The National Emergencies Act allows the President to issue a proclamation to invoke particular emergency authorities as needed. The President’s proclamation that the 2009 H1N1 influenza pandemic constitutes a national emergency fulfills the second of the two conditions required for the Secretary of HHS to be able to grant 1135 waivers. The President’s proclamation coupled to the HHS Secretary’s prior public health emergency declaration for 2009 H1N1 influenza enables the HHS Secretary to issue waivers or modifications under section 1135 of the Social Security Act for certain Medicare, Medicaid, CHIP, and HIPAA requirements as discussed above. The President’s proclamation does not trigger a Stafford Act declaration or provide financial or other resources.
In general, when an incident overwhelms or is anticipated to overwhelm State resources, the Governor may request Federal assistance, including assistance under the Stafford Act. The Stafford Act authorizes the President to provide financial and other assistance to State and local governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts following Presidential emergency or major disaster declarations under the Stafford Act. The Stafford Act is triggered by a Presidential declaration of a major disaster or emergency under that Act, when an event causes damages of sufficient severity and magnitude to warrant Federal disaster assistance to supplement the efforts and available resources of States, local governments, and the disaster relief organizations in alleviating the damage, loss, hardship, or suffering.
Most incidents are not of sufficient magnitude to warrant a Presidential declaration. However, if State and local resources are insufficient, a Governor may ask the President to make such a declaration. Ordinarily only a Governor can initiate a request for a Presidential emergency or major disaster declaration. In extraordinary circumstances, the President may unilaterally declare a major disaster or emergency. In order to assist States in assessing impacts and evaluating the need for Federal assistance in a pandemic influenza, FEMA has developed a fact sheet for requesting Stafford Act assistance from the Federal government: http://www.fema.gov/pdf/emergency/pandemic_influenza_fact_sheet.pdf.
As noted above, 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. The President’s proclamation of a national emergency under the National Emergencies Act, coupled to the HHS Secretary’s prior public health emergency declaration for 2009 H1N1 influenza will allow the Secretary of HHS maximum flexibility to issue waivers or modifications under section 1135 of the Social Security Act nationwide as needed. The process for requesting specific waivers or modifications under section 1135 is discussed below. As the 2009 H1N1 pandemic evolves, if State and local resources become insufficient, then states may request assistance under the Stafford Act through the usual Stafford Act process.
Q: Is the HIPAA Privacy Rule suspended during a national or public health emergency?A: No. The HIPAA Privacy Rule is not suspended during a national or public health emergency. However, the Secretary of HHS may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.
Specifically, the Secretary of HHS may waive sanctions and penalties against a covered hospital that does not comply with the following 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 (45 CFR 164.510(b)); (2) the requirement to honor a request to opt out of the facility directory (45 CFR 164.510(a)); (3) the requirement to distribute a notice of privacy practices (45 CFR 164.520); (4) the patient's right to request privacy restrictions (45 CFR 164.522(a)); and (5) the patient's right to request confidential communications (45 CFR 164.522(b)).
Q: When and to what entities does the HIPAA 1135 waiver granted in response to the 2009 H1N1 influenza pandemic apply?A: The HIPAA waiver only applies to hospitals nationwide that have instituted a disaster response plan and for up to 72 hours from the time the hospital implements its disaster response plan. In addition, hospitals may only operate under such a HIPAA waiver during the emergency period beginning on October 23, 2009 through the duration of the HHS Secretary’s public health emergency declaration for 2009 H1N1 influenza.
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. HIPAA waivers are only effective if taken in a manner that does not discriminate among individuals on the basis of their source of payment or their ability to pay.
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