September 23, 2016
On September 16, CMS finalized a rule establishing emergency preparedness requirements applicable to seventeen types of providers and suppliers. The rule becomes effective November 15, 2016 and covered facilities must achieve compliance by November 15, 2017. The requirements incorporate as minimum standards “well known, industry best practice standards” of emergency preparedness, namely the following four components:
- Risk Assessment and Emergency Planning;
- Policies and Procedures; a
- Communication Plan; and a
- Training and Testing Program.
CMS cited a number of recent public emergencies and disasters that motivated an evaluation of existing preparedness requirements, including terrorist attacks; natural disasters such as hurricanes, floods, tornadoes, and wild fires; and diseases such as pandemic H1N1 flu, MERS, Ebola, and Enterovirus. CMS found its existing requirements insufficient to adequately promote the health and safety of “persons served by Medicare- and Medicaid-participating facilities” during such events. CMS also expressed intent to standardize preparedness protocols to reconcile the varying standards imposed by the accreditation bodies of certain categories of facilities.
Which Healthcare Organizations Must Abide by the New Requirements?
The new rule binds the following types of facilities: Religious Nonmedical Health Care Institutions; Ambulatory Surgical Centers; Hospices; Psychiatric Residential Treatment Facilities; Programs of All-Inclusive Care for the Elderly; Hospitals; Transplant Centers; Long-Term Care Facilities – Skilled Nursing Facilities; Intermediate Care Facilities for Individuals with Intellectual Disabilities; Home Health Agencies; Comprehensive Outpatient Rehabilitation Facilities; Critical Access Hospitals; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; Community Mental Health Centers; Organ Procurement Organizations; Rural Health Clinics and Federally Qualified Health Centers; End-Stage Renal Disease Facilities.
As used in the rule, the terms “emergency” and “disaster” do not refer exclusively to an event resulting in an official, public declaration of a state of emergency. Even an event confined within a single facility, such as a localized power failure or cybersecurity event, falls under the rule’s ambit.
The one exception to the rule’s requirement that each facility meet the new standards individually is that an integrated health system may develop a system-wide, unified emergency preparedness program with corresponding policies and procedures, communication plan, and training and testing program. Because compliance surveys occur at the facility level, however, each facility within the system must be capable of demonstrating (1) that it contributed to the program’s development and (2) its ability to implement the unified program and comply with the rule’s requirements.
The Four Components
Risk Assessment and Emergency Planning
Recognizing the diversity of emergency risks facing different healthcare facility categories, and even different facilities within each category, CMS has attempted to provide flexibility in applying the four required components. Each facility must conduct its preparedness planning according to the facility’s individual risk profile as determined by an “all-hazards risk assessment.” A satisfactory emergency preparedness plan under the rule will anticipate the “full spectrum of emergencies or disasters” to which the facility is most susceptible. Specifically, the rule requires that a facility considers the probability of dangers such as equipment failures and interruptions in water and power supplies. The risk assessment must also address the needs of the facility’s patient population. To accomplish this, the rule encourages but does not require “facilities…to confer with entities and resources that they consider appropriate,” such as individuals with disabilities, in creating the emergency plan.
Despite the flexibility permitted in developing an emergency plan, the rule makes clear that CMS surveyors will assess whether a facility satisfactorily “based its emergency preparedness plan on facility-based and community-based risk assessments using an all-hazards approach.”
Policies and Procedures
The rule does not provide significant guidance regarding the formulation of policies and procedures except that they are intended to facilitate execution of the emergency plan.
The communication plan is to include methods to preserve coordination of patient care during an emergency (1) within the facility, (2) with providers at other facilities, and (3) with federal, state, tribal, regional, and local public health and emergency agencies such that “patient care functions…are carried out in a safe and effective manner.” Facilities should be aware that this component of the rule requires compliance with pertinent state law.
Training and Testing Program
A facility’s training and testing program must include initial testing for existing and new staff and other care providers, as well as annual refresher trainings. In some circumstances, such as those involving hospitals, the rule treats staff, volunteers, and contracted care providers as separate types of personnel, but it does not differentiate between them as regards their responsibilities during an emergency: “training should be provided consistent with facility [personnel’s] expected roles” during an emergency. This component has two purposes: to ensure personnel understand emergency policies and procedures, and to test the emergency plan for needed improvements.
Preexisting Policies and Procedures, Communication Plans, Training and Testing Programs
While CMS cautions that facilities with preexisting preparedness plans “will be required to develop and maintain an emergency preparedness plan based on an all-hazards approach,” the rule does not explicitly proscribe the preservation of existing policies and procedures, communication plans, and training and testing programs, so long as they support an emergency preparedness plan that satisfies the minimum standards required by the rule.
Facilities’ responsibilities that did not predate the new rule include requirements for coordination with broader care and emergency systems, such as state or local governments; documented contingency planning; and training of facility staff and other personnel.
To the extent that some of a facility’s risks are linked to factors shared with other facilities – e.g. location in or proximity to a flood-prone area – CMS encourages facilities to form coalitions for assistance in satisfying the new rule’s requirements.
Covered facilities should take immediate steps to ensure compliance with this new rule. While the rule’s implementation date is a little more than a year away, conducting risk assessments and developing policies, procedures, and training programs can be time intensive. If you have any questions about compliance with this rule or require assistance complying with the rule, please contact a member of HDJN’s Compliance Team.
The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel, Johnson & Nagle, PC, is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel, Johnson & Nagle, PC be liable for any direct, indirect, or consequential damages resulting from the use of this material.