HHS Public Health Emergency Authorities

Transcription

1 HHS Public Health Emergency Authorities Jennifer E. Ray and Susan E. Sherman HHS Office of the General Counsel April 28,

2 Topics. Overviewof HHS Authorities. HHS Authorities for Preparedness and Response. Three Areas of Public Health Emergency Response:. Deploymentof Personnel. Public Health Emergency Declarations. MedicalCountermeasure Distribution 22

3 HHS Authorities -- Statutes. Public Health Service Act, 42 U.S.C. 201 et seq.. Federal Food, Drug and Costnetic Act, 21 U.S.C. 201 et seq.. Social SecurityAct, 42 U.S.C. 301 et seq.. Stafford Act, 42 U.S.C et seq.. National Emergencies Act, 50 U.S.C

4 Recent Legislation. Patriot Act of Public Health Security and Bioterrorism Preparedness and Response Act of Homeland SecurityAct of SmallpoxEmergency Personnel Protection Act of BioShieldAct of Public Readinessand Emergency Preparedness (PREP) Act of Pandemic and All-Hazards Preparedness Act of

5 HHS Authorities. HHS Secretary "shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response [Framework]", PHS Act HHS is the lead for Emergency Support Function (ESp) 8, Public Health and Medical Services Annex and Biological Incident Annex of the National Response Framework; Support agency for ESF 6, Mass Care, Housing, and Human Services. The HHS Assistant Secretaryfor Preparedness and Response (ASPR) serves as the Secretary's principal advisor on matters related to Federal public health and medical preparedness and response for public health emergencies, PHS Act

6 Federal-State Cooperation. The Secretary is authorized to develop and implement a plan under which HHS personnel, equipment, medical supplies, and other resources may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems, PHS Act 311. The Secretary may, at the request of the State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance, PHS Act 311. The ASPR coordinates with State, local, and tribal public health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during a public health emergency, PHS Act 2811(b)(4)(B) 26

7 Deployment of Personnel. Provide medical surge. Sheltering/Patient Collection Sites. Federal MedicalStations. Deployable health care platform that can deliver large-scale primary healthcare services in the form of non-acute hospital bed surge capacity, special needs sheltering capacity, or quarantine support. Backfillhealthcare facilities/ mo bile medical units. Assistwith patient evacuation. StaffingIncident ResponseCoordinationTeams and serving as liaisons to other response teams. Human servicesteams (ESF#6). Case management 27

8 Federal Employees Licensing - Liability and. FederalTort ClaimsAct(FTCA)- covered employee not personally liable for negligent acts committed within scope of Federal employment. FTCA for malpractice and negligence claims against PHS employees, PHS Act 224. FederalEmployeeCompensationAct (FECA)- worker's comp coverage for Federal civilian employees who are injured or killed while in the performance of their duties. For positions requiring a state license, OPM regulations and Federal job descriptions generally require an employee to be licensed in "a" state. Federal government determines what qualificationsare necessary and is responsible for verification 28

9 Volunteer Health Professionals (VHP) - Liability and Licensing. Patchwork of liabilityprotections for VHPs (and in certain cases, paid healthcare professionals). Mutualaidcompacts- EMAC. State emergency powers to make, amend, or rescind temporarily orders, rules, and regulations necessary to carry out the state's emergency functions. Statutory provisions extending immunity or indemnifying VHPs when Governor declares emergency. Good Samaritan statutes. State Volunteer Protection Acts (VPAs). Uniform Emergency Volunteer Health Practitioners Act. Federal Volunteer Protection Act of Sta~esh~ve a variety of statutory and regulatory mechanisms to extend license reciprocity. EMAC, State emergency powers, State emergency management statutes. Profession specific compacts - Nurse Licensure Compact. Red Cross has negotiated reciprocal licensing agreements with each state 29

10 Commissioned Corps. Regular CommissionedCorps and Reserve Commissioned Corps for duty in time of emergency, PHS Act 203. Commissioned Corps officers must be citizens, are appointed and compensated under separate personnel system without regard to civil service laws. Reserve Corps officers are at all times subject to call to active duty by the Surgeon General. President may use the Commissioned Corps in war or an emergency proclaimed by the President 30

11 National Disaster Medical System. Coordinatedeffort of DHS, DoD, VA, and HHS collaborating with States and public and private entities, PHS Act Provide health services, health-related social services, other appropriate human services and auxiliary services (veterinary, mortuary, and other) to respond to the needs of victims of public health emergency and be present where and when the Secretary determines. location is at risk of a public health emergency. Intermittent employeesof Public Health Service. FTCA, FECA, and USERRA coverage. Healthcare providers only need to be licensed in "a" state 31

12 Medical Reserve Corps (MRC). Comprisedof practicingand retired physicians,nurses, and others formed at local (or state) level to address their communities' ongoing public health needs and to assist their communities during large-scale emergency situations, PHS Act During a public health emergency, the Secretary is authorized to activate and deploy willing members of the Corps to areas of need, with the concurrence of state, local, or tribal officials. May also be activated as intermittent employees of Public Health Service. FTCA, FECA, and USERRA coverage. Healthcare providers only need to be licensed in "a" state. Secretarymay deploy select members without hiring and pay travel or transportation expenses, including a per diem. Such individualsare subject to the laws of the State in which their activities are undertaken 32

13 Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP). Nationalsystemof state-basedprograms that include: recruitment, advance registration, licensure and credential verification, assignment of standardized credential levels, and mobilization of volunteers, PHS Act Inclusion in network does not constitute Federal appointment. VHPs who register are generally not Federal employees, although HHS could utilize certain emergency and temporary hiring authorities to hire certain VHPs on a temporary basis. In general, VHPS will not qualify for FTCA or FECA coverage. VHPs will need to obtain a license to practice across state lines unless there is a mechanism providing them with reciprocity 33

14 Public Health Emergency Declaration (PHE). The Secretarymaydeclarea PHE if he or she determines,after consultation with such public health officials as may be necessary, that (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, PHS Act 319. Termination. Secretarial determination that emergency no longer exists or after 90 days, whichever occurs first. Renewal. May be renewed by the Secretary for additional 90 days periods 34

15 Following a Declaration the Secretary May:. Access Public Health Emergency Fund (when funds are available). Consistent with other authorities, make grants, provide awards for expenses, and enter into contracts and conduct and support investigations. Extend deadlines,waive sanctions for submission of data or reports 35

16 Support Other Discretionary Actions by the Secretary:. Waivecertain Medicare, Medicaid and CHIP requirements (includingtemporary waiver of EMTALA), SSA Waive certain HIPAA sanctions for 72 hours, SSA Declare an emergency justifyingemergencyuse of an investigationalproduct, FFDCA 564. Waivecertain requirements for medical countermeasure distribution, FFDCA Exempt select agent requirements, PHS Act 351A. Appoint temporary personnel, waive dual compensation reduction, 5 C.F.R (i)(1),5 D.S.C. 8344,8468. Adjust Medicare payment for Part B drugs, SSA 1847A. Waiveof RyanWhiteHIV/AIDS requirements, PHS Act XXVI 36

17 Waiver under Section 1135 of the Social Security Act (SSA). Waiver authority can be used to waive or modify certain Medicare, Medicaid, and CHIP requirements applicable to health care providers. Enumerated requirements can be waived or modified. Conditions of participation, program participation requirements, certification requirements. EMTALA sanctions. Stark self referral sanctions. Certain HIPAA sanctions. Deadlines and timetables for the performance of required activities (can be modified only, not waived). Requirements that healthcare providers hold licenses in the State in which they provide services(for the purposes of Medicare, Medicaid, and CHIP only). Other 37

18 1135Waiver Authority. Both a Presidentialdeclaration under the Stafford Act or the National Emergencies Act and a HHS Secretarial declaration of a public health emergency must be made to trigger section 1135 authority. Applies onlyin the "emergency area" during the "emergency period". Emergencyarea is the geographic area covered by the two triggering declarations. Emergencyperiod is:. End of Presidential declaration;. End of public health emergency declaration;or. 60 days from the date the waiver is published 38

19 1135 Waiver Authority. Waiversof HIPAA sanctions and non-pandemic related waivers of sanctions under EMTALA are generally limited to a 72 hour period beginning upon implementation of a hospital disaster protocol. HIPAA and EMTALA waiversare not effective for actions that discriminate among individuals on the basis of payment source or ability to pay. When a public health emergencyinvolves pandemic infectious disease, waivers of EMT ALA sanctions can extend through the duration of the public health emergency 39

20 PHE/1135 Requests. Unlike StaffordAct declarations that ordinarily require a formal request by a state Governor, there is no statutory requirement that a Governor or other entity make a formal request for a PHE declaration or an 1135 waiver. However, Governors may wish to make a formal request to HHS for a PHE/1135 waiver. When state officials believe that a PHE and 1135 waivers are needed, they usually work with their HHS Regional Emergency Coordinator and regional CMS officials to discuss their request. When the Secretary of HHS issues an 1135 waiver, generally hospitals and other entities need to work with HHS Regional CMS officials who will facilitate CMS' granting of specific waiver requests on a case-by-case basis. 40

21 Strategic National Stockpile. Secretaryof HHS, in coordinationwith the Secretaryof Homeland Security, and consultation with Director, CDC, maintains a stockpile of drugs, vaccines, and other biological products, medical devices, and other supplies in such numbers, types, and amounts determined by the Secretary of HHS to be appropriate and practicable to provide for the emergency health security of the Ucited States, including the emergency health security of children and other vulnerable populations, PHS Act 319F-2. ASPR exercises the responsibilities and authorities of the Secretary with respect to coordination of the Strategic National Stockpile (SNS), PHS Act

22 Stockpile Deployment. As required by Secretary of Homeland Security to respond to an actual or potential elllergency. At the discretion of HHS Secretary to respond to an actual or potential public health etnergency or other situation in which deploytnent is necessary to protect public health and safety. Dotnestic and foreign deploytnents that tneet.. statutory criteria 42

23 Emergency Use of Investigational Drugs (EVA). The Secretarymay authorize use of unapproved new drugs, unlicensed biological products, unapproved/ not cleared medical devices to respond to an emergency involving a chemical, biological, radiological, or nuclear agent. Seriousor Life-Threatening Disease or Condition. Reasonableto believeproduct may be effective,known and potential benefits outweigh potential risks, no adequate, approved, available alternative. Applies to unapproved products and unapproved uses of approved products, FFDCA 564 or 43

24 EVA Process. Determination by DHS Secretaryof an actual or significant potential for domestic emergency involving heightened risk of attack with a specified chemical, biological, radiological, or nuclear (CBRN) agent, or. Determinationby DOD Secretary of an actual or significant potential for military emergency involving a heightened risk to US military forces of attack with a specified CBRN agent; or. Determination by the HHS Secretaryunder section 319 of the PHS Act of a public health emergency that actually or potentially affects national security and involves a specified CRBN agent 44

25 EVA Process. HHS Secretary declares emergency justifying EUA. SpecifiesCBRN agent and product. Different from a PHE under section 319 of the PHS Act. Different from a PREP Act declaration. FDA Commissioner Issues EUA. Disease or conditions for which product may be used to diagnose, prevent, or treat. Secretary's findings regarding known and potential risks and benefits, safety, potential effectiveness and assessment of available scientific evidence. Required conditions, additional conditions. FederalRegisterNotice of Declarations,EUAs 45

26 EVA Duration. Secretary's Declaration tertninates in one year or when circumstances justifying the EVA cease to. exlst. May be renewed. FDA Authorization lasts until Secretary's declaration terminates or authorization is revoked if criteria for authorization are tnet. Maybe renewed no longer 46

27 Public Readiness Preparedness and Emergency (PREP) Act. Authorizes Secretaryto issue a declaration to provide immunity from tort liability (except for willful misconduct) for claims:. Death; physical, mental, emotional injury, illness, disability, condition, fear thereof; medical monitoring, property damage, loss, business interruption. Causally related to development, distribution, administration or use of "covered countermeasures". Against"covered persons", PHS Act 319F-3. Authorizesemergencyfund in u.s. Treasuryfor compensation for injuries from covered countermeasures, PHS Act 319F-4 47

28 Covered Countermeasures. Qualified Pandemic or Epidemic Product. drug, biologicalproduct, device against pandemic or epidemic disease (or against adverse effects of such drugs, biologicalproducts, or devices). Approved, licensed, or under Emergency Use Authorization (EUA), Investigational Drug (IND) or Device (IDE) application. SecurityCountermeasure. Drug, biologicalproduct device against harm from biological, chemical, radiological or nuclear agent (or against adverse effects of such drugs, biological products, or devices). Necessary to protect public health. Approved, cleared, licensed, qualifyfor approval or licensing within eight years of federal procurement, EUA, IND, or IDE. Product Authorized under EVA 48

29 Covered Persons. Manufacturers. Distributors. Program Planners (State, local government, tribe, others who supervise or administer countermeasure programs). QualifiedPersons (licensedhealth professionals and others identified by the Secretary who prescribe, administer, or dispense countermeasures). United States. Officials,Agents,Employeesof allof the above 49

30 Secretary's Declaration. Considers desirability of encouraging design, development, clinical testing, investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administering, licensing, use of countermeasure, and other relevant factors. Determines that disease, health condition, or threat to health constitutes a public health emergency or a credible risk of future health emergency. Recommendsmanufacture,testing,development,distribution, administration or use of countermeasures. Statesliabilityimmunity in effect for recommended activities 50

31 Declaration Contents. Categoryof diseases,health conditions, or health threats for which administration and use of countertneasure is recotntnended;. Effective titne period. Population receivingcountertneasure. Geographic area of administration and use. Any limitations on distribution. Any additional qualifiedpersons 51

32 Limitations. Willfulmisconduct. Countertneasuresused and adtninistered outside conditions of declarations. Claitns not causallyrelated. Claims flled in foreign jurisdictions. Claitns other than tort liability. Countertneasuresobtained through nonvoluntary means (governtnent progratn planners only; current declarations only) 52

33 Current Declarations. Pandemic Influenza Vaccines, 72 Fed. Reg. 4710, Fed. Reg Pandemic Influenza Antivirals, 73 Fed. Reg Anthrax Countermeasures, 73 Fed. Reg Botulinum Toxin Countermeasures, 73 Fed. Reg Acute Radiation Countermeasures, 73 Fed. Reg Smallpox Countermeasures, 73 Fed. Reg Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices, 73 Fed. Reg

34 Contact Information JenniferE. Ray Office of the General Counsel Departtnent of Health and Hutnan Services 202/ , ennifer.ra., - hhs. '-'" ov Susan E. Sherman Office of the General Counsel Departtnent of Health and Hutnan Services 202/ Susan.Shertnan hhs. ov