The September 11, 2001, terrorist attacks on the United States underscored for the Department of Health and Human Services (HHS) and other federal agencies the inflexibility and rigidity of various HHS statutes and regulations to respond to public health emergencies. Shortly after the 9/11 attacks, former HHS Secretary Tommy Thompson urged Congress to pass legislation permitting temporary waivers of HHS statutory authority in order to address sudden, acute emergencies where the normal statutory rules that govern HHS act as a barrier to rapid response to the victims of the emergencies. Over the course of the next several years, Congress responded by enacting a series of provisions designed to permit HHS to act quickly to respond to the needs of individuals facing a public health emergency. These statutes supplemented existing authority that the Secretary of HHS already possessed to waive the otherwise applicable rules to the operation of the Medicare and Medicaid programs.

The recent outbreak of H1N1 influenza virus, or swine flu, in the United States and across the world has prompted the United States government to respond in several ways, including through the use of some of the post-9/11 statutory enactments. It is possible that the HHS Secretary will invoke additional waivers available to her as a result of this outbreak. This memorandum analyzes the statutory authorities available to the Secretary, the means by which they can be triggered, and historical precedent.

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