. This is the risk assessment and plans, not the entire program. The surveyor will interview the facility leadership and ask them to describe the facility’s emergency preparedness program. They will ask to see the facility’s written policy and documentation on the emergency preparedness program. These items will fall under E001 if not available. Next, the surveyor will verify the facility has an emergency preparedness plan and then ask the facility leadership to identify the hazards identified in the facility’s risk assessment and how the risk assessment was conducted. The surveyor will review the plan to verify it contains all the required elements. Last, the surveyor will verify that the plan is reviewed and updated annually by looking for documentation of the date of the review and updates that were made to the plan based on the review.
The first of the four provisions that should be in the emergency preparedness plan are the Risk Assessment and Planning. This should be completed and updated annually. Facility leadership should develop an emergency plan based on a risk assessment. Perform a risk assessment using an “all hazards” approach focusing on capacities and capabilities.
The second of the four provisions are the policies and procedures for emergency preparedness. Facility leadership should develop and implement policies and procedures based on the emergency plan and risk assessment. Policies and procedures are based on what has been determined to be a risk during the All Hazardous Risk Assessment. There should be a policy and procedure document for each item that has been determined to be a risk. The policy and procedure should include what to do in response to a risk and what needs to be done to get back to normal operations when the emergency has passed. Policies and procedures must address a range of issues including subsistence needs, evacuation plans, procedures for sheltering in place and tracking patients and staff during an emergency.
The third of the four elements of the emergency plan are the communication plan. Facility leadership should develop a communication plan that complies with both federal and state laws. The communication plan should include communications equipment or communication systems that will be used when the emergency plan is activated.
The last provision of the required four provisions is the Training and Testing Program. Facility leadership should develop and maintain training and testing programs which include initial training of the emergency preparedness plan and the annual training. The facility should conduct emergency drills and exercises to test the emergency plan. Tag E-0001 will be cited if the facility does not have an emergency preparedness program. Individual tags can also be cited for missing elements of the program. E-0004 is the Emergency Plan, E-0013 are the Policies and Procedures, E-0029 is the Communication Plan and E-0036 is Training and Testing of the Plan.
Emergency preparedness is an ongoing process that needs annual updates, initial and annual education along with drills and testing. During an emergency the facility team should know their responsibilities and roles without hesitation.
Emergency Preparedness Resources
- State Operations Manual Appendix Z – Emergency Preparedness for All Provider and Certified Supplier Types Interpretiveuidance