On September 16th 2016, CMS released a final rule which established national emergency preparedness requirements for Medicare and Medicaid participating providers to prepare and plan for disasters. CMS's goal is to ensure that the providers and suppliers are prepared during emergencies and disasters. CMS found that previous requirements did "not go far enough" to guarantee the safety of patients during emergencies.
This includes Rural Health Clinic regulations which have been significantly expanded as we will discuss below.
Implementation Date: November 15th 2017
While these regulations are currently effective, the implementation date is not until November 15th 2017 so RHCs have until then to comply.
The regulation changes the Rural Health Clinics requirements for "Emergency Procedures." The previous requirements on emergency preparedness at §491.6(c) have been eliminated and instead expanded into a new section §491.12.
The old regime required RHCs to prepare for emergencies via three provisions:
- Traing staff in handling emergencies;
- Placing exit signs in appropriate locations; and
- Taking other appropriate measures consistent with the conditions of the area where the clinic is located.
CMS has significantly expanded and refined these requirements. We strongly recommend that RHCs review section §491.12 in its entirety on the GPO's website.
Emergency Plan §491.12 (a)
The first step to creating an emergency preparedness plan is to create what CMS calls an "all hazards approach" to emergency preparedness. An "all-hazards approach" to emergency planning focuses on the preparedness of providers for a full range of emergencies. This could mean preparing for natural disasters or considering risks around the area of a RHCs. CMS leaves it up to RHCs to develop their own process for creating a risk assessment. However, CMS does expect that the participation of all staff including an administrator, physician, a nurse practitioner or physician assistance and a registered nurse to be involved in assessing the risk of the RHC.
The plan must include strategies for addressing emergency events identified by the risk assessments and identify what services the RHC would be able to provide during an emergency.
Finally, the emergency plan should include a process for cooperation with local, state and federal emergency preparedness officials in a case of an emergency. The regulations specify that the RHC should document attempts to contact such officials for certification purposes.
It is important to note, that unlike hospitals CMS did not require RHCs to have a system to track the location of staff and patients in the facility's care during and after emergency (although the regulations do seem to contradict themselves a bit in §491.12(c)(4). Furthermore, RHCs do not have to provide for basic subsistence needs for staff and patients.
Policies and Procedures §491.12 (b)
After an RHC creates an emergency plan, RHCs must then develop policies and procedures to address possible emergencies. RHCs must plan for safe evacuation from the RHC which includes the appropriate placement of exit signs and responsibilities of staff members.
There must be a way to shelter in place for people who remain in the facility. RHCs must also preserve their medical documentation. Finally RHCs must have a plan to use volunteers and other emergency personnel during an emergency.
Communication Plan §491.12 (c)
RHCs must develop and maintain an emergency preparedness communication plan. The plan should comply with federal and state laws and must be updated at least annually. The communication plan must include all relevant contact information and alternative means of communicating with staff and local emergency agencies.
The RHC must also have a way to provide information about the condition and location of the patients in the clinic at the time of the emergency. Finally, an RHC must have a way to indicate their needs and ability to provide assistance to the emergency authority.
Training and Testing §491.12 (d)
RHCs must develop and maintain a training and testing program based on the risk assessment, emergency plan and communication plan. This training program must include a documented initial training with all new and existing staff which is performed annually.
Furthermore, RHCs must test their emergency plan at least annually. CMS will consider a plan properly tested if the RHC performs and analyzes either two full scale community based exercises or one full scale community based exercise and a tabletop exercise.
Integrated healthcare systems §491.12 (e)
It is important to note that under this regulation there is an option to develop an emergency preparedness plan as an entire health system or independently as an RHC. If an RHC is part of a healthcare system it may elect to participate in the healthcare system's coordinated emergency preparedness program instead of creating their own.
CMS estimates that it will cost $6,016 per RHC to implement these emergency preparedness rules. The NARHC is concerned about the costs of complying with this rule, especially for those clinics subject to the RHC cap.
Trump Executive Orders
Finally, we would be remiss if we did not point out that these regulations were finalized under the Obama Administration and there is a possibility that the Trump Administration could revoke them.
President Trump issued two orders that may affect these regulations. The first is a Presidential memorandum which holds all new rules until a member of the Trump Administration approves the rule. Confusingly, the emergency preparedness rule is "effective" but not yet being implemented, so it is unclear if these regulations are affected by the regulatory freeze.
The second executive order which aims to reduce regulation and control regulatory costs directs the agencies to ensure that "the total incremental cost of all new regulations, including repealed regulations to be finalized" during fiscal year 2017 shall be no greater than zero. Because it will cost RHCs and other providers a significant amount of money to comply with the emergency preparedness rule, CMS must identify other regulatory burdens to eliminate with equal or greater compliance costs, which may prove difficult.
While it is feasible that the Trump Administration could find a way to revoke this emergency preparedness rule, it is also very possible that the Trump Administration decides to keep this rule in place. As such RHCs should be ready for the November 15th 2017 implementation date.