Is Your Hospital Prepared for the Next Emergency? September 30, 2010

1. Is Your Hospital Prepared for the Next Emergency?September 30, 2010 Presenters: Emily Black Grey, Esq., Breazeale, Sachse & Wilson, LLP, Baton Rouge, LA Paul W. Pitts, Esq., Reed Smith, LLP, San Francisco, CA Shirley P. Morrigan, Esq., Foley & Lardner, LLP, Los Angeles, CA Moderator: Dawn R. Crumel, Esq., Children’s National Medical Center, Washington, DC LACA_2558922.1

2. Contributions From: • Public Interest Committee • In-House Counsel • Life Sciences • Medical Staff, Credentialing, and Peer Review • Payors, Plans, and Managed Care • Teaching Hospitals and Academic Medical Centers

3. Agenda for Today

5. Emergency Preparedness Statutory Overview See Section I of Toolkit

6. Section I, Tab A in the Toolkit • HHS Public Health Emergency Authorities • Summarizes relevant federal laws • Authority of Secretary of HHS • Relationship with State, local, and tribal officials • Elements of a public health emergency • Other Discretionary Actions [waivers]

7. Section I, Tab B • Robert T. Stafford Disaster Relief and Emergency Assistance Act • Statutory framework for a Presidential declaration of an emergency or major disaster • Declaration opens the way for federal resources to be made available

8. Section I,Tab B (cont’d) Stafford Act, cont’d • Federal resources supplement state and local resources for disaster relief and recovery • Except in exclusively or predominantly federal areas, the Governor or Acting Governor of the affected State must request a declaration from the President • Sets forth types of assistance available

9. Section I, Tab C • Requesting a Section 1135 Waiver • After disaster or emergency is declared by the President • After Secretary of HHS declares a public health emergency • Secretary of HHS may temporarily waive or modify the requirements of • Medicare • Medicaid, or • the Children’s Health Insurance Program

10. Section I,Tab C (cont’d) • Examples of Section 1135 waivers or modifications • Medicare Conditions of Participation • Preapproval requirements • Requirements that professionals be licensed • EMTALA sanctions for direction or relocation of an individual to receive a medical screening examination in an alternative location • Stark self-referral sanctions

11. Section I, Tab C (cont’d) Rules on Waivers • Waivers end no later than • Termination of the emergency period, or • 60 days from the date the waiver or modification is first published • Unless the Secretary of HSS extends the waiver for additional periods up to 60 days, up to the end of the emergency period

12. Section I, Tab C (cont’d) Rules on Waivers (cont’d) • Waivers of EMTALA and HIPAA requirements are limited to • A 72-hour period beginning upon implementation of a hospital disaster protocol • Waiver of EMTALA requirements for emergencies that involve a pandemic disease • Last until the termination of the pandemic-related public health emergency • Section 1135 waiver authority applies only to Federal requirements and does not apply to State requirements

13. Section I, Tab D FEMA Disaster Relief • Presidential declaration of emergency or disaster • Triggers access by FEMA to the Disaster Relief Fund to provide Federal direct and financial assistance to render aid, emergency services, and rehabilitation assistance • Authorizes FEMA to coordinate the administration of all disaster relief

14. Section I, Tab D (cont’d) FEMA Definitions “any natural catastrophe . . . or, regardless of cause, any fire, flood, or explosion, in any part of the United States, which in the determination of the President causes damage of sufficient severity and magnitude to warrant major disaster assistance under this Act to supplement the efforts and available resources of States, local governments, and disaster relief organizations in alleviating the damage, loss, hardship, or suffering caused thereby.” Major Disaster

15. Section I, Tab D (cont’d) FEMA Definitions (cont’d) “any occasion or instance for which, in the determination of the President, Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.” Emergency

16. Section II of the Toolkit Sample Determinations of Public Health Emergency • Toolkit contains nine examples

18. Survey & Certificationof Health Care Providers During an EmergencySee Section VIII Certification

19. Types of Certification Requirements Waived by DHHS/CMS Under section 1135, the Secretary can waive • conditions of participation, certification requirements, program participation or similar requirements, or pre-approval requirements for individual health care providers, • licensing requirements, including the requirement that physicians and other health care professionals hold licenses in the State in which they provide services,

20. Types of Certification Requirements Waived by DHHS/CMS(cont’d) • sanctions under EMTALA for the redirection of an individual to another location to receive a medical screening examination, • limitations on payments under the Medicare Advantage program for use of out-of-network providers, and • sanctions and penalties from noncompliance with certain HIPAA privacy regulations

21. Types of Providers Impacted by Waivers The Secretary’s waiver can impact any entity that furnishes health care items or services, and includes a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services

22. Provider Survey and Certification Frequently Asked Questions • CMS has published responses to a list of frequently asked questions concerning public health emergencies • The FAQs address questions applicable to all provider types, questions for specific providers, and a comprehensive list of resources for emergency preparedness

23. Survey & Certification Emergency Preparedness Website CMS has developed a survey and certification website and listserve for the specific purpose of providing useful emergency planning and response information See Section VIII Certification, Subpart C of Toolkit.

24. Description and Summary of CMS Checklists Developed for Emergency Preparedness CMS has developed several emergency preparedness tools to assist health care providers, patients and residents in planning for emergencies • Recommended Tool for Effective Health Care Facility Planning • Recommended Tool for Persons in LTC Facilities • Recommended Tool for Persons with Medical Needs Living at Home, Family, Friends, Guardians, and Caregivers

25. Summary of Practices in State Survey Agencies • Under section 1864 of the Social Security Act, CMS has agreements with the state survey agencies to carry out the Federal survey and certification obligations. During an emergency these survey and certification responsibilities continue, although certain actions may be adjusted to address the circumstances of a particular emergency • Many state agencies have adopted emergency preparedness standards and tools

26. Summary of Practices in State Survey Agencies (cont’d) • CMS has published a report describing the emergency preparedness efforts implemented by the state survey agencies in FL, MA, and NJ • Contact your state survey agency and request the latest information concerning the agency’s emergency preparedness requirements and plan

27. Accreditation by The Joint Commission and Healthcare Facilities Accreditation Program (HFAP)

28. The Joint Commission • On Nov. 24, 2008, The Joint Commission imposed a series of requirements related to emergency management • The hospital has an Emergency Operations Plan • The hospital engages in planning activities prior to developing its written Emergency Operations Plan • The hospital prepares for how it will communicate, manage resources, security, staff, and grant privileges to practitioners during emergencies

29. Communications Planning • Notifying external authorities, employees, staff, patients and families that emergency response measures have been initiated • Communications with area health care organizations, regarding contact information, resources and assets that are available to be shared • Communications about patient names with area health care entities and third parties • State Department of Health, Police, FBI, etc.

30. Resource Management • Identify how hospital will obtain and replenish medications and supplies • Identify how hospital will share such resources with area health care providers • How hospital will transport patients, their medications, supplies, clinical information, equipment and staff to alternate site

31. Security and Safety • Clarify and identify roles of community security agencies • Management of hazardous waste and materials • Provisions for radioactive, biological and chemical isolation and decontamination • Plan for control of personnel within the facility, and vehicles that access the facility during an emergency

32. Management of Staff • Identify reporting relationships in hospital's incident command structure • Address staff support needs • Housing, transportation, family support needs, etc. • Protocol to identify various types of licensed independent practitioners

33. Privileging • MS 4.110 - Disaster privileges may be granted when the hospital's emergency management plan has been activated and the hospital cannot manage immediate patient care needs • Bylaws clearly delineate who may grant disaster or emergency privileges • Medical Staff identifies how it will oversee volunteer independent staff who receive disaster privileges and how they will be identified • Hospital complies with Joint Commission "protocol" for issuance of disaster privileges to independent license practitioners

34. Other • Hospital evaluates the effectiveness of its emergency management planning activities and the Emergency Operations Plan • Including conducting an emergency response exercise by activating the Emergency Operations Plan twice a year • One of those includes influx of simulated patients

35. Certification & Accreditation Scenario

36. Scenario • During a major disaster, your client’s entire facility is significantly damaged and rendered unfit for health care services for many months. Further, a significant portion of your client's patient population and staff have relocated to other communities in the state. The services of this provider are needed in another community and your client hopes to remain a viable business and continue to provide services • What can be done to relocate or expand in another location?

37. Scenario (cont’d) • Conditions of Participation Section 1135 permits the waiver of conditions of participation • The extent of the waiver is essential in determining whether a provider may relocate to a new community and continue enrollment • Waivers only apply in the areas where the Secretary has declared a public health emergency • Relocation beyond the emergency area may require re-enrollment

38. Scenario (cont’d) • Licensing and State Survey State agencies have adopted plans for survey and certification of providers during an emergency and the period following the initial emergency • See Section VII Certification, Subpart C for additional resources on the practices of various state survey agencies • Health care providers should be familiar with their state agency's emergency preparedness requirements and plan, including how to reach key state officials during an emergency period

39. Scenario (cont’d) • Accreditation The accreditation standards for The Joint Commission and HFAP are primarily prospective, meaning they focus on planning for a disaster • See Section VIII Certification, Subpart B of Toolkit • If these standards have been met, the facility will have a communication plan for reorganizing in a new location

40. Scenario (cont’d) • During a major disaster, a portion of your client’s facility is significantly damaged and rendered unfit for health care services for many months • How can the remaining facility space be used to meet the increased need for services? • For example, can acute and SNF beds be exchanged in order to accommodate patient needs?

42. Operational Issues for Health Care Providersduring an Emergency

43. Joint Commission • Standard EM.01.01.01: The hospital engages in planning activities prior to developing its written Emergency Operations Plan (EOP). • Standard EM.02.01.01: The hospital has an EOP designed to coordinate its communications, resources and assets, safety and security, staff responsibilities, utilities, and patient clinical and support activities during an emergency.

44. Joint Commission • Standard EM.02.02.01: As part of its EOP, the hospital prepares for how it will communicate during emergencies • Standard EM.02.02.03: As part of its EOP, the hospital prepares for how it will manage resources and assets during emergencies.

45. Joint Commission • Standard EM.02.02.07: As part of its EOP, the hospital prepares for how it will manage staff during an emergency. • Standard EM.02.02.09: As part of its EOP, the hospital prepares for how it will manage utilities during an emergency.

46. Operational Scenario • In the course of a major disaster, the power lines, phone lines and cell phone towers are downed. The water supply is contaminated. The area around your facility is impassable and the main generator was destroyed. The backup power system purchased last year won’t start. Because no cell phones have signals, you attempt to send text messages to the company that sold you the backup generator. It appears that your facility is without power for the near future.

47. Operational Scenario • In the following two days, a steady stream of civilians traverse the destroyed area around your facility seeking medical attention and shelter, but no other help has arrived. The helicopters pass overhead but do not stop. Your facility is beyond capacity and the medical staff who have remained since the disaster are exhausted after more than 48 hours in difficult conditions. The cell phones are running out of power as well.

48. Operational Scenario • Listening to a battery-operated radio in the administration office, you learn that the state capitol is devastated and subject to a mandatory evacuation order. The CMS Regional Office, hospital licensing agency, medical board, and nursing board are all unavailable for the forseeable future. On the third night after the disaster, medical supplies, food and fresh water are running low. A helicopter full of out-of-state physicians and nurses arrives; they have come to help and tell you that more out-of-state providers will be arriving over the next few days to help evacuate your facility. • How can the toolkit help you find anticipate problems presented by this disaster and help you find solutions?

49. Toolkit Checklists for the “Twilight Zone”Section XVII of Toolkit • For discussion today: • Power • Communications • Medications and Supplies • Staffing • Liability of Out of State Providers • Transportation • Additional information: • Safety at the facility • the deceased • Additional people and pets at the facility

50. Practical Operational Advice – Power • With generators, evaluate: • Placement of unit and control panels including surrounding area and potential hazards. • Fuel Source. How many total hours of fuel are maintained on site and how will additional fuel be obtained? • How frequently is the generator serviced? • What does the generator power? Are air conditioning and heat included?