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Information
for service providers concerning the Social Security Act, Section 1135
H1N1/NEA
and 1135 waivers.pdf
H1N1/Authority to waive requirements during national emergencies.pdf
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)
Q:
Why do this now; why can’t 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:
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))
5. 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 patient’s location. See 45 CFR
164.510(b)(4).
Learn More: * See
http://www.hhs.gov/ocr/hipaa/KATRINAnHIPAA.pdf for information on
sharing information in emergency situations.
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