President
Barack Obama's Declaration of National Emergency over the
H1N1 Swine Flu
October 24,
2009
Source: http://www.flu.gov/professional/federal/h1n1emergency10242009.html
October 24, 2009 - President Obama Signs Emergency
Declaration for H1N1 Flu
Authority
Section 1135 of the Social Security Act [42 USC
§1320b5] 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
Childrens 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 hospitals 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)
Q: Why do this now; why cant 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. 1135 Waivers still require specific requests be
submitted to HHS and processed, and some State laws may
need to be addressed as well. Adding a potential delay
while waiting for a National Emergency Declaration is not
in the best interest of the public, particularly if this
step can be done proactively as the President has done
today.
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 (vice 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). In addition, 1135 waiver
authority has been granted previously as a precautionary
measure, as in the case of the recent 56th Presidential
Inauguration (2009).
Q: Specifically, what will this NEA Declaration enable
and what will this 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. 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: Is the HIPAA Privacy Rule suspended during a
national or public health emergency?
A (from the HHS Office of Civil Rights website): No;
however, the Secretary of HHS may waive certain
provisions of the Rule under the Project Bioshield Act of
2004 (PL 108-276) and section 1135(b)(7) of the Social
Security Act.
What provisions may be waived
If the President declares an emergency or disaster and
the Secretary declares a public health emergency, the
Secretary may waive sanctions and penalties against a
covered hospital that does not comply with certain
provisions of the HIPAA Privacy Rule:
the requirements to obtain a patient's agreement to
speak with family members or friends involved in the
patients care (45 CFR 164.510(b))
the requirement to honor a request to opt out of the
facility directory (45 CFR 164.510(a))
the requirement to distribute a notice of privacy
practices (45 CFR 164.520)
the patient's right to request privacy restrictions
(45 CFR 164.522(a))
the patient's right to request confidential
communications (45 CFR 164.522(b))
When and to what entities does the waiver apply
If the Secretary issues such a waiver, it only
applies:
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 its 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.
Regardless of the activation of an emergency waiver,
the HIPAA Privacy Rule permits disclosures for treatment
purposes and certain disclosures to disaster relief
organizations. For instance, the Privacy Rule allows
covered entities to share patient information with the
American Red Cross so it can notify family members of the
patients location. See 45 CFR 164.510(b)(4).
Learn More: * See http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/katrinanhipaa.pdf
for information on sharing information in emergency
situations.