This federal CMS emergency preparedness regulation requires healthcare facilities to develop and implement policies and procedures addressing their role in providing care at alternate care sites (ACS) under Section 1135 waivers declared during public health emergencies. Facilities must document how they will coordinate with state and local emergency management officials regarding staffing, equipment, and supplies at alternate sites. Policies must also address operations when a waiver has not been declared and planning for returning to full compliance when a waiver expires. These policies and procedures must be reviewed and updated at least every two years (annually for long-term care facilities).
View official sourceE-0026 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(b)(8), §416.54(b)(6), §418.113(b)(6)(C)(iv), §441.184(b)(8), §460.84(b)(9), §482.15(b)(8), §483.73(b)(8), §483.475(b)(8), §485.625(b)(8), §485.920(b)(7) §494.62(b)(7). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (8) [(6), (6)(C)(iv), (7), or (9)] The role of the [facility] under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. *[For RNHCIs at §403.748(b):] Policies and procedures. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternative care site identified by emergency management officials. Interpretive Guidelines applies to: §403.748(b)(8), §416.54(b)(6), §418.113(b)(6)(C)(iv), §441.184(b)(8), §460.84(b)(9), §482.15(b)(8), §483.73(b)(8), §483.475(b)(8), §485.625(b)(8), §485.920(b)(7), §494.62(b)(7) NOTE: This does not apply to Transplant Programs, HHAs, CORFs, Clinics, Rehabilitation Agencies and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, OPOs, RHCs/FQHCs. General The facility’s emergency preparedness program must include policies and procedures which outline the facility’s role in the provision of care and treatment under section 1135 waivers during a declared public health emergency in alternate care sites. Facilities should also be aware of what flexibilities are exercised with or without an 1135 waiver. Alternate Care Sites (ACS) ACS is a broad term for any building or structure that is temporarily converted for healthcare use. ACS’s are one of several alternate care strategies that can be used in a disaster. A facility’s individual ACS structure and process may include several different models and require different planning considerations based on the type of emergency. Models for a facility’s ACS may be dependent on factors such as: emergency/disaster spread across a community; anticipated longevity of operating in the ACS setting; level of capacity the ACS can provide and how this correlates with the need for transfers and discharge, among many other considerations. The requirement under the emergency program is that facilities must develop and implement policies and procedures which describe the facility’s role in providing care at an ACS during emergencies. It is expected that state or local emergency management officials might designate such ACS’s, and would plan jointly with local facilities on issues related to staffing, equipment and supplies at such alternate sites. This requirement encourages providers to collaborate with their local emergency officials in such proactive planning to allow an organized and systematic response to assure continuity of care even when services at their facilities have been severely disrupted. Planning related to the development of ACS is a proactive step to ensuring continuity of services. While the establishment and use of ACS are generally only acceptable during an emergency and require CMS approval, the facility’s program must address the facility’s ability to provide care in an alternate setting. Considerations may include patient population, supplies, equipment, and staffing as well as physical environment. Planning considerations also include the capabilities of an ACS if authorized during a declared public health emergency. Section 1135 Emergency Waiver Policies and procedures must specifically address the facility’s role in emergencies where the Secretary waives or modifies certain statutory and regulatory requirements for healthcare facilities in response to emergencies under section 1135 of the Act related to the provision of care at an alternate care site identified by emergency officials. The Secretary is authorized to issue a section 1135 waiver only when both the President declares a disaster or emergency under the Stafford Act or the National Emergencies Act, and the HHS Secretary declares a Public Health Emergency under section 319 of the Public Health Services Act. Examples of 1135 waivers issued during prior emergencies have included waivers of various CoPs and CfCs; Licensure for Physicians or others to provide services in the affected State; EMTALA requirements; and Medicare Advantage out of network providers and HIPAA. Facilities’ policies and procedures should address what coordination efforts are required during a declared emergency in which a waiver of federal requirements under section 1135 of the Act has been issued by the Secretary related to alternate care sites. For example, due to a mass casualty incident in a geographic location, the Secretary may waive licensure requirements for physicians in order for these individuals to assist at a specific facility where they do not normally practice. In such cases, the provider or supplier should have policies and procedures which address the responsibilities of these physicians during this waiver period. The policies may establish, for example, a lead person in charge for accountability and oversight of assisting physicians not usually under contract with the facility. Waivers issued under section 1135 of the Act are time-limited, and waives only federal requirements, not state requirements for licensure or conditions of participation. The purpose of section 1135 waivers are to ensure that sufficient health care items and services are available to meet the needs of the individuals in such areas. They are also intended to ensure healthcare providers (defined in section 1135(g)(2) of the Act) that can furnish such items or services in good faith, but are unable to comply with federal requirements, are allowed reimbursement during an emergency or disaster even if providers can’t comply with certain requirements that would under normal circumstances bar Medicare, Medicaid or CHIP payment. Section 1135 waivers typically end no later than the termination of the emergency period, or 60 days from the date the waiver or modification is first published unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period. Facilities should also have in place policies and procedures which address emergency situations in which a declaration was not made and where an 1135 waiver may not be applicable, such as during a disaster affecting the single facility. In this case, policies and procedures should address potential transfers of patients; timelines of patients at alternate facilities, etc. We would expect that state or local emergency management officials might designate such alternate sites, and would plan jointly with local facilities on issues related to staffing, equipment and supplies at such alternate sites. This requirement encourages providers to collaborate with their local emergency officials in proactive planning to allow an organized and systematic response to assure continuity of care even when services at their facilities have been severely disrupted. Health department and emergency management officials, in collaboration with facility staff, would be responsible for determining the need to establish an alternate care site as part of the delivery of care during an emergency. The alternate care site staff would be expected to function in the capacity of their individual licensure and best practice requirements and laws. Decisions regarding staff responsibilities would be determined based on the facility- and community based assessments and the type of services staff could provide (81 FR at 63882). These elements should be included in the facilities policy and procedure under this standard. During emergencies such as a widespread pandemic, a PHE may continue for a longer period of time than initially anticipated. In the event a facility is operating under a Section 1135 Waiver, including a potential blanket waiver, facilities should also consider their policies and procedures related to the use of the waiver flexibility and timeframe. While facilities are authorized to use an Section 1135 waiver during the duration of the PHE, in accordance with state emergency and pandemic plans, it may be prudent for facilities to consider how to continue operations when the 1135 Waiver has expired (end of the declared PHE) as facilities are expected to come back into full compliance at the end of the declared emergency. For instance, in the event a pandemic PHE or EID has decreased in a specific community (as generally outlined by CDC), the facility may no longer need the flexibility provided in an 1135 waiver. Therefore, the facility should consider not using or forgoing the waiver and ensuring it is back in substantial compliance with the specific requirement(s) waived even while the PHE may continue. The intent behind an 1135 waiver is to provide relief and flexibilities while the facility is directly impacted or challenged with meeting the Medicare requirement(s). For additional information on 1135 waivers and process for submission please visit the Quality, Safety & Oversight Group Emergency Preparedness Website https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/SurveyCertEmergPrep/1135-Waivers . We also recommend providers and suppliers review the ACS Toolkit developed by ASPR which can be found at: https://files.asprtracie.hhs.gov/documents/acs-toolkit-ed1-20200330-1022.pdf. Survey Procedures • Verify the facility has included policies and procedures in its emergency plan describing the facility’s role in providing care and treatment (except for RNHCI, for care only) at alternate care sites under an 1135 waiver. NOTE: This policy and procedure requirement does not require a facility to have an 1135 waiver on hand at the time of the survey as such waivers are established or granted by CMS only during a declared emergency period. Section 1135 waivers by nature are time limited.