Copyright American Health Lawyers Association 2016. Reprinted with permission.
The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 15, 2016 establishing national emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers to plan adequately for natural and man-made disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems.1 Additionally, the rule assists providers and suppliers in their preparation to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. The rule is effective on November 15, 2016 with an implementation deadline of November 15, 2017. CMS published the proposed rule on December 27, 2013, titled “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.”2 The proposed and final rules included discussions of previous events such as the 2009 H1N1 influenza pandemic, tornadoes in 2011 and 2012, and Hurricane Sandy, as well as emerging diseases, such as MERS-CoV and Ebola, and the Enterovirus D68. With regard to Ebola, health care providers expressed concern about their safety when caring for patients with Ebola, specifically citing the need for a more comprehensive approach. As such, this rule issues emergency preparedness requirements that attempt to establish a comprehensive, consistent, flexible approach that incorporates lessons learned from the past and current best practices.
The final rule addresses three key areas that CMS believes are necessary to maintain access to health care services during emergencies: safeguarding human resources; maintaining business continuity; and protecting physical resources.
Four core or essential elements, identified in the final rule, that CMS believes are central to an effective and comprehensive framework of emergency preparedness for certain Medicare and Medicaid participating suppliers and providers are as follows:3
- Risk Assessment and Emergency Planning. The final rule requires each provider and supplier to develop an emergency plan based on a risk assessment. The provider must document and use an all-hazard approach. An all-hazards approach is defined as an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters. The approach is specific to the location of the provider or supplier and considers the particular types of hazards most likely to occur in their area. Providers or suppliers are advised to consider care-related emergencies; equipment power failures; interruptions in communications, which may include cyberattacks; loss of a portion of a facility; and the interruption in the normal supply of essentials such as water and food.
- Policies and Procedures. This core element requires providers or suppliers develop and implement policies and procedures based on the emergency plan and the risk assessment. The policies and procedures must address a myriad of issues that include but are not limited to the provision of subsistence needs, alternate energy sources, and evacuating or sheltering in place.
- Communication Plan. This element requires facilities to develop a communication plan that complies with federal and state law. Patient care must be well-coordinated within the facility, across health care providers, and with state and local public health departments and emergency management agencies and systems to protect patient health in the event of a disaster.
- Training and Testing. The regulation requires providers or suppliers to develop and maintain training and testing program. This program must include both training on emergency procedures and participating in exercises to test the emergency plan at least on an annual basis.
The final rule lists 17 providers and suppliers that will have to comply with the new requirements, including Ambulatory Surgical Centers, Hospitals, Long Term Care—Skilled Nursing Facilities, Community Mental Health Centers, End-Stage Renal Disease Facilities, Hospices, Religious Nonmedical Health Care Institutions, Inpatient Psychiatric Services for Individuals Under 21 in Psychiatric Residential Treatment Facilities, Programs of All-Inclusive Care for the Elderly, Transplant Centers, and Intermediate Care Facilities for Individuals with Intellectual Disabilities.4
Finally, many facilities may need additional time to come into compliance. As such, the final rule will not be enforced or facilities will not be surveyed on the requirements until after the implementation deadline of November 15, 2017.
We would like to thank Priscilla Keith (Community Health Network Inc., Indianapolis, IN) for authoring this email alert. We also would like to thank Benjamin C. Fee (Dorsey & Whitney LLP, Des Moines, IA) and Neerja D. Razdan (University of Maryland Medical System, Baltimore, MD) for reviewing this email alert.
1 42 C.F.R. §§ 403, 416, 418, 441, 40, 482, 483, 484, 485, 48, 491, and 494.
2 78 Fed. Reg. 79082.
3 Supra note 1.