President Obama has declared the H1N1 flu epidemic a National Emergency to ensure best possible care for patients affected by the disease.  Citizens can receive care faster with fewer paperwork delays and with more flexibility. 

US officials said that last week swine flu activity was widespread in 46 states with over 1,000 deaths linked to the virus. Although figures are hard to verify, it is thought H1N1 has hospitalized about 20,000 people in the US.

Section 1135 of the Social Security Act  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.   Then, healthcare facilities may petition for 1135 waivers in response to particular needs within the geographic and time limits of the emergency declarations.  This weekend, the president fulfilled this second requirement paving the way for healthcare facilities to better cope in case the number H1N1 patients suddenly increases dramatically.

The requirements that may be waived under Section 1135 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. 

Questions and answers about what this means for you and your family

Q:  Why do this now?

            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.  1135 Waivers still require specific requests be submitted to HHS and, in some cases, to individual states to comply with state laws.  It is in the best interest of the public to reduce administrative delays, particularly if a step can be done proactively as the President has just done.

            If requested, and HHS grants an 1135 waiver, healthcare facilities will be able to utilize alternate care sites, modified patient triage protocols, patient transfer procedures, and other actions that occur when they fully implement disaster operations plans.

Q:  How can waivers be used?

• Hospitals can request to set up an alternative screening location for patients away from the hospital?s main campus
• Hospitals can request to facilitate transfer of patients between ERs and inpatient wards between hospitals
• Critical Access Hospitals can request a waiver of a 25-bed limit and average patient stays of less than 96 hours
• Skilled Nursing Facilities can request a waiver requiring CMS approval prior to increasing the number of certified beds

            Yes, there are several instances where 1135 Waiver authority has been granted healthcare facilities cope with large patient burdens.  Recent examples include Hurricane Katrina (2005), Hurricanes Ike and Gustav (2008), and the North Dakota flooding (2009). 

            No; however, the Secretary of HHS may waive certain provisions of the Rule.

If the President declares an emergency or disaster and the Secretary declares a public health emergency, sanctions and penalties may be waived against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule:

1. the requirements to obtain a patient's agreement to speak with family members or friends involved in the patient?s care
2. the requirement to honor a request to opt out of the facility directory
3. the requirement to distribute a notice of privacy practices 
4. the patient's right to request privacy restrictions 
5. the patient's right to request confidential communications

Q:  When and to what entities does the waiver of the HIPPA Privacy Rule apply?

   1. In the emergency area and for the emergency period identified in the public health emergency declaration.

   2. To hospitals that have instituted a disaster protocol.  The waiver would apply to all patients at such hospitals.

   3. For up to 72 hours from the time the hospital implements a disaster protocol.

  When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.