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October 24, 2009 - President Obama Signs Emergency Declaration for H1N1 Flu http://www.flu.gov/professional/federal/h1n1emergency10242009.html

Authority

Section 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain regulatory 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 a National Emergency either through a Stafford Act Declaration or National Emergencies act Declaration. If these conditions are met, then 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 1135:

The Secretary may tailor authorities granted under Section 1135 waivers to match the specific situational needs, but the requirements that may be waived include those related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Active 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 Active Labor Act (EMTALA) would prohibit hospitals from certain rapid triage or sorting activities and prevent the establishment of off-site, alternate care facilities that could off-load emergency department demand.

* Waivers are permitted only to the extent they ensure that sufficient health care items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries in the emergency area during the emergency period. The “emergency area” and the “emergency period” are the geographic area, in which, and the time period, during which, the dual declarations exist. * Permitted actions include the waiver or modification of conditions of participation, other certification requirements, program participation requirements, pre-approval requirements for health care providers; waiver of sanctions for certain directions or relocations and transfers that otherwise would violate the Emergency Medical Treatment and Labor Act (EMTALA); waiver of sanctions related to Stark self-referral prohibitions; modifications to deadlines and timetables for the performance of required activities; and waiver of sanctions and penalties arising from noncompliance with certain Health Insurance Portability and Accountability Act (HIPAA) privacy regulations.

Examples of use of waivers:

* Hospitals request to set up an alternative screening location for patients away from the hospital’s main campus (requiring waiver of the Emergency Medical Treatment and Labor Act-EMTALA) * Hospitals request to facilitate transfer of patients between ERs and inpatient wards between hospitals (requiring waiver of both EMTALA and HIPAA regulations) * Critical Access Hospitals requesting waiver of 42 CFR 485.620, which requires a 25-bed limit and average patient stays less than 96 hours * Skilled Nursing Facilities requesting a waiver of 42 CFR 483.5, which requires CMS approval prior to increasing the number of certified beds in a distinct part

Past instances where authority to grant Section 1135 waivers was enabled for recent disaster events include

* Hurricane Katrina (2005) * 56th Presidential Inauguration (2009) * Hurricanes Ike and Gustav (2008) * North Dakota flooding (2009)

The list is a lot longer, I just coped this part. Either it is much worse or it is really bad the choice was never yours. Think I'll play 1135 on the lotto tomorrow!