During the last several years, the United States and its emergency planning and response agencies have been challenged by many natural and man-made disasters. In response to the September 11, 2001 terrorist attacks, catastrophic hurricanes in the Gulf Coast states in 2005, major flooding in Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012, the Centers for Medicare & Medicaid (CMS) was prompted to examine readiness for public health emergencies in the U.S.
CMS performed a comprehensive review of existing emergency regulatory preparedness policy, guidance and requirements for both Medicare suppliers and providers. In CMS’s assessment, while many suppliers and providers have emergency preparedness requirements, these requirements do not go far enough in ensuring that facilities are properly equipped and prepared to protect the people they serve during emergencies. CMS believes that existing requirements are insufficient to address the complexity of actual emergencies and to support the needs of patients, staff and the broader community. CMS deemed the current regulations also fail to enforce consistency in the level of emergency preparedness required across health care providers—across facility types there is extreme variance in existing emergency preparedness requirements. For example, some accrediting organizations have requirements that exceed the minimum required by CMS, while other provider types have no requirements.
Beyond CMS, there have been concerns raised by Congress, the health care community and the general public about the insufficiency and inability of health care facilities to respond to the complexities of emergencies and appropriately plan and prepare emergency response procedures. The U.S. has faced a number of emerging diseases, such as Ebola, MERS-CoV and enterovirus-68. Health care providers have expressed concerns about their safety in treating these diseases, citing the need for advanced preparation, lack of effective policies and procedures, communication plans and training.
On September 8, 2016, the Federal Register posted the final rule Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers after a draft rule was published for feedback in December 2013. The regulation went into effect on November 16, 2016, giving health care providers and suppliers affected by this rule one year to comply and implement all regulations on November 16, 2017. CMS intends for the rule to establish national emergency preparedness requirements that ensure adequate planning for natural and man-made disasters and increase coordination with federal, state, tribal, regional and local emergency preparedness systems, leveraging lessons learned from past and current best practices.
The final rule addresses what CMS categorizes as three key essentials necessary for maintaining health care services during emergencies: safeguarding human resources, maintaining business continuity and protecting physical resources.
What This Means for Providers and Suppliers
The CMS requirements will apply to 17 different provider and supplier types (both inpatient and outpatient), with each type having its own specific set of emergency preparedness regulations incorporated into a set of conditions for certification. CMS states that all supplier and provider types must be in compliance with the regulations in order to participate in the Medicare/Medicaid program. The rule affects the Conditions of Participation (CoPs) and Conditions for Coverage (CfCs)—conditions that must be met by Medicare/Medicaid participating providers and suppliers.
Based on research and engagement with stakeholders, four elements were identified that make up the core framework for emergency preparedness planning: risk assessment and emergency planning, policies and procedures, communications planning, and testing and training. These core elements apply across all supplier and provider types, with specific requirements tailored to each individual type to meet their specific needs and circumstances, along with the needs of their patients, residents, clients and participants.
Each provider and supplier type is responsible for implementing an emergency preparedness program that incorporates all four elements and the additional type-specific requirements by November 16, 2017. Some facility-specific requirements include that home health agencies and hospices are required to inform officials of patients in need of evacuation, and long-term care and psychiatric residential treatment facilities must share information from the emergency plan with residents and family members or representatives.
The Core Framework
Risk Assessment and Planning: Facilities must take an all-hazards approach to their risk assessment that reviews all the possible hazards, disasters and effects on facility operations and safety, to ensure appropriate focus during emergency planning. This approach should be customized to the location of the facility and consider the types of hazards most likely to occur in the area. Risks may include, but are not limited to, natural disasters, care-related emergencies; equipment/power failures; interruptions in communications, including cyberattacks; loss of all or a portion of the facility; and interruptions in the supply chain of essentials.
The outputs of this assessment must be utilized to develop a comprehensive emergency preparedness plan that addresses the four phases of emergency management—mitigation, preparedness, response and recovery, and focus on developing capacities and capabilities that are critical to a broad range of emergencies. The plan must:
- Be reviewed and updated annually
- Include strategies for addressing issues identified in the risk assessment
- Address the patient population, including at-risk patients (language, mobility, mental and physical impairment, etc.)
- Address continuity of operations, including succession planning with clear lines of authority
- Identify the process for ensuring cooperation and collaboration at local, regional, state or federal levels
Policies and Procedures: Policies and procedures should be developed to support the successful execution of the emergency plan and mitigate the risks identified in the risk assessment. These policies and procedures span multiple dimensions, including addressing the provision of subsistence needs for staff and patients during evacuation or shelter in place; provision of alternate sources of energy; systems to track location of staff and patients during and after an emergency; arrangements for transfer of patients and provision of care and treatment at alternate sites, among others. Review and update annually.
Communication Plan: CMS is requiring facilities to develop an emergency preparedness communication plan that complies with both federal and state law. There must be primary and alternate ways to communicate with staff and emergency management agencies identified in the plan, as well as methods to share information and medical documentation with other health care providers to maintain continuity of care. Patient care must be well coordinated within the facility and across health care providers. Facilities also need to provide local authorities with information about their occupancy, needs and ability to provide assistance to other facilities.
Testing and Training: CMS requires that facilities develop and maintain a multi-year testing and training program to accompany plan implementation. Initial training should be provided to new and existing staff, and annual emergency preparedness training should be delivered for staff to demonstrate knowledge of emergency procedures. Emergency drills and exercises to test the facility’s plans should be conducted not just at the facility level, but more broadly as an annual community exercise to identify gaps and opportunities for improvement. The testing and training plan must align to the Homeland Security Exercise and Evaluation Program (HSEEP) guidance on the establishment of a Training and Exercise Planning Workshop (TEPW), maintained by the Federal Emergency Management Agency (FEMA).
The Fine Print
Health care facilities not only have their own challenges but are subject to those that exist within their communities in terms of emergency response. For example, communities with volunteer fire departments have very few resources during the day, and response time is much slower than in the evening. Health care facilities often take for granted that emergency responders will be there when desperately needed, unaware that their town may lack the physical or human resources to address their needs. Rural areas, too, suffer from long response times and a lack of trauma facilities that can shelter patients if another facility is affected.
It’s critical for facility preparedness to coordinate with local responders to makes sure they familiarize themselves annually with the facility and are prepared for any scenarios they might encounter when responding to an emergency, such as an active shooter, a flood or other natural disasters. Completing the CMS requirements to the detail and degree required may be a heavy lift for most facilities, particularly those that have no previous accreditation requirements for emergency planning.
Companies, such as Evans Incorporated, specialize in consulting with health care facilities to meet the CMS requirements. With a custom hazard-assessment tool and trained experts, Evans Incorporated can help health care facilities navigate the complex challenges of developing a robust emergency preparedness program, without letting any detail go unnoticed. To learn more: www.evansincorporated.com/who-we-work-with/healthcare/healthcare-emergency-preparedness/.
