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October 24, 2009 - President Obama Signs Emergency Declaration for H1N1 Flu
Read the official declaration
On October 24, 2009, President Obama signed a proclamation declaring the 2009 H1N1 influenza pandemic a National Emergency to facilitate our ability to respond to the pandemic by enabling – if warranted – the waiver of certain statutory Federal requirements for medical treatment facilities. In particular, this proclamation is aimed at providing HHS the ability to waive legal requirements that could otherwise limit the ability of our nation’s health care system to respond to the surge of patients with the 2009 H1N1 influenza virus.
AuthoritySection 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain requirements for healthcare facilities in response to emergencies. Two conditions must be met for the Secretary to be able to issue such “1135 waivers”: first, the Secretary must have declared a Public Health Emergency; second, the President must have declared an emergency or major disaster either through a Stafford Act Declaration or National Emergencies Act Declaration. If these conditions are met, then the Secretary may waive or modify Federal requirements as listed in section 1135. After the Secretary invokes section 1135, healthcare facilities may petition for 1135 waivers in response to particular needs, and only within the geographic and temporal limits of the emergency declarations.
Under Section 1135The Secretary will issue waivers or modifications under section 1135 for specific requirements to match the specific situational needs. The requirements that may be waived include certain requirements related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA). These requirements provide important protections for patients during normal day-to-day operations, but they may impede the ability of healthcare facilities to fully implement disaster operations plans that enable appropriate care during emergencies. For example, requirements under the Emergency Medical Treatment and Labor Act (EMTALA) prohibit hospitals from sending an individual to an off-campus location for an appropriate screening.
Past instances where the Secretary invoked the Section 1135 waiver authority for recent disaster events include:Q: Why declare a National Emergency for the 2009 H1N1 pandemic now; why can’t we wait until a hospital or region needs these 1135 Waivers?A: The H1N1 epidemic is moving rapidly. By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly. When the Secretary of HHS invokes section 1135, HHS has in past practice accepted requests from affected healthcare facilities, providers, and/or States for specific waivers or modifications. HHS will be requiring such requests in connection with this emergency and will need to process such requests quickly. Adding a potential delay by requiring HHS to wait for a National Emergency Declaration before it could issue necessary 1135 waivers is not in the best interest of the public, particularly if this step can be done proactively as the President has done.
Q: Do 1135 waivers affect State laws or regulations?A: Under section 1135, only certain Federal requirements relating to Medicare, Medicaid, CHIP, and HIPAA may be waived or modified as listed in section 1135. An 1135 waiver does not affect State laws or regulations.
Q: Has the authority to grant 1135 waivers been granted before?A: Yes, there are several instances where 1135 Waiver authority has been granted under the Stafford Disaster Relief and Emergency Assistance Act (as opposed to the National Emergencies Act) to help healthcare facilities cope with large patient burdens. Recent examples include Hurricane Katrina (2005), Hurricanes Ike and Gustav (2008), and the North Dakota flooding (2009). The Secretary was also prepared and able to invoke the 1135 waiver authority in connection with the 56th Presidential Inauguration (2009) in the event that 1135 waivers became necessary.
Q: Specifically, what will this National Emergency Act (NEA) Declaration enable? What will 1135 waivers allow hospitals to do if a waiver is requested and granted?A: An NEA Declaration fulfills the second of the two conditions required for the Secretary of HHS to be able to grant 1135 waivers. Healthcare facilities that receive specific waivers or modifications under section 1135 will be able to continue to provide care even if they are out of compliance with certain Medicare, Medicaid and CHIP requirements.
Q: How does the President’s National Emergency declaration under the National Emergencies Act differ from a Stafford Act declaration? How does the request process for assistance under the Stafford Act differ from the request process for 1135 waivers?A: Presidential proclamation of a national emergency under the National Emergencies Act and a Presidential declaration of an emergency or major disaster under the Stafford Act are distinct and separate declarations.
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