CENTERS FOR MEDICARE AND MEDICAID SERVICES EMERGENCY PREPAREDNESS RULE

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15.1 Summary

In 2016, the Centers for Medicare and Medicaid Services (CMS) published a Final Rule entitled “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” (CMS Emergency Preparedness Rule), which established national emergency preparedness requirements for participating providers and certified suppliers (hereinafter referred to as facilities) to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. The regulation became effective on November 16, 2016, with compliance required on November 15, 2017. Thus, healthcare systems must be involved in emergency preparedness, response, and recovery activities.

The CMS Emergency Preparedness Rule applies to 17 categories of Medicare and Medicaid providers and suppliers as Conditions of Participation and Conditions for Coverage for CMS. Providers and suppliers must meet four mandated core elements: (1) risk assessment and emergency plan; (2) policies and procedures; (3) communication plan; and (4) training and testing. In addition, the CMS Emergency Preparedness Rule includes specific requirements that vary based on provider or supplier type.

15.2 National Emergency Preparedness Requirements

The Centers for Medicare and Medicaid Services (CMS) promulgated the “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” Final Rule (CMS Emergency Preparedness Rule), to establish national emergency preparedness requirements for facilities to plan adequately for disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. These national requirements are designed to assist facilities with adequately preparing to meet the needs of patients, clients, residents, and participants during disasters and emergencies, and also provide consistent requirements across types of facilities.

The goals of the CMS Emergency Preparedness Rule are to:

  • Safeguard human resources, maintain business continuity, and protect physical resources;
  • Establish consistent emergency preparedness requirements across facilities; and
  • Establish a more coordinated response to natural and man-made disasters.

A number of resources are available to assist facilities with complying with the CMS Emergency Preparedness Rule, including https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Emergency-Prep-Rule.html and https://asprtracie.hhs.gov/cmsrule.

On September 20, 2018, CMS issued a proposed rule to revise the applicable conditions of participation for facilities and conditions for coverage as part of its efforts to reduce regulatory burden in accordance with Executive Order 13771 “Reducing Regulation and Controlling Regulatory Costs” (January 30, 2017). Significant changes to the CMS Emergency Preparedness Rule were proposed, including changing the required updates and training to be every two years rather than annually. Specific changes by facility type were also proposed. The proposed changes are designed to “simplify the emergency preparedness requirements, eliminate duplicative requirements, and/or reduce the frequency with which providers and suppliers would need to perform certain required activities.”

15.3 Applicable Facilities

The CMS Emergency Preparedness Rule applies to 17 categories of Medicare and Medicaid facilities. Eight are inpatient facilities:

  • Hospitals
  • Critical access hospitals
  • Religious nonmedical healthcare institutions
  • Psychiatric residential treatment facilities
  • Long-term care facilities
  • Intermediate care facilities for individuals with intellectual disabilities
  • Hospices
  • Transplant centers

Ten facilities are outpatient facilities:

  • Ambulatory surgical centers
  • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services
  • Community mental health centers
  • Comprehensive outpatient rehabilitation facilities
  • End-stage renal disease facilities
  • Rural health clinics and federally qualified health centers
  • Home health agencies
  • Hospices (hospices are also considered inpatient facilities so are listed twice)
  • Organ procurement organizations
  • Programs of all-inclusive care for the elderly

Table 2a. Affected Provider and Supplier Types (updated January 24, 2018)

Inpatient Facility Type Final Rule Reference
Critical Access Hospitals Section II. N
Hospices Section II. F
Hospitals Section II. C
Intermediate Care Facilities for Individuals with Intellectual Disabilities Section II. D
Long Term Care Section II. J
Psychiatric Residential Treatment Facilities Section II. G
Religious Nonmedical Healthcare Institutions Section II. D
Transplant Centers Section II. I

Table 2b. Affected Provider and Supplier Types (updated January 24, 2018)

Outpatient Facility Type Final Rule Reference
Ambulatory Surgical Centers Section II. E
Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services Section II. O
Community Mental Health Centers Section II. P
Comprehensive Outpatient Rehabilitation Facilities Section II. M
End-Stage Renal Disease Facilities Section II. S
Home Health Agencies Section II. L
Hospices Section II. F
Organ Procurement Organizations Section II. Q
Programs of All Inclusive Care for the Elderly Section II. H
Rural Health Clinics and Federally Qualified Health Centers Section II. R

Tables reproduced from CMS and Disasters: Resources at Your Fingertips https://asprtracie.s3.amazonaws.com/documents/cms-and-disasters-resources-at-your-fingertips.pdf.

Each facility has its own set of emergency preparedness regulations incorporated into its Conditions of Participation (CoP) and Conditions for Coverage (CfC).

CMS develops CoPs and CfCs that healthcare organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs. These health and safety standards are the foundation for improving quality and protecting the health and safety of Medicare and Medicaid beneficiaries. More information about CoPs and CfCs can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs.

15.4 Four Mandated Elements

The CMS Emergency Preparedness Rule includes four mandated core elements, with specific requirements that vary based on type of facility:

  • Risk assessment and emergency planning;
  • Policies and procedures;
  • Communications plan; and
  • Training and testing.

Specific requirements for each type of facility is beyond the scope of the Manual. CMS created a table that provides an overview of the CMS Emergency Preparedness Rule by provider type, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/EP-Rule-Table-Provider-Type.pdf.

15.4.1    Risk Assessment and Emergency Plan

Each facility must develop an emergency plan based upon a facility and community-based risk assessment using an “all-hazards” approach that provides an integrated system for emergency planning focused on capacities and capabilities. The emergency plan should be reviewed and updated at least annually. The risk assessment should include:

  • Hazards likely in geographic area;
  • Care-related emergencies;
  • Equipment and power failures;
  • Interruption in communications, including cyber-attacks;
  • Loss of all or a portion of facility; and
  • Loss of all or a portion of supplies.

See, e.g., CMS Core Emergency Preparedness Rule Elements

15.4.2    Policies and Procedures 

Each facility must develop and implement policies and procedures based upon the emergency plan and risk assessment that are reviewed and updated at least annually. Policies and procedures must comply with federal and state laws and address a range of issues, which may include subsistence needs, evacuation plans, sheltering in place, and tracking patients and staff during an emergency.

See, e.g., CMS Core Emergency Preparedness Rule Elements

15.4.3    Communication Plan

Each facility must develop and maintain an emergency preparedness communication plan that complies with federal, state, and local laws and provides a system to contact staff, including patients’ physicians and other necessary persons. Patient care must be coordinated within the facility, across healthcare providers, and with state and local public health departments and emergency management systems to protect patient health and safety in the event of a disaster. The communication plan should be reviewed and updated annually.

See, e.g., CMS Core Emergency Preparedness Rule Elements

15.4.4    Training and Testing 

Each facility must develop and maintain training and testing programs, including initial training in policies and procedures, which comply with federal, state, and local laws. Facility staff must demonstrate knowledge of emergency procedures and be provided with training at least annually. Facilities must conduct drills and exercises to test the emergency plan or participate in an actual incident that tests the plan. The training and testing program should be reviewed and updated annually. See, e.g., CMS Core Emergency Preparedness Rule Elements

15.5 Enforcement and Penalties for Non-Compliance

State survey agencies are responsible for evaluating compliance with the CMS Emergency Preparedness Rule. If a facility is found to be non-compliant with the requirements of the CMS Emergency Preparedness Rule, state survey agencies will follow the same process regarding noncompliance as with any other CoP and CfC. Non-compliance with CMS Emergency Preparedness Rule requirements may lead to termination of the facility’s participation agreement with CMS. See https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-29.pdf.These surveys are initiated in conjunction with regularly scheduled survey cycles.

15.6 Section 1135 Waivers and the CMS Emergency Preparedness Rule

Under section 1135 of the Social Security Act (SSA), the United States Secretary of Health and Human Services (HHS Secretary) may temporarily waive or modify certain federal requirements to ensure that sufficient healthcare items and services are available to meet the needs of individuals enrolled in SSA programs in the emergency area and during the emergency time (absent any determination of fraud or abuse).

Under the CMS Emergency Preparedness Rule, inpatient facilities are required to have policies and procedures in place to address the facility’s role in a section 1135 waiver in the provision of care and treatment at an alternate care site identified by emergency management officials. See, e.g., 42 C.F.R. § 482.15(b)(8).

Additional information regarding section 1135 waivers, including required elements, can be found at section 4.3 of the Manual and https://www.phe.gov/Preparedness/legal/Pages/1135-waivers.aspx.



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