Department of Health and Human Services Secretarial Declaration of a Public Heath Emergency

Declaration: The Secretary of the Department of Health and Human Services (HHS) may, under section 319 of the Public Health Service (PHS) Act determine that: a) a disease or disorder presents a public health emergency; or b) that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.

Duration and Notification: The declaration lasts for the duration emergency or 90 days, but may be extended by the Secretary.  Congress must be notified of the declaration within 48 hours, and relevant agencies, including the Department of Homeland Security, Department of Justice, and Federal Bureau of Investigation, must be kept informed.

Prior to issuing the declaration, the Secretary should consult with public health officials as necessary.

Following a section 319 declaration, the Secretary can:

• Take appropriate actions in response to the emergency, including: making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder.
  
  
•  Access “no-year” funds appropriated to the Public Health Emergency Fund (when funds are so appropriated).  The Secretary must report to Congress 90 days after the end of the fiscal year about any funds spent from the Public Health Emergency Fund, the emergency for which funds were spent, and activities undertaken with respect to the emergency.  Public Health Emergency Funds supplement, and do not supplant, other Federal, State, and local funds provided for public health grants, awards, contracts, and investigations.
  
  
• Grant extensions or waive sanctions relating to submission of data or reports required under laws administered by the Secretary, when the Secretary determines that, wholly or partially as a result of a public health emergency, individuals or public or private entities are unable to comply with deadlines for such data or reports.  The Secretary must notify Congress and publish a Federal Register notice before or promptly after granting an extension or waiver.
  
  
• Exempt (for 30 days, subject to one 30-day renewal) a person from select agents requirements as necessary to provide for timely participation of the person in a response to a domestic or foreign public health emergency that involves the select agent or toxin.  The Secretary may also exercise this authority in an emergency without formally declaring a public health emergency.
  
  
•  Declare an emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizing emergency use of an investigational product.  In this case, the Secretary must determine under section 319 of the PHS Act that there is a public health emergency that affects or has significant potential to affect national security that involves a specified chemical, biological, radiological, or nuclear (CBRN) agent.  The Secretary’s declaration of an emergency under section 564 of the FFDCA can also be based on a: a) determination by the Secretary of Homeland Security that there is an actual or significant potential for a domestic emergency involving heightened risk of attack with an CBRN agent; or b) determination by the Secretary of the Department of Defense that there is an actual or significant potential for a military emergency involving heightened risk of attack to U.S. military forces with a CBRN.
  
  
• Waive certain Medicare, Medicaid, State Children’s Health Insurance Program (SCHIP) and Health Insurance Portability and Accountability Act (HIPPAA) requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act (SSA) programs and that providers of such services in good faith who are unable to comply with certain statutory requirements are reimbursed and exempted from sanctions for noncompliance other than fraud or abuse.
  
  
  • For purposes of waiver, an emergency area and period is where and when there is: a) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Stafford Act, and b) a public health emergency declared by the Secretary.
    
    
    • The President may declare a major disaster under the Stafford Act when a natural catastrophe (hurricane, tornado, fire, etc.), or, regardless of cause, a fire, flood, or explosion, causes damage of sufficient severity and magnitude that effective response is beyond State and local capabilities and major disaster assistance is warranted.
      
      
    • The President may declare an emergency under the Stafford Act when Federal assistance is needed to supplement State and local efforts and capabilities to save lives, protect property, and public health and safety, or lessen or avert the threat of a catastrophe and the situation is of such severity and magnitude that effective response is beyond State and local capabilities.
      
      
    • The President may declare a national emergency under the National Emergencies Act by transmitting a proclamation to Congress that is published in the Federal Register.  Upon such declaration, authorities or powers made available by statute for use in an emergency are exercised only as specified by the President in his declaration or an Executive Order.  The emergency may be terminated by Presidential proclamation or a joint resolution by Congress.  In regard to international emergency economic powers, the President may declare an emergency to deal with any unusual and extraordinary threat which has its source in whole or substantial part outside the U.S. to the national security, foreign policy, or economy of the U.S.
      
      
  • Notice and Reporting: At least two days before formally exercising the waiver authority, the Secretary must provide a certification and notice to Congress that describes the specific provision to be waived or modified, the health care providers to whom the waiver will apply, the geographic area in which the waiver or modification will apply, the period of time the modification will be in effect, and a statement that the waiver or modification is necessary to achieve the purposes of the SSA.  The Secretary must report to Congress within one year after the end of the emergency period evaluating the approaches used, and making recommendations for improvements.
    
    
  •  Duration: Waivers may be retroactive to the beginning of the emergency period (or any subsequent date).  The waiver or modification terminates either upon termination of the emergency period or 60 days after the waiver or modification is first published (subject to 60-day renewal periods).  However, waiver of EMTALA or HIPAA requirements is effective only for 72 hours beginning on implementation of a hospital disaster protocol; after the 72 hours, HIPAA requirements apply to patients still under the hospital’s care.
    
    
  • The following requirements may be waived:
    
    
    • conditions of participation or other certification requirements, or program participation and similar requirements for individual providers or types of providers;
      
      
    • pre-approval requirements for providers or health care items or services;
      
      
    • requirements that physicians and other health care professionals hold licenses in the State in which they provide services if they have a license from another State (and are not affirmatively barred from practice in that State or any State in the emergency area);
      
      
    • sanctions under the Emergency Medial Treatment and Active Labor Act (EMTALA) for redirection of an individual to another location to receive a medical screening examination pursuant to a state emergency preparedness plan or transfer of an individual who has not been stabilized if the transfer arises out of emergency circumstances.  A waiver of EMTALA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay;
      
      
    • sanctions related to Stark self-referral prohibitions which could apply when a physician refers a patient for services to a provider in which the physician has a financial interest;
      
      
    • deadlines and time tables for performance of required activities to allow  timing of such deadlines to be modified;
      
      
    • limitations on payments to permit Medicare+Choice enrollees to use out-of-network providers in an emergency situation.  To the extent possible, the Secretary must reconcile payments so that enrolles do not pay additional charges and so that the plan pays for services included in the capitation payment;
      
      
    • sanctions and penalties arising from noncompliance with HIPAA privacy regulations relating to: a) obtaining a patient’s agreement to speak with family members or friends or honoring a patient’s request to opt out of the facility directory, b) distributing a notice of privacy practices, or c) the patient’s right to request privacy restrictions or confidential communications.  The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay.
      
      
• Make temporary (up to one year or the duration of the emergency) appointments of personnel to positions that directly respond to the public health emergency when the urgency of filling positions prohibits examining applicants through the competitive process.
  
  
• Waive dual compensation (salary offset) for temporarily re-employed annuitants during a public health emergency declared by the Secretary or national emergency declared by the President (see above) involving a direct threat to life or property or other unusual circumstances.