On Dec. 27, 2013, CMS released a Proposed Rule that would establish national emergency preparedness requirements for 17 different types of Medicare- and Medicaid-participating providers and suppliers (including, among others, hospitals, ambulatory surgical centers, hospices, long-term care facilities, home health agencies, critical access hospitals, organ procurement organizations and End Stage Renal Disease (ESRD) facilities) to ensure that they adequately plan for natural and man-made disasters, and coordinate with federal, state, tribal, regional and local emergency systems. These requirements are intended to help providers and suppliers establish a comprehensive regulatory approach to emergency preparedness and response that ensures continuity of care. This client alert is the first in a three-part series that will discuss the Proposed Rule’s application to ESRD facilities (including outpatient dialysis and home dialysis training programs), hospitals (including LTCHs) and ambulatory surgery centers.

The Proposed Rule would add additional requirements to the Conditions for Coverage for ESRD facilities and relocate the emergency preparedness Conditions for Coverage requirement established in the April 2008 Final Rule “Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule.” Below is an overview of the Proposed Rule’s requirements for ESRD facilities. Comments on the Proposed Rule are due by Feb. 25, 2014.

  1. Emergency Plan. ESRD facilities must develop and maintain an emergency preparedness plan based on a facility-based and community-based risk assessment utilizing an “All-Hazards Approach.” The All-Hazards Approach focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters. The Plan must include strategies for addressing emergency events identified in the risk assessment, the needs of the patient population and the process for ensuring cooperation and collaboration with all levels of government emergency response agencies. The plan must be reviewed annually.
  2. Policies and Procedures. The Proposed Rule requires ESRD facilities to, at a minimum, develop policies and procedures addressing the following emergency preparedness and response topics:
    1. Patient and staff tracking during and after an emergency;
    2. Safe evacuation from the ESRD facility;
    3. Shelter-in-place requirements;
    4. Medical records documentation, availability and confidentiality;
    5. The use of volunteers in an emergency;
    6. Backup arrangements with other dialysis facilities and providers to receive patients;
    7. Role of the ESRD facility under a Section 1135 waiver in the provision of care and treatment at an alternate care site. A Section 1135 waiver allows the Secretary of Health and Human Services (HHS) to temporarily waive or modify requirements to ensure that sufficient healthcare items and services are available to meet the needs of individuals in an emergency area, and that providers who provide such services in good faith can be reimbursed and exempted from sanctions; and
    8. Processes for ensuring that emergency medical system assistance and emergency equipment can be obtained when needed.
  3. Communication Plan. The Proposed Rule requires ESRD facilities to develop and maintain an emergency preparedness communication plan that includes contact information for staff, patients, other facilities and emergency response groups. The communication plan must also describe how protected health information will be shared in a HIPAA-compliant manner during and after the emergency.
  4. Training, Testing and Patient Orientation. The Proposed Rule requires ESRD facilities to perform and document annual employee training on emergency procedures and requires annual mock disaster drills. Lastly, patients at ESRD facilities must receive orientation and training on emergency procedures, including: what to do in case of an emergency, where to go to evacuate during an emergency or to receive emergency dialysis, whom to contact in case of an emergency and how to disconnect themselves from their dialysis machines in case of an emergency.
  5. ESRD Networks. Current regulations require ESRD facilities to be organized into ESRD Network areas. However, CMS did not propose to incorporate the ESRD Network requirements into the Proposed Rule.

Once CMS issues its Final Rule on emergency preparedness later this year it is anticipated that ESRD facilities will need to implement new, or modify existing, disaster preparedness procedures. Please contact one of the authors below if you have any questions regarding the Proposed Rule or if you are interested in commenting on the Proposed Rule by the Feb. 25, 2014, deadline.