The Centers for Medicare & Medicaid Services (CMS) has released a long-awaited final rule establishing emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they can meet the needs of patients and residents during emergency situations, both natural and man-made. According to CMS, the final requirements “establish a 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.” CMS projects that compliance with the rule will cost $373 million in the first year, with subsequent annual costs of approximately $25 million.

The new requirements apply to 17 provider types (with certain variations): hospitals; critical access hospitals (CAHs); long-term care (LTC) facilities; psychiatric residential treatment facilities; intermediate care facilities for individuals with intellectual disabilities; religious nonmedical health care institutions; transplant centers; hospices, ambulatory surgical centers, Program for the All-inclusive Care for the Elderly (PACE) organizations; home health agencies; comprehensive outpatient rehabilitation facilities; community mental health centers; organ procurement organizations; clinics, rehabilitation, and therapy providers; rural health clinics/federally qualified health clinics; and end-stage renal disease providers.

The sweeping final rule (the advance version spans 651 pages) covers four aspects of emergency preparedness:

  • Risk assessment and planning: Providers and suppliers must perform a risk assessment using an “all-hazards” approach focusing on capabilities needed to prepare for a full spectrum of emergencies. This approach is location-specific and considers the types of hazards most likely to occur in a provider or supplier’s area (e.g., equipment and power failures, interruptions in communications, and interruptions in the normal supply of essentials, such as food and water).
  • Policies and procedures: Providers must develop and implement policies and procedures to support successful execution of their emergency plan and issues identified in their risk assessment.
  • Communication plan: Providers must develop and maintain an emergency preparedness communication plan that complies with both 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 systems.
  • Training and testing: Providers must develop and maintain emergency preparedness training and testing programs, including initial and annual training and emergency drills to identify gaps and areas for improvement.

In response to public comments on the proposed rule, CMS adopted a number of changes in the final rule. For instance,

  • CMS is removing a requirement that certain facilities track all staff and patients after an emergency, and clarifying requirements for documenting the location of on-duty staff and sheltered patients that are relocated during an emergency.
  • CMS is revising testing requirements to allow certain facilities to choose the type of exercise they must conduct to meet the second annual testing requirement.
  • For hospitals, CAHs, and LTC facilities, CMS is revising emergency and standby power system requirements by removing the requirement for an additional four hours of generator testing and removing the requirement that a facility must maintain fuel onsite.
  • For all provider and supplier types, CMS will allow a separately certified health care facility within a health care system to elect to be a part of the healthcare systems unified emergency preparedness program.

The rule is scheduled to be published on September 16, 2016. The rule is effective 60 days after publication, and affected providers and suppliers must comply with the regulations one year from the publication date (i.e., by November 15, 2017).