Emergency Preparedness for Medicare and Medicaid-participating Providers and Suppliers Final Rule

A number recent of natural and man-made disasters, such as 9/11, the subsequent anthrax attacks, Hurricane Katrina in 2005, the 2000 flooding in Midwestern states in 2009, the 2009 H1N1 influenza pandemic, and Hurricane Sandy in 2012 have challenged the public health system’s ability to adequately respond in terms of protecting patients and ensuring continuity of services. As a result, the Centers for Medicare and Medicaid Services (CMS) has decided to establish “comprehensive, consistent, flexible, and dynamic regulatory approach to emergency preparedness and response that incorporates the lessons learned from the past, combined with the proven best practices of the present”.

With the aim of improving overall public health emergency preparedness, CMS issued a Final Rule on September 16, 2016 (CMS-3178-F) establishing national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers. The Final Rule incorporates these emergency preparedness requirements into provider conditions for participation (CoPs) and supplier conditions for coverage (CfC). The Final Rule impacts a total of 17 institutional provider and supplier types, including Hospitals, Critical Access Hospitals (CAHs), Hospices, Home Health Agencies (HHAs), Long Term Care (LTC) facilities, Federally Qualified Health Centers (FQHCs), End-Stage Renal Disease (ESRD) Facilities, among others.

The Emergency Preparedness Final Rule requires providers to implement an emergency preparedness program whose primary goals are to safeguard human resources, maintain business continuity, and protect physical resources. The components of the emergency preparedness program include the following:

• Risk assessment and emergency planning: The Final Rule requires providers and suppliers to perform a risk assessment using an “all-hazards” approach as a basis for the development of an emergency preparedness plan. An “all-hazards” approach implies than an organization wishes to establish emergency preparedness for a wide spectrum or disaster types or emergency scenarios. As with all emergency preparedness exercises, the “all-hazards” approach is very much dependent on the location of the provider or supplier because some hazards, particularly natural ones, are more likely in one region than another. For example, a provider whose facility is located in the gulf coast will plan for a set of natural hazards that is different from the one a supplier in Alaska would consider. It is also important to consider care-related emergencies, such as a significant event that creates a spike in demand for healthcare services, equipment and power failures, interruption in communications, the partial or total loss of a facility, and interruptions in the normal supply of essentials, such as food and water.
• Policies and procedures: The Final Rule requires that facilities develop and implement policies and procedures that support the successful execution of the emergency plan in the scenarios identified during the risk assessment process.
• Communication plan: The emergency preparedness communication plan is intended to ensure that patient care is well-coordinated within the facility and across healthcare providers when the need arises. In addition, the communication plan must ensure coordination with state and local public health departments and emergency management agencies and systems to protect patient health and safety in the event of a disaster. In particular, the communication plan must include a system to contact appropriate staff, patients’ treating physicians, and other necessary persons in a timely manner to ensure continuation of patient care functions.
• Training and testing: Any effective emergency preparedness plan must be supported by an adequate training and testing program. The Final Rule requires initial training for new and existing staff in emergency preparedness policies and procedures as well as annual refresher training. The facility must offer annual emergency preparedness training so that staff can demonstrate knowledge of emergency procedures. The facility must also conduct drills and exercises to test the emergency plan to identify gaps and areas for improvement.

The planning and implementation considerations for the previously described elements of the emergency preparedness program are dependent on the type of supplier. The Final Rule describes specific guidance for each provider and supplier type, which helps lay the groundwork for planning and implementation activities. The deadline for providers and suppliers to implement the emergency preparedness program requirements is one year after the effective date of the Final Rule or November 15, 2017.

The overall goals of the Final Rule in terms of safeguarding human resources, maintaining business continuity, and protecting physical resources imply a significant planning and implementation effort for providers and suppliers, particularly for inpatient facilities that must coordinate activities with a number of stakeholders in their communities, and residential facilities for which food and shelter alternative arrangements must be established. The Final Rule does not propose overly prescriptive requirements for any of the providers and suppliers, regardless of size, but institutions that have a broader operational footprint and/or a more complex clinical services delivery model will find it challenging to comply with the requirements in the Final Rule. This will be especially true for providers and suppliers whose prior emergency preparedness efforts had a limited scope or their planning and implementation efforts have not been reviewed and updated recently. Given the amount of planning and coordination involved, providers and contractors should start their planning and implementation activities as soon as feasible and under the guidance of experienced professionals in emergency preparedness and the requirements in the Final Rule.

In future articles, we will discuss specific CMS guidance and make recommendations to organizations seeking to implement their emergency preparedness program according to the requirements in the Final Rule.