CMS SOM App. Z, Tag E-0026

§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.