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CMS Releases Proposed Emergency Preparedness CoP Regulations

Hospitals and other providers should be aware of imminent changes to the Medicare Conditions of Participation (CoP) which will add new emergency preparedness requirements. The proposed rule requires an all-hazards risk assessment, a comprehensive emergency preparedness plan, and numerous policies and procedures on significant operational issues that may arise in emergencies. Further, annual training and testing of a provider’s emergency preparedness will be required as well.

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. 78 Fed.Reg. 79082 (December 27, 2013). Hospitals are a significant focus, because CMS recognizes that “hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.”[1] However, the proposed regulations also add emergency preparedness requirements to the CoPs or Conditions for Coverage (CfC) for sixteen other provider/supplier types, as CMS works to bring a more uniform and consistent approach to emergency preparedness. Those include:

  • Ambulatory Surgical Centers (ASCs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • End-Stage Renal Disease (ESRD) Facilities
  • Federally Qualified Health Centers (FQHCs)
  • Home Health Agencies (HHAs)
  • Hospices
  • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)
  • Long Term Care (LTC) Facilities
  • Organ Procurement Organizations (OPOs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Rural Health Clinics (RHCs)
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)Transplant Centers

 

Background


CMS conducted an extensive review of the current state of emergency preparedness,[2] mindful of the challenges presented to the United States in recent years by the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012. The result: CMS determined that the current emergency preparedness regulatory requirements are not sufficiently comprehensive or sufficiently uniform to ensure readiness for public health emergencies.

CMS acknowledges that many hospitals already have an emergency preparedness program, and those programs have been steadily becoming more comprehensive. For example, some areas have formed community-wide coalitions where public and private entities work together to prepare for emergencies. The Proposed Rule is intended to address the need for greater uniformity and cohesiveness across the country. CMS directs that the implementation of an emergency preparedness program should have four core elements: (1) risk assessment and planning, (2) policies and procedures, (3) communication plan, and (4) training and testing.[3] CMS begins with an extensive discussion of the new hospital CoPs, explaining that it serves as a framework on which the other CoPs and CfCs are based. A discussion follows which explains how those hospital requirements are modified for each provider/supplier type.

The Proposed CoP Changes for Hospitals

The new, proposed hospital CoP requirements, at 42 C.F.R. §482.15, mandate that hospitals have an emergency preparedness program and emergency preparedness plan which includes the following key components.

All-Hazards Risk Assessment, §485.15(a). A hospital must develop an emergency plan based on a community–based, all hazards, risk assessment. This approach focuses on developing capabilities for a broad range of disasters, rather than concentrating on one particular threat. To assist, CMS provides a citation to the fifteen all hazards National Planning Scenarios, which range from pandemic flu to a major earthquake or hurricane to a nuclear or terrorist attack. CMS also provides information about and links to various publications to assist hospitals in developing and conducting an all-hazards risk assessment, for example, guidance from agencies such as the Federal Emergency Management Agency (FEMA) and the Agency for Healthcare Research (ARHQ).[4] This risk assessment must include the identification of essential business functions that the hospital should continue, emergencies the hospital reasonably expects to confront, and contingencies for which the hospital should plan. Further, it should address the hospital’s location, any natural or man-made emergencies that may cause it to cease or limit operations, and a determination of whether arrangements with other entities are needed to ensure that essential services can be provided. The assessment must consider the patient population such as the elderly, children, pregnant women, non-English speaking persons, and those with chronic medical disorders or a lack of transportation.

Emergency Plan, §485.15(a). A hospital must develop a plan based upon the all hazards risk assessment. The plan must: (1) be based on and include the documented, risk assessment, (2) include strategies to address the emergency events identified by the risk assessment, (3) address the hospital’s patient population including at-risk persons, the type of services the hospital can provide in an emergency, and continuity of operations, and (4) include a process to ensure collaboration with the efforts of local, tribal, regional, state, and federal emergency preparedness officials, including documentation of the hospital’s efforts to contact those officials and of its participation in collaborative planning efforts. CMS provides citations to ten different “Emergency Planning Resources” to assist hospitals in developing an emergency plan. For instance, a hospital can look to HRSA’s “Health Care Center Emergency Management Program Expectations"; The Joint Commission’s “Standing Together: An Emergency Planning Guide For America's Communities”; or “Providing Mass Medical Care With Scarce Resources: A Community Planning Guide" by the ARHQ. CMS encourages providers to work with critical partners such as emergency management, public health, and other providers, noting the importance of a community’s Healthcare Coalition in addressing emergencies, sharing resources and ensuring healthcare resiliency. The hospital’s emergency preparedness plan must be reviewed and updated at least annually.

Policies & Procedures, §485.15(b). Hospitals must develop and maintain policies and procedures in accordance with their emergency plan and communications plan (discussed below). These must be reviewed and updated annually. CMS provides a list of mandatory elements:

Hospitals and other providers should be aware of imminent changes to the Medicare Conditions of Participation (CoP) which will add new emergency preparedness requirements. The proposed rule requires an all-hazards risk assessment, a comprehensive emergency preparedness plan, and numerous policies and procedures on significant operational issues that may arise in emergencies. Further, annual training and testing of a provider’s emergency preparedness will be required as well.

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. 78 Fed.Reg. 79082 (December 27, 2013). Hospitals are a significant focus, because CMS recognizes that “hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.”[1] However, the proposed regulations also add emergency preparedness requirements to the CoPs or Conditions for Coverage (CfC) for sixteen other provider/supplier types, as CMS works to bring a more uniform and consistent approach to emergency preparedness. Those include:

  • Ambulatory Surgical Centers (ASCs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • End-Stage Renal Disease (ESRD) Facilities
  • Federally Qualified Health Centers (FQHCs)
  • Home Health Agencies (HHAs)
  • Hospices
  • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)
  • Long Term Care (LTC) Facilities
  • Organ Procurement Organizations (OPOs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Rural Health Clinics (RHCs)
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)Transplant Centers

 

Background


CMS conducted an extensive review of the current state of emergency preparedness,[2] mindful of the challenges presented to the United States in recent years by the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012. The result: CMS determined that the current emergency preparedness regulatory requirements are not sufficiently comprehensive or sufficiently uniform to ensure readiness for public health emergencies.

CMS acknowledges that many hospitals already have an emergency preparedness program, and those programs have been steadily becoming more comprehensive. For example, some areas have formed community-wide coalitions where public and private entities work together to prepare for emergencies. The Proposed Rule is intended to address the need for greater uniformity and cohesiveness across the country. CMS directs that the implementation of an emergency preparedness program should have four core elements: (1) risk assessment and planning, (2) policies and procedures, (3) communication plan, and (4) training and testing.[3] CMS begins with an extensive discussion of the new hospital CoPs, explaining that it serves as a framework on which the other CoPs and CfCs are based. A discussion follows which explains how those hospital requirements are modified for each provider/supplier type.

The Proposed CoP Changes for Hospitals

The new, proposed hospital CoP requirements, at 42 C.F.R. §482.15, mandate that hospitals have an emergency preparedness program and emergency preparedness plan which includes the following key components.

All-Hazards Risk Assessment, §485.15(a). A hospital must develop an emergency plan based on a community–based, all hazards, risk assessment. This approach focuses on developing capabilities for a broad range of disasters, rather than concentrating on one particular threat. To assist, CMS provides a citation to the fifteen all hazards National Planning Scenarios, which range from pandemic flu to a major earthquake or hurricane to a nuclear or terrorist attack. CMS also provides information about and links to various publications to assist hospitals in developing and conducting an all-hazards risk assessment, for example, guidance from agencies such as the Federal Emergency Management Agency (FEMA) and the Agency for Healthcare Research (ARHQ).[4] This risk assessment must include the identification of essential business functions that the hospital should continue, emergencies the hospital reasonably expects to confront, and contingencies for which the hospital should plan. Further, it should address the hospital’s location, any natural or man-made emergencies that may cause it to cease or limit operations, and a determination of whether arrangements with other entities are needed to ensure that essential services can be provided. The assessment must consider the patient population such as the elderly, children, pregnant women, non-English speaking persons, and those with chronic medical disorders or a lack of transportation.

Emergency Plan, §485.15(a). A hospital must develop a plan based upon the all hazards risk assessment. The plan must: (1) be based on and include the documented, risk assessment, (2) include strategies to address the emergency events identified by the risk assessment, (3) address the hospital’s patient population including at-risk persons, the type of services the hospital can provide in an emergency, and continuity of operations, and (4) include a process to ensure collaboration with the efforts of local, tribal, regional, state, and federal emergency preparedness officials, including documentation of the hospital’s efforts to contact those officials and of its participation in collaborative planning efforts. CMS provides citations to ten different “Emergency Planning Resources” to assist hospitals in developing an emergency plan. For instance, a hospital can look to HRSA’s “Health Care Center Emergency Management Program Expectations"; The Joint Commission’s “Standing Together: An Emergency Planning Guide For America's Communities”; or “Providing Mass Medical Care With Scarce Resources: A Community Planning Guide" by the ARHQ. CMS encourages providers to work with critical partners such as emergency management, public health, and other providers, noting the importance of a community’s Healthcare Coalition in addressing emergencies, sharing resources and ensuring healthcare resiliency. The hospital’s emergency preparedness plan must be reviewed and updated at least annually.

Policies & Procedures, §485.15(b). Hospitals must develop and maintain policies and procedures in accordance with their emergency plan and communications plan (discussed below). These must be reviewed and updated annually. CMS provides a list of mandatory elements:

Hospitals and other providers should be aware of imminent changes to the Medicare Conditions of Participation (CoP) which will add new emergency preparedness requirements. The proposed rule requires an all-hazards risk assessment, a comprehensive emergency preparedness plan, and numerous policies and procedures on significant operational issues that may arise in emergencies. Further, annual training and testing of a provider’s emergency preparedness will be required as well.

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. 78 Fed.Reg. 79082 (December 27, 2013). Hospitals are a significant focus, because CMS recognizes that “hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.”[1] However, the proposed regulations also add emergency preparedness requirements to the CoPs or Conditions for Coverage (CfC) for sixteen other provider/supplier types, as CMS works to bring a more uniform and consistent approach to emergency preparedness. Those include:

  • Ambulatory Surgical Centers (ASCs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • End-Stage Renal Disease (ESRD) Facilities
  • Federally Qualified Health Centers (FQHCs)
  • Home Health Agencies (HHAs)
  • Hospices
  • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)
  • Long Term Care (LTC) Facilities
  • Organ Procurement Organizations (OPOs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Rural Health Clinics (RHCs)
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)Transplant Centers

 

Background


CMS conducted an extensive review of the current state of emergency preparedness,[2] mindful of the challenges presented to the United States in recent years by the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012. The result: CMS determined that the current emergency preparedness regulatory requirements are not sufficiently comprehensive or sufficiently uniform to ensure readiness for public health emergencies.

CMS acknowledges that many hospitals already have an emergency preparedness program, and those programs have been steadily becoming more comprehensive. For example, some areas have formed community-wide coalitions where public and private entities work together to prepare for emergencies. The Proposed Rule is intended to address the need for greater uniformity and cohesiveness across the country. CMS directs that the implementation of an emergency preparedness program should have four core elements: (1) risk assessment and planning, (2) policies and procedures, (3) communication plan, and (4) training and testing.[3] CMS begins with an extensive discussion of the new hospital CoPs, explaining that it serves as a framework on which the other CoPs and CfCs are based. A discussion follows which explains how those hospital requirements are modified for each provider/supplier type.

The Proposed CoP Changes for Hospitals

The new, proposed hospital CoP requirements, at 42 C.F.R. §482.15, mandate that hospitals have an emergency preparedness program and emergency preparedness plan which includes the following key components.

All-Hazards Risk Assessment, §485.15(a). A hospital must develop an emergency plan based on a community–based, all hazards, risk assessment. This approach focuses on developing capabilities for a broad range of disasters, rather than concentrating on one particular threat. To assist, CMS provides a citation to the fifteen all hazards National Planning Scenarios, which range from pandemic flu to a major earthquake or hurricane to a nuclear or terrorist attack. CMS also provides information about and links to various publications to assist hospitals in developing and conducting an all-hazards risk assessment, for example, guidance from agencies such as the Federal Emergency Management Agency (FEMA) and the Agency for Healthcare Research (ARHQ).[4] This risk assessment must include the identification of essential business functions that the hospital should continue, emergencies the hospital reasonably expects to confront, and contingencies for which the hospital should plan. Further, it should address the hospital’s location, any natural or man-made emergencies that may cause it to cease or limit operations, and a determination of whether arrangements with other entities are needed to ensure that essential services can be provided. The assessment must consider the patient population such as the elderly, children, pregnant women, non-English speaking persons, and those with chronic medical disorders or a lack of transportation.

Emergency Plan, §485.15(a). A hospital must develop a plan based upon the all hazards risk assessment. The plan must: (1) be based on and include the documented, risk assessment, (2) include strategies to address the emergency events identified by the risk assessment, (3) address the hospital’s patient population including at-risk persons, the type of services the hospital can provide in an emergency, and continuity of operations, and (4) include a process to ensure collaboration with the efforts of local, tribal, regional, state, and federal emergency preparedness officials, including documentation of the hospital’s efforts to contact those officials and of its participation in collaborative planning efforts. CMS provides citations to ten different “Emergency Planning Resources” to assist hospitals in developing an emergency plan. For instance, a hospital can look to HRSA’s “Health Care Center Emergency Management Program Expectations"; The Joint Commission’s “Standing Together: An Emergency Planning Guide For America's Communities”; or “Providing Mass Medical Care With Scarce Resources: A Community Planning Guide" by the ARHQ. CMS encourages providers to work with critical partners such as emergency management, public health, and other providers, noting the importance of a community’s Healthcare Coalition in addressing emergencies, sharing resources and ensuring healthcare resiliency. The hospital’s emergency preparedness plan must be reviewed and updated at least annually.

Policies & Procedures, §485.15(b). Hospitals must develop and maintain policies and procedures in accordance with their emergency plan and communications plan (discussed below). These must be reviewed and updated annually. CMS provides a list of mandatory elements:

Hospitals and other providers should be aware of imminent changes to the Medicare Conditions of Participation (CoP) which will add new emergency preparedness requirements. The proposed rule requires an all-hazards risk assessment, a comprehensive emergency preparedness plan, and numerous policies and procedures on significant operational issues that may arise in emergencies. Further, annual training and testing of a provider’s emergency preparedness will be required as well.

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. 78 Fed.Reg. 79082 (December 27, 2013). Hospitals are a significant focus, because CMS recognizes that “hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.”[1] However, the proposed regulations also add emergency preparedness requirements to the CoPs or Conditions for Coverage (CfC) for sixteen other provider/supplier types, as CMS works to bring a more uniform and consistent approach to emergency preparedness. Those include:

  • Ambulatory Surgical Centers (ASCs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • End-Stage Renal Disease (ESRD) Facilities
  • Federally Qualified Health Centers (FQHCs)
  • Home Health Agencies (HHAs)
  • Hospices
  • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)
  • Long Term Care (LTC) Facilities
  • Organ Procurement Organizations (OPOs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Rural Health Clinics (RHCs)
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)Transplant Centers

 

Background


CMS conducted an extensive review of the current state of emergency preparedness,[2] mindful of the challenges presented to the United States in recent years by the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012. The result: CMS determined that the current emergency preparedness regulatory requirements are not sufficiently comprehensive or sufficiently uniform to ensure readiness for public health emergencies.

CMS acknowledges that many hospitals already have an emergency preparedness program, and those programs have been steadily becoming more comprehensive. For example, some areas have formed community-wide coalitions where public and private entities work together to prepare for emergencies. The Proposed Rule is intended to address the need for greater uniformity and cohesiveness across the country. CMS directs that the implementation of an emergency preparedness program should have four core elements: (1) risk assessment and planning, (2) policies and procedures, (3) communication plan, and (4) training and testing.[3] CMS begins with an extensive discussion of the new hospital CoPs, explaining that it serves as a framework on which the other CoPs and CfCs are based. A discussion follows which explains how those hospital requirements are modified for each provider/supplier type.

The Proposed CoP Changes for Hospitals

The new, proposed hospital CoP requirements, at 42 C.F.R. §482.15, mandate that hospitals have an emergency preparedness program and emergency preparedness plan which includes the following key components.

All-Hazards Risk Assessment, §485.15(a). A hospital must develop an emergency plan based on a community–based, all hazards, risk assessment. This approach focuses on developing capabilities for a broad range of disasters, rather than concentrating on one particular threat. To assist, CMS provides a citation to the fifteen all hazards National Planning Scenarios, which range from pandemic flu to a major earthquake or hurricane to a nuclear or terrorist attack. CMS also provides information about and links to various publications to assist hospitals in developing and conducting an all-hazards risk assessment, for example, guidance from agencies such as the Federal Emergency Management Agency (FEMA) and the Agency for Healthcare Research (ARHQ).[4] This risk assessment must include the identification of essential business functions that the hospital should continue, emergencies the hospital reasonably expects to confront, and contingencies for which the hospital should plan. Further, it should address the hospital’s location, any natural or man-made emergencies that may cause it to cease or limit operations, and a determination of whether arrangements with other entities are needed to ensure that essential services can be provided. The assessment must consider the patient population such as the elderly, children, pregnant women, non-English speaking persons, and those with chronic medical disorders or a lack of transportation.

Emergency Plan, §485.15(a). A hospital must develop a plan based upon the all hazards risk assessment. The plan must: (1) be based on and include the documented, risk assessment, (2) include strategies to address the emergency events identified by the risk assessment, (3) address the hospital’s patient population including at-risk persons, the type of services the hospital can provide in an emergency, and continuity of operations, and (4) include a process to ensure collaboration with the efforts of local, tribal, regional, state, and federal emergency preparedness officials, including documentation of the hospital’s efforts to contact those officials and of its participation in collaborative planning efforts. CMS provides citations to ten different “Emergency Planning Resources” to assist hospitals in developing an emergency plan. For instance, a hospital can look to HRSA’s “Health Care Center Emergency Management Program Expectations"; The Joint Commission’s “Standing Together: An Emergency Planning Guide For America's Communities”; or “Providing Mass Medical Care With Scarce Resources: A Community Planning Guide" by the ARHQ. CMS encourages providers to work with critical partners such as emergency management, public health, and other providers, noting the importance of a community’s Healthcare Coalition in addressing emergencies, sharing resources and ensuring healthcare resiliency. The hospital’s emergency preparedness plan must be reviewed and updated at least annually.

Policies & Procedures, §485.15(b). Hospitals must develop and maintain policies and procedures in accordance with their emergency plan and communications plan (discussed below). These must be reviewed and updated annually. CMS provides a list of mandatory elements:

Hospitals and other providers should be aware of imminent changes to the Medicare Conditions of Participation (CoP) which will add new emergency preparedness requirements. The proposed rule requires an all-hazards risk assessment, a comprehensive emergency preparedness plan, and numerous policies and procedures on significant operational issues that may arise in emergencies. Further, annual training and testing of a provider’s emergency preparedness will be required as well.

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. 78 Fed.Reg. 79082 (December 27, 2013). Hospitals are a significant focus, because CMS recognizes that “hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.”[1] However, the proposed regulations also add emergency preparedness requirements to the CoPs or Conditions for Coverage (CfC) for sixteen other provider/supplier types, as CMS works to bring a more uniform and consistent approach to emergency preparedness. Those include:

  • Ambulatory Surgical Centers (ASCs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • End-Stage Renal Disease (ESRD) Facilities
  • Federally Qualified Health Centers (FQHCs)
  • Home Health Agencies (HHAs)
  • Hospices
  • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)
  • Long Term Care (LTC) Facilities
  • Organ Procurement Organizations (OPOs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Rural Health Clinics (RHCs)
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)Transplant Centers

 

Background


CMS conducted an extensive review of the current state of emergency preparedness,[2] mindful of the challenges presented to the United States in recent years by the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012. The result: CMS determined that the current emergency preparedness regulatory requirements are not sufficiently comprehensive or sufficiently uniform to ensure readiness for public health emergencies.

CMS acknowledges that many hospitals already have an emergency preparedness program, and those programs have been steadily becoming more comprehensive. For example, some areas have formed community-wide coalitions where public and private entities work together to prepare for emergencies. The Proposed Rule is intended to address the need for greater uniformity and cohesiveness across the country. CMS directs that the implementation of an emergency preparedness program should have four core elements: (1) risk assessment and planning, (2) policies and procedures, (3) communication plan, and (4) training and testing.[3] CMS begins with an extensive discussion of the new hospital CoPs, explaining that it serves as a framework on which the other CoPs and CfCs are based. A discussion follows which explains how those hospital requirements are modified for each provider/supplier type.

The Proposed CoP Changes for Hospitals

The new, proposed hospital CoP requirements, at 42 C.F.R. §482.15, mandate that hospitals have an emergency preparedness program and emergency preparedness plan which includes the following key components.

All-Hazards Risk Assessment, §485.15(a). A hospital must develop an emergency plan based on a community–based, all hazards, risk assessment. This approach focuses on developing capabilities for a broad range of disasters, rather than concentrating on one particular threat. To assist, CMS provides a citation to the fifteen all hazards National Planning Scenarios, which range from pandemic flu to a major earthquake or hurricane to a nuclear or terrorist attack. CMS also provides information about and links to various publications to assist hospitals in developing and conducting an all-hazards risk assessment, for example, guidance from agencies such as the Federal Emergency Management Agency (FEMA) and the Agency for Healthcare Research (ARHQ).[4] This risk assessment must include the identification of essential business functions that the hospital should continue, emergencies the hospital reasonably expects to confront, and contingencies for which the hospital should plan. Further, it should address the hospital’s location, any natural or man-made emergencies that may cause it to cease or limit operations, and a determination of whether arrangements with other entities are needed to ensure that essential services can be provided. The assessment must consider the patient population such as the elderly, children, pregnant women, non-English speaking persons, and those with chronic medical disorders or a lack of transportation.

Emergency Plan, §485.15(a). A hospital must develop a plan based upon the all hazards risk assessment. The plan must: (1) be based on and include the documented, risk assessment, (2) include strategies to address the emergency events identified by the risk assessment, (3) address the hospital’s patient population including at-risk persons, the type of services the hospital can provide in an emergency, and continuity of operations, and (4) include a process to ensure collaboration with the efforts of local, tribal, regional, state, and federal emergency preparedness officials, including documentation of the hospital’s efforts to contact those officials and of its participation in collaborative planning efforts. CMS provides citations to ten different “Emergency Planning Resources” to assist hospitals in developing an emergency plan. For instance, a hospital can look to HRSA’s “Health Care Center Emergency Management Program Expectations"; The Joint Commission’s “Standing Together: An Emergency Planning Guide For America's Communities”; or “Providing Mass Medical Care With Scarce Resources: A Community Planning Guide" by the ARHQ. CMS encourages providers to work with critical partners such as emergency management, public health, and other providers, noting the importance of a community’s Healthcare Coalition in addressing emergencies, sharing resources and ensuring healthcare resiliency. The hospital’s emergency preparedness plan must be reviewed and updated at least annually.

Policies & Procedures, §485.15(b). Hospitals must develop and maintain policies and procedures in accordance with their emergency plan and communications plan (discussed below). These must be reviewed and updated annually. CMS provides a list of mandatory elements:

Hospitals and other providers should be aware of imminent changes to the Medicare Conditions of Participation (CoP) which will add new emergency preparedness requirements. The proposed rule requires an all-hazards risk assessment, a comprehensive emergency preparedness plan, and numerous policies and procedures on significant operational issues that may arise in emergencies. Further, annual training and testing of a provider’s emergency preparedness will be required as well.

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. 78 Fed.Reg. 79082 (December 27, 2013). Hospitals are a significant focus, because CMS recognizes that “hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.”[1] However, the proposed regulations also add emergency preparedness requirements to the CoPs or Conditions for Coverage (CfC) for sixteen other provider/supplier types, as CMS works to bring a more uniform and consistent approach to emergency preparedness. Those include:

  • Ambulatory Surgical Centers (ASCs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • End-Stage Renal Disease (ESRD) Facilities
  • Federally Qualified Health Centers (FQHCs)
  • Home Health Agencies (HHAs)
  • Hospices
  • Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)
  • Long Term Care (LTC) Facilities
  • Organ Procurement Organizations (OPOs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Rural Health Clinics (RHCs)
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)Transplant Centers

 

Background


CMS conducted an extensive review of the current state of emergency preparedness,[2] mindful of the challenges presented to the United States in recent years by the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012. The result: CMS determined that the current emergency preparedness regulatory requirements are not sufficiently comprehensive or sufficiently uniform to ensure readiness for public health emergencies.

CMS acknowledges that many hospitals already have an emergency preparedness program, and those programs have been steadily becoming more comprehensive. For example, some areas have formed community-wide coalitions where public and private entities work together to prepare for emergencies. The Proposed Rule is intended to address the need for greater uniformity and cohesiveness across the country. CMS directs that the implementation of an emergency preparedness program should have four core elements: (1) risk assessment and planning, (2) policies and procedures, (3) communication plan, and (4) training and testing.[3] CMS begins with an extensive discussion of the new hospital CoPs, explaining that it serves as a framework on which the other CoPs and CfCs are based. A discussion follows which explains how those hospital requirements are modified for each provider/supplier type.

The Proposed CoP Changes for Hospitals

The new, proposed hospital CoP requirements, at 42 C.F.R. §482.15, mandate that hospitals have an emergency preparedness program and emergency preparedness plan which includes the following key components.

All-Hazards Risk Assessment, §485.15(a). A hospital must develop an emergency plan based on a community–based, all hazards, risk assessment. This approach focuses on developing capabilities for a broad range of disasters, rather than concentrating on one particular threat. To assist, CMS provides a citation to the fifteen all hazards National Planning Scenarios, which range from pandemic flu to a major earthquake or hurricane to a nuclear or terrorist attack. CMS also provides information about and links to various publications to assist hospitals in developing and conducting an all-hazards risk assessment, for example, guidance from agencies such as the Federal Emergency Management Agency (FEMA) and the Agency for Healthcare Research (ARHQ).[4] This risk assessment must include the identification of essential business functions that the hospital should continue, emergencies the hospital reasonably expects to confront, and contingencies for which the hospital should plan. Further, it should address the hospital’s location, any natural or man-made emergencies that may cause it to cease or limit operations, and a determination of whether arrangements with other entities are needed to ensure that essential services can be provided. The assessment must consider the patient population such as the elderly, children, pregnant women, non-English speaking persons, and those with chronic medical disorders or a lack of transportation.

Emergency Plan, §485.15(a). A hospital must develop a plan based upon the all hazards risk assessment. The plan must: (1) be based on and include the documented, risk assessment, (2) include strategies to address the emergency events identified by the risk assessment, (3) address the hospital’s patient population including at-risk persons, the type of services the hospital can provide in an emergency, and continuity of operations, and (4) include a process to ensure collaboration with the efforts of local, tribal, regional, state, and federal emergency preparedness officials, including documentation of the hospital’s efforts to contact those officials and of its participation in collaborative planning efforts. CMS provides citations to ten different “Emergency Planning Resources” to assist hospitals in developing an emergency plan. For instance, a hospital can look to HRSA’s “Health Care Center Emergency Management Program Expectations"; The Joint Commission’s “Standing Together: An Emergency Planning Guide For America's Communities”; or “Providing Mass Medical Care With Scarce Resources: A Community Planning Guide" by the ARHQ. CMS encourages providers to work with critical partners such as emergency management, public health, and other providers, noting the importance of a community’s Healthcare Coalition in addressing emergencies, sharing resources and ensuring healthcare resiliency. The hospital’s emergency preparedness plan must be reviewed and updated at least annually.

Policies & Procedures, §485.15(b). Hospitals must develop and maintain policies and procedures in accordance with their emergency plan and communications plan (discussed below). These must be reviewed and updated annually. CMS provides a list of mandatory elements: