Legal Issues Related to H1N1 June 9, 2009

1. Legal Issues Related to H1N1June 9, 2009 American Bar Association, Health Law Section Clinician Outreach and Communication Activity, CDC Public Health Law Program, CDC

2. Legal Issues Related to H1N1The Health Lawyer’s Perspective Steven D. Gravely, J.D., M.H.A. Troutman Sanders LLP Richmond, Virginia

3. Introduction • SARS (2002) spared the U.S. but did real damage to Toronto • Avian Influenza (H5N1) is deadly and continues to slowly spread • H1N1 spread rapidly around the world and IS NOT OVER but has been relatively mild • Our luck is running out!

4. What can we do? My hospital will have less liability risk if we don’t plan and just do the best that we can during the next disaster. The threat is imminently foreseeable. There are specific legal issues that health care providers must address now or face liability for negligent failure to prepare and negligent failure to respond. Fiction FACT

5. ALTERED STANDARDS OF CARE

6. Altered Standards of Care: The Context • Healthcare system is under significant stress in “normal time” • Introduce a significant event into this environment and substantial disruptions to the delivery of care are inevitable • Health care providers must plan now for allocating scarce resources in disasters

7. The truth about altered standards of care… My hospital doesn’t need to plan for allocating scarce resources because my health department is working on this. Many state health departments are working on allocation algorithms, but they cannot create an algorithm for each scarce resource nor can they tell hospitals how to implement the algorithms that the department creates. Fiction FACT

8. “Ideally, hospitals should be able to follow guidance and decision support tools to make resource allocation decisions that are sanctioned and approved at the Federal level and distributed by the State. Even with the support of these tools or policies, however, it is the hospital that will have to take on the role of implementing them…If no guidance exists, it will be incumbent on the hospital to have a plan or strategy for bringing together the appropriate personnel who can make the best decisions possible and reevaluate the situation during each planning cycle.” AHRQ Providing Mass Medical Care with Scarce Resources: A Community Planning Guide (November 2006)

9. EMTALA

10. What is EMTALA? • Emergency Medical Treatment and Active Labor Act • Requires hospitals to screen and stabilize all patients who present to the emergency department for care • Complaint driven process • CMS will investigate any alleged violations • Civil monetary penalty of up to $50,000 per violation • Patients can also bring civil action against the hospital

11. The truth about EMTALA… I do not need to worry about EMTALA in my planning because it will be waived during an emergency. While the Secretary of HHS does have the authority to waive imposition of sanctions for failure to comply with certain EMTALA requirements during a disaster, hospitals should not expect a wholesale set aside and still need to plan as if EMTALA will be in full force and effect during a disaster. Fiction FACT

12. Hospital Responsibilities During a Disaster • Medical Screening Exam (MSE) • Not the same as triage • Hospitals must perform an MSE on all patients except under a Section 1135 waiver • Hospital may be able to postpone the MSE • Must be conducted by a Qualified Medical Person (QMP) • Provide stabilization services and MSEs “within the capabilities” of the facility • Staff • Resources • Hospital’s past practices of accommodating patients in excess of their capacity

13. What does this mean for planning efforts? • Hospital should be aware of the exception for transfers in accordance with “community response plans” • States, in collaboration with hospitals, should review current pandemic flu response plans to include appropriate amendments in light of statutory exception and Section 1135 Waiver • Hospitals should • Modify their EMTALA diversion policies to recognize and document capabilities and capacity • Develop policies regarding scope and protocol for providing MSEs to patients seeking prescription refills • Adopt special disaster QMP designations • Develop policies and procedures for the transfer of patients when hospital is unable to provide stabilization • Develop policies and procedures reflecting the “community response plan”

14. HIPAA

15. The truth about HIPAA… The Office of Civil Rights has created a definitive planning tool that will help me determine whether I can share information during a disaster. Fiction

16. FACT OCR HIPAA Emergency Planning Tool

17. The truth about HIPAA… Fiction I do not need to worry about HIPAA in my planning because it will be waived during an emergency. Following Hurricane Katrina, Secretary of DHHS issued a 72-hour waiver of sanctions and penalties for noncompliance with the following HIPAA requirements for hospitals engaged in hurricane relief efforts: • To obtain a patient’s agreement in order to speak with family members or friends or to honor a patient’s request to opt out of the facility directory; • To distribute a notice of privacy practices; • To provide patients with an opportunity to request privacy restrictions or confidential communications. FACT

18. What does this mean for planning efforts? • Healthcare providers should plan as though HIPAA will be in full force and effect during an emergency • Consider all situations in which PHI may be shared during an emergency • Transfers to other healthcare facilities including alternate care facilities • Patient tracking • Public health reporting • Consider creating a separate set of HIPAA policies for emergency and disaster situations which take into account any applicable exceptions • Educate employees, staff, and providers

19. Staffing

20. The truth about Human Resources… Fiction Hospitals are accustomed to dealing with staffing shortages now and will adapt to higher levels of absenteeism during a pandemic. According to recent OSHA guidance, the healthcare industry may see absenteeism rates that exceed 40% during a pandemic. FACT

21. Staffing Challenges • Numerous HR laws and regulations • HR planning issues for a pandemic • Absenteeism - Screening • Leave policies - Absence Reporting • Workforce Protection - Volunteers • Education/Communication • Absenteeism typically number one priority issue

22. Framework for Absenteeism Discussion • Causes of absenteeism • Illness • Family responsibilities • Fear • Minimizing occurrence of absenteeism by getting healthy staff to report to work • Incentives • Protective Measures • Technology • Education and Communication • Psychological Support • Managing consequences of absenteeism by working with the staff you have • Supplemental Staffing • Maximizing Available Staff

23. Financial Sustainability

24. The truth about financial sustainability during an emergency… FEMA will cover a hospital’s losses so it does not need to plan for financial sustainability during an emergency. In some cases, FEMA will cover some of the hospital’s losses, but it will not cover the costs of providing definitive medical care to patients. Fiction FACT

25. Financial SustainabilityIssues to Consider • Clean claims • Prompt pay • Accelerated and advanced payment • Waivers • Business interruption insurance • Stafford Act/FEMA reimbursement

26. For more information, please contact COCA@cdc.gov with attention to Steve Gravely

27. HHS Legal Response to H1N1 ABA/CDC Teleconference on Legal Issues Related to H1N1 June 9, 2009 Joseph Foster Office of the General Counsel Department of Health and Human Services Privileged Attorney Work Product

28. Determination that a Public Health Emergency (PHE) Exists • Determination by the HHS Secretary that: • A disease or disorder presents a public health emergency; or • A public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists. • Termination and renewal • Terminates after 90 days or revocation by the Secretary, whichever occurs first. • May be renewed for additional 90 day periods. Privileged Attorney Work Product

29. PHE May Authorize • Access to emergency funds (if appropriated), PHS Act § 319(b). • Extension of deadlines, waive sanctions for submitting data/reports, PHS Act, § 319(d). • Waiver of certain Medicare, Medicaid, CHIP requirements, SSA § 1135. • Waiver of HIPPA sanctions for 72 hours, SSA § 1135. • Waiver of certain requirements for medical countermeasure distribution, FFDCA § 505-1. • Exemption of select agent requirements, PHS Act § 351A. • Appointment of temporary personnel, waiver of dual compensation reduction, 5 U.S.C. §§ 8344, 8468. • Adjustment of Medicare payment for Part B drugs, SSA § 1847A. • Waiver of certain Ryan White HIV/AIDS requirements, PHS Act, Title XXVI. • Declaration of an emergency justifying emergency use of unapproved products or approved products for unapproved uses, FFDCA § 564. Privileged Attorney Work Product

30. Emergency Use Authorization (EUA) • Authorization by the FDA Commissioner to use unapproved products or approved products for unapproved uses in an emergency. • For drugs, biological products, devices. • Specifies diseases or conditions for use. • Risks, benefits, conditions. • Published in Federal Register. Privileged Attorney Work Product

31. EUA Process • Determination of: • Domestic emergency by DHS Secretary. • Military emergency by DOD Secretary. • Public health emergency by HHS Secretary. • Declaration • Issued by HHS Secretary justifying emergency use. • Specifies CBRN agent and product. • Different from PHE and PREP Act declarations. • Terminates in one year or when circumstances justifying EUA cease to exist (may be renewed). • EUA • Issued by FDA Commissioner. • Terminates in one year or until Secretary’s declaration terminates (may be renewed). Privileged Attorney Work Product

32. EUA & H1N1 • EUAs (5 total) • Antivirals (Tamiflu, Relenza). • N95 Respirators. • Diagnostics. • Issues • Translation. • State & local stockpiles (antivirals). • Expiring product. Privileged Attorney Work Product

33. Public Readiness and Emergency Preparedness (PREP) Act • Authorizes Secretary to issue a declaration to provide immunity for tort liability. • Declaration must specify certain information, e.g., determination of threat or credible risk, recommendation for action, effective time period, receiving population, and limitations. • Protects “covered persons,” which includes manufacturers, distributors, program planners, and “qualified persons” (licensed health professionals or other individuals authorized by state law to prescribe, administer, or dispense). • Applies to “covered countermeasures;” statutorily defined; generally includes drugs, devices, biological products, and products covered under an EUA. Privileged Attorney Work Product

34. PREP Act Coverage • Covers any loss that has a causal relationship to any stage of development, distribution, administration, or use of a countermeasure including: • Death; physical, mental, or emotional injury, illness, disability or condition (or fear thereof); medical monitoring; loss of damage to property. • Does not cover: • Claims other than tort claims, e.g. civil rights laws, ADA, labor laws. • Claims with no causal relationship. • Claims outside the declaration. • Claims filed in foreign courts. Privileged Attorney Work Product

35. PREP Act Compensation Program • Compensation fund • Established upon issuance of the declaration. • Must be appropriated. • Compensation available for: • Medical benefits. • Lost wages. • Death benefits. • Reduced by insurance or workers’ compensation. Privileged Attorney Work Product

36. PREP Act & H1N1 • H1N1 Declarations • Antivirals (Tamiflu, Relenza) by amendment. • Influenza diagnostics, personal respiratory protection devices, and respiratory support devices. • Issues of interest • Program planners definition. • “Administration” definition. • Private stockpiles. Privileged Attorney Work Product

37. Resources • Public health emergency • Section 319 of the Public Health Service (PHS) Act (42 U.S.C. § 247d). • Emergency use authorization • Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3). • http://www.cdc.gov/h1n1flu/eua/. • http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm. • Public Readiness and Emergency Preparedness Act • Sections 319F-3 and 319F-4 of the PHS Act (42 U.S.C. §§ 247d-6d, 247d-6e). • http://www.hhs.gov/disasters/discussion/planners/prepact/index.html. Privileged Attorney Work Product

38. H1N1 Influenza in Massachusetts: Legal Issues Priscilla Fox, J.D. Deputy General Counsel Massachusetts Department of Public Health June 9, 2009

39. Health information privacy • MDPH Confidentiality Policy: H1N1 cases • Public desire/need to know vs. individual privacy rights • State regulations allow disclosure of PHI without consent when “necessary for disease investigation, control, treatment and prevention purposes.” • The way we balanced: • County ok, but combine 2 small counties (town not ok) • Age range vs. specific age • Date of onset; whether hospitalized

40. Further work • When is disclosure “necessary for disease investigation, control, treatment and prevention purposes?” • Will vary based on virulence of disease, how spread, etc. • Epidemiologists should work to specify disclosure criteria in advance

41. School Closure Authority • Local school officials decide on closure, BUT • MDPH and/or local boards of health (351 of them!) can order closure if: • School officials fail to follow health officials’ recommendations to close AND • Failure to close presents a danger to public health

42. School closures • Recommendations were used. E.g.: • Base closure on capacity to operate with particular level of absenteeism • Isolate & send home students and staff with ILI • Report higher than normal absenteeism to MDPH • If close, submit Closure Reporting Form • Consult with local health authorities & MDPH about reopening • 31 closures up to 6/4/09 (includes public, private, parochial schools, & colleges)

43. Information for Schools

44. Police Enforcement Policy • No explicitstatutory authority for police enforcement of health orders in absence of declared emergency • Counsel from various agencies developed written policy to guide police • Authority of MDPH & local boards of health • Authority of police • Community caretaking function • Enforcement of health-related orders

45. Use of Antivirals State law gives MDPH authority to set rules & priorities for distribution of drugs when Commissioner of Public Health determines that an emergency exists due to shortage. Commissioner issued Order for dispensing of Tamiflu & Relenza, requiring strict compliance with clinical guidelines posted on MDPH website. Order provided background/legal authority for the next step . . .

46. Distribution of SNS Assets • Written agreements between MDPH and recipients of assets, signed upon receipt • Antivirals • Dispense only in compliance with MDPH guidelines; qualified person in facility must provide approval to clinician desiring to prescribe or dispense • Record-keeping • PPE: use in compliance with guidelines; monitor • Agreements included hospitals, clinics, ambulatory care practices, EMS

47. “Polishing” Template Orders • Governor-declared public health emergency (did not happen for H1N1 in Mass.) gives broad powers to Commissioner of Public Health. Examples: • Suspending hospital regulations on bed capacity, staffing ratios, discharge planning • Suspending portion of state patients’ rights statute, e.g. right to confidentiality of all communications • Closing public transportation/large gatherings

48. Pending Legislation Bill updating Mass. public health laws passed Senate on April 28 Would provide expanded liability protection for volunteers, including MSAR (Mass. ESAR-VHP system), MRCs

49. Authority of Local Boards of Health and Health Officers and H1N1 (Swine Flu) Timeline and Report Priscilla D. Keith, J.D.,General Counsel Health and Hospital Corporation of Marion County and the Marion County Health Department

50. Authority of Local Boards of Health and Health Officers • General Powers: • All Necessary Powers. A local board of health possesses all powers necessary to supervise the health and life of persons within its jurisdiction. See IND. CODE §§16-19-3-1 (general powers of ISDH), 16-20-1-21 (local boards of health have all powers granted to ISDH). • Geographic Scope. The power and jurisdiction of a local board of health or health officer are limited to the area in which the board or officer serves. IND. CODE § 16-20-1-1(b).